Senior Principal Scientist, Nonclinical Submissions Writer

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:

Scientific/Technology

All Job Posting Locations:

San Diego, California, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Principal Scientist, Nonclinical Submissions Writer.  This position is a hybrid role and can be located in Spring House, PA or San Diego, CA.

The Senior Principal Scientist, Nonclinical Submissions Writer, within the Preclinical Sciences and Translational Safety (PSTS) organization, will prepare and review regulatory submission documents that summarize toxicology, safety pharmacology, drug metabolism, and pharmacokinetics studies.  This role will collaborate closely with nonclinical safety, pharmacokinetic (PK) and discovery biology project leads, medical writers, global regulatory dossier leaders, and other subject matter experts (SMEs) to drive the integrated assessment of all nonclinical data in dossiers for submission to international health authorities.  This individual will represent PSTS as the main point of contact on cross-functional global dossier teams and ensure delivery of state-of-the-art submissions aligned with global requirements

Principal Responsibilities:

• Generate nonclinical submission documents to meet pipeline goals with timely, high-quality deliverables (e.g., Investigator’s Brochures, IND/CTA/NDA nonclinical modules, briefing books, health authority responses) across all programs and development phases.

• Partner with Nonclinical Safety, Drug Metabolism and Pharmacokinetics, Bioanalytical, and Pharmacology Leads and other SMEs to develop clear storytelling in submissions by positioning key messages, providing robust context, and clearly explained risk assessments.

• Plan, write, review, edit, and finalize nonclinical sections of regulatory documents for development compounds and marketed products; represent nonclinical on cross-functional teams; coordinate writing activities and timelines.

• Support the implementation of best practices and continuous improvement; maintain adherence to Standard Operating Procedures (SOPs) and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, and quality colleagues.

• Engage in development, evaluation, and implementation of generative Artificial Intelligence (AI) writing and Quality Control (QC) tools for regulatory document generation.

• Collaborate with Global Document Specialists and Global SEND (Standardization for Exchange of Nonclinical Data) managers to prepare submission-ready components and ensure the technical and scientific correctness of SEND data.

• Work effectively in a global, matrix environment across different time zones.

• Adhere to timelines; proactively identify and communicate submission-related issues and develop contingency plans.

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 8 years of relevant experience in nonclinical drug development is required.

• Extensive experience with summary document writing supporting diverse modalities and therapeutic areas is required.

• Strong writing skills coupled