Principal Scientist, Nonclinical Submissions Writer

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

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

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 & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist Nonclinical Submissions Writer. This position is a hybrid role and will be located in San Diego CA.

The 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. Investigators 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 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 6 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 preferred.

• 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.

The anticipated base pay range for this position in all other U.S. locations is $117000 to $201250.

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. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/ performance year. Bonuses are awarded at the Companys discretion on an individual basis.

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 Companys 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

For additional general information on company benefits please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on December 26 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

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.

#LI-Hybrid

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).


This position is eligible to participate in the Companys long-term incentive program.


Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 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 the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year


For additional general information on Company benefits please go to: - Experience:

Staff IC