Director, Global Nonclinical Writing and Submissions

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

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

Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-036414

• Belgium - Requisition Number: R-038682

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

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. Investigators 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:

• A minimum of a Masters degree in Biomedical Sciences Toxicology Pharmacology or a related discipline is required. Advanced degree (PharmD Ph.D. or equivalent) in Biomedical Sciences Toxicology Pharmacology or a related discipline is preferred.

• A minimum of 10 years of relevant experience in nonclinical writing and submissions supporting diverse modalities and therapeutic areas is required.

• A minimum of 4 years of direct people management experience is required.

• Strong knowledge of nonclinical drug development is required.

• Strong knowledge of global submissions requirements is required.

• Strong change/process management experience is required.

• Knowledge of Good Laboratory Practice (GLP) and data security/integrity standards required.

• Must have excellent communication and interpersonal skills with the ability to assure full clarity on intent and audience specific content.

• Must have strong negotiating troubleshooting and organizational skills.

• The ability to work effectively in a collaborative environment and to help coach and mentor staff similarly is required.

• This position will require up to 10% domestic and international travel.

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.

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