Regulatory Medical Writer Senior Analyst

2 weeks ago


Toronto, Ontario, Canada Johnson & Johnson Full time

At Johnson & Johnson Innovative Medicine, we believe in creating a world where complex diseases are prevented, treated, and cured. As a Senior Analyst, Oncology Regulatory Medical Writing, you will play a crucial role in helping us achieve this vision.

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As part of our Integrated Data Analytics & Reporting team, 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.

Maintaining and applying knowledge of the industry, company, and regulatory guidelines is essential for success in this role.

  • Prepare and finalize clinical documents according to regulatory requirements.
  • Lead cross-functional document planning and review meetings.
  • Collaborate with global teams and stakeholders across time zones.

We offer competitive compensation and benefits, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Our comprehensive benefits package also includes vacation time, sick leave, holiday pay, and work-life balance support.



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