Owning operational readiness and standards alignment for Standard Exchange of Nonclinical Data (SEND) deliverables supporting regulatory submissions.
Serving as the primary point of contact for SEND-related deliverables and issue resolution across internal collaborators and external partners.
Ensuring high-quality packages through validation, QC, controlled terminology governance, and continuous process improvement.
Monitoring upcoming submissions (using internal JJIM tools) and proactively confirm deliverable needs, timing, readiness, and risks with partners.
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.
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.
Contributing to strategic initiatives integrating CRO SEND-ready data into unified systems.
Overseeing internal FTEs and contractors globally.

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.
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.

Benefits

Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Retirement plan (pension)
Savings plan (401(k))
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year
Holiday pay –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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

SENDnonclinical toxicologydata quality workflowsQCdata standardizationscientific writingGood Laboratory Practiceregulatory submissiondata managementdataset review

Soft Skills

communicationnegotiationinfluenceproblem-solvingcollaborationleadershipproactive attitudeflexibilitydecision-makingteam management