Senior Medical Writer
3 weeks ago
We are seeking a highly motivated and collaborative Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will play a critical role in planning, developing, and writing complex clinical documents to support medical and regulatory activities across our portfolio.
Key Responsibilities- Apply expert medical writing proficiency to lead the planning and authoring of clinical and regulatory documents and submission packages.
- Serve as a document planning and writing expert, guiding a medical writing and project team during the planning and authoring stages across all document types and regulatory submissions.
- 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, assessing and implementing AI technologies to advance our technological and digital capabilities.
- Lead the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance as applicable.
- 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.
- 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.
- 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 software (e.g., word processing, graphics, reference manager, EndNote, document management systems).
- You are self-driven and thrive working in a collaborative, team environment.
- 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.
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