About the role

Standards Management Expert contributing to Clinical Data Standards, ensuring compliance with regulatory requirements and aligning with healthcare innovations. Leading projects and collaborating across functions to develop medicines of tomorrow.

Responsibilities

This position is responsible for the development and maintenance of clear specifications for standard content across the data lifecycle, including data collection, review, delivery and analysis & reporting, aligned with protocol and medical writing requirements.
The role is responsible for acquiring and maintaining deep expertise in the various data collection, review and analysis tools and templates applied in the clinical trials, specifically those in use in J&J (e.g., AUTOCODE), in industry standards, including but not limited to CDISC standards and adjacent data standards (e.g., HL7 / FHIR, OHDSI/OMOP).
The position will maintain oversight of ongoing standards development work and projects they are accountable for.
The position will give specific attention to the fit with the CDS standards strategy, interdependences between projects, prioritization of projects, and standards development work in CDS while assessing the organizational readiness in CDS and the IDAR functions to implement the solutions in an optimal way in the clinical studies.

A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience.
Advanced degrees preferred (e.g., Master, PhD)
At least 8 years of relevant pharmaceutical/scientific experience in a related discipline, e.g., data management, biostatistics, clinical or statistical programming
Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM)
Demonstrated written and verbal communications skills
Demonstrated customer focus and solution-oriented experience
Demonstrated interpersonal skills to build relationships with internal and external business partners
Demonstrated leadership on cross-functional projects
Demonstrated leadership in decision making and problem solving
Excellent spoken and written English.

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 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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year