Director, Global Nonclinical Writing and Submissions

Director, Global Nonclinical Writing And Submissions

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Nonclinical Writing and Submissions. This position is a hybrid role and will be located in Spring House, PA.

The Director, Global Nonclinical Writing and Submissions, within the Preclinical Sciences and Translational Safety (PSTS) organization, will drive the nonclinical writing strategy and lead the team to deliver state-of-the-art submissions aligned with global requirements.

Principal Responsibilities :

• Lead and mentor the nonclinical writing team, including internal and contracted writers, to meet pipeline goals with timely and high-quality deliverables (e.g., Investigator's Brochures, IND / CTA / NDA nonclinical modules, briefing books, health authority responses) across all programs and development phases.
• Review of documents prepared by writers and ensure adherence to standards, quality, and strong positioning of key messages and risk assessment.
• Maintain awareness of global submissions landscape and ensure nonclinical submissions strategy evolves to produce state-of-the-art, compliant deliverables.
• Ensure consistent support and implementation of best practices across portfolio and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, and quality colleagues.
• Collaborate effectively with leaders across PSTS and Johnson & Johnson Research and Development to ensure appropriate readiness for submissions within the portfolio from pre-portfolio to post-registration phases.
• Manage timelines and resources; ensure early identification and timely communication of submissions-related issues and develop contingency plans proactively to address issues.

Qualifications :

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.