Associate Director, Medical Writing Expert

2 weeks ago


Plainsboro, New Jersey, United States Genmab Full time
About the Role

We are seeking a highly skilled Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will be responsible for 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.
  • Initiate and drive strategic medical writing initiatives and processes to ensure execution on company priorities.
  • Contribute to the development and implementation of Medical Writing strategy in line with organizational strategy.
  • Lead a submission team and ensure quality of documents or sections of documents prepared by self/other writers.
Requirements
  • 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.
  • Ability to interpret and summarize complex tabular and graphical data presentations.
About You

We are looking for a self-driven and collaborative individual who thrives in a fast-paced environment. You should have excellent oral and written communication skills, be able to work on multiple tasks and shifting priorities, and be a dedicated team player.

We offer a position where you will be involved in strategic project activities, have ample opportunities for growth and development, and be part of a dynamic and innovative team.



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