Senior Principal Scientist, Nonclinical Submissions Writer

Senior Principal Scientist, Nonclinical Submissions Writer

Hybrid role located in Spring House, PA or San Diego, CA.

Company: Johnson & Johnson Innovative Medicine

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.

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 SOPs and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, and quality colleagues.
• Engage in development, evaluation, and implementation of generative AI writing and QC tools for regulatory document generation.
• Collaborate with Global Document Specialists and Global SEND 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

• Minimum: Master’s degree in Biomedical Sciences, Toxicology, Pharmacology, or related discipline (PharmD, Ph.D., or equivalent preferred).
• Minimum eight years of relevant experience in nonclinical drug development.
• Extensive experience with summary document writing supporting diverse modalities and therapeutic areas.
• Strong writing skills and good understanding of electronic submission requirements.
• Knowledge of GLP standards and regulatory requirements for nonclinical modules.
• Knowledge of ICH guidelines, FDA and EMA/CHMP regulations and other international regulatory requirements.
• Experience handling multiple dynamic programs with competing and aggressive timelines in a matrix environment.
• Excellent communication and interpersonal skills.
• Strong negotiating, troubleshooting, and organizational skills.
• Strong attention to detail.
• Ability to integrate data, highlight key messages, and infuse storytelling into nonclinical submission documents.
• Ability to collaborate effectively in a cross‑functional team environment.
• Up to 10% domestic and international travel required.

Required Skills

• Clinical Data Management
• Drug Discovery Development
• EHS Compliance
• Emergency Planning
• Performance Measurement
• Presentation Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Program Management
• Regulatory Affairs Management
• Research and Development
• Risk Management
• Safety Audits
• Safety Investigations
• Safety-Oriented
• Scientific Research
• Strategic Thinking
• Tactical Planning
• Technical Credibility

Preferred Skills

• Data science for real‑world evidence
• Advanced analytics (AA)

Benefits

• Vacation — up to 120 hours per calendar year
• Sick time — up to 40 hours per calendar year (56 hours for Washington residents)
• Holiday pay, including floating holidays — up to 13 days per calendar year
• Work, personal and family time — up to 40 hours per calendar year
• Parental leave — 480 hours within one year of birth/adoption/foster care of a child
• Condolence leave — 30 days for an immediate family member, 5 days for extended family
• Caregiver leave — 10 days
• Volunteer leave — 4 days
• Military spouse time‑off — 80 hours
• Medical, dental, vision, life insurance, short‑term and long‑term disability, business accident insurance, and group legal insurance
• Consolidated retirement plan (pension) and 401(k) savings plan; eligible for long‑term incentive program

Compensation

Base pay range: $137,000 to $235,750. Eligible for annual performance bonus per company guidelines.

EEO Statement

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 J&J is committed to providing an inclusive interview process. Accommodations can be requested by contacting the Employee Health Support Center ( ) or AskGS.

Next Steps

Apply directly through the J&J careers site. This posting is anticipated to close on November 21, 2025.