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Summary The Director, Market Access Strategy is part of a team that collectively defines and delivers solutions to maintain an industry leading approach to market access. This role is responsible to provide market access perspectives to help inform strategic decision-making. The Director will ensure that the organization has a coherent, well supported, forward thinking, Market Access strategy that optimizes our ability to reach appropriate patients as well as the overall potential value of the portfolio to the organization. Location: Remote This role works cross functionally with multiple internal stakeholders, including Strategic Pricing & Contracting, Therapeutic Area Strategy leads, Policy, Product General Managers, Finance, and Strategy & Growth. About the Role Key Responsibilities:<ul><li>Partnering with internal subject matter experts to understand Market Access external stakeholder business models and management, industry trends, how they may evolve in the future, and the implications to our business/portfolio, including and the market access portfolio risks and/or opportunities to optimize coverage and patient access</li><li>Working with the Novartis Policy team to assess the potential implications of new or proposed policy changes on our inline and pipeline products</li><li>Ensuring that leadership across the organization is well-informed of Market Access opportunities and challenges</li><li>Supporting leadership and extended team initiatives to educate the organization on Market Access conditions</li><li>Coordinating rapid, ad hoc assessments of emergent business questions, aligning position, and disseminating throughout the organization</li><li>Developing leadership presentations to support the Chief Market Access Officer</li><li>Managing lunch-and-learn and newsletter programming for the internal US Market Access and the broader organization to ensure a common understanding of the US Market Access position on key market access developments and to showcase noteworthy achievements</li><li>Drafting an annual US Market Access Outlook to inform brand planning across the organization (e.g., perspectives on biosimilar landscape evolution, policy changes that might affect our products, key customer evolution)</li><li>Developing industry-leading frameworks, tools and resources, so therapeutic area teams can efficiently develop Market Access forecasting assumptions, including pricing, payer coverage, and implications of forecasted quality of coverage on physician demand and patient Rx fulfillment</li><li>Overseeing critical market research</li><li>Mastering the NVS Material Approval Process, including FUSE platform, compliance with pharma/FDA marketing policies, and vendor payment systems</li><li>Positioning the Market Access Portfolio Strategy team as a destination for high-potential associates across the organization and creating a work environment where team members are encouraged to collaborate and develop</li><li>Working within ethical a n d compliance polici e s, ensuring a diverse and incl u s ive environment free from all forms of discriminati o n and harassment, adhering with Company policies, state and federal laws and regulations and ensuring t h ose around him/her do the same</li></ul> This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require a travel expectation of 20% - 25% of the time. What you'll bring to the role: Education: Bachelor's degree required; MBA, Health Policy or equivalent preferred Essential Requirements:<ul><li>Minimum of 7 years of pharmaceutical experience in a combination of Management Consulting and Market Access as well as Portfolio Strategy, Insights & Analytics, Managed Care Finance, Communications, and/or Business Development</li><li>Previous experience in management / strategy consulting, with a focus on life sciences market access</li><li>Awareness and understanding of US healthcare dynamics and different stakeholder perspectives on pharmaceutical value</li><li>Strong interpersonal, communication, and influencing skills combined with an ability to successfully collaborate across a matrixed organization</li><li>Ability to analyze complex business issues and trends and to synthesize information into clear and compelling insights and recommendations delivered in a persuasive way to the organization</li><li>Demonstrated high degree of emotional intelligence, adaptability, and creativity in solution-oriented ideation</li><li>Demonstrated prioritization, organizational, and project management skills</li><li>Proven results-oriented approach (e.g., fails fast to learn faster) and embodiment of an agile, growth mindset</li></ul>Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $212,000.00 and $318,000.00/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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Director, Market Access Strategy - Remote (1 of 2 roles)

About the Role Location: The location for this position will be based out of East Hanover, NJ and will follow a hybrid working model. The Executive Director, Corporate Marketing Strategy & Execution leads a team accountable for managing all corporate marketing operations including development, planning, and execution of various corporate marketing programs and advertising initiatives that enhance brand positioning and drive awareness and understanding of the Novartis Corporate Brand in support of the organizations growth goals and reputation. The ED of Corporate Marketing interprets business objectives and develops successful marketing campaigns from idea to execution. They also ensure that the organization's message is clearly defined and distributed across appropriate channels and targeted audiences, to drive Novartis corporate brand awareness and value. Major accountabilities: &bull; Conduct market research and analysis to identify market opportunities with key stakeholder groups within the competitor landscape. &bull; Liaison with various areas of the organization to ensure that the objectives and efforts are aligned with the organization's goals. Ensure synergy between corporate, brand and industry campaigns and events to maximize impact and ROI &bull; Develop and execute multi-channel corporate marketing strategies aligned with Novartis Brand and Corporate Affairs strategic priorities. Ensure that marketing activities align to the Novartis corporate brand positioning, messaging and guidelines. &bull; Develop, test, and scale compelling ad campaigns and creative themes that resonate with target audiences and create a measurable change in belief and bias to action &bull; Develop and manage the corporate marketing budget, ensuring resources are allocated against our highest priorities. &bull; Drive social and digital marketing strategy and execution, leveraging technology, data analytics, and benchmarking to optimize campaign performance &bull; Stay abreast of emerging digital marketing trends and technologies to maintain a competitive edge &bull; Establish a holistic partnership, sponsorship and event strategy that is integrated with our corporate marketing efforts &bull; Develop strategy and visual identity for corporate website, working with corporate affairs teams to develop content for key stakeholders &bull; Support corporate reporting teams to deliver compelling visuals and format for ESG and annual report &bull; Collaborate with creative services team and studio team for execution &bull; Create a reliable network of strategic partnerships with external agencies and other marketing professionals The pay range for this position at commencement of employment is expected to be between $201,600 and $302,400 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements What you will bring to the role: &bull; Bachelors degree in Marketing or related field. Advanced degree preferred. &bull; Proven experience in senior marketing leadership roles, preferably in a corporate setting. &bull; Demonstrated knowledge in audience targeting for digital and social channels, as well as depth of experience in media buys &bull; Deep understanding of marketing principles, strategies and best practices &bull; Strong strategic thinking and analytical skills, with the ability to translate data into actionable insights &bull; Excellent leadership and team management abilities, with a track record of building and developing high-performing teams &bull; Demonstrated experience in developing and executing successful marketing campaign across multiple channels &bull; Strong communication and interpersonal skills, with the ability to influence and collaborate effectively with stakeholders at all levels Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Imagine what you could do here at Novartis! Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network #LI-HYBRID Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Executive Director, Corporate Marketing Strategy & Execution

About the Role Love data management? Bring that passion to Novartis! Multiple openings. This key Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s). Key Responsibilities: &bull; Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits. &bull; Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans &bull; Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director &bull; Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards &bull; Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs. &bull; Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database Diversity & Inclusion / EEO We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:<ul> <li>Novartis: e-mail [email protected] or call +1 (877)395-2339</li><li>Sandoz: e-mail [email protected] or call: +1-609-422-4098</li></ul> Role Requirements Essential Requirements: &bull; Bachelor's degree in life science, computer science, pharmacy, nursing or closely related discipline. &bull; 4 years' experience in Drug Development with at least 5+ years' in Clinical Data Management &bull; Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines &bull; Excellent understanding of clinical trials methodology, GCP and medical terminology &bull; Proven ability to interrogate and view data through various programming/GUI techniques. &bull; Must be able to anticipate challenges and risks and proactively suggest/implement solutions &bull; Ability to work under pressure demonstrating agility through effective and innovative team leadership &bull; Excellent interpersonal skills and proven ability to operate effectively in a global environment. &bull; Ability to influence and communicate across functions and to external stakeholders &bull; Understanding of project management concepts in order to aid delivery across a program &bull; Excellent oral and written skills Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network The pay range for this position at commencement of employment is expected to be: between $124,000 - $186,000; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Prin Clin Sci (Data Mgr)

About the Role Location: East Hanover, NJ #LI-Hybrid Hiring for multiple roles. About the role: Love data management? Bring that passion to Novartis! This key Senior Principal Clinical Data Scientist will be responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality, and timelines for all assigned indications within one or more Global Clinical Program(s)/Project(s). Key Responsibilities: &bull; Provides DM leadership across assigned trial(s) and Program(s) ensuring strong DM representation across the CTT. Acts as an ambassador for CDAM across the organization, showcasing business value and benefits. &bull; Demonstrates a business understanding of the compound profile and data strategy to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i.e. ensuring consistency across data quality plans &bull; Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director &bull; Competent in relevant CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards &bull; Maintains awareness of the status of start-up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by Sr GHs/GHs. &bull; Provides accelerated feedback to assure well written, stable protocols and amendments. Recognize and resolve protocol issues that may impact database Diversity & Inclusion / EEO The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Role Requirements Essential Requirements: &bull; Bachelor's degree in life science, computer science, pharmacy, nursing or closely related discipline. &bull; 7 years' experience in Drug Development with at least 5+ years' in Clinical Data Management &bull; Demonstrated strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines &bull; Excellent understanding of clinical trials methodology, GCP and medical terminology &bull; Proven ability to interrogate and view data through various programming/GUI techniques. &bull; Must be able to anticipate challenges and risks and proactively suggest/implement solutions &bull; Ability to work under pressure demonstrating agility through effective and innovative team leadership &bull; Excellent interpersonal skills and proven ability to operate effectively in a global environment. &bull; Ability to influence and communicate across functions and to external stakeholders &bull; Understanding of project management concepts in order to aid delivery across a program &bull; Excellent oral and written skills Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network The pay range for this position at commencement of employment is expected to be: between $124,000 - $186,000; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Accessibility and reasonable accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Sr Prin Clinical Data Scientist (Prog Data Mgr)

Site Name: Cambridge Binney Street Posted Date: Apr 29 2024 Within the Analytical R&D group, the Analytical Industrialization Leader (AIL) is in charge of defining and leading the implementation of best-in-class, phase appropriate and breakthrough analytical lifecycle approaches and novel strategies allowing implementation in commercial QC, in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with guidance This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:<ul><li>Define and lead the implementation of best-in-class, phase appropriate and breakthrough analytical lifecycle approaches i.e. novel strategies allowing faster analytical validation (e.g. validation during development, at & on-line testing, ...), enhanced management of assay performances, management of reference standards and reagents and novel strategies allowing implementation (transfer) in commercial QC.</li><li>Support the analytical platforms from ARD for the deployment and actual application of these strategies to novel products in the R&D pipeline.</li><li>Participate actively to interactions with Health Authorities during file submissions, consultations and inspections.</li><li>Coach Analytical R&D development scientists and Analytical Product Leaders while creating a network of SMEs.</li><li>Engage with internal stakeholders (Quality, Regulatory, Commercial QC, TDLs, APLs and peer TRD function Heads) to ensure alignment of long-term goals, effective collaborations and successful project outcomes.</li><li>Accountable for compliance, harmonization and improvement of ARD SOP(s) related of analytical method qualification and validation, method transfer, analytical method comparability, reference material and reagents and analytical method lifecylcle (SST, invalid rules,...); and with QC</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Master's degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field.</li><li>10+ years of experience in the pharmaceutical industry in the analytics for biologics (analytical development, product characterization or Quality Control of recombinant proteins, monoclonal antibodies, fusion proteins, conjugates and/or vaccines drug candidates.</li><li>Experience in pharmaceutical laboratory techniques to interact efficiently with analytical and pharmaceutical processes and regulatory and GMP requirements.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus.<ul><li> Ph.D. or equivalent in biological, analytical, or pharmaceutical sciences, or similar field. </li><li>Reliable individual, with strong managerial skills; ability to influence at all levels of the organization and externally.</li><li>Ability to communicate across all organizational levels.</li><li>Customer focused; ability to understand requirements of QC stakeholders</li><li>Strong presentation skills.</li><li>Good understanding of vaccines or similar biologics controls and manufacturing (primary and secondary operations) as well as raw material manufacturing technologies.</li><li>Good knowledge of quality and risk management principles and tools.</li><li>Flexible, proactive thinking. Passion for improvements.</li><li>Ability to adapt, work under uncertainty and accommodate flexible work demands.</li><li>Global perspective; cultural sensitivity</li><li>Recognized as expert within GSK (GMS and Vaccines) for analytical methods lifecycle.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Director, Analytical Industrialization Leader

Site Name: USA - New Hampshire - Concord , USA - Maine - Portland Posted Date: May 28 2024 For more than 140 years, GSK has pioneered novel research methods and technologies to help protect people from infectious diseases. Our vaccines portfolio of more than 20 marketed vaccines is the broadest in the industry, helping to protect people throughout their lives. We believe prevention, at scale and for impact, is the best health investment for society, patients, and the economy. Vaccine-preventable diseases are a significant burden on society and healthcare systems; approximately $1 trillion in productivity is lost each year due to preventable conditions. This includes the impact from the 330,000 older adults hospitalized globally each year with RSV, the approximately 1 in 3 people who will develop shingles in their lifetime and the 3-11% of people infected with seasonal influenza each year. Our Vaccines portfolio will reach over 1 billion people globally this decade. Each year, around 40% of children globally receive a GSK vaccine and GSK is well-placed to lead in the growing adult immunization market. GSK's US vaccines business is organized into local ecosystem teams, designed to support the unique needs of the customer base in the given geography. In a local ecosystem commercial model, there are multiple customer-facing roles, each with unique customers/call points, but all dependent upon a high degree of collaboration. The Immunization Specialist, or IS , is pivotal in most ecosystems, responsible for engaging health care providers (HCPs) to drive uptake of GSK vaccines. The role of the Immunization Specialist is to educate HCPs on both disease state and the approved GSK vaccine solutions. The IS must possess strong customer engagement skills, knowledge of GSK vaccines and competitor vaccines, to be able to present a GSK vaccines product and portfolio value proposition. The IS must also collaborate closely within the ecosystem team, including the vaccine ecosystem lead (VEL), vaccine key account lead (VKAL), the vaccine account executive (VAE), and the retail account executive (RAE) roles. Details This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Develop and maintain specialized expertise in vaccine therapeutic areas, products, and markets.</li><li>Demonstrate knowledge of GSK vaccines, competitive products, and GSK promotional strategies and objectives in a way that meets customer needs.</li><li>Demonstrate high-level selling skills, including account-based selling, strategic thinking, drive for results, and the ability to ask for the business.</li><li>Demonstrate the ability to provide value to each targeted account through proper blending of science & service based upon each account's individual needs.</li><li>Demonstrate the ability to effectively follow and use the vaccines sales process in a way that engages customers and ultimately leads to vaccine purchases and/or referrals.</li><li>Collaborate with ecosystem team, including VKAL's, VAE's, and RAE's, to help pull through GSK vaccine business.</li></ul>Why You? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's Degree</li><li>2+ years business-to-business or pharmaceutical sales experience.</li><li>Strong track record of high-level performance and consistent achievements.</li><li>Ability to travel domestically as necessary.</li><li>Valid driver's license.</li><li>Must be able and willing to drive or operate a vehicle - driving is an essential function of this role.</li></ul> Preferred Qualifications If you have the following characteristics, it would be a plus: <ul><li>Minimum 2 years vaccines sales experience.</li><li>Nursing (MSN, RN, LPN) or other healthcare qualification and experience.</li><li>Demonstrated competency of science, business acumen, and customer engagement.</li><li>Demonstrated learning agility.</li><li>Strong account selling skills, including business to business experience in a healthcare related market.</li></ul>Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:<ul><li>Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigors, and risk.</li><li>Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.</li><li>Continuously looking for opportunities to learn, build skills and share learning.</li><li>Sustaining energy and well-being</li><li>Building strong relationships and collaboration, honest and open conversations.</li><li>Budgeting and cost-consciousness</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Vaccines Pediatric Immunization Specialist;  Portsmouth, NH - Portland, ME

Site Name: USA - California - San Diego, USA - California - Palm Springs Posted Date: May 28 2024 Company Overview ViiV Healthcare is a global specialty HIV company, the only one that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV. ViiV Healthcare is highly mission-driven in our unrelenting commitment to being a trusted partner for all people living with and affected by HIV. Our aim is to think, act, and connect differently through a focus on education on for the prevention and treatment for HIV. We go to extraordinary lengths to deliver the sorts of breakthroughs, both in prevention, treatments, care solutions and communities, that really count. We go beyond the boundaries of medicine by taking a holistic approach to HIV through developing and supporting sustainable community programs and improving access to care. We are fully committed to push through every challenge until HIV/AIDS is eradicated. ViiV Healthcare has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition. We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV epidemic. We are aware of how much is at stake for those at-risk or affected by HIV and we show up every day 100% committed to the patients. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. But ViiV Healthcare isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are hungry to make a difference. While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. Job Details Are you energized by a highly visible role within the managed markets environment, that allows you to help fulfill our mission to leave no person living with HIV behind? If so, this Field Reimbursement Manager role could be an ideal opportunity to consider. The Field Reimbursement Manager will provide external and internal reimbursement and access support for ViiV Healthcare (VHC) products within a specified geographic region. This position is a customer-facing, field-based role responsible for supporting appropriate patient access to ViiV Healthcare products, including coverage coding and payment assistance. The FRM will: <ul><li> Educate providers about important product reimbursement information and processes across settings of care. </li><li> Review key payer policies, coverage and authorization criteria with prescribing providers and their staff. </li><li> Communicate ViiV Access Support Services that may be available to help appropriate patients access ViiV Healthcare medicines. </li><li> Review acquisition options (specialty pharmacy and buy-and-bill) and potential implications to the facility/practice and patient. </li><li> Compliantly discuss applicable coding necessary for claim submission (HCPCS, CPT, ICD-10, billable units). </li><li> Act as the primary access and reimbursement resource for internal field counterparts. </li><li> Work with colleagues across the business to assess the access landscape, changing insurance dynamics and patient journey. </li><li> Lead regional matrix partner calls to review regional activity, access barriers and opportunities. </li><li> Serve as an integral member of the ViiV field team with a primary focus on ensuring each appropriate patient leverage healthcare coverage and ViiV support programs to maximize access to ViiV Healthcare medicines. </li><li> Engage Medicare Administrative Contractors to ensure appropriate coverage of VHC products. </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> Bachelor's Degree </li><li> Ability to travel up to 75% including overnights </li><li> Must be located within 50 miles of a major airport in or near the territory </li><li> Valid driver's license. </li><li> Minimum of 5 years' experience in pharmaceutical and/or health care industry (must include experience in a specialty division) with at least 3 years in field reimbursement, payer marketing, patient support programs and/or reimbursement HUB programs. </li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus <ul><li> MBA, MPH or other advanced degree </li><li> Strong knowledge of the payer environment including state, federal, private third-party reimbursement issues, methodologies and policies for physician-administered drugs </li><li> Strong customer focus with building relationships, issue identification and resolution, problem-solving and project management skills </li><li> Ability to operate independently and handle multiple projects with a high degree of initiative and operate successfully in matrix environment reporting into reimbursement function while deployed in the field </li><li> Highly organized, strategic thinker with excellent verbal, written and presentation communication skills </li><li> Reimbursement experience for specialty injected/infused products in a buy and bill setting across all sites of care </li><li> Strong knowledge of provider office and hospital outpatient department reimbursement environments, regulations, customers, and market dynamics. </li><li> Strong knowledge of Specialty Pharmacy providers and relevant access dynamics </li><li> Comprehensive understanding of Medicare Parts A, B, C, D and knowledge of commercial insurance reimbursement. </li><li> Understanding of the miscellaneous and permanent J code, Q code and possible issues surrounding appropriate billing. </li><li> Experience working with reimburse ment call centers in support of patient access </li></ul> #LI-GSK #LI-ViiV The annual base salary for new hires in this position ranges from $151,300 to $204,700 taking into account a number of factors including work location, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program ViiV offers US employees. All ViiV employees receive the same benefits options and plans as GSK employee. Why Us? At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK. Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind. If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.

Field Reimbursement Manager - San Diego/Palm Springs, CA

Site Name: USA - Pennsylvania - King of Prussia Posted Date: May 28 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. As part of the R&D Records Management and Archiving (RMA) team, this position will:<ul><li>Ensure that the R&D Archives are inspection ready at all times to ensure that country regulatory agency inspections, e.g., FDA, MHRA, etc., proceed smoothly and without incident</li><li>Ensure that all regulatory agency requests of the business to produce archived materials are met within current SLAs.</li><li>Ensure physical and electronic archives are managed and operated in compliance with GSK policies, SOPs, standards and external regulations, partnering with R&D, IT and infrastructure groups</li><li>Ensure that R&D physical and electronic proprietary information records are protected and preserved in accordance with specific government regulatory requirements and company policies, for up to 65 years, e.g., GxP regulations, GSK Global Records Retention </li><li>Ensure delivery of the archive service (including processing and retrieval of records) to R&D and Legal, meeting legal, regulatory and business requirements </li></ul> Key Responsibilities: <ul><li>Provide direction to outsourced operations staff and other third party suppliers regarding scheduling and prioritization of work assignments</li><li> Represent GSK R&D as the named GLP or GCP Archivist during internal audits and external inspections, including resolving findings </li><li>Partner with the R&D business and business IT groups who support them to enhance the management and archiving of proprietary information to maintain long term protection and minimise risk to GSK</li><li>Facilitate new and improved electronic archiving processes and promote good records management practice</li><li>Develop and maintain a thorough knowledge of R&D business processes and objectives through effective working relationships with relevant R&D business groups</li><li>Contribute to the overall strategy and objectives of the RMA organisation, and the development of proprietary information management policies, standards and best practices</li></ul> Basic Qualifications: <ul><li>Bachelor's degree in related field</li><li>Three or more years of experience in records management or archiving</li></ul> Preferred Qualifications: <ul><li>Awareness of new developments in archiving and relevant regulations </li><li>Familiarity with AI/ML technologies used in drug discovery and development</li><li>Extensive experience and application of in depth knowledge of electronic proprietary records, archiving or information management</li><li>Experience in the pharmaceutical industry, particularly a good working knowledge of relevant regulations (e.g. GxP, ICH) as they apply to archiving </li><li>Understanding of R&D business processes and requirements, especially relating to Discovery, PreClinical and Clinical records generation and management and feeds them into RMA service, product or process strategy </li><li>Good knowledge of the GSK organizational structure, general awareness of GSK's major disease franchises and a good understanding of the GSK R&D process and of information generation within GSK</li><li>Well-developed analytical and problem solving skills</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Archivist

Site Name: USA - Pennsylvania - King of Prussia Posted Date: May 28 2024 We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. As a Process Mechanic, you would be responsible to p erform preventative and corrective maintenance, troubleshooting, and repair of biopharmaceutical process equipment. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:<ul><li> Troubleshoots and safely repair process systems on a routine and emergency basis to assure continuous production operations. </li><li> Maintain and repair sanitary valves and actuators, agitation systems, rotary lobe pumps, centrifugal pumps, cartridge mechanical seals, centrifuges, chromatography columns, autoclaves, equipment washers, and other sanitary/sterile equipment and systems. </li><li> Must be familiar with PLC's and distributed control systems and their operation and interaction with the process equipment and systems. </li><li> Uses schematics to diagnose electrical control and motor circuits. </li><li> Safely perform preventative and corrective maintenance tasks on process equipment and systems. Make recommendations for maintenance tasks and frequencies and procedural/operational changes to enhance equipment life and maintainability. Identify spare parts and consumables necessary to perform these tasks. </li><li> Perform metal fabrication tasks as necessary. </li><li> Inspect, replace, align, adjust, and lubricate mechanical system components including bearings, gear boxes, belt drives, shaft couplings, mechanical seals, and related devices </li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>High school diploma</li><li>2+ years of prior experience in engineering or maintaining industrial process or utility equipment</li></ul>Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Any type of technical certification, such as welding, mechatronics, machinery.</li><li>Familiar with cGMP's, regulatory guidelines, governmental codes, and standard operating procedure.</li><li>Strong communications skills, both verbal and written.</li><li>Skills and knowledge to serve as a resource to less experienced employees</li><li>The ability to work rotating shift work. Work safely, independently, and without direct supervision.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Process Mechanic

Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 28 2024 GSK site location: Upper Providence. Minimum 2 days per week on-site is required. Do you have a background in formulation and drug product development and have experience and a background in data management? We are keen to hear from people who are excited by the possibilities of using data to enable great science. We are looking for people who can: <ul><li>Understand our processes, collaborate with various groups within GSK and enable and support our data driven approach to science</li><li>Work with drug development experts to collect user requirements for ELN templates/dashboards </li><li>Contribute to streamlining and automating data and information flows during experimental studies including information transfer during study setup, data extraction from instrumentation and transferring data to our storage systems</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's degree required.</li><li>Experience with pharmaceutical drug or analytical method development</li><li>Experience with creating templates for capturing information with an ELN/LIMS system</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Experience with data management in pharmaceutical drug product development</li><li>Experience with data visualization and creating dashboards</li><li>Experience in one or more of the following languages/tools: Python, JavaScript, R, RShiny, SQL, Spotfire, Tableau</li></ul> #LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Data Scientist

Site Name: USA - Maryland - Rockville Posted Date: May 16 2024 GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD. OQ Manager will be responsible for Operational Quality's day to day activities at LSM/SSM site including batch record review and day to day Quality Operations. The OQ Manager will manage a team of Quality professionals accountable for batch record reviews confirmation of GMP operations in production and support groups i.e. laboratory and engineering. The job holder will be the main liaison with production management team and will participate in daily planning meetings, approve deviations to processes, to support LSM/SSM activities Key Responsibilities:<ul><li>Manage team of Operational Quality professionals (24/7) to support production activities and shop floor presence</li><li>Ensure Operational Quality schedules and activities support batch record review and batch disposition needs Review and approve deviation reports, corrective actions, to support GMP decisions and material disposition.</li><li>Review and approve SOPs, batch records, forms and all other GMP documentation to support day to day operations </li><li>With the Operational Quality Associate Director, the OQ Manager will serve as QA representative at product team meetings (PTM, CMC, POMM), participate in facility design teams and specific drug product development teams</li><li>Support Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employees</li><li>Ensure that Quality risks in productions areas are understood and appropriately mitigate to support production schedules </li><li>Actively support performance initiatives to support performance improvements in the BDS release area to achieve site service goals.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BS Degree</li><li>5+ years in a GMP pharmaceutical environment</li><li>2+ years of Quality Assurance, or Operational Quality experience</li><li>Supervisory or management experience.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Biopharm experience preferred</li><li>2+ years supervisory experience strongly preferred</li><li>Experience managing deviations and changes to processes as author, reviewer, or approver</li><li>Knowledge in Performance Improvements tools i.e. Six Sigma or equivalent</li><li>Ability to interpret and apply GMP, ICH and other regulatory guidelines. Critically evaluate individual processes and projects, then synthesize their insights to arrive at a summary of overall organizational status</li><li>Excellent organization skills - spearhead both the planning and implementation stages of multiple projects</li><li>Effective oral and written communication skills - able to speak, actively listen, and write/present well to different levels of the organization</li><li>Sound leadership skills and the ability to work effectively in a cross-functional team environment; Ability to manage appropriate resources (personnel, projects, budget, etc...) toward accomplishment of department and corporate goals.</li><li>Ability to handle multiple projects and interface with individuals from various departments at various levels.</li><li>Ability to work in a fast-paced environment in a results-oriented fashion. </li><li>Technical expertise - a firm understanding and application of process improvements, Biopharm technical elements and Quality Compliance requirements for the role.</li><li>Organization skills</li><li>Leadership skills - coach and company game-changer, inspiring other team members to give their best effort and setting the direction for improvement initiatives</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Operational QA Manager

Site Name: USA - North Carolina - Zebulon Posted Date: May 28 2024 As the GPS Lead (Director of Operational Excellence/Project Management/Strategy) , you will have the opportunity to provide leadership to the Project Management Office (PMO), Operational Excellence and Strategy teams to: ensure delivery of strategic programs, partner with the business to deliver continuous improvement (CI), create desired CI culture and build capability. The Director of Lean Operations/Project Management/Strategy will have 5-7 direct reports, including Lean Practitioners/Project Managers. As a key member of the Site Leadership team, the GPS Lead (Director of Operational Excellence/Project Management/Strategy) is accountable for: <ul><li>Liaising across SLT to ensure strategy is well defined and deployed across the teams in an efficient and reliable manner</li><li>Leading initiatives across the organization either in support of our strategy or to help improve the way we work</li><li>Ensuring site critical projects and programs, which encompasses complex business, technical, and business change projects, have clear scope, governance, prioritization, resource management, risk management, business change management and financial controls in place to provide a smooth transition from project to fully supported customer hand-over</li><li>Being an active leader for the organization using shadow of the leader to positively demonstrate coaching, leading and developing the teams</li><li>Ensuring active development of both the organization and team members</li><li>Coaching and mentoring site in general project management skills and tools</li><li>Coaching and training GSK Production System (GPS/OE) tools and principles to develop the skills and capability of all the Site personnel</li><li>Leading site GPS maturity improvement plan</li><li>Interface and partner with the GSK central teams and other sites to contribute, share and leverage best practice Program Management and GPS as appropriate</li><li>Accountable to ensure robust and consistent PMO processes exist in order to deliver clear scope, governance, prioritization, resource management, risk management and financial controls are in place to provide a smooth transition from project to fully supported customer hand-over</li></ul> This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Work with Site Director and Site Leadership team to identify, agree and deploy GPS priorities, Strategy Deployment 3 year plan and targets for following year and critical projects across site, including those to be led by GPS and PMO team</li><li>Accountable for day to day consistency of deployment of GPS as well as all key improvement activities across site and supporting value streams</li><li>Track progress of the site GPS deployment roadmap and self-assessment of site maturity level</li><li>Support development of deployment across site and ongoing coaching against the training and capability building plan as agreed by the GPS network</li><li>Drive CI learnings across site through shared learnings, process confirmations to ensure consistency and identify opportunities for improvement or teach points</li><li>Prepare and lead appropriate governance councils and continuous improvement of governance</li><li>Benchmark site performance against other sites / companies</li><li>Direct the management and implementation of multiple large and complex projects, develop program plans and timelines, make staffing decisions based on assessment of team members' skills and workloads as well as identify obstacles</li><li>Ensure PMO team delivers:</li><li>Design and execution of project plans and budgets: (1) On time and on budget delivery of projects, including business change management plan (2) Compliance with regulatory requirements, GSK policies and standards (3) Robust risk management; including Business Continuity Plans: Establishing strong relationships across project teams, functions and stakeholders for delivery and execution of projects (4) Prepare contingency and recovery plans if delays or overruns are anticipated, engaging stakeholders through effective governance processes</li><li>Accountable for defining strategy for DDA at site including building a team, setting vision, establishing priorities, and executing at pace</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Bachelor of Science Degree (BSc)</li><li>10 plus years of manufacturing experience, including 5 plus of managing a team covering a broad range of activities and operations (Production and/or Engineering, and Quality Assurance / Logistics)</li><li>Experience with hands on training and coaching</li><li>Led improvement initiatives and/or culture change year on year resulting in both financial and non-financial benefit</li><li>Experience in pharmaceutical processing, validation and cGMPs</li><li>Technical experience building integrated program plans</li><li>Strategic Planning and Strategy deployment execution experience</li><li>Lean/Six Sigma Experience including green belt certification</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus:<ul><li>Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers</li><li>Master Black Belt OR Black Belt Certification</li><li>Networking and influence at Site Management Team level</li><li>Diagnosis of complex performance issues and problem solving in the context of site goals</li><li>People change management concepts and practice</li><li>Project planning and execution management Strategy planning and execution</li><li>Knowledge of program and system life cycles</li><li>Ability to plan effectively in order to deliver sustainable business change programs</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

GPS Lead (Director of Operational Excellence/Project Management/Strategy)

Site Name: USA - Pennsylvania - Philadelphia, Mississauga, UK - London - Brentford Posted Date: May 28 2024 Associate Director - Epidemiology The Associate Director in Epidemiology will support the development of asset or disease specific epidemiology strategy and providing scientific leadership in the application of epidemiological expertise and methods to inform internal and external decision-making across all phases of medicine development to increase efficiency and effectiveness of delivering medicines to patients. This position functions within the Epidemiology Department, which contributes to the successful development of new medicines. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the entire spectrum of drug development, from early discovery to registration and lifecycle management. We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will<ul><li>Maintain and expand an epidemiology support strategy aligned with the medicine development strategy, utilizing your expertise in epidemiology and the disease area.</li><li>Improve disease understanding relevant to medicine development, including but not limited to: incidence, prevalence, risk factors, natural history course, treatment patterns, co-morbidities, co-medications/vaccinations, outcome measures, serotypes, biomarkers, unmet needs, and their variations across demographics and geographies.</li><li>Support and be accountable for advising scientifically on Real World Evidence strategies.</li><li>Contribute to medication safety evaluation by providing background event rates, synthesizing existing evidence including through meta-analyses, and identifying high-risk populations.</li><li>Propose and lead post-marketing activities, including risk evaluation mitigation strategies, epidemiology studies for signal detection and inference, and post-authorization studies supporting benefit/risk evaluation.</li><li>Critically appraise existing epidemiology evidence and generate new evidence through delivery of specific research plans/protocols and analysis of healthcare databases available within GSK.</li><li>Develop strong partnerships with internal stakeholders in a multi-disciplinary framework (clinical, safety, regulatory, health outcomes, asset leadership) to meet product needs.</li><li>Plan resource allocation to accomplish multiple research projects and attain project and study timelines.</li><li>Identify innovative, timely, and cost-effective methods to conduct epidemiologic studies.</li><li>Propose and negotiate the content of epidemiologic strategy and budget with matrix leaders.</li><li>Communicate study findings effectively to relevant internal and external audiences.</li><li>Provide input into regulatory submission documents and represent the function to regulatory agencies as required.</li><li>Participate in departmental initiatives aimed at driving innovative solutions through evaluation and creation of tools, methodologies, or processes.</li><li>May contribute to advancing the science through membership or leadership of external initiatives (e.g., ICPE, IMI).</li></ul> Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals:<ul><li>Doctoral degree (PhD., ScD or DrPH) in epidemiology (preferred) or a relevant discipline (i.e., health services research, health outcomes research, public health, statistics, or pharmaceutical sciences)</li><li>At least one year experience conducting pharmacoepidemiologic research in the pharmaceutical industry or equivalent experience in an academic or government setting. </li></ul> Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:<ul><li>Expertise in infectious disease epidemiology</li><li>Self-motivated with the ability to work independently to develop credibility with colleagues within and outside Epidemiology, as well as interact effectively in multi-disciplinary matrix teams to influence decisions.</li><li>Excellent oral and written communication skills and demonstrated ability to communicate scientific evidence to peers and at scientific meetings.</li><li>Broad experience in collaborating with research partners</li><li>Problem-solver; ability to see solutions to complex, unique situations where the epidemiological principles need to be applied.</li><li>Ability to work well within a global and matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.</li><li>Ability to relay complex, technical information from real world studies to cross-functional teams, stakeholders, and non-technical audiences</li><li>Excellent understanding of the pharmaceutical environment across multiple countries/regions</li><li>Experience in leading epidemiology research in US, EU, and Asia-Pacific</li><li>Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk.</li><li>Managing individual and team performance.</li></ul>The annual base salary for new hires in this position ranges from $127,840 to $172,960 taking into account a number of factors including work location, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Associate Director, Epidemiology (Infectious Disease)

Site Name: Durham Blackwell Street Posted Date: Mar 1 2024 Are you an experienced Computer Compliance Quality Assurance Professional looking for a challenging opportunity to leverage your expertise to assist GSK Senior Management in the identification, prioritization and monitoring of quality, compliance and technical risks? If so, this role within our Quality Audit and Compliance organization could be a great position for you to explore. We currently have an opportunity for a Computer Compliance Quality Audit Manager to join our team here at GSK. The Computer Compliance Quality Audit Manager is responsible The Computer Compliance Quality Audit Manager is responsible for evaluating the level of compliance with the GSK Quality Management System for the manufacture and supply of products and local regulations for the markets supplied for the following auditee types:<ul><li>GSK Pharma and Vaccine manufacturing sites</li><li>IT Software Application Suppliers</li><li>Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS) providers supporting GxP activities for GSK Global Supply Chain</li><li>3rd Party Service Suppliers providing services associated with Application Development & Maintenance services and Business Process Outsourcing associated high risk GxP systems utilized by Global Supply Chain</li><li>Software as a Medical Device (SaMD) audits. </li></ul>Your excellent communication and influencing skills will be a key deliverable for success in the role. Travel: Approximately 40 to 50% travel is required. In this role you will...<ul><li>Prepare, conduct, and manage GMP compliance audits of scheduled auditees utilizing a risk-based approach to determine audit scope and depth.</li><li>Liaise with Site Quality Directors, External Supply Operational Quality, Global Computer System Validation, and other stakeholders to agree GMP audit dates.</li><li>Ensure effective audit preparation, audit conduct and reporting.</li><li>Identify and document site gaps to GSK Quality Management System and applicable cGMP requirements.</li><li>Preparation of clear concise audit reports that ensure senior management is apprised of the identified risks and that appropriate corrective action plans are implemented.</li><li>Expand knowledge base through proactive knowledge sharing and collaboration.</li><li>Drive continuous improvement of audit systems and processes.</li></ul>In addition:<ul><li>Manage the interface with auditees and stakeholders (the latter may include Site Directors, Site Quality Directors, Manufacturing & Quality Directors of 3rd Party Service Suppliers).</li><li>Communicate learning points through Quality Alerts.</li><li>Promote early visibility of regulatory / compliance issues.</li><li>Provide input to Global QMS Documents and Audit function SOPs / GUIs.</li><li>Develop self and others through giving and receiving feedback to promote excellence and continuous improvement (e.g. peer review of reports, support GSK Auditor Certification Process as trainer or interviewer).</li></ul>Additionally, more experienced staff may undertake:<ul><li>Management of the interface with senior stakeholders, including regional Supply Division Heads, regional Quality Operational Heads and Cluster Leads, Heads of Support Functions and PSC R&D Quality.</li><li>Management of large elements of the audit process with minimal direction from the Audit Director.</li><li>Lead multi-departmental projects.</li><li>Perform review/ approval of audit documents as a delegate.</li></ul> Typical work output will involve: <ul><li>Entity internal audits of GSK Pharma and Vaccines manufacturing sites</li><li>Entity external audits of IT Software Application Suppliers, and 3rd Party Service Suppliers</li><li>Entity external audits of Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS) providers supporting GxP activities.</li><li>Entity external audits 3rd Party Service Suppliers</li><li>Software as a Medical Device (SaMD) audits. </li><li>For Cause audits based on identified risks or regulatory actions</li><li>Progress audits against risk mitigation plans or regulatory citation commitments</li><li>Clear, concise and objective audit reports that ensure senior management is apprised of the identified risks and that appropriate corrective action plans are implemented.</li></ul>Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor of Science degree in Information Technology and/or engineering discipline.</li><li>Demonstrable Vaccines/Steriles subject matter expertise (or a technically similar discipline). For example, extensive experience in the pharmaceutical industry including specifically in Vaccines / Steriles related industries. </li></ul>Preferred Qualifications/ Experience If you have the following characteristics, it would be a plus: <ul><li>Broad based understanding of pharmaceutical manufacturing.</li><li>Previous Experienced in computer system validation activities, developing and implementing validation program for IT, analytical instruments and manufacturing control systems for Biologics/Pharmaceutical manufacturing processes.</li><li>Experienced in conducting external Computer Compliance audits from Software as a service SaaS and Software as a Medical Device (SaMD) providers.</li><li>A working knowledge and competency in evaluation of ALCOA+ principles within the pharmaceutical industry.</li><li>Excellent written, verbal, questioning, and listening skills.</li><li>Ability to utilize critical thinking of complex quality systems and processes.</li><li>Auditor accreditation/certified either through the GSK internal Auditor Certification Program (or progressing through GSK's ACP program) or via an external certified body.</li><li>Experience managing the interface with stakeholders (Site Directors, Site Quality Directors, Heads of Support Functions). </li><li>Understanding and experience of corporate governance processes.</li><li>Understand or have a background in New Product Introduction requirements.</li><li>Risk Management knowledge, application and evaluation.</li><li>Application of continuous improvement change control and risk assessment.</li><li>Reading and verbal multiple language communication skills is considered an advantage.</li><li>Experienced in performing system life cycle audits with respect to FDA validation and part 11 requirements and pharmaceutical and medical device industry practice.</li><li>Experienced in conducting external Computer Compliance audits from Software as a service SaaS and Software as a Medical Device (SaMD) providers.</li><li>Experience with and good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for Vaccines, Biopharmaceuticals and Pharmaceuticals.</li><li>Experience identifying and/or managing quality and compliance risks.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why Us? GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Computer Compliance Audit Manager

Site Name: Durham Blackwell Street, Philadelphia Walnut Street Posted Date: May 28 2024 Position Summary The Director, Patient Assistance and Access Solutions leads a team that is responsible for developing industry-leading patient assistance programs for GSK's Specialty and Oncology portfolios. The role reports to the Senior Director, Patient Access Programs Foundation. The leader in this role develops strategies in support of the GSK Patient Access Programs Foundation (PAP) Foundation programs associated with the Specialty and Oncology Business Unites and oversees operations these Patient Assistance Programs. The Director, Patient Assistance Programs is responsible for leading ongoing external benchmarking and landscape analysis to ensure GSK offers to meet the needs of patients within associated disease states. The leader in this role also must scope, design, and build programs that ensure patient access to GSK's pipeline assets associated with Specialty and Oncology products. The role oversees critical third-party vendor relationships required to deliver the assigned programs. Key Responsibilities <ul><li>Leadership and Operational Excellence: Manage the continual development and day-to-day operations of GSK's Specialty and Oncology Patient Assistance Programs (PAPs), ensuring operational excellence in support of patient needs.</li><li>Documentation and Training: Manage the development and maintenance of SOPs, business rules, work instructions and training materials related to GSK Patient Assistance Programs.</li><li>Process Improvement: Ensure tight integration of programs with a focus on continuous improvement of PAP operational processes and systems to deliver an optimal patient experience.</li><li>Stakeholder Alignment: Collaborate with appropriate stakeholders to implement best-in-class Patient Assistance Programs to meet the needs of eligible patients.</li><li>Forecasting and Supply Coordination: Coordinate with trade, forecasting, and distribution teams to manage PAP forecasts and supply needs for Specialty and Oncology products.</li><li>Collateral and Communication Guidance: Provide input and guidance for Patient Support related collateral materials and service provider communications. Participate in the review of materials and communications associated with the Patient Assistance Programs.</li><li>Expertise and Training: Contribute subject matter expertise to field training content development and initiatives as requested.</li><li>Budget Oversight: Oversee program budgets for Specialty and Oncology Patient Assistance Programs reviewing monthly invoicing and payments to assigned vendors.</li><li>Advisory Council Participation: Serve as a member of the Patient Assistance Program Advisory Council, contributing to the development and delivery of quarterly Board Meeting content.</li><li>Website Management: Oversee the development and updates of the GSK Foundation Website, working closely with GSK Tech and PAP stakeholders to ensure accurate and timely information.</li></ul> Why You? Basic Qualifications <ul><li> Bachelor's degree </li><li> 8-10 years of pharmaceutical experience with a proven track record of leadership in Patient Experience/Services/Support </li></ul> Preferred Qualifications <ul><li>Master's Degree</li><li>Experience working with 501C Charitable Foundations</li><li>Demonstrated success in implementing and managing external partners including, detailed process workflows, SOPs, and KPIs</li><li>Functional knowledge of health insurance and benefits (private and public payers), with a solid understanding of the following processes: HIPAA, insurance eligibility and benefit verification, securing insurance authorizations, appealing insurance denials, and application of financial assistance for eligible patients</li><li>In-depth knowledge of pharmaceutical manufacturer compliance requirements and patient confidentiality (HIPAA regulations)</li><li>Highly knowledgeable of patient assistance programs</li><li>Previous experience working in a matrixed environment.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Director Patient Assistance Programs, Oncology and Specialty

Site Name: Durham Blackwell Street, USA - Pennsylvania - Philadelphia Posted Date: May 28 2024 Are you energized by the challenge of accelerating a procurement organization at a biopharma company that cares about being ambitious for patients, while being accountable for impact and doing the right thing? If so, this Procurement Manager role could be an exciting opportunity to consider. As a Procurement Manager, you will be accountable for supporting the US business through the full procurement lifecycle from stakeholder engagement and sourcing to contracting and supplier management. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Strategy execution<ul><li>Represent the best interests of the market by aligning with appropriate regional and Global category teams. Work in collaboration with these teams to provide requirements and market information to support effective regional and global strategy creation and execution.</li><li>Execute sourcing strategies for multiple spend categories in scope of responsibility, operating with a truly global mindset while ensuring all applicable LOC or regional dimensions are accommodated.</li><li>Have a clear understanding of how global strategies affect the US market and build an education & communication process for Procurement leads and US commercial business units.</li><li>Support the business to understand GSK Procurement policies and ensure that users are trained / supported accordingly. Be the local expert on third party oversight and risk management frameworks to protect GSK in supplier interactions and contracting.</li></ul>Benefit delivery<ul><li>Ensure financial benefits are managed in accordance with the Global spend management framework. Ensure business unit and Finance agreement to financial value delivered and transparency on treatment of benefits in the budgeting process.</li><li>Deliver effective Procurement targets against budgets (Plans of Purchase) in agreement with key stakeholders and Finance in accordance with the spend management framework and aligned to the US budgets set out by the respective category teams.</li><li>Identify and deliver value to the business aligned to assurance of supply, quality, service, cost and innovation and delivering stakeholders and business partner requirements through execution of category strategies.</li><li>Drive operational efficiencies by ensuring contract & preferred supplier list compliance as well as managing tail spend.</li></ul>Business partnering & stakeholder management <ul><li>Build strategic relationships with local GSK stakeholders to understand business requirements, identify opportunities to create value, and to express Procurement's value proposition. Align sourcing strategies accordingly.</li><li>Influence key stakeholders and business partners to support strategy development, endorse recommended strategies, support execution and agree how benefit delivery will be budgeted.</li><li>Ensure third party contracts are managed ahead of expiration dates for business continuity and strategic value.</li></ul>External supplier relationships<ul><li>Execute and maintain effective contracts with suppliers that will allow GSK to maximize opportunity both globally and locally. Ensure US views on supplier negotiations are taken into consideration. Ensure all contracts are valid and updated in GSK's contract management system.</li><li>Manage the supply base for the categories within scope through a robust performance management process. Ensure supplier performance is understood, measured, tracked and maintained.</li><li>Ensure effective processes and communication links exist between the suppliers and the US stakeholders. .</li></ul>Supply chain & risk management<ul><li>Transform the supply chain to release value and make GSK more responsive to business and customer needs - for example in cost control, complexity reduction, simplification, best practice procurement and use of KPIs.</li><li>Identify and manage significant risks in the supply chain. Ensure appropriate mitigation plans are in place, in use, and that the risks are communicated appropriately within business units impacted, Procurement and the supply base.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's degree</li><li>Experience using Microsoft tools, sourcing and contract tools such as: SAP Ariba modules or Conga.</li><li>Experience leveraging data to identify cost-saving opportunities, optimize supplier performance, and generate procurement insights for strategic decision-making.</li><li>Experience with contracting/contract terms for third party service providers (ie. MSA/SOW/Other)</li><li>Available during core working hours (8-4 / 9-5 EST).</li><li>Available to work in the Durham, NC office 2-3 times per week.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>MBA, MCIPS (or international equivalents)</li><li>Use of strategic thinking to build relationships (with stakeholders and suppliers) and create sourcing plans.</li><li>Strong knowledge of Marketing Procurement.</li><li>Proven sourcing expertise across categories.</li><li>Managing fast, efficient, and transparent information flows.</li><li>Project management skills and negotiation skills an asset.</li><li>Strong influencing and interpersonal skills.</li><li>Experience in managing projects within a LOC's needs and regulation (ie. taxes, law, regulation).</li><li>Solve issues, beware of risks, support implementation and robustly forecast spend and savings.</li><li>Comfortable working with ambiguity/limited information.</li><li>Organized and strong under pressure, confident in prioritization of activities.</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Procurement Manager

Site Name: USA - Michigan - Grand Rapids, USA - Indiana - South Bend, USA - Michigan - Kalamazoo Posted Date: May 28 2024 For more than 140 years, GSK has pioneered novel research methods and technologies to help protect people from infectious diseases. Our vaccines portfolio of more than 20 marketed vaccines is the broadest in the industry, helping to protect people throughout their lives. We believe prevention, at scale and for impact, is the best health investment for society, patients, and the economy. Vaccine-preventable diseases are a significant burden on society and healthcare systems; approximately $1 trillion in productivity is lost each year due to preventable conditions. This includes the impact from the 330,000 older adults hospitalized globally each year with RSV, the approximately 1 in 3 people who will develop shingles in their lifetime and the 3-11% of people infected with seasonal influenza each year. Our Vaccines portfolio will reach over 1 billion people globally this decade. Each year, around 40% of children globally receive a GSK vaccine and GSK is well-placed to lead in the growing adult immunization market. GSK's US vaccines business is organized into local ecosystem teams, designed to support the unique needs of the customer base in the given geography. In a local ecosystem commercial model, there are multiple customer-facing roles, each with unique customers/call points, but all dependent upon a high degree of collaboration. The Vaccines Account Executive, or VAE, is pivotal in most ecosystems, owning the B2B customer relationship in mid to large-sized group provider accounts, including large primary care provider groups, multi-disciplinary medical groups, independent hospitals, and public health providers (FQHC's, local health departments, etc.). The role of the VAE is to engage C/D level clinical & non-clinical stakeholders within larger provider organizations to understand unique customer needs/priorities and to deliver a customized value proposition. The VAE should possess strong customer engagement skills, experience with healthcare contracting, knowledge of the target customer organization and decision-making process. Details This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: <ul><li>Work within a local ecosystem team as the account owner for large primary care provider groups, multi-disciplinary medical groups, independent hospitals, and public health providers (FQHC's, local health departments, etc.).</li><li>Responsible for gaining a deep understanding of customer needs to customize and enhance GSK's value proposition within the targeted organization.</li><li>Identify alternative value proposition scenarios that will differentiate GSK Vaccine products to ensure access to GSK vaccines for appropriate patients.</li><li>Coordinate pull-through initiatives with other ecosystem team members, including Adult and Pediatric Immunization Specialists.</li><li>Build and maintain matrix partnerships to ensure seamless coordination and communication across all aspects of the GSK-customer relationship, including medical and market access.</li><li>Coordinate communication across sectors/business units to maximize business opportunities.</li><li>Embed and grow Mastering Customer Engagement" principles, Business Improvement and Strategic Account Plans.</li><li>Establish a consultative relationship on business issues with respective overlapping teams.</li><li>Provide lateral leadership and foster teamwork to generate access for GSK Vaccines positioning and competitive product strategies in a highly complex, dynamic environment.</li><li>Develop and implement business reviews with top accounts, including contract options/performance, diagnosis, and presentation of additional value-added terms or offers through an approved technology platform.</li><li>Support the local ecosystem lead (LEL) in continuous business acumen and vaccine portfolio growth.</li></ul>Why You? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: <ul><li>Bachelor's Degree</li><li>4+ years pharmaceutical sales experience</li><li>Valid driver's license</li><li>Travel Required: Up to 20%</li></ul> Preferred Qualifications If you have the following characteristics, it would be a plus: <ul><li>3+ years of account management experience directly involved in hospitals/hospital systems/public health systems or key accounts.</li><li>2+ years vaccines sales experience.</li><li>Knowledge of the vaccines marketplace, GSK and competitive portfolios and customers.</li><li>Experience with vaccines or pharmaceutical contracting.</li><li>Experience and success working in large provider group customers, including large primary care provider groups, multi-disciplinary medical groups, independent hospitals and public health providers (Awardees, FQHC's, local health departments, etc.).</li><li>Experience calling on clinical and non-clinical decision makers within these customers.</li><li>Experience with lateral leadership in a highly matrixed organization.</li><li>Solid strategic aptitude, advanced business acumen.</li><li>Demonstrated ability to develop and execute local level business and strategic account plans.</li><li>Strong communication, presentation (live and remote) & influencing skills.</li></ul>#GSK-LI Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Vaccines Account Executive; Grand Rapids, Kalamazoo, MI and South Bend, IN

Site Name: USA - Massachusetts - Waltham, Upper Providence Posted Date: May 28 2024 JD - Senior Manager, Analytical Development, SED As a Senior Manager of Analytical Development, you will join a team of scientists responsible for managing analytical activities throughout development and registration of pre-clinical and development-stage biologic candidates within the Strategic External Development (SED) organization. The successful candidate will serve as a project and/or technical lead in a broad analytical area and manage the collaboration with appointed CDMOs to directly support GSK's biologics pipeline. The scope of the role spans from overseeing release- and stability-indicating method development and validation to characterization and comparability studies, as well as reference standard qualification. Under minimal guidance, the successful candidate will be responsible for overseeing, developing, and executing aligned CDMO and GSK goals for large molecule analytical development. It will further extend to investigations and preparation of CMC content for regulatory submissions, method transfer and troubleshooting. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... <ul><li>Lead and manage analytical development activities performed at CROs/CDMOs associated with method development, qualification/validation, transfer and characterization of drug substance, drug product, in-process testing and reference standards qualification.</li><li>Develop and execute strategies for product and process characterization with a focus on CQA assessment, specification, release, stability, and comparability studies.</li><li>Facilitate tech transfer of methods to GMP testing facility, commercial groups and to CMO's.</li><li>Collaborate with process and quality functions to ensure strong cross functional collaborations and integrated process and product development and characterization.</li><li>Author, review and/or approve key source documents for relevant sections of regulatory filings (IND, IMPD, BLA, etc.).</li></ul><ul><li>Lead and track analytical development commitments to support all CMC filing activities for pre-INDs, INDs, IMPDs, CTAs and BLAs, draft and review of regulatory filings, and address RTQs.</li></ul><ul><li>Assure all documentation and other regulatory compliance systems are maintained according to GSK corporate standards.</li><li>Establish and implement processes, technical concepts, and methodologies to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results.</li><li>Partner with Quality Assurance and Regulatory Affairs-CMC to ensure completion of appropriate documentation and maintenance of high-quality standards.</li><li>Provide clear communication to partners and functional line management regarding progress against technical and project objectives/milestones.</li></ul>Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:<ul><li>Ph.D. or M.S. in chemistry, biochemistry, cell biology, biochemical/bioprocess engineering, or related science/engineering field with extensive biopharmaceutical industry experience.</li><li>6+ years (for Ph.D.) or 8+ years (for M.S.) of combined biopharmaceutical industry and postgraduate analytical experience.</li><li>5+ years of hands-on experience with biochemical, biophysical and/or biological methods used for biopharmaceutical characterization.</li><li>3+ years of CMC analytical development experience of therapeutic proteins/antibody-drug conjugates (ADCs), and preferably with analytical project leadership experience of biologics.</li><li>1+ years of experience in tech transfer of methods and life cycle management.</li></ul> Preferred Qualifications: <ul><li>Experience with a variety of biologic modalities (ADCs, monoclonal antibodies, bi- and multi-specifics, co-formulated drug products, etc.), and exposure to all stages of biologics drug development.</li><li>Hands-on experience in biochemical and/or biophysical assay development and qualification/validation .</li><li>Thorough knowledge of structure-function relationship of therapeutic proteins. </li><li>Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts.</li><li>Ability to work in a fast-paced, multi-disciplinary and dynamic environment with potential for changing priorities, with flexibility to support multiple development programs simultaneously.</li><li>Ability to lead innovation, change, and drive for results.</li></ul> Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Sr. Manager, Large Molecule Analytical Development

Site Name: USA - Pennsylvania - Upper Providence Posted Date: May 28 2024 Are you looking for a collaborative analytical chemist role that allows you to contribute to scientific strategy and accelerate Pharmaceutical Research and Development? If so, this role could be an ideal opportunity to explore. GlaxoSmithKline (GSK) is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. As a scientist in Analytical Development, you will design and perform experiments to develop, validate, and transfer various analytical methods and state-of-the art analytical technologies that focus on pharmaceutical product development, manufacturing, and controls. You will be involved in all aspects of pharmaceutical development, including engagement with project teams and other stakeholders for various projects in different stages of development. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: <ul><li> Develop and perform assays that support the development, release and stability testing of pharmaceutical drug substance and drug product for clinical trials. </li><li> Review of experiments, stability protocols, and other key documents </li><li> Influence the direction of associated analytical control strategies across the process. </li><li> Contribute and support departmental cross-training activities on analytical techniques used for analysis of molecules. </li><li> Contribute to sections for patents or regulatory submissions, as well as scientific papers and internal reports. </li></ul> Why You? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li> A Bachelor's degree or Master's degree in Pharmaceutics, Chemistry, Analytical Chemistry, or related scientific discipline. </li><li> 5+ years of laboratory-based experience designing experiments. </li><li> 5+ years' experience using analytical techniques such as HPLC, GC, or dissolution. </li><li> Experience with method development & validation, pharmacopeia compliance, analytical life cycle management.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li> PhD in Analytical Chemistry or related scientific discipline </li><li> Experience with the pharmaceutical product lifecycle. </li><li> Experience with analytical support of challenging long-acting injectable, parenteral, and sterile formulations. </li><li> Working knowledge and experience in small molecule, therapeutic oligonucleotide and mAb-related analytical techniques such as HPLC, UPLC, CE, GC, dissolution, UV/Vis Spectrophotometry, KF, MS, NMR, IR, USP compendial methods and laboratory procedures. </li><li>Strong technical writing skills for documentation.</li><li> Experience in regulatory documentation authoring (IND, NDA, MAA, etc.) </li><li>Ability to collaborate and communicate well with others in and across groups in matrix</li><li> Working knowledge and experience quality control testing and GMPs </li><li> Knowledge of ICH guidelines </li><li>Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system)</li><li>Data Skills: SQL, PowerBI, Spotfire</li></ul>#LI-GSK Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Senior Scientist

Site Name: USA - Pennsylvania - Upper Providence, Stevenage Posted Date: May 28 2024 GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our goal is to be one of the most innovative, best performing, and trusted healthcare companies. In GSK, the Pipeline Project Manager (PPM) will act as the 'COO' of the asset and will partner with project leads to help teams plot the best course, then accelerate through complexity and uncertainty with no compromise to quality or safety. The Senior Director PPM can be a project-focused position, a leadership position (leading a group of PPMs), or a combination of both. Pipeline Project Managers compose a community of drug/vaccine development and commercialization experts applying industry-leading project management practices to plan and deliver pipeline projects with industry-leading performance:<ul><li>Apply a holistic perspective and broad knowledge of drug/vaccine development to help Research and Development teams test ideas and optimize the strategy.</li><li>Empower teams to challenge convention, manage uncertainty, and accelerate delivery of critical milestones.</li><li>Continuously assess progress and clear the way for uninterrupted focus on the critical path.</li><li>Build high-performing teams by cultivating trust and outcomes-focused ways of working.</li><li>Share learnings and proven practices across PPM so that we learn and grow as an organization.</li></ul>The PPM can also operate at program level, as when a commercialization team oversees multiple projects under the umbrella of a single program strategy. The Senior Director has demonstrated success managing strategically important, top priority R&D pipeline projects and applies strategic drug development and leadership skills to facilitate successful outcomes for Medicine/Vaccine/Early Development Teams. The Senior Director is seen as a thought leader in project management, promoting and helping to establish best practices for project management. The Senior Director leads through others with direct and/or indirect line management responsibilities for a group of PPMs. Key Responsibilities: This is a leadership role that is accountable for delivering multiple oncology projects and people development.<ul><li>Represent programs and PPM team members as part of TA PPM leadership team (where appropriate), leading and/or contributing to organizational strategy, improvement initiatives, capability development efforts, and talent (line) management for a TA PPM group.</li><li>As a visible PM leader, work with other PPM leaders and R&D stakeholders within and across TAs to ensure development of an industry-leading project management capability focused on accelerating pipeline projects.</li><li>When directly supporting a project, facilitate and/or contribute to asset strategy and evidence strategy, and lead development of the integrated project plan to ensure feasibility and alignment with TA strategy, prioritization, and pipeline performance objectives.</li><li>Own the single integrated plan that builds team commitment to shared goals with schedules and budgets based on clear dependencies and assumptions.</li><li>Lead options planning, generate recommendations, alternatives, and tradeoffs to strengthen decision-making and optimize the project strategy.</li><li>Leads team preparation for governance decisions and owns schedule, risk, and budget inputs.</li><li>Identify opportunities to accelerate by challenging constraints that impact critical path and near-critical path activities.</li><li>Orchestrate seamless handoffs with focus on the critical path through proactive project plan monitoring, risk management, and cross-functional management of project issues with timely escalation to leadership as required.</li><li>Ensure rigor, consistency, and compliance in established systems to drive timely, high-quality data and reporting in and across projects.</li><li>Build trusting relationships with the team and stakeholders to encourage transparency and collaboration. Use strong facilitation skills to lead regular project team meetings and apply consistent best practice for meeting agendas, actions, minutes, and other meeting documentation.</li><li>Establish and sustain agreed-upon ways of working for effective team communication, decisions, and conflict resolution.</li><li>Actively promote GSK's Code and values. Seek diverse perspectives, cultivate psychological safety, and ensure that all relevant voices are heard to strengthen outcomes and foster broad commitment. Work on any assignment as directed.</li></ul>Basic Qualifications <ul><li>Master's Degree or equivalent experience in Lifesciences or Business</li><li>Strong experience with Planisware, MS Project, and/or other recognized Project Management tool is required.</li></ul>Project Management Expertise<ul><li>Extensive project management experience in a matrix team environment in pharmaceutical R&D.</li><li>Demonstrated expertise in all aspects of project management, based on established PM principles and methods (e.g., PMI/PMBOK).</li><li>Extensive experience building and maintaining high-quality project plans, budget and resource forecasts, and project management documentation (key assumptions, risks, etc.). </li><li>Expert-level ability to communicate clear, concise view of project status, critical path, and upcoming work to help the team and functions work in concert. </li><li>Experience leading and facilitating the identification, visualization, and acceleration of the project's critical path, including the ability to explain the critical path activities and dependencies to project stakeholders.</li><li>Extensive expertise in managing project risks, ensuring that the risks across functions are appropriately identified, measured, managed, and communicated.</li><li>Expert proficiency in established PM planning tools.</li><li>Extensive experience facilitating and documenting effective project team meetings.</li><li>Experience leading or contributing to organizational project management capabilities and PM-related improvement initiatives as needed.</li></ul>Drug Development Experience<ul><li>Experience in early and late oncology drug development and organizational knowledge to validate the operational feasibility, challenge project team assumptions, and prompt subject matter experts to consider the impact of portfolio strategy and external landscape (regulatory, commercial, and competitive).</li><li>Extensive experience guiding teams to develop recommendations and options inclusive of benefit, cost, and risk trade-offs to realize the project strategy.</li><li>Extensive experience preparing for governance interactions to enable funding, resourcing, and strategic and operational project decisions.</li><li> Demonstrated experience in championing data quality. </li><li> Experience in delivering projects within budget and ensuring efficient use of resources. </li></ul>Leadership & Interpersonal Skills<ul><li>Knowledge of formal high-performance team concepts and experience leading or partnering with project leaders to establish and sustain a high-performance team environment.</li><li>Demonstrated ability to build trust and strengthen collaborative relationships with matrixed team members across teams, sub-teams, and functions.</li><li>Demonstrated ability to identify, capture, share, and apply learnings and best-practice across projects.</li><li>Demonstrated experience proactively collaborating with a wide variety of project, functional, and leadership stakeholders.</li><li>Must posses effective, clear, concise communication skills.</li><li>Knowledge of established models for critical thinking, innovation, negotiation, and influencing skills, and experience leading teams in the use of those models to achieve positive outcomes.</li></ul>Preferred Qualifications <ul><li>Project/Program Management Professional (PMP) certificate.</li><li>Direct line management experience leading within a global project management function with development and talent management responsibilities.</li><li>Experience advancing Antibody Drug Conjugate projects.</li></ul>*LI-GSK Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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