Johnson & Johnson - Santa Fe, NM

posted 5 months ago

Full-time - Senior
Remote - Santa Fe, NM
Chemical Manufacturing

About the position

The Director, Regulatory Medical Writing at Johnson & Johnson is a strategic leadership role focused on delivering high-quality regulatory documentation across multiple therapeutic areas. This position involves collaboration with various teams to develop submission strategies, manage timelines, and ensure compliance with regulatory requirements. The role emphasizes mentoring and training within the Regulatory Medical Writing team, promoting best practices, and driving innovation in submission processes.

Responsibilities

  • Lead early strategic submission discussions in collaboration with Key Stakeholders and Senior Leadership.
  • Mentor, support, and coach 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 submission processes.

Requirements

  • A minimum of a Bachelor's or equivalent University/College degree is required; advanced degree 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 and savings 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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