Director, Global Nonclinical Writing and Submissions
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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. Learn more at https://www.jnj.com
Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub Function
Nonclinical Safety
Job Category
People Leader
All Job Posting Locations
Beerse, Antwerp, Belgium
Job Description
Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Nonclinical Writing and Submissions. This hybrid role is located in Beerse, Belgium. 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 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 Master’s 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 is required in nonclinical writing and submissions supporting diverse modalities and therapeutic areas.
* 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.
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