Medical Writing Director
2 weeks ago
We are seeking a highly skilled and experienced 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 clinical documents to support medical and regulatory activities across our portfolio.
Key Responsibilities- Lead the planning and authoring of complex, strategic clinical and regulatory documents and submission packages.
- Develop and manage timelines, coordinate document review, and drive decision-making.
- Initiate and drive strategic medical writing initiatives and processes with high technical acumen.
- Contribute to the development, review, implementation, and improvement of departmental processes, policies, and standard operating procedures.
- 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.
- BA/BS degree in life sciences and at least 10 years' medical or scientific writing experience, in the pharmaceutical industry.
- Extensive experience writing protocols, investigator's brochures, clinical study reports, Health Authority briefing packages, and regulatory filings.
- Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), and regulatory guidelines.
- Ability to interpret and summarize complex tabular and graphical data presentations.
- Proficiency in the use and understanding of computer software, including word processing, graphics, and document management systems.
- You are a self-driven and collaborative individual with a passion for medical writing and a commitment to excellence.
- You have a strong analytical mindset and excellent communication skills, with the ability to work effectively in a team environment.
- You are a strategic thinker with a focus on process improvement and a willingness to take on new challenges.
- You are a dedicated team player with a commitment to delivering high-quality results under tight deadlines.
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced medical writer looking for a new challenge, we encourage you to apply for this exciting opportunity.
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