6084-Janssen Research & Development Legal Entity
Senior Principal Scientist, Nonclinical Submissions Writer
6084-Janssen Research & Development Legal Entity, San Diego, California, United States, 92189
Company Overview
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 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 Spring House, Pennsylvania, United States of America
Job Description 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 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., 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 Master’s degree in Biomedical Sciences, Toxicology, Pharmacology or a related discipline is required. An advanced degree (PharmD, Ph.D. or equivalent) 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 with a good understanding of electronic submission requirements.
Knowledge of Good Laboratory Practice (GLP) standards, regulatory requirements specific to nonclinical modules and ICH guidelines (FDA, EMA/CHMP) 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.
The ability to integrate data, highlight key messages and infuse storytelling into nonclinical submission documents.
The ability to collaborate effectively in a cross‑functional team environment.
Travel & Compensation 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 $137,000 to $235,750.
Benefits 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
Employment Type & Experience Type: Full‑Time
Experience required: 8+ years (as stated in Qualifications)
Annual Salary (U.S.): $137,000 – $235,750
Closing Date This job posting is anticipated to close on November 21, 2025. The company may, however, extend this period.
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.
Accommodations for Applicants with Disabilities If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (URL omitted) or contact AskGS to be directed to your accommodation resource.
Job Posting Identifier #LI-Hybrid
#J-18808-Ljbffr
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 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 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., 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 Master’s degree in Biomedical Sciences, Toxicology, Pharmacology or a related discipline is required. An advanced degree (PharmD, Ph.D. or equivalent) 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 with a good understanding of electronic submission requirements.
Knowledge of Good Laboratory Practice (GLP) standards, regulatory requirements specific to nonclinical modules and ICH guidelines (FDA, EMA/CHMP) 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.
The ability to integrate data, highlight key messages and infuse storytelling into nonclinical submission documents.
The ability to collaborate effectively in a cross‑functional team environment.
Travel & Compensation 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 $137,000 to $235,750.
Benefits 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
Employment Type & Experience Type: Full‑Time
Experience required: 8+ years (as stated in Qualifications)
Annual Salary (U.S.): $137,000 – $235,750
Closing Date This job posting is anticipated to close on November 21, 2025. The company may, however, extend this period.
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.
Accommodations for Applicants with Disabilities If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (URL omitted) or contact AskGS to be directed to your accommodation resource.
Job Posting Identifier #LI-Hybrid
#J-18808-Ljbffr