Regulatory Medical Writing Lead

2 days ago


Espoo, Uusimaa, Finland Johnson & Johnson Full time
Job Description:

We are seeking a highly skilled Regulatory Medical Writing Lead to support our Oncology therapeutic area. In this role, you will be responsible for preparing and finalizing clinical documents such as clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.

You will lead cross-functional document planning and review meetings, interact with peer writers and colleagues from other departments, and coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.

Maintain and apply knowledge of the industry, company, and regulatory guidelines. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision.

Compounds lead and/or submission lead experience is preferred.

Key Responsibilities:
  • Prepare and finalize clinical documents
  • Lead cross-functional document planning and review meetings
  • Coach or mentor more junior writers
  • Maintain and apply knowledge of industry, company, and regulatory guidelines


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