Associate Director, Medical Writing NJ

2 months ago

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

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 be responsible for planning, developing, and writing 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 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.
  • 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, such as assessing and implementing AI technologies.
  • Lead, and actively contribute to, 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.
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, Health Authority responses, and Pediatric Investigational Plans (PIPs).
  • 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, such as word processing, graphics, reference manager, EndNote, document management systems.
About You

We are looking for a self-driven and collaborative individual who thrives in a team environment. You should be capable of working on multiple tasks and shifting priorities, and leading cross-functional teams under strict timelines. You should be motivated and detail-oriented, with the ability to work across all trial phases and prioritize your own tasks.

You should be a dedicated team player and a great communicator with excellent oral and written communication skills. You should be proactive and open-minded, with a quality mindset and a commitment to contributing to the overall success of Genmab.

Additional Information

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.

We are committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application.

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