At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

We are looking for a highly motivated and collaborative Associate Director, Medical Writing. This is and individual contributor/technical position, not people-management position. As Associate Director, Medical Writing, you will serve as an expert Medical Writer who is responsible for planning, developing, and writing clinical documents to support medical and regulatory activities across the Genmab portfolio by ensuring that scientifically robust messages and arguments are developed and conveyed consistently across documents. Ideally, you will have an academic degree in life sciences with a broad background that has given you a solid knowledge on clinical drug development and regulatory requirements.

The work done by the Associate Director, Medical Writing is complex and strategic and requires advanced stakeholder management acumen for effective collaboration with internal Genmab-and external collaborative partner company-functions that include, but are not limited to, medical, statistics, programming, trial management, data management, regulatory, nonclinical, CMC, and project management. The successful candidate will have strong analytical skills, high quality standards, and is committed to meet deadlines. In addition, it is essential the candidate is well-organized, proactive, and flexible, and has the ability to work on multiple tasks. simultaneously.

The Associate Director, Medical Writing may be tasked with the development of the following documents, including, but not limited to: clinical trial outlines, clinical trial protocols/amendments, investigators brochures, PIPs, DSURs, CSRs, Health Authority briefing books, clinical submission documents, and other clinical documentation to support the conduct of the clinical trials and regulatory submissions/filings. The Associate Director, Medical Writing may also serve as a document or process subject matter expert, leading cross-functional and cross-department process improvement initiatives.

We offer a position where you will be involved in strategic project, as well as trial-related activities, and will have ample opportunities, responsibilities, and influence on defining your own work. You will also be involved in developing processes and tools to support further development of the department.

Key Responsibilities include:
Apply expert medical writing proficiency to lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
Serve as a document planning and writing expert; responsible for guiding a medical writing and project team during the planning and authoring stages across all document types and regulatory submissions, including facilitating document contributor/review meetings, developing and managing timelines, coordinating document review, and driving decision-making.
Initiate and drive strategic medical writing initiatives and processes with high technical acumen to ensure execution on company priorities.
Contribute to/lead Medical Writing digitalization efforts (eg, assessment and implementation of AI technologies) as Genmab continues to achieve on its 2023 Vision and advance its technological and digital capabilities.
Lead, and actively contribute to, the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable. Own relevant medical writing processes; lead medical writing SOP creation/update initiatives.
Closely coordinate with the Technical Document Manager and Document Quality Control groups to ensure adequate planning and end-to-end support for high-quality deliverables.
May be responsible for managing the oversight of medical writing vendors/CROs, ensuring high performance standards are met.
Proactively lead and/or engage in department activities and serve as a mentor for junior writers.
Actively provide input to the overall strategy, unified objectives, and areas for development of the Medical Writing department.


Requirements - what you must have
BA/BS degree in life sciences and at least 10 years' medical or scientific writing experience, in the pharmaceutical industry. Oncology and immunology experience highly preferred.
Extensive experience writing protocols, investigator's brochures, clinical study reports, Health Authority briefing packages, Health Authority responses, and Pediatric Investigational Plans (PIPs). Experience authoring clinical components in regulatory filings (NDA, BLA, MAA).
Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (eg, protocols, investigator brochures, and clinical study reports), CTA/IND/HA regulatory submissions, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
Expert knowledge of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
Ability to interpret and summarize complex tabular and graphical data presentations.
Proficiency in the use and understanding of computer...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity