Job Description
DePuy Synthes is recruiting for a Manager, HCC R&D, Clinical Research / Medical Affairs, located in the US or United Kingdom.
West Chester, PA - Requisition Number: 078298
Leeds, United Kingdom - Requisition Number: 081285
The Manager, R&D, Clinical Research, Medical Affairs is responsible for supporting and executing an effective Global compliance program across R&D, Clinical Research, Medical Affairs, and related scientific engagement activities.
This role partners closely with Global Clinical, Medical Affairs, and R&D teams to help identify, assess, and mitigate compliance risks while enabling compliant and ethical innovation. It serves as a trusted compliance partner to business stakeholders, providing practical, risk‑based guidance on clinical studies, investigator interactions, scientific exchange, and external collaborations. This role plays a critical part in embedding compliance into day‑to‑day operations and supporting sound, compliant decision‑making across the organization.
Key Responsibilities
* Provide strategic HCC leadership, oversight and execution of the Global Health Care Compliance program for R&D, Clinical Research, Medical Affairs, and related activities, aligned with enterprise compliance frameworks and regulatory requirements.
* Act as a compliance partner and trusted advisor to Global R&D, Clinical Research and Medical Affairs teams, providing timely, practical guidance on clinical trials, investigator and site interactions, advisory boards, and scientific exchange.
* Assist in identifying, assessing, and mitigating compliance risks associated with clinical research activities and medical engagement models.
* Support compliance risk assessments, issue management, and monitoring activities related to R&D, Clinical Research and Medical Affairs.
* Collaborate with Legal, Privacy, Quality, Finance, and other assurance functions to deliver coordinated compliance support and risk mitigation.
* Contribute to the development, implementation, and maintenance of policies, procedures, and training materials related to R&D, Clinical Research and Medical Affairs compliance.
* Support responses to internal inquiries, audits, monitoring activities, and regulatory requests related to clinical and medical compliance topics.
* Monitor regulatory, enforcement, and industry trends impacting R&D, Clinical Research and Medical Affairs and elevate emerging risks as appropriate.
* Drive continuous improvement by identifying opportunities to simplify processes and strengthen compliance effectiveness.
Education
Required: Bachelor’s degree in Law, Business, Compliance, Finance, Healthcare Administration, Life Sciences, or a related field.
Preferred: Advanced degree or professional certification in Compliance, Legal, Risk, Ethics, or related disciplines.
Experience and Skills
Required: 5–7 years of experience in healthcare compliance, clinical research operations, medical affairs, legal, audit, or related functions.
Working knowledge of healthcare compliance laws, regulations, and industry standards applicable to clinical research and medical affairs.
Experience supporting risk‑based compliance programs in regulated environments.
Ability to translate complex compliance requirements into practical guidance for business partners.
Strong analytical, problem‑solving, and decision‑making skills.
Effective written and verbal communication skills, with the ability to engage and influence stakeholders.
Preferred Experience and Skills
* Experience in medical devices, pharmaceuticals, or broader life sciences industries.
* Familiarity with clinical trial conduct, investigator interactions, and scientific engagement models.
* Experience working in matrixed organizations with cross‑functional stakeholders.
* Exposure to compliance risk assessments, monitoring, or issue management processes.
* Change management or process improvement experience.
Other
Language: Fluency in English required.
Travel: Up to 15–20% domestic travel.
Certifications: Compliance, legal, or ethics certifications preferred but not required.
Preferred Skills
* Audit Management
* Complaints Investigation
* Compliance Frameworks
* Compliance Management
* Consulting
* Corporate Governance
* Corrective and Preventive Action (CAPA)
* Healthcare Industry
* Health Care Regulation
* Interpersonal Influence
* Legal Services
* Medical Compliance
* Organizing
* Process Improvements
* Program Management
* Technical Credibility
Equal Opportunity Employer 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.
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