DIRECTOR, REGULATORY MEDICAL WRITING (1 OF 4)

Company: J&J Family of Companies
Location: Honolulu
Posted on: November 12, 2024

Job Description:

Director, Regulatory Medical WritingLocation: Honolulu, Hawaii
Make your application after reading the following skill and qualification requirements for this position.
DescriptionJohnson & Johnson is currently seeking a Director, Regulatory Medical Writing. This is a global role primarily located in the United States, with remote work options considered on a case-by-case basis.The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader responsible for delivering high-quality regulatory documentation. This position will focus on submission strategies across multiple therapeutic areas (TAs) and is an individual contributor role.Responsibilities

• Lead early strategic submission discussions with Key Stakeholders and Senior Leadership.
• Mentor and support RegMW submission leads and team members.
• Develop and maintain submission training materials specific to clinical content.
• Promote consistency and standardization of RegMW submission best practices.
• Conduct ongoing critical path analysis to drive efforts to uncover new opportunities.
• Communicate RegMW mitigation strategies and escalate submission-related risks as needed.QualificationsA minimum of a Bachelor's degree is required; an advanced degree (Masters, PhD, MD) is preferred.A minimum of 12 years of relevant pharmaceutical/scientific experience is required, including:
• 10 years of relevant medical writing experience.
• 5 years of submission experience across multiple new molecular entities.
• Extensive understanding of clinical Module 2 and Module 5 documents.Strong communication skills and the ability to drive decision-making are essential. This position will require up to 10% travel.Compensation and BenefitsThe anticipated base pay range for this position in the San Francisco Bay Area, CA is $193,000 to $312,110, and in all other U.S. locations is $157,000 to $271,400. This position is eligible for an annual performance bonus and various employee benefit programs.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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