Johnson & Johnson - Springfield, IL

posted 5 months ago

Full-time - Senior
Remote - Springfield, IL
Chemical Manufacturing

About the position

The Director, Regulatory Medical Writing at Johnson & Johnson is a senior-level role focused on leading the development of high-quality regulatory documentation for marketing applications across various therapeutic areas. This position involves strategic planning, collaboration with cross-functional teams, and mentoring medical writing professionals to ensure successful submissions. The role emphasizes the importance of regulatory compliance and effective communication within the organization and with external partners.

Responsibilities

  • Lead early strategic submission discussions with key stakeholders and senior leadership.
  • Develop and maintain submission training materials specific to clinical content.
  • Collaborate with Compound Development Teams (CDTs) to align on submission strategy and goals.
  • Promote consistency and standardization of Regulatory Medical Writing (RegMW) best practices across submissions.
  • Identify risks and contribute to risk mitigation discussions for submission-related activities.

Requirements

  • A minimum of a Bachelor's degree is required; advanced degrees (Masters, PhD, MD) are preferred.
  • At least 12 years of relevant pharmaceutical/scientific experience is required.
  • A minimum of 10 years of relevant medical writing experience is required.
  • At least 5 years of submission experience across multiple new molecular entities is required.
  • Extensive understanding of clinical Module 2 and Module 5 documents is required.

Nice-to-haves

  • Experience with Module 1 documents is preferred.
  • Green Belt Certification or process improvement experience is preferred.

Benefits

  • Medical, dental, and vision insurance coverage.
  • Life insurance and short- and long-term disability insurance.
  • 401(k) retirement plan participation.
  • Vacation time of up to 120 hours per calendar year.
  • Sick time of up to 40 hours per calendar year.
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