Principal Scientist, SEND Submissions

Johnson & Johnson•San Diego, PA

16h

About The Position

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 We are searching for the best talent for a Principal Scientist, SEND Submissions to be located in Spring House, PA or La Jolla, CA. Purpose: The Principal Scientist will own operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions. They will serve as the primary point of contact for SEND-related deliverables and issue resolution across internal collaborators and external partners, while ensuring high-quality packages through validation, QC, controlled terminology governance, and continuous process improvement.

Requirements

A minimum of a Bachelor’s degree in Toxicology, Pharmacology, Biology, or a related science is required. An advanced degree is preferred.
6+ years of relevant experience is required.
Background in nonclinical toxicology study data structure and workflows with insight into SEND standard is required.
Familiarity with regulatory submission requirements and processes is required.
Knowledge of Good Laboratory Practice is required.
Familiarity with medical and scientific terminology is required.
Strong written and verbal communication skills and the ability to negotiate and influence decision-making processes, think and manage issues to resolution, and contribute to study teams and scientific discussions are required, with prior experience in scientific data evaluation, integrated safety assessment, and scientific writing.
Capable of making fast decisions when necessary, while maintaining positive and inclusive team relationships, is required.
Personal leadership skills, a proactive and flexible attitude, a sense of urgency, and excellent collaboration skills are required.

Nice To Haves

Current participation with industry standards organizations such as CDISC and/or PHUSE is preferred.
Strong biomedical data management and data standardization skills are preferred.
Proven ability to build internal and external networks related to SEND processes is preferred.
Ability to lead teams of scientists and technical staff in a global matrix organization is preferred.

Responsibilities

Serving as the Johnson & Johnson Innovative Medicine (JJIM)'s SEND subject matter expert.
Functioning as the primary internal and external point of contact for all SEND deliverables, process questions, and issue resolution.
Monitoring upcoming submissions (using internal JJIM tools) and proactively confirm deliverable needs, timing, readiness, and risks with partners (in conjunction with Nonclinical Writers and Nonclinical Study Leads).
Collaborating with the Manager of Clinical Data Standards to develop and verify nonclinical Study Data Standardization Plan sections.
Managing end-to-end nonclinical SEND submission package readiness: study file management, QC, and final package assembly.
Performing and/or overseeing validation and data quality workflows (dataset review, triage, remediation, and documentation).
Supporting authoring and QC of nSDRG content to ensure accuracy, completeness, and that the document is reviewer-ready.
Supporting internal system operations with a variety of repositories, data collection, and SEND generation tools.
Leading/supporting, as applicable, internal Artificial Intelligence and Machine Learning initiatives.
Coordinating cross-functional inputs (scientists, Bioanalysis/TK, Histopathology) to deliver compliant SEND artifacts to contract research organizations for incorporation (e.g., PC/PP files, XPT outputs).
Administering and maintaining SEND Controlled Terminology mappings and metadata updates within JJIM Systems.
Tracking and reporting team metrics/KPIs; identifying trends and recommending process/tool improvements.
Coordinating and facilitating bi-weekly SEND team meetings.
Providing internal leadership with regular status updates and recommendations regarding risks, opportunities, and resourcing.
Representing the organization in external standards forums (PHUSE/CDISC) and translating the knowledge gained into J&J internal guidance and actions (e.g., SENDIG reviews).
Contributing to strategic initiatives integrating CRO SEND-ready data into unified systems.
Overseeing internal FTEs and contractors globally.

Benefits

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
consolidated retirement plan (pension)
savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours