Associate Director, Medical Writing
Genmab
June 25, 2026
Remote friendly (Princeton, NJ)
United States
Clinical Research and Development
Associate Director, Medical Writing
Responsibilities
- Author and review complex clinical and regulatory documents (clinical trial protocols, clinical overviews, CTD/eCTD regulatory submission documents; Health Authority briefing books, responses, publications such as abstracts/posters/slide decks/manuscripts).
- Represent medical writing on Clinical Trial Team, protocol review committee, and regulatory submission teams.
- Lead submission team activities; oversee preparation of critical documents.
- Facilitate document preparation (scheduling, timelines, managing reviews and decisions).
- Mentor new employees/consultants and role-model for junior writers.
- Lead development/review of standard processes and templates; support process improvements for cross-functional/global collaboration.
- Maintain knowledge of relevant regulatory guidelines; adhere to applicable SOPs, practices, and technical standards.
- Communicate clinical results via discussions, presentations, regulatory documents, and publications.
Qualifications / Skills
- Strategic thinker; thorough, systematic, organized.
- Proactive, accountable, goal-oriented; innovative; strong team player.
- Superior oral/written communication; strong planning/coordinating; ability to manage multiple tasks.
- Excellent English grammar; expert in Microsoft 365.
- Analytical skills to interpret/present clinical data.
- Advanced leadership; expertise managing complex projects and submissions.
- High-level knowledge of regulatory requirements/compliance.
- Close interaction with internal/external stakeholders (regulatory bodies, medical/safety, investigators, CROs, etc.).
Benefits (US-based, within first year for regular full-time employees)
- 401(k) 100% match on first 6%.
- Health (two options incl. HDHP/HSA), dental, vision.
- Paid vacation, sick leave, holidays; 12 weeks discretionary paid parental leave.
- Voluntary plans (critical illness, accident, hospital indemnity).
- Backup care, family support, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions
- “For US based candidates” salary band: $160,080–$240,120 (final offer depends on skills/experience/location; may include discretionary bonuses/long-term incentives).
Responsibilities
- Author and review complex clinical and regulatory documents (clinical trial protocols, clinical overviews, CTD/eCTD regulatory submission documents; Health Authority briefing books, responses, publications such as abstracts/posters/slide decks/manuscripts).
- Represent medical writing on Clinical Trial Team, protocol review committee, and regulatory submission teams.
- Lead submission team activities; oversee preparation of critical documents.
- Facilitate document preparation (scheduling, timelines, managing reviews and decisions).
- Mentor new employees/consultants and role-model for junior writers.
- Lead development/review of standard processes and templates; support process improvements for cross-functional/global collaboration.
- Maintain knowledge of relevant regulatory guidelines; adhere to applicable SOPs, practices, and technical standards.
- Communicate clinical results via discussions, presentations, regulatory documents, and publications.
Qualifications / Skills
- Strategic thinker; thorough, systematic, organized.
- Proactive, accountable, goal-oriented; innovative; strong team player.
- Superior oral/written communication; strong planning/coordinating; ability to manage multiple tasks.
- Excellent English grammar; expert in Microsoft 365.
- Analytical skills to interpret/present clinical data.
- Advanced leadership; expertise managing complex projects and submissions.
- High-level knowledge of regulatory requirements/compliance.
- Close interaction with internal/external stakeholders (regulatory bodies, medical/safety, investigators, CROs, etc.).
Benefits (US-based, within first year for regular full-time employees)
- 401(k) 100% match on first 6%.
- Health (two options incl. HDHP/HSA), dental, vision.
- Paid vacation, sick leave, holidays; 12 weeks discretionary paid parental leave.
- Voluntary plans (critical illness, accident, hospital indemnity).
- Backup care, family support, financial wellness tools, emotional well-being support.
- Commuter benefits, tuition reimbursement, Lifestyle Spending Account.
Application instructions
- “For US based candidates” salary band: $160,080–$240,120 (final offer depends on skills/experience/location; may include discretionary bonuses/long-term incentives).