Genmab is a biotechnology company dedicated to developing innovative antibody products and treatments. They are seeking a Director of Medical Writing to advance their medical writing portfolio and lead the planning and authoring of clinical documentation. The ideal candidate will have 12+ years of experience in clinical or regulatory medical writing, a Master's degree, and significant experience in writing critical clinical documents for regulatory filings. They will lead a team of medical writers, develop processes and standards, and collaborate with internal teams to ensure quality and timeliness of regulatory filings and clinical documentation.
Requirements
- Bachelor's degree in science or related area; Master's/advanced degree preferred
- 12+ years in clinical or regulatory medical writing in biotech/pharma industry or 15+ years of relevant, cumulative biotech/pharma industry experience with at least 10 years regulatory Medical Writing experience
- Oncology experience required
- Significant experience in writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA)
- Advanced familiarity with all phases of drug development and a clinical operations organization
- Significant experience in working with drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with all regulatory documents (including CTA/IND submissions, protocols, investigator brochures, and clinical study reports)
- Significant experience managing/guiding internal cross-functional teams
- Experience in managing a functional team/overseeing the work of other writers/CROs/vendors
- Proven performance in earlier role/comparable role
Benefits
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
