Director, Regulatory Medical Writing Specialist

4 weeks ago

Markham, Ontario, Canada Johnson & Johnson Full time
Job Title: Director, Regulatory Medical WritingJob Summary:

We are seeking a highly experienced Director, Regulatory Medical Writing to join our team at Johnson & Johnson. As a key member of our Regulatory Medical Writing team, you will be responsible for leading the development of high-quality regulatory documentation, including clinical Module 2 and Module 5 documents. Your expertise will be essential in ensuring compliance with global regulations and guidelines.

Key Responsibilities:
  • Lead the development of clinical Module 2 and Module 5 documents, ensuring compliance with global regulations and guidelines.
  • Collaborate with cross-functional teams to ensure alignment on submission strategy and scope.
  • Develop and maintain submission training materials, including training teams as needed.
  • Promote consistency and standardization of RegMW submission best practices across all submissions and TAs.
  • Develop and continually evolve training resources.
  • Provide clarity in team roles, responsibilities, and accountabilities.
Requirements:
  • A minimum of 12 years of relevant pharmaceutical/scientific experience.
  • A minimum of 10 years of relevant medical writing experience.
  • A minimum of 5 years of submission experience across multiple new molecular entities.
  • Extensive understanding and experience leading teams through delivery of clinical Module 2 and Module 5 documents.
  • Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing applications.
What We Offer:
  • A competitive salary and benefits package.
  • The opportunity to work with a global leader in the pharmaceutical industry.
  • A dynamic and collaborative work environment.

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