Director, Regulatory Medical Writing (1 of 4)

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. Responsibilities

Lead early strategic submission discussions in collaboration with Key Stakeholders and Senior Leadership. Mentor, support, and coach RegMW submission leads, MWs, and team members. Develop and maintain submission training materials specific to clinical content, training teams as needed. Support development of and team adherence to label-driven submission best practices. Identify and provide team training as needed. Communicate RegMW critical path activities throughout submission delivery as needed. 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 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. In all other U.S. locations, the range is $157,000 to $271,400. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

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