Regulatory Writing Senior Manager
About The Position
The Regulatory Writing Senior Manager serves as a functional area lead on product teams, leads regulatory writing activities for complex product submissions, provides functional area expertise, trains and mentors more junior writers, and leads departmental activities. The role involves authoring or overseeing regulatory submission documents, formally reviewing and approving documents in accordance with applicable standard operating procedures, supervising contract and freelance writers, and generating document timelines. The position also contributes to departmental and cross-departmental initiatives.
Requirements
- Doctorate degree and 2 years of directly related experience, or a master’s degree and 6 years of directly related experience, or a bachelor’s degree and 8 years of directly related experience, or an associate’s degree and 10 years of directly related experience, or a high school diploma/GED and 12 years of directly related experience.
Nice To Haves
- Experience with regulatory documents in Regulatory Affairs, Research, Development, or a related area.
- 5 or more years of experience in medical writing in the biotechnology or pharmaceutical industry.
Responsibilities
- Author or oversee authoring of regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Tables of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans.
- Conduct formal review and approval of authored documents according to applicable standard operating procedures.
- Lead regulatory writing activities, with limited supervision, for complex product submissions, including new and supplemental drug applications and biologics license applications.
- Serve as the functional area lead on product teams, such as Global Regulatory Teams, Evidence Generation Teams, Global Safety Teams, and Label Working Groups.
- Provide functional area input for the Global Regulatory Plan and team goals.
- Supervise contract and freelance writers and mentor junior medical writers as assigned.
- Lead departmental and cross-departmental initiatives, as appropriate.
- Generate document timelines.
Benefits
- Comprehensive employee benefits package, including health and welfare plans for employees and eligible dependents.
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
- Flexible work models, including remote work arrangements where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
