Associate Director, Medical Writing

Overview

At Genmab, we are dedicated to building extra[not]ordinary futures by developing antibody products and groundbreaking medicines that change lives in cancer treatment and serious diseases. We strive to create a global workplace where individuals’ unique contributions are valued and drive innovative solutions for 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 drive, develop, and write clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will contribute to the medical writing portfolio within the clinical and regulatory areas, authoring documents such as briefing documents, clinical trial medical synopses, protocols, investigator’s brochures, PIPs, CSRs, Health Authority briefing books, Health Authority responses, and other clinical documentation to support trials and regulatory submissions/filings.

Key Accountabilities

• 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 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 related field preferred; advanced degree preferred.
• At least 8 years of relevant medical or scientific writing experience in the pharmaceutical industry. Oncology experience preferred.
• Familiarity with all phases of drug development processes, clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans for 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) required. Also 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 of regulatory requirements and drug development processes, Good Clinical Practice (GCP), and regulatory requirements/guidelines for regulatory documents.
• Ability to interpret and summarize tabular and graphical data presentations.

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

Compensation (US) For US-based candidates, the proposed salary…