Senior Principal Scientist, Nonclinical Submissions Writer

Johnson & Johnson-posted 11 days ago
Full-time • Senior
Hybrid • San Diego, PA
5,001-10,000 employees
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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: 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

  • 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.
  • A minimum of a Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required.
  • 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 with a good understanding of electronic submission requirements required.
  • Knowledge of Good Laboratory Practice (GLP) standards is required.
  • Knowledge of regulatory requirements specific to nonclinical modules is required.
  • Knowledge of ICH (International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use) guidelines, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements, is required.
  • Experience handling multiple, dynamic programs with competing and aggressive timelines in a matrix environment is required.
  • Must have excellent communication and interpersonal skills.
  • Must have strong negotiating, troubleshooting and organizational skills.
  • Must have strong attention to detail.
  • The ability to integrate data, highlight key messages, and infuse storytelling into nonclinical submission documents is required.
  • The ability to collaborate effectively in a cross-functional team environment is required.
  • This position will require up to 10% domestic and international travel.
  • Advanced degree (PharmD, Ph.D. or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is preferred.
  • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
  • Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year
  • The Company maintains highly competitive, performance-based compensation programs.
  • Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
  • This position is eligible to participate in the Company’s long-term incentive program.
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