Johnson & Johnson - Olympia, WA

posted 5 months ago

Full-time - Senior
Remote - Olympia, WA
Chemical Manufacturing

About the position

The Director, Regulatory Medical Writing at Johnson & Johnson is a strategic leadership role focused on the delivery of high-quality regulatory documentation across multiple therapeutic areas. This individual contributor position involves collaboration with Compound Development Teams to influence submission strategies and ensure cohesive planning for clinical components. The role emphasizes mentorship, training, and the promotion of best practices in regulatory medical writing, while also managing risks and driving innovation in submission processes.

Responsibilities

  • Lead early strategic submission discussions with key stakeholders and senior leadership.
  • Develop and hold the cross-functional team accountable for the clinical storyboard document.
  • Mentor and support RegMW submission leads and team members.
  • Maintain and evolve submission templates and training materials.
  • Communicate RegMW critical path activities throughout submission delivery.
  • Promote lean writing and strategic reviews.
  • Collaborate with CDT to develop submission strategy and scope.
  • Contribute to the development of draft labels and regulatory strategy plans.
  • Drive consistency and standardization of RegMW submission best practices.
  • Identify risks and contribute to risk mitigation discussions.

Requirements

  • A minimum of a Bachelor's 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 of clinical Module 2 and Module 5 documents is required.
  • Knowledge of global regulations and regulatory requirements related to marketing applications is required.
  • Strong content awareness of Regulatory Medical Writing interdependencies is required.
  • Experience with medical writing service providers is required.
  • Experience leading Regulatory Medical Writing submissions in a matrixed setting is required.
  • Effective oral and written communication skills are required.

Nice-to-haves

  • 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.
  • Work, Personal and Family Time - up to 40 hours per calendar year.
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