Director, Medical Writing

About the role

The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical documentation to support the conduct of trials and regulatory submissions/filings. The role also involves collaborating with various internal teams and participating in the development of templates and medical writing processes.

Responsibilities

• Lead the planning and authoring of complex strategic clinical and regulatory documents, including clinical trial protocols, amendments, clinical study reports, and investigator’s brochures.
• Oversee the preparation of clinical overviews, summaries in CTD/eCTD format for regulatory submissions, Health Authority briefing books, responses, and scientific publications (abstracts, posters, slide presentations, and manuscripts).
• Represent medical writing on internal teams such as the Clinical Development Team and/or Clinical Trial Team, protocol review committee, regulatory submission teams, and ad-hoc working groups to support company initiatives.
• Independently lead cross-departmental submission teams, ensuring high performance standards and compliance with regulatory requirements.
• Mentor new employees and consultants and serve as a role model for junior writers.
• Guide medical writing staff during the planning and execution stages across all document types and regulatory submissions.

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

Qualifications

• 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

Skills

• Strong communication and collaboration skills
• Ability to work independently and as part of a team
• Knowledge of regulatory guidelines and requirements
• Experience with clinical trial protocols and regulatory submissions
• Proficiency in medical writing software and tools

Benefits

Genmab offers competitive compensation, including a salary range of $198,240.00—$297,360.00 for this position, with additional forms of compensation available. Health benefits, including two medical plan options, dental, and vision insurance, are provided. Voluntary plans such as critical illness, accident, and hospital indemnity insurance are also available. Time off includes paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave. Support resources include access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support. Additional perks include commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses.

Pay

$198,240.00—$297,360.00

Schedule

Full-time