Job Description - Director, Regulatory Medical Writing (1 of 4) (2406211847W)
Johnson & Johnson is currently seeking a Director, Regulatory Medical Writing. The primary location for this position is the United States. Secondary locations are Canada, United Kingdom, Switzerland, Netherlands, Belgium, Germany, Spain, and France. This is a global role and is open to other countries. Remote work options may be considered on a case-by-case basis and if approved by the company.
The Director, Regulatory Medical Writing (RegMW) is a highly experienced medical writer and influential leader with strategic responsibilities related to the delivery of high-quality regulatory documentation. This position will focus on submission strategies across multiple therapeutic areas (TAs) and is an individual contributor role. The submission strategist is the primary RegMW interface to the Compound Development Teams (CDTs) at the early stages of submission preparation and the RegMW expert for the delivery of Johnson & Johnson Innovative Medicine marketing applications.
The scope of the role begins with collaboration on the early draft label to aid in early planning and influence submission teams. This individual will be responsible for long-term planning and translating the strategy into integrated plans for submission clinical components. This includes partnering with the team to ensure all critical interdependencies are integrated into a cohesive, cross-functional timeline with a credible critical path.
Leadership:
Lead early strategic submission discussions in collaboration with Key Stakeholders and Senior Leadership grounded in "Label as Driver".
Lead and hold the cross-functional team accountable for the development of the clinical storyboard document.
Mentor, support, and coach RegMW submission leads, MWs, and team members as needed.
Promote development of robust RegMW document shells and lean authoring principles.
Collaborate with CDT to develop/align on submission strategy and scope.
Connect with key stakeholders to ensure robust source documentation is developed in advance of submission strategy development.
Transition near-execution phase responsibilities to the submission lead MW as needed.
Drive rapid and informed decision making.
Actively identify risks and contribute to risk mitigation discussions.
Qualifications:
A minimum of a Bachelor's or equivalent University/College degree is required. Advanced degree (Masters, PhD, MD) 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.
Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing applications is required.
Strong content awareness and understanding of Regulatory Medical Writing interdependencies between all major documents of electronic Common Technical Document (eCTD) is required.
Must have effective, oral and written and cross-cultural communication skills.
This position will require up to 10% travel.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $193,000 to $312,110. The anticipated base pay range for this position in all other U.S. locations is $157,000 to $271,400.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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