Senior Regulatory Writing Manager
Amgen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $143,169 - $174,830 per year
Job Level
Senior
About the role
- 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 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
- 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
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submission documentsClinical Study ReportsInvestigator BrochuresProtocolseCTD Module 2 Clinical Summary Documentsmedical writingdrug applicationsbiologics license applicationsdocument timelines
Soft skills
leadershipmentoringsupervisioncross-departmental collaboration
Certifications
Doctorate degreeMaster’s degreeBachelor’s degreeAssociate’s degreeHigh school diploma / GED