Note: The job is a remote job and is open to candidates in USA. Amgen is seeking a Regulatory Writing Senior Manager to lead regulatory writing activities for complex product submissions and serve as the functional area lead on product teams. The role also oversees and reviews regulatory documents, mentors writers, and leads departmental initiatives.
Responsibilities
- Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures
- With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- Provide functional area input for Global Regulatory Plan and team goals
- Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
- Lead departmental and cross-departmental initiatives, as appropriate
- Generate document timelines
Skills
- Doctorate degree and 2 years of directly related experience
- Master's degree and 6 years of directly related experience
- Bachelor's degree and 8 years of directly related experience
- Associate's degree and 10 years of directly related experience
- High school diploma / GED and 12 years of directly related experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Benefits
- Health and welfare plans for staff and eligible dependents.
- Financial plans with opportunities to save towards retirement or other goals.
- Work/life balance.
- Career development opportunities.
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
- 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.
Company Overview