We are looking for a highly motivated, independent and talented Medical Writer. Manager and Associate Director level available for more experienced candidates. As a member of the medical writing team, you will be responsible for driving, developing, and writing clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. As a Medical Writer, you will be responsible for ensuring that scientifically robust messages and arguments are developed and conveyed consistency 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 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.
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.
Draft and edit documents used to support clinical trial conduct and reporting, including clinical trial protocols, investigator’s brochures, and clinical study reports, including subject narratives. Additionally, may be responsible for drafting or assisting in drafting edit Health Authority briefing packages, Health Authority responses, and clinical CTD submission documents.
Drive trial team participation in the preparation of such documents, including calling/scheduling/facilitating meetings, developing and managing timelines, document review, and decisions.
Provide peer review and editing support for other clinical/regulatory documents, as needed.
Adhere to guidelines, SOPs, and practices and technical and industry standards during all aspects of work.
Support developing and reviewing standard processes and templates.
Work effectively in cross-functional working groups.
What we ask
At least 5 years’ medical or scientific writing or editing experience, preferably in the pharmaceutical industry. Oncology experience highly preferred for senior-level consideration.
Experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred.
Basic familiarity of the drug development process, clinical trial protocol design, CTA/IND submissions, investigator’s brochures, plans required for the conduct of clinical studies, and clinical study data collection and results reporting.
Knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
Knowledge of or experience writing protocols, investigator’s brochures, and clinical study reports. Senior level candidates should also have knowledge of Health Authority briefing packages, Health Authority responses, and Pediatric Investigational Plans (PIPs).
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).
Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, EndNote, document management systems.
Ability to interpret and summarize tabular and graphical data presentations.
Moreover, you meet the following personal requirements:
- You are capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines.
- You are motivated and detail-oriented.
- You have the ability to work across all trial phases and prioritize your own tasks.
- You are a dedicated team player and a great communicator with excellent oral and written communication skills.
- You are proactive and open-minded
- You have a quality mindset and thrive in a fast-paced and changing environment.
- You are result- and goal-oriented and committed to contributing to the overall success of Genmab.