About the Role
Genmab is seeking a Director, Medical Writing to advance its medical writing portfolio across clinical and regulatory programs. The role is responsible for leading and overseeing the authoring of complex clinical and regulatory documentation supporting clinical trials and major regulatory submissions and filings.
This senior leadership position works closely with Clinical Development, Clinical Operations, Regulatory, and other cross-functional teams. The successful candidate will bring extensive biotech/pharmaceutical medical writing experience, strong oncology expertise, and demonstrated leadership in regulatory medical writing, document strategy, process development, and cross-functional collaboration.
Key Responsibilities
• Lead the planning and authoring of complex strategic clinical and regulatory documents.
• Author and oversee clinical trial protocols, protocol amendments, clinical study reports, and investigator's brochures.
• Oversee clinical overviews and summaries in CTD/eCTD format for regulatory submissions.
• Oversee Health Authority briefing books and responses.
• Oversee scientific publications, including abstracts, posters, slide presentations, and manuscripts.
• Represent Medical Writing on Clinical Development Teams, Clinical Trial Teams, protocol review committees, regulatory submission teams, and ad-hoc working groups.
• Lead cross-departmental submission teams and ensure compliance with regulatory requirements.
• Mentor new employees and consultants and serve as a role model for junior medical writers.
• Guide medical writing staff through planning and execution across document types and regulatory submissions.
• Lead the development, review, implementation, and improvement of departmental processes, policies, SOPs, training, and work guidance.
• Drive strategic Medical Writing initiatives and processes aligned with company priorities.
• Oversee Medical Writing vendors and CROs and ensure high performance standards.
• Maintain current knowledge of relevant regulatory guidelines and requirements.
• Ensure adherence to applicable guidelines, SOPs, practices, and technical standards.
• Maintain current knowledge and competencies within relevant therapeutic and professional areas.
• Support knowledge sharing, skill development, and effective collaboration with stakeholders and colleagues.
Required Qualifications
• Bachelor's degree in science or a related area.
• 12+ years of clinical or regulatory medical writing experience in the biotechnology or pharmaceutical industry; or 15+ years of relevant cumulative biotech/pharmaceutical industry experience, including at least 10 years of regulatory Medical Writing experience.
• Oncology experience.
• Significant experience writing or leading the writing of critical clinical documents for major regulatory filings, including NDA, BLA, and MAA submissions.
• Advanced familiarity with all phases of drug development and clinical operations.
• Significant experience with drug development processes, Good Clinical Practice (GCP), and regulatory requirements and guidelines for clinical and regulatory documents.
• Experience with regulatory documents including CTA/IND submissions, protocols, investigator brochures, and clinical study reports.
• Significant experience managing or guiding internal cross-functional teams.
• Experience managing a functional team or overseeing the work of medical writers, CROs, or vendors.
• Proven performance in an earlier comparable or relevant role.
Preferred Qualifications
• Master's degree or other advanced degree in science or a related area.
• Additional experience in strategic Medical Writing leadership and process development.
• Experience working in a fast-growing, dynamic biotechnology or pharmaceutical company.
Skills & Competencies
• Medical writing
• Regulatory medical writing
• Clinical documentation
• Regulatory submissions
• NDA, BLA, and MAA submissions
• CTA/IND submissions
• Clinical trial protocols
• Clinical study reports
• Investigator's brochures
• CTD/eCTD documentation
• Health Authority responses
• Scientific publications
• Oncology
• Drug development
• Clinical operations
• Good Clinical Practice (GCP)
• Regulatory compliance
• Cross-functional team leadership
• Vendor and CRO management
• Process development
• SOP development
• Strategic planning
• Mentoring and staff development
• Communication and collaboration
• Quality and attention to detail
Education & Experience
Education
• Bachelor's degree in science or a related area is required.
• Master's degree or advanced degree is preferred.
Experience
• 12+ years of clinical or regulatory medical writing experience in the biotech/pharmaceutical industry; or
• 15+ years of relevant cumulative biotech/pharmaceutical industry experience, including at least 10 years of regulatory Medical Writing experience.
• Oncology experience is required.
• Significant experience with critical clinical documents supporting major regulatory filings is required.
Work Arrangement & Schedule
• Work Arrangement: Remote
• Location: Princeton, New Jersey, United States
• Employment Type: Not specified in the source job description.
• Work Environment: Genmab supports an agile working environment, with opportunities to work remotely or from office locations where applicable.
• Schedule: Not specified in the source job description.
Compensation & Benefits
Salary
• U.S. Salary Range: $198,240–$297,360 per year.
• Actual salary may vary based on skills, qualifications, experience, and location.
• Certain positions may be eligible for discretionary bonuses and long-term incentives.
Benefits for eligible regular full-time U.S. employees
• 401(k) plan with 100% company match on the first 6% of contributions.
• Medical plan options, including HDHP with HSA.
• Dental and vision insurance.
• Critical illness, accident, and hospital indemnity insurance.
• Paid vacation, sick leave, and holidays.
• 12 weeks of discretionary paid parental leave.
• Child and adult backup care.
• Family support programs.
• Financial wellness resources.
• Emotional well-being support.
• Commuter benefits.
• Tuition reimbursement.
• Lifestyle Spending Account for wellness and personal expenses.
Compliance / Additional Information
Genmab is committed to creating an inclusive workplace where individual contributions are valued and differences are welcomed. The company states that it welcomes people across differences in backgrounds, experiences, and perspectives.
Genmab is committed to protecting applicant personal data and privacy. Additional employment terms may apply to positions in specific countries, including the Netherlands.