Role
The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. The role includes authoring and overseeing the creation of clinical documentation to support trials and regulatory submissions.
Responsibilities
Document Creation and Review
- Lead planning and authoring of complex clinical and regulatory documents such as protocols, amendments, clinical study reports, and investigator brochures.
- Oversee preparation of clinical overviews, summaries in CTD/eCTD format for regulatory submissions, Health Authority briefing books, responses, and scientific publications (abstracts, posters, slide presentations, manuscripts).
Team Leadership & Collaboration
- Represent medical writing on internal teams such as Clinical Development, Clinical Trial, protocol review committee, regulatory submission teams, and ad‑hoc working groups.
- Lead cross‑departmental submission teams, ensuring high performance and regulatory compliance.
- Mentor new employees and consultants; serve as role model for junior writers.
- Guide staff during planning and execution stages across all document types and regulatory submissions.
Process Development
- Develop, review, implement, and improve departmental processes, policies, SOPs, training, and work guidance.
- Initiate and drive strategic medical writing initiatives aligned with company priorities.
- Oversee vendors/CROs ensuring performance standards are met.
Regulatory and Quality Adherence
- Maintain up‑to‑date knowledge of regulatory guidelines and requirements.
- Ensure adherence to guidelines, SOPs, practices, and technical standards in all work.
Professional Development
- Maintain current knowledge and competencies within relevant therapeutic and professional areas.
- Contribute to knowledge sharing, skill‑building, and good collaboration with stakeholders and colleagues.
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, or 15+ years cumulative biotech/pharma experience with at least 10 years regulatory medical writing experience.
- Oncology experience required.
- Significant experience writing and leading critical clinical documents for major regulatory filings (NDA, BLA, MAA).
- Advanced familiarity with all phases of drug development and a clinical operations organization.
- Experience working with drug development processes, GCP, regulatory requirements associated with all regulatory documents (CTA/IND submissions, protocols, investigator brochures, clinical study reports).
- Significant experience managing and guiding internal cross‑functional teams.
- Experience managing a functional team/overseeing work of other writers/CROs/vendors.
- Proven performance in earlier comparable role.
Compensation
For U.S. based candidates, the proposed salary band is $198,240.00—$297,360.00. This range reflects experience, qualifications, and location. Additional compensation may include discretionary bonuses and long‑term incentives.
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 discretionary paid parental leave.
- Support Resources: 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.
Locations
Genmab maximizes efficiency in an agile working environment. Offices are open and community‑based. Employees can work onsite or remotely, with a focus on connection and innovation.
About You
- You are genuinely passionate about our purpose.
- You bring precision and excellence to all that you do.
- You believe in our rooted‑in‑science approach to problem‑solving.
- You are a generous collaborator who can work with a broad spectrum of backgrounds.
- You take pride in enabling the best work of others on the team.
- You can grapple with the unknown and be innovative.
- You have experience working in a fast‑growing, dynamic company (or a strong desire to).
- You work hard and are not afraid to have a little fun while you do so.