Amgen is hiring a Regulatory Writing Senior Manager to serve as the functional area lead on product teams. In this role, you will provide critical expertise, lead writing activities for complex submissions, and help drive departmental goals.
What You'll Do
- Author or oversee the authoring of all regulatory submission documents, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, and eCTD Module 2 Clinical Summary Documents.
- Conduct formal review and approval of authored documents following standard operating procedures.
- Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications.
- Serve as functional area lead on product teams such as the Global Regulatory Team and Evidence Generation Team.
- Provide functional area input for the Global Regulatory Plan and team goals.
- Supervise contract and freelance writers and mentor junior medical writers.
- Lead departmental and cross-departmental initiatives.
- Generate document timelines.
What We're Looking For
- Doctorate degree and 2 years of directly related experience
- OR Master’s degree and 6 years of directly related experience
- OR Bachelor’s degree and 8 years of directly related experience
- OR Associate’s degree and 10 years of directly related experience
- OR High school diploma / GED and 12 years of directly related experience
Nice to Have
- Experience with regulatory documents in Regulatory Affairs, Research, Development or a related area.
- 5+ years of experience in medical writing within the Biotech/Pharmaceutical industry.
Team & Environment
You will serve as the functional area lead on product teams, guiding strategy and execution.
Benefits & Compensation
- Compensation range: $152,684.00 - $193,308.00 USD
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans and bi-annual company-wide shutdowns.
Work Mode
This role offers a hybrid work model, combining on-site collaboration with remote work arrangements.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
