Associate Director, Medical Writing

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

We are looking for a highly motivated, independent and talented Associate Director of Medical Writing. In this role, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio.

• Independently author and review complex clinical and regulatory documents, including clinical trial protocols, clinical overviews, and summaries in CTD/eCTD format for regulatory submissions.
• Draft and edit more strategic documents, such as Health Authority briefing books, responses, and publications (abstracts, posters, slide presentations, and manuscripts for scientific journals).
• Represent medical writing on internal teams such as the Clinical Trial Team, protocol review committee, and regulatory submission teams.
• Lead submission team activities and oversee the preparation of critical documents.
• Facilitate team participation in document preparation, including scheduling meetings, developing timelines, and managing document reviews and decisions.
• Act as a mentor for new employees and consultants and serve as a role model for junior writers.
• Lead the development and review of standard processes and templates.
• Support ongoing improvements in cross‑functional and global collaboration, sharing best practices and knowledge.

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field preferred; advanced degree preferred.
• At least 8 years relevant medical or scientific writing experience in the pharmaceutical industry; oncology experience preferred.
• Familiarity with all phases of drug development processes (discovery to market), clinical trial protocol design, CTA/IND submissions, investigator's brochures, plans required for the conduct of clinical trials, and clinical trial data collection and results reporting.
• Experience authoring clinical trial protocols (Phase 1–3) and clinical components in regulatory filings (NDA, BLA, MAA) is required. Additionally, experience preparing investigator's brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses.
• Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• General understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize tabular and graphical data presentations.

• Strategic thinker with a big‑picture orientation.
• Thorough, systematic, and organized.
• Proactive, accountable, and goal oriented.
• Innovative and a good team player.
• Excellent at sharing knowledge and acting as a mentor.
• Superior communication skills, capable of conveying scientific or medical information clearly and concisely.
• Exceptional planning and coordinating abilities.
• Ability to manage multiple tasks simultaneously.
• Extensive knowledge of English grammar.
• Expert in Microsoft 365.
• Analytical skills with the ability to interpret and present clinical data and other complex information.
• Advanced leadership skills to guide and mentor team members.
• Expertise in managing complex projects and submissions.
• Strong influence and representation skills in high‑level cross‑functional teams.
• Strategic vision to drive departmental goals and initiatives.
• High level of knowledge of regulatory requirements and compliance.

For US based candidates, the proposed salary band for this position is $—$.

• 401(k) Plan: 100% match on the first…