Johnson & Johnson - Atlanta, GA

posted 5 months ago

Full-time - Senior
Remote - Atlanta, GA
Chemical Manufacturing

About the position

The Director, Regulatory Medical Writing at Johnson & Johnson is a senior 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 in collaboration with key stakeholders and senior leadership.
  • Mentor and support regulatory medical writing submission leads and team members.
  • Collaborate with Compound Development Teams to develop and align on submission strategy and scope.
  • Promote consistency and standardization of regulatory medical writing submission best practices across all submissions.
  • Actively identify risks and contribute to risk mitigation discussions for regulatory medical writing aspects of submissions.

Requirements

  • A minimum of a Bachelor's degree is required; advanced degrees (Masters, PhD, MD) are preferred.
  • A minimum of 12 years of relevant pharmaceutical/scientific experience is required.
  • A minimum of 10 years of relevant medical writing experience is required.
  • A minimum of 5 years of submission experience across multiple new molecular entities is required.
  • Extensive understanding and experience leading teams through delivery 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, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • 401(k) retirement plan participation.
  • Vacation - up to 120 hours per calendar year.
  • Sick time - up to 40 hours per calendar year; up to 56 hours for Washington residents.
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year.
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