Description
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 as it relates 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.
Principal Responsibilities:
Leadership:
With a focus on clinical scientific content, lead early strategic submission discussions in collaboration with Key Stakeholders and Senior Leadership that are grounded in “Label as Driver”.
Lead and hold the cross-functional team accountable for the development of the clinical storyboard document.
Advising/Influencing:
Mentor, support, and coach RegMW submission leads, MWs, and team members, as needed.
Support upkeep and evolution of submission templates, job aids, and training materials.
Communicate RegMW critical path activities throughout submission delivery as needed.
Advocate for lean writing and strategic reviews.
Identify/provide team training as needed.
Collaborating:
Collaborate with CDT to develop/align on submission strategy and scope.
Connect with key stakeholders and hold them accountable to ensure robust source documentation is developed.
Transition near-execution phase responsibilities to the submission lead MW, as needed.
Innovating:
Promote consistency and standardization of RegMW submission best practices.
Drive rapid and informed decision making.
Lead ongoing assessment of submission health and communicate operational submission metrics.
Risk Management:
Actively identify risks and contribute to risk mitigation discussions.
Communicate RegMW mitigation strategies and escalate RegMW submission-related risks 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.
Experience leading and managing Regulatory Medical Writing submissions in a matrixed setting 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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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