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About the Role This is a field-based and remote opportunity. Novartis is more than an organization. It is a thriving community where talented people can truly belong. Working closely and collaboratively, we achieve a collective impact that is far greater than any of us could achieve alone. When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for the world. Every advance we make, however large or small, helps to improve the lives of patients and their families. It inspires us to go further, always seeking 'better' for the people relying on us. The Territory Account Specialist is responsible for providing solutions to their customers by acting as the key orchestrator of Novartis resources and solutions for a variety of customers, including Health Care Providers, Reimbursement Personnel, Practice Administrators, Key Account, and Integrated Delivery Network partners and is accountable for working collaboratively to help ensure customer inquiries are solved by the appropriate Novartis Subject Matter Expert (SME). The Territory Account Specialist is well-versed in the following areas: Clinical Selling, Account Selling, Access Navigation, Problem Solving, Team Orchestration / Collaboration, and Omni-Channel Engagement. Key Responsibilities: &bull; Facilitate clinical dialogue that compels the customer to act on behalf of their patients and engage the entire account to understand any obstacles that exist to provide appropriate solutions to ensure customer needs are met. &bull; Identify shared priorities and leverage knowledge and tactics within the full account to develop a strategic territory business plan that drives product demand by meeting the needs of key partners and ultimately their patients to drive superior results. &bull; Orchestrate in a collaborative manner with territory colleagues, other field-based and home-office personnel teams to proactively address customer needs and provide appropriate access support. &bull; Apply expertise and knowledge of the marketplace, applicable competitors, industry, and cross-functional activities/plans to anticipate and optimally manage business opportunities/challenges. &bull; Analyze territory market data and trends to gain insights into the local business environment, drive pull-through and lead virtual and / or live engagements with customers. &bull; Lead any required planning meetings with key partners to solve more sophisticated customer problems and work collaboratively across functions to ensure customer needs are met with urgency. &bull; Provide appropriate access support in the moment and collaborate effectively with Patient Specialty Services (PSS) associates to meet customer needs. &bull; Understand how to leverage systems and omni-channel/multi-channel options to apply the full suite of Novartis capabilities to personalize and engage with customers in both face-to-face and virtual environments. Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected] . Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: Territory Account Specialist: $102,400 and $153,000/year | Senior Territory Account Specialist: $124,000 and $186,000/year | Executive Territory Account Specialist: $136,800 and $205,200/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 Essential Requirements: &bull; Bachelor's degree required, advanced degree a plus. &bull; 2+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. &bull; Strong ability to collaborate, work cross-functionally within a matrix environment, can communicate clinical product information, has a proven track-record of consistent high-performance, and well-versed in navigating and successfully selling to large accounts and key customer segments. &bull; Self-starter with analytic abilities to seek out, prioritize, and apply relevant information to solve problems to meet the needs of key customers, while also demonstrating ethical leadership and ability to foster environment that promotes ethical behavior and compliance with company policies & laws. &bull; This is a remote position that will support key accounts in an assigned region. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. No relocation assistance available. Must have a valid driver's license. Desirable Requirements: &bull; Experience across therapeutic groups, disease states, account management strategy, and new product launches. &bull; Broad understanding in patient services, market access, buy and bill, specialty pharmacy, reimbursement and/or medical calling on HCPs with respect to a sophisticated product or reimbursement pathway. Company will not sponsor visas for this position. Leveling Guidelines: the position will be filled at level commensurate with experience. Territory Account Specialist: &bull; 2+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. Senior Territory Account Specialist: &bull; 5+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. Executive Territory Account Specialist: &bull; 10+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years. 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. 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 For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. 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

public

Allergy Territory Account Specialist -Fort Collins, CO - Remote

About the Role This is a remote position To write, review and/or handle the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach/mentor and/or train less experienced writers. Major Activities 1. To author, review and/or independently handle high quality clinical and safety documents: Clinical Study Reports (CSR), Risk Management Plans (RMP), CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e.g., Briefing Books, answers to questions). 2. Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing specialist content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. 3. Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT). 4. Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions. 5. Documentation specialist in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD. 6. Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents. 7. Lead process improvement in RWS and cross-functional initiatives and/or activities. &bull; Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. &bull; ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. preferred &bull; Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). &bull; Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs. &bull; Excellent communication skills (written, verbal, presentations) &bull; Expert knowledge of biostatistics principles. 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 &bull; Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable. &bull; ≥ 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. preferred &bull; Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). &bull; Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs. &bull; Excellent communication skills (written, verbal, presentations) &bull; Expert knowledge of biostatistics principles. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. 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 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 Commitment to Diversity & Inclusion: 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. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $144,000-$216,000year; 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: 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 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

Associate Director Regulatory Writing

About the Role This is a Remote Position 1.To author, review and manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP), submission documents (e.g., summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics). 2.Core member of Clinical Trial Team (CTT) / contributor to Safety Management Team. 3.Major contributor to planning of data analyses and presentation used in CSRs and submission documents. 4.Documentation specialist in CTTs and Clinical Submission Teams (CST) to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD. 5.Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents. Extended member of International Clinical Team (ICT) 6.Lead Writer for simple submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Core member of CST. 7.Contribute to process improvement in RWS and/or cross-functional initiatives or activities. 8.Coach and/or mentor less experienced writers. The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 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 &bull; ≥ 4 years medical writing experience or other relevantpharma industry experience combined with scientific andregulatory knowledge, plus in-depth knowledge of medicalwriting processes. Preferred &bull; Advanced knowledge of and experience in global regulatoryenvironment and process (key regulatory bodies, keydocuments, approval processes, safety reportingrequirements). Preferred &bull; Advanced knowledge of and repeat experience in globalregistration of drugs (complex submissions). &bull; Excellent communication skills (written, verbal, presentations) &bull; Advanced knowledge of biostatistics principles. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. 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 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 Commitment to Diversity & Inclusion: 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. 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 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

Senior Regulatory Writer

About the Role The Manager, Quality Control is responsible for the day-to-day operations of the internal QC laboratories at the manufacturing or testing site. This includes testing is performed in alignment with all relevant quality standards, and ensuring appropriate Quality Control processes, policies, and standard operating procedures to achieve the company's objectives are met. &bull; Develops cooperative and strong working relationships with Manufacturing, Quality Assurance and MS&T to achieve company objectives. &bull; Ensures that any results generated by internal and external laboratories, are in compliance with GMP. &bull; Responsible for oversight of routine testing, testing results review and approval and generation of Certificate of Analysis, as required. &bull; Acts as a subject matter expert for applicable areas. &bull; Ensures that internal and external laboratories comply with cGMP standards. &bull; Reviews and approves qualification/validation and routine testing documentation. &bull; Maximize Quality and process improvements. &bull; Executed proper investigation into the root cause of product and/or process failures and assists in determining appropriate product disposition and/or process improvements. 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 &bull; Bachelor's Degree in Chemistry, Biology or related sciences with 8 years of experience in pharmaceutical industry or equivalent and 2 years of direct supervisory experience. &bull; Demonstrated ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, influencing, motivating, and consensus and team building. &bull; Strong critical thinking, deductive reasoning, and decision-making skills. &bull; Strong understanding of material sampling, analytical techniques, manufacturing operations, GMPs and the principles behind them. &bull; Understanding of laboratory equipment such as ddPCR, qPCR, UPLC/HPLC, ICP-MS, UV/Vis Spectrophotometer, Densitometer, Gel Imager, pH, Osmometer, Cell based methods, Microbiology methods, etc. &bull; Strong ability to work independently and effectively, prioritizing and delivering on tight timelines. &bull; Approximately 10-15% travel required. The pay range for this position at commencement of employment is expected to be between $112,800 and $169,200 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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. 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 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

Manager, QC Cell Based Assays

About the Role The Supply Chain Planner II, is responsible for maintaining the master production schedule for Commercial and Clinical products for a manufacturing facility. Responsibilities: Site planning, scheduling, and WIP/FG Inventory management activities ensuring safety and compliance with company policies and procedures. Partners with cross functional site teams and collaborate on best practices across the supply chain organization. Day to day planning and scheduling activities for Commercial and Clinical products to support the master production schedule for the site including MSAT/MFG engineering protocol runs. Manufacturing and TRD BOM management, updates and maintenance; working closely with SMEs and Master Data team. Work order creation, ensuring timely execution of ERP transactions, and maintaining data and real-time transactional accuracy within the ERP system. Works closely with key partners across the site to ensure timely execution of the master production schedule; support Site Quality to prioritize batch disposition in alignment with the product demand. Supports Clinical Tech Transfer (TT) teams in preparation for new programs to include new BOM's, BOM changes, new Item Codes, Inventory requests, etc. Communications support for Clinical manufacturing changes and to ensure plan alignment between Global Program Teams, Global Supply Chain, Site MFG, and Site Finite Scheduling team. CR impact assessments, action items, and tracking status related to Supply Chain Planning needs. Maintains agreed upon supply of Drug Substance, Drug Product, and Finished Goods to satisfy the Global Demand requirements and tracks and maintains key performance metrics related to the performance of the end-to-end supply chain. 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 Requirements: B.S. degree in supply chain, engineering, science, business or other relevant degree for SC Planner I; or 2+ years of supply chain or planning experience; or 2 years' experience in lieu of degree; or 4 years' supply chain or planning experience in lieu of degree for SC Planner II. Biopharmaceutical based GMP manufacturing operations is a plus. Experience working with ERP systems Must be able to operate, with limited supervision, and exercise proper judgment. Strong communication and organizational skills, detail oriented. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. The pay range for this position at commencement of employment is expected to be between $69,300 and $103,900 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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. 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 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

Supply Chain Planner I/II

Allergy Territory Account Specialist -Pasadena, CA - Remote

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Allergy Territory Account Specialist - Fresno, CA - Remote

About the Role INTERNAL ROLE TITLE: Clinical Program Leader LOCATION: Cambridge, MA #LI-Onsite About the role: To provide strategic medical guidance for and to the lead the development of experimental oncology agents in the TCO portfolio, beginning with the candidate selection phase of preclinical development and continuing through clinical proof-of-concept and transition to full development. Your Key Responsibilities: &bull; Leads the EPT, reports to clinical site head &bull; Provides strategic medical guidance for the development of new oncology agents (both small molecules, biologics, cell therapies and radioligand therapies) that are in preclinical development, typically beginning at the candidate selection phase. &bull; Creates a clinical development strategy for new oncology agents that are within the candidate selection to proof-of-concept (PoC) and transition to full development timeframe. The development strategy combines the CPL's medical knowledge with the expertise of colleagues in a wide range of other fields (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. &bull; Although registration studies are not within the responsibility of TCO, the CPL in TCO must provide an early clinical development strategy that foresees and supports subsequent registration trials &bull; Integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator's Brochure and first-in-human protocol. &bull; Collaborates with clinical scientists to develop clinical protocols for TCO compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports). &bull; Applies their medical knowledge to guide the safe, ethical and efficient conduct of the trials under their responsibility. They are knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them. &bull; Liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents their projects to those groups and authorities. &bull; Writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings. &bull; Participates in task forces to support continuous improvement and other management objectives. The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; 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. 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; This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/or international). &bull; MD or DO degree required. Hematology, Medical Oncology or both. MD, PhD preferred. &bull; 3-5 pharma/biotech industry experience in hematology/oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience. &bull; Must have facility with the interpretation of preclinical data in heme/oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) &bull; Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials &bull; Proven ability to analyze and interpret efficacy and safety data relating to oncology. &bull; Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology &bull; Excellent medical/scientific writing skills &bull; Effective written and oral communication skills &bull; Proven ability to manage and develop a team &bull; Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies 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 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. 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. 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

Clinical Program Leader

About the Role INTERNAL ROLE TITLE: Clinical Program Leader LOCATION: Cambridge, MA #LI-Onsite About this role: Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Key responsibilities: &bull; Acts as a clinical leader for a region / large countries or strategic sites responsible for assigned clinical program(s) -driving medical strategy implementation and operational deliverables for development and marketed products in a defined therapeutic area. &bull; Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program and/or programs. &bull; Ensures effective cross-functional communications to align with global strategy &bull; Leads development of clinical sections of trial and program level regulatory documents &bull; Drives execution of the section of the clinical program in partnership with global line functions. &bull; Supports the clinical research leaders by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas &bull; Acts as the medical expert, engages interactions with external collaborators (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS collaborators. &bull; Contributes to medical/scientific training of relevant Novartis collaborators. May serve as speaker for franchise medical/scientific training -May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) &bull; Develops high potential talents for succession positions to ensure business continuity. &bull; Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt &bull; Distribution of marketing samples (where applicable) The pay range for this position at commencement of employment is expected to be between $257,600 and $386,400 / year; 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. 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; This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will not require travel as defined by the business (domestic and/or international). &bull; MD or DO degree required. MD, PhD, board certified Oncologist; thoracic oncology expertise strongly preferred. Laboratory-based science training is preferred. &bull; 3-5 years of pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting. In case of no industry experience, substantially longer academic experience in oncology and clinical study experience is required. &bull; Ability to interpret preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology) &bull; Solid understanding of Pharmacokinetic / Pharmacodynamic and biostatistics to clinical development and clinical trials &bull; Proven track record to analyze and interpret efficacy and safety data relating to oncology &bull; Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology &bull; Excellent medical/scientific writing skills &bull; Effective written and oral communication skills &bull; Excellent personal ethical integrity and a dedication to improving the outcomes for patients with malignancies 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 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. 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. 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

About the Role This position is located at our Cambridge, MA site and will not have the ability to be located remotely. Multiple positions available. About the role: The number 1 cause of death in men and women globally is cardiovascular diseases, taking an estimated 17.9 million lives each year (nearly a third of all death). Novartis is committed to developing transformative treatments for cardiovascular and metabolic diseases, including heart failure, arrhythmias and atherosclerotic cardiovascular disease, as well as diseases across a wide range of therapeutic areas. The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis that collaborates across the company and beyond, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 900 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. The TM Discovery & Profiling (TMDP) is a group of physicians and clinical researchers who drive innovative science from discovery to the patient through the selection, profiling, and effective development of medicines. Translational medicine experts oversee Phase 1 and 2 clinical trials to demonstrate proof-of-concept (PoC) in patients, as well as support for Phase 3 development. Translational medicine experts are key and highly visible members of global cross-functional project teams that design and implement early research and discovery projects, that then culminate in clinical PoC studies. Translational medicine experts collaborate with colleagues in biology and chemistry to identify targets in diseases with significant unmet medical needs and provide input on likely clinical development pathways. The PoC studies led by our translational medicine experts are among the most critical steps in drug development at Novartis. After PoC and if the program proceeds to full development, the translational medicine expert continues as a key member of the full development team up to and including registration. As a Cardiovascular Metabolism (CVM) TM Expert, you will collaborate with the CVM TM Head or other experienced TM Expert to develop high value decision-strategies for the Translational Medicine component of drug development projects and lead global cross-functional project teams through the PoC phase and beyond. Your main accountabilities will be: &bull; Lead global project teams through PoC phase to drive implementation of the PoC strategy; participate in project teams through program life cycle from NTRC to registration. &bull; Responsible for clinical portions of the Integrated Development Plan (IDP) through PoC. &bull; Responsible for implementation of studies during the PoC phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in PoC studies. &bull; Acts as medical monitor for one or more global clinical studies. &bull; Communicate clinical team matters to project teams and relevant Decision Boards (DADB). &bull; Convene relevant (internal and external) leaders together to consider the proposed approach to PoC. &bull; Evaluate clinical centers and foster communication with crucial collaborating investigators. &bull; Oversee publication and external presentation of PoC clinical study results. &bull; Accountable for compound related biomarker strategies; works closely with Biomarker Experts in implementation. &bull; In collaboration with research scientists, identify, develop, and implement strategy for preclinical support of program-related objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities. &bull; Participate in team presentations to health authorities as TM expert. 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: - Doctoral degree, MD required with clinical subspecialty training preferred in cardiovascular and metabolic disease; Additional PhD/post-doctoral equivalent research preferred - At least 5 years' experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience - Recognized for medical expertise. - Recognized for scientific expertise: respected by colleagues internally and externally, have made significant contributions to the field and created / established new concepts; record of high quality publications in international scientific journals. - Excellent written and oral communication/presentation skills. - Independence: Able to work independently on study planning and execution, and with supervision on project planning. - Innovation: Seeks out new clinical discovery opportunities and PoC approaches. - Demonstrated passion for science. 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. 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. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $257,600 - $386,400/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 learn 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

Cardiologist Physician Scientist, Translational Medicine

About the Role Onsite About the role: As a Principal Scientist in the Translational Medicine Drug Disposition Bioanalytical group, you will have the opportunity to make a difference. In this key role, you will apply your bioanalytical expertise and leadership skills to design and conduct studies for our novel modality biologics portfolio. If you have a collaborative nature, a commitment to teamwork across an organization and a relentless focus on improving patient care we want you to apply. Your Key Responsibilities: &bull; Designing, developing, validating assays and performing clinical sample analysis using biological techniques for PK, PD and immunogenicity following SOPs and guidelines in a supervisory role &bull; Participating in or leading the bioanalytical strategy sub-team discussions and overseeing the execution of the strategy. &bull; Data processing, evaluating results, interpreting data, and drawing relevant conclusions. Critically analyzing data on study and project levels and communicating findings in a clear and timely manner. &bull; Keeping timely raw data records in accordance with company and health authority guidelines, as an individual contributor and/or supervisor. &bull; Managing study timelines and ensuring accuracy of project progress through company tracking tools. &bull; Authoring study protocols, reports, and contributing to health authority documents. &bull; Supervising, coaching and/or mentoring in a matrix team laboratory environment. 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 biological related sciences or equivalent and 10 years of relevant experience, preferably in biologics bioanalysis. &bull; Strong laboratory background with proficiency in several biological techniques (ELISA, ECL, mass spectrometry, PCR, etc.) and their associated software. &bull; Ability to work independently and/or supervise a small team and organize work across multiple projects to meet timelines. &bull; Eagerness to take on additional responsibilities when required; flexibility to adapt to changing priorities and strategies. &bull; A collaborative spirit and willingness to mentor/coach peers within and outside of immediate team. Preferred Qualifications: &bull; Advanced degree in related field of study (PhD applicants should have 5 years of relevant experience) &bull; Experience in regulated bioanalysis &bull; Supervisory experience 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. 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. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $118,000 - $177,500/year; 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. 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 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

GCP Bioanalysis Principal Scientist

About the Role The VP, Launch Excellence is responsible for developing, leading and implementing enterprise governance, frameworks, capabilities and tools for new product launches in order to deliver superior innovative results consistently and systematically. This individual will ensure critical steps are implemented with quality in a timely manner across all products and functions in order to: o Create and embed best-in-class processes, tools framework, capabilities including addressing key business questions for a best in class insight generation early on, systematic pressure testing of launch prep at each key interval, identification of critical make it or break it and timely resolution o Enable the delivery of best-in-class launches impact across the lifecycle thanks to clarity, visibility & transparency of readiness at L-3, L-2, L-1 and where required proactive course correction o Continue learnings and benchmarking internally and externally, inside and outside pharma industry o Ensure brand choices and resource allocation for maximum impact o Continuously innovate our approach to launches to stay ahead of the curve and trends o Shape in partnership with P&O the culture and talent agenda to support the vision to become a launch machine. o Tap into functional organizational launch teams to create and integrated approach Major Accountabilities: &bull; Oversee team responsible for launch excellence. &bull; Drive strategic thinking for launch excellence CoE, to ensure development and adoption of consistent processes and best practices for upcoming launches. &bull; Develop capabilities of teams, leading efforts to train and upskill associates by embedding launch capabilities and by building excellence in strategy and execution from previous launch learnings and best practices. &bull; Act as launch expert and strategic thought-partner to guide, pressure-test and challenge launch teams and coach on agile approaches, workshop design, competitive readiness and scenario planning, launch funding, evidence generation planning and scientific narratives, etc. o Coach brands to customize launch CoE content for brand specific needs (e.g. blueprints, archetypes, KPIs specific to a brand) to ensure that approach matches key drivers for a given brand o Influence, coordinate and partner with launch teams at key decision points, providing suggestions for areas of additional refinement and to share potential best practices in order to ensure proper launch readiness assessments at key decision points (from pre-launch milestones through launch and beyond) &bull; Develop, manage and lead a consistent and robust product launch process and governance structure to provide oversight and to ensure consistency of tracking and incorporating best practices across launches, leveraging internal & external insights (inside & outside of pharmaceutical industry) &bull; Ensure robust strategic thinking is embedded into forecasting process, drawing on external perspectives and best practices to ensure forecasts have been properly pressure-tested with appropriate scenario planning incorporated & consistency across brands and disease-areas &bull; Provide guidance and lead efforts for the creation of effective intelligence programs (including annual budget planning etc.) in support of key stakeholders involved in integrated product strategy &bull; Provide long-term launch planning support by providing portfolio view of upcoming launches through frameworks, archetypes and overall resourcing/planning/timing &bull; Analyze resource allocation to each product in the launch portfolio, considering product archetype and provide recommendations to launch teams and/or senior leadership &bull; Promote culture of including early US customer input into development plans, Target Product Profiles (TPP), Lifecycle Management plans, Forecasts, ensuring decisions are strategically sound &bull; Coordinate with IPS and Business Planning Lead to ensure processes are cohesive and are designed to facilitate launch excellence from a strategy and execution standpoint The pay range for this position at commencement of employment is expected to be between $284,000.00 and $426,000.00 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. This position will be located at the East Hanover, NJ site and will not have the ability to be located remotely. This position will require 10-20% travel as defined by the business (domestic and/ or international)." 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: Education: -Bachelor's Degree is required in relevant area, MBA preferred &bull; 15+ years in pharmaceutical, biotech, healthcare, medical devices or healthcare consulting industry inclusive of at least 2 different functional areas (Marketing, Patient Services, Product, etc.) &bull; Track record in launching consistently innovative medicine and strong experience in a product focus organization. &bull; Multi-industry experience launching products (e.g. consumer, med tech) &bull; US Commercial Experience and launch experience in the pharma industry &bull; 2+ years in project management and translation of strategy into execution &bull; 2+ years leading complex projects requiring global and local alignment &bull; Experience in project management and translation of strategy into execution &bull; Strong ability to simplify complex concepts & strategies and tell a story" orally and in writing &bull; Strong analytical skills and an ability to generate insights and develop relevant action plans &bull; Strong influencing skills, and the ability to exercise tact and diplomacy in stressful situations &bull; Ability to manage multiple priorities and a heavy workload &bull; Ability to lead and inspire a team, people leadership experience &bull; Location: East Hanover, NJ; 10-20% travel is required Preferred: &bull; 2+ years within a management consulting group (e.g. McKinsey, BCG, Bain) &bull; MBA or Health Policy Degree / Advanced Degree &bull; Global or Regional experience (Projects or full time roles or temporary roles for 6 months or more) &bull; Minimum 3+ year commercial experience preferably with a multi-functional experience in a pharma-ceutical, biotech, healthcare or consulting environment &bull; Curious, with excellent listening skills; able to challenge current thinking &bull; Track record of exceptional performance and execution that drives results &bull; Ability to lead, manage and motivate teams, with or without authority &bull; Experience working collaboratively across the matrix Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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

VP, Launch Excellence

About the Role Location: Remote About the Role: Job Purpose: The Associate Director, Access & Reimbursement, Radioligand Therapy (RLT) is a remote/field-based role that covers the following states but not limited to San Jose, Fresno, Bakersfield, California & Hawaii. The Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. Ability to travel and cover geography, at least 50% travel required. The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care. ADARs will serve as the access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects. ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third-party affiliates). Key Responsibilities: &bull; Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows. &bull; Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices. &bull; Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products. &bull; Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient re-imbursement and coordinate on reimbursement issues with third party payers at the provider-level. Analyze account re-imbursement issues & opportunities (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient pull-through. &bull; Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments. &bull; Accountable for informing customers on NVS-sponsored patient support programs to enable patients starting and staying on therapy (i.e., Co-pay). &bull; Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). &bull; Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement; Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. &bull; Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPPA and other privacy laws and regulations and in-ternal Company compliance guidelines). Buy and Bill Specific &bull; Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel. &bull; Responsible for establishing preferred acquisition pathways. Educate on and support buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration. &bull; Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement. &bull; Analyze reimbursement issues & opportunities, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams. &bull; Accountable for engagement with non-prescribers, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc. Radioligand Therapies Specific The ADAR will be a critical partner to the Novartis Patient Support (NPS) customer engagement team on supply capacity, site procurement eligibility, as well as a customer facing resource for communications on orders and logistics. &bull; Understand RLT key priorities in core disease areas, financial goals, and site initiatives to influence overall account and regional business strategies. &bull; Assess and understand site and/or other appropriate organizations' level of readiness for procurement of nuclear medicines and billing to facilitate orders for products and so that they can engage and educate on procurement systems and processes, access, and reimbursement. Be able to understand where gaps in procurement exist and work with Cross-Functional partners to resolve. &bull; Partner with the customer engagement teams to assist the communication and facilitation of procurement and logistics with both the site and the local field teams. (e.g., procurement, logistics processes and timing) as well as patient-specific support (benefit verification, PA and appeals and copay programs) &bull; Major accountabilities apply to therapy, diagnostic and theragnostic treatment centers. Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. 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'll Bring to the Role: Education: Bachelor's degree required; Business and/or biological science education preferred. Advanced degree preferred. Essential Requirements: &bull; 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s). &bull; Experience working with highly complex practices and/or health systems to establish access and acquisition pathways. &bull; Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access. &bull; Deep expertise and experience integrating manufacturer-sponsored patient support programs. &bull; Experience with specialty products acquired through Specialty Pharmacy networks. &bull; Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail) &bull; Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region. Desirable Requirements: &bull; Expertise in therapeutic area such as Oncology, Prostate Cancer or Nuclear Medicines 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 $174,400 and $261,600/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 Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. 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

AD, Access & Reimbursement NPS Radioligand Therapy Remote San Jose CA

About the Role Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With a strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly. The ideal location for this role is the East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific East Hanover site for periodic live meetings will be at the employee's expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 10-20% travel. The Director, Ethics, Risk & Compliance Advisor- Integrated Marketing will be responsible to identify, assess, and support effective management of risks presented by Integrated Marketing strategies for assigned marketing domains areas across all US therapeutic areas (TAs) and products to ensure execution of strategies is in compliance with applicable NPC policies, procedures and CIA requirements. The ERC Integrated Marketing Advisor will clearly identify, assess and articulate risks as part of early concept discussions for novel and complex marketing strategies (e.g. omnichannel engagement, use of dynamic content, social media) and recommend effective risk management when they are implemented. The ideal candidate is passionate about both enabling compliant marketing strategies and ensuring ERC guidance to Integrated Marketing teams is clear and actionable. Your responsibilities will include, but are not limited to: &bull;Collaborate with Integrated Marketing stakeholders in connection with innovative or complex marketing strategies to identify, assess, and support effective management of risks to ensure execution of such strategies is in compliance with applicable NPC policies, procedures and CIA requirements, whether as part of a pilot to test and validate the strategy or across multiple TAs/products at scale. &bull;Provide specialized ERC advice to marketing domains with high and/or emerging risks (e.g. omnichannel engagement, use of dynamic content, social media) to assess risk in early concept discussions, discuss risk with business owners to achieve an aligned understanding, provide clear and actionable ERC advice on how to effectively mitigate such risks upon implementation, evaluate effectiveness of risk mitigation and document key milestones throughout the process. &bull;Effectively engage with Integrated Marketing leadership teams for assigned domains to ensure they have a holistic view of ERC risks presented in their strategies (key watch areas, what's going well, etc.) and collaborate to implement strategies to address key or emerging risks. &bull;Proactively monitor evolving US healthcare environment, enforcement trends and compliance programs of other pharmaceutical, biotech and medical device companies related to assigned marketing domains to identify and share insights within ERC. &bull;Be a knowledge expert related to Novartis healthcare compliance policies, procedures and CIA requirements and how they apply to associates' roles and responsibilities throughout of the US organization. &bull;Proactively engage with Ops/Analytics teams supporting assigned Integrated Marketing teams to evaluate data to identify trends and proactively mitigate key and/or emerging risks &bull;Develop trusted relationships with associates of all levels in Integrated Marketing teams to promote a SpeakUp culture and collaborate with Integrated Marketing teams to strengthen a positive culture towards compliance and ethical decision making as an integral part of how we reimagine medicine for patients. &bull;Engage with Therapeutic Area General Manager and related cross-functional leaders to ensure a holistic view of risks across the strategies leveraged for assigned therapeutic area(s) (key watch areas, what's going well, etc.) and ensure clear and actional ERC guidance is provided or seamless transition to the appropriate ERC stakeholder. This position will require 10-20% travel. 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 What you'll bring to the role: &bull;Bachelor's Degree is required in relevant area &bull;8+ years in pharmaceutical, medical device or biotech companies; consulting, compliance or legal counseling of pharmaceutical or biotech companies; or combination thereof, including 3+ years in or counseling the Marketing function &bull;2+ years in compliance, legal or regulatory counseling for pharmaceutical, medical device or biotech companies Preferred: &bull;MBA or JD #transformingforgrowth Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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. 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 send an e-mail to [email protected] or 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. The pay range for this position at commencement of employment is expected to be between $183,200 and $274,800/year; however, while salary ranges are effective from 1/1/22 through 12/31/22, 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

Director, Ethics Risk & Compliance Integrated Marketing Advisor

About the Role The location of the position will be at our Cambridge, MA site and will not have the ability to be located remotely. Hundreds of millions of people globally are negatively impacted by neurodegenerative diseases. Among these, disorders such as Alzheimer's, Parkinson's and Huntington's diseases limit independence, often shortening the lives of patients and place enormous burdens on family and society. Novartis is exploring new frontiers to treat neurodegenerative disorders. In the role of Executive Director you will provide medical and scientific leadership and expertise in a role that significantly impacts the entire Novartis Neurodegenerative drug development pipeline. In this key position you will: &bull; Drive success of early global programs, develop and implement strategies to achieve clinical Proof of Concept &bull; Drive success of late global programs when appropriate by developing and implementing strategies that lead to clinical pharmacology, design of mechanistic studies and profiling packages that meet regulatory requirements and support differentiated and competitive drug labeling &bull; Provide scientific expert assessments and support for in-licensing opportunities, including due diligences In collaboration with your Translational Medicine (TM) Therapeutic Area Head or other TM Experts, your responsibilities will include: &bull; Develop high value decision-strategies for the TM component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in single or multiple indications, including Parallel Indication Expansion-Proof of Concepts - Represent TM and lead global project teams through First in Human and Proof of Concept phase to drive implementation of the Proof of Concept strategy - Convene relevant internal and external leaders together to consider the proposed approach to Proof of Concept - In collaboration with research scientists, contribute to the proposal of new targets or indications for existing compounds; identify, develop, and implement strategy for preclinical support of clinical program-related scientific objectives. This includes assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications, and other relevant activities - Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies. - Responsible for clinical portions of the Integrated Development Plan, including the Clinical Development Plan and Clinical Pharmacology Plan &bull; Accountable for compound and disease related biomarker strategies, working closely with Biomarker Experts in implementation &bull; Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures. &bull; Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study &bull; Provide medical and scientific leadership and expertise to all line functions on the study team &bull; Represent clinical TM aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups) &bull; Represent clinical TM in reviews of external opportunities &bull; Oversee publication and external presentation of study results &bull; Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches &bull; Contribute to initiatives that drive innovation, quality, and efficiency across TM In this role you may have people management responsibility with 1-3 direct reports and matrix people responsibility per project: 5-8 cross-functional members from within TM plus other functions per project team. Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $284,000 - $426,000/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 Key Requirements &bull; Medical Degree and additional PhD/post-doctoral equivalent research experience &bull; Specialized further training in neurodegenerative or movement disorders required &bull; 15 plus years combined professional academic or industrial experience &bull; Advanced / business-level / fluent English (oral and written) &bull; Recognized for medical expertise: demonstrated excellence and clinical / patient expertise in neurodegenerative diseases &bull; Recognized for scientific expertise: respected by colleagues internally and externally, you've made significant contributions to your field and created / established new concepts; record of high quality publications in international scientific journals. &bull; Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for leading the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience. You are used to working independently and within teams including scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills &bull; Excellent written and oral communication/presentation skills, used to distilling and effectively conveying significant messages to different audiences 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. 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. .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. 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, Trans Med for Neuroscience, Neurodegeneration

Site Name: Cambridge Binney Street Posted Date: Mar 19 2024 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 impact the health of 2.5 billion people around the world in the next 10 years. GSK has an exciting new opportunity for an experienced Process Engineer who will work closely with Manufacturing senior leadership to achieve department goals, interdepartmental manufacturing readiness, and batch release requirements. The Process Engineer is also responsible for owning and driving manufacturing improvement projects from concept to completion, with a particular focus on creating efficiencies that contribute to safety, quality, cost, on-time delivery, and right first-time performance. The Process Engineer supports by working cross-functionally with internal support departments and occasionally with external manufacturing to drive project completion. Key Responsibilities:<ul><li>Work independently to drive/own and cross functional team performance. </li><li>Develop a strong understanding of the manufacturing process and details of the associated hands-on operating requirements.</li><li>Learn complex concepts and communicate the information in a way that is engaging and understood by users.</li><li>Collaborate closely with SMEs and QA teams to create clear, concise, and technically accurate documentation.</li><li>Perform all tasks associated with Quality Record Management and Initiation and collaboratively resolve issues.</li><li>Own and manage Manufacturing process specific change controls, and CAPA's.</li><li>Author Minor and Major Deviation Investigations.</li><li>In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools.</li><li>Devises and implements CAPAs to address root cause and ensure effectiveness.</li><li>Collaborate with technical and operational stakeholders, writes and/or revises SOPs, batch records, technical reports, and other operational related documents if required.</li><li>Generate training material and conduct training for manufacturing staff.</li><li>Execute and collaborate with MFG and cross functional SMEs on Human Error Reduction CAPAs/Right First Time Initiatives.</li><li>Drive and own improvement projects that support department KPI's, with a focus on cost, innovation, on-time delivery, and quality. Manage projects from concept to completion; create and manage project plan, work cross- functionally and provide adequate training to impacted areas.</li><li>Generate and Manage Metrics.</li><li>Act as back-up to Manufacturing Management to perform Validation Protocol Review and approval.</li><li>Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, MSAT, QA and Validation team.</li><li>Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.</li><li>Collaborate with engineering and validation teams to implement and qualify new equipment and controls.</li><li>Represent the interests of the Manufacturing team, serve in multidisciplinary project teams, working closely with other team members in a cooperative fashion to ensure project progression.</li><li>Be actively engage in Inspection Readiness activities and support internal and regulatory audits as needed.</li><li>Adhere to cGMPs is always required during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner for serious GMP deficiencies, process deviations, product defects and relevant actions.</li><li>Perform other duties and projects as assigned, according to the changing needs of the business.</li></ul> Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: <ul><li>BS Degree in Engineering or equivalent technical discipline</li></ul><ul><li>3+ years of Biotech/Life Science/Pharmaceutical Biologics GMP Manufacturing related experience is required.</li></ul> Preferred Qualifications: If you have the following characteristics, it would be a plus: <ul><li>Facilitation and demonstration skills</li><li>Independent collaboration with outside resources</li><li>More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP) General knowledge of Quality/Regulatory GMP requirements in a biologics Pharma/ Biotech industry.</li><li>The knowledge, understanding, and application of cGMP's as it relates to Commercial operations.</li><li>Excellent written (especially technical writing), presentation and verbal communication skills.</li><li>Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules.</li><li>Attention to detail and good investigation, problem-solving skills.</li><li>Prioritize and deliver work in a fast-paced, deadline-driven environment.</li><li>The ability to adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.</li><li>Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint.</li><li>Very strong attention to detail.</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.

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