Regulatory Writing Senior Manager
Amgen
Summary
Serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities.
Job description
Key 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
Requirements
- 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 Insurance
- Dental Insurance
- Vision Coverage
- Life Insurance
- Disability Insurance
- Flexible Spending Accounts
- Retirement and Savings Plan
- Annual Bonus
- Stock-Based Long-Term Incentives
- Paid Time Off
- Company-Wide Shutdowns
- Flexible Work Arrangements
- Career Development Opportunities
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.