Medical Writing Operations Senior Manager - QC Reviewer (Remote)
The Medical Writing Operations Senior Manager is responsible for day to-day technical operations within the Medical Writing Associates group. The Senior Manager focuses on standardizing and improving the QC review process to ensure consistency and reliability in the QC of Medical Writing (MW) documents. The Senior Manager applies technical expertise to develop solutions to technical and operational problems and oversees the development, implementation, and maintenance of QC processes and standards for Medical Writing.
Key Duties and Responsibilities:
- Implements and manages QC audit processes
- Represents MW on cross functional teams, including those related to document QC, formatting, and electronic submissions
- Proactively solves technical and operational problems within role area and identifies areas for process improvements
- Participates in and provides technical feedback for MW processes
- Maintains a high level of knowledge related to current developments in the field, including pharmaceutical regulations pertaining to documentation for regulatory submissions
- Applies technical and analytical skills and recommends changes to troubleshoot systems or processes
- Provides expertise to QC project scheduling as needed
- Designs training plans, such as a QC and standards training plan for entry writers
- Prepares and delivers effective presentations for internal and external audiences, as needed
- Contributes to the medical writing priorities for clinical studies, serving as a Medical Communication Scientist as needed
Knowledge and Skills:
- Demonstrates strong oral and written communication skills
- Knowledgeable of processes behind hiring decisions
- Keeps abreast of relevant technology, M1D regulatory initiatives that relate to clinical regulatory documents, and is able to make intelligent recommendations regarding new technologies and methodologies
- Contributes to and supports short- and long term strategic direction for teams or projects
- Successfully leads/influences activities within Medical Writing and cross-functionally
- Seeks out and plans technical direction and promotes technological innovation
Education and Experience:
- Master's Degree (or equivalent degree) and 6+ years relevant work experience
- Or, Bachelor's Degree and 8+ years relevant work experience
Salary range: 116,700 - 169,200 USD Annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [Register to View]