Manager, Pre‑Clinical & Clinical Compliance

Johnson & Johnson Innovative Medicine • West Chester, PA

1d • $102,000 - $177,100 • Hybrid

About The Position

The Manager, Pre‑Clinical & Clinical Compliance is responsible for leading compliance activities supporting pre‑clinical and clinical research programs. This role ensures that study design, execution, documentation, and oversight comply with applicable regulations, quality standards, and internal policies. The position plays a critical role in protecting patient safety, ensuring data integrity, and enabling compliant advancement of products through the development lifecycle by partnering closely with R&D, Clinical, Regulatory Affairs, and Quality teams.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related discipline (required).
• Typically 6-8 years of progressive experience in pre‑clinical, clinical, regulatory, or compliance roles within a regulated industry.
• Strong working knowledge of compliance requirements applicable to pre‑clinical and clinical research.
• Experience supporting audits, inspections, or compliance assessments related to development activities.
• Ability to manage complex compliance topics across cross‑functional stakeholder groups.
• English required.

Nice To Haves

• Advanced degree in a scientific, regulatory, or quality‑related field (preferred).
• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with global regulatory expectations for pre‑clinical and clinical programs.
• Experience working in a global or matrixed organization.
• Exposure to regulatory authority interactions related to development compliance.
• Quality or Regulatory certifications (e.g., RAC).
• Strong analytical, risk‑management, and problem‑solving skills.
• Effective written and verbal communication skills.
• Quality or Regulatory certifications preferred but not required.

Responsibilities

• Lead and manage compliance activities for pre‑clinical and clinical programs, ensuring adherence to regulatory and quality requirements.
• Provide compliance oversight for study protocols, reports, and supporting documentation.
• Partner with R&D, Clinical, Regulatory Affairs, and Quality teams to support compliant study execution and lifecycle management.
• Interpret applicable regulations and standards and translate them into practical compliance requirements for study teams.
• Support internal audits, external audits, and regulatory inspections related to pre‑clinical and clinical compliance.
• Monitor compliance risks, trends, and findings; drive corrective and preventive actions as needed.
• Ensure consistent application of global and local compliance procedures, controls, and governance.
• Drive continuous improvement initiatives to strengthen compliance effectiveness and operational readiness.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager