Director, Medical Writing

At Genmab, we are dedicated to building extra[not]ordinary® 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. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! 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 Director, Medical Writing participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. This role collaborates with the other members of the Medical Writing Leadership Team to manage the planning, oversight, and execution of the Medical Writing portfolio, drive strategic initiatives, and identify development areas within Medical Writing. Responsibilities: Document Creation and Review: 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). Team Leadership and Collaboration: 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. Process Development: Lead the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance. Initiate and drive strategic Medical Writing initiatives and processes to ensure alignment with company priorities. Manage the oversight of Medical Writing vendors/CROs, ensuring high performance standards are met. Regulatory and Quality Adherence: Maintain up-to-date knowledge of relevant regulatory guidelines and requirements. Ensure adherence to guidelines, SOPs, practices, and technical standards in all aspects of work. Professional Development: Maintain current knowledge and competencies within relevant therapeutic and professional areas. Contribute to knowledge sharing, skill-building, and good collaboration with stakeholders and colleagues. 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 e