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DePuy Synthes is recruiting for a(n) Lead MSA SOP Strategy & Compliance Leader,locatedininWest Chester, PA,Raynham, MA, Warsaw, IN, Palm Beach Gardens, FL, Raritan, NJ, or Leeds, UK.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

US - Requisition Number: R-071882

UK - Requisition Number:R-073360

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics company,operatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Job Overview

The Lead MSA SOP Strategy & Compliance Leader role is responsible for shaping and governing the strategic direction of Standard Operating Procedures (SOPs) across DePuy Synthes Medical and Scientific Affairs (MSA), with a strong focus on clinical research, Medical Affairs, clinical evaluation, and evidence-generation processes related to orthopedic medical devices. This role plays a leadership function in ensuring SOP strategies remain aligned with evolving global clinical regulations, medical device standards, industry guidance, and business priorities while enabling operational excellence across the organization.

This is an impactful role for a strategic leader who brings direct experience in industry-sponsored clinical research, clinical evaluations, CER/SSCP-related processes, or post-market evidence generation, and who enjoys operating at the intersection of clinical evidence, regulatory intelligence, SOP governance, and cross-functional collaboration in a highly regulated medical technology environment.

Key Responsibilities

• Continuouslymonitorthe external environment for global regulations, standards, and guidance related to clinical trial conduct, as well as Clinical Evaluation Reports (CERs) and Summary of Safety and Clinical Performance (SSCPs).

• Serve as a single point of contact and coordinate with subject matter experts in the Clinical & Medical Affairs teams to support internal and external audits by providing SOP documentation andevidence, coordinating responses to audit observations, and ensuringtimelycompletion of related corrective and preventive actions (CAPAs) as applicable

• Assess regulatory and guidance changes for applicability and business impact; summarize implications and recommended actions for MSA SOP strategy and operational execution.

• Serve as the primary liaison between external regulatory intelligence and internal SOP owners to ensuretimelyawareness, alignment, and decision-making.

• Establish, operationalize, and oversee the MSA SOP governance process (charter, roles/responsibilities, meeting cadence, decision rights, and documentation expectations).

• Drive strategic input and alignment from key governance functions, including Clinical Research/Operations, Scientific Operations (CER strategy & writing), and Medical Affairs, as well as other cross-functional stakeholders as needed.

• Maintain a forward-looking SOP update roadmap and prioritize revisions based on regulatorychangedrivers, risk, and business needs.

• Oversee end-to-endlogisticsand project management for SOP updates, including coordinating drafting, redlines/markups, version control, and consolidation of feedback.

• Coordinate communication andimplementationsupport for SOP changes (e.g., release planning, stakeholder notifications, and readiness activities) in partnership with SOP owners.

• May be assigned responsibilities related to study resourcing and project management responsibilities, asrequired

• Provide input on study specific documents as requested, such as protocol, informed consent, ISO 14155 gap assessments,etc

Required Qualifications

• Bachelor's degreerequired(e.g., Business, Science, Engineering, Quality, Regulatory, or related field).

• Advanced degree (e.g., Master's, MBA, or equivalent) preferred.

Experience and Skills

Required:

• Typically requires 6-8 years of progressive experience in Clinical Research/Operations, Medical Affairs, Clinical Evaluation, Scientific Operations, or a closely related clinical evidence-generation function within industry; medical device or MedTech experience is strongly preferred.

• Experience supporting clinical research, clinical evaluation, CER/SSCP, PMCF, or related medical device evidence-generation activities, including audit or inspection readiness for clinical processes.

• Demonstrated experience leading SOP, process, or governance strategy supporting clinical research, Medical Affairs, clinical evaluation, or clinical evidence deliverables at an enterprise or global level.

• Strong understanding of global clinical, medical device, and external compliance environments, including regulations, standards, and guidance that impact clinical investigations, PMCF, clinical evaluations, CERs, SSCPs, and related evidence outputs.

• Experience working in complex, matrixed organizations.

• Knowledge and application of clinical regulations and standards applied in different clinical areas and regions isrequired.

Preferred:

• Direct experience within a medical device or MedTech organization, especially in clinical research, Medical Affairs, clinical evaluation, or clinical evidence strategy.

• Familiarity with global quality system standards and regulatory frameworks as they apply to clinical research, clinical evaluation, PMCF, CERs, SSCPs, and medical device evidence-generation processes.

• Experience supportinglargescaletransformation or system implementation initiatives.

• Demonstrated ability to interpret external regulations or guidancedocuments, andtranslate them into practical SOP strategies.

• Experience working in global ormultiregionalroles.

• Proven ability to leadcrossfunctionalinitiatives and influence stakeholders without direct authority.

• Excellent strategic thinking,problemsolving, anddecisionmakingskills.

• Strong written and verbal communication skills, with experience presenting to senior leaders.

Otherrequirements

• Language:Proficiencyin Englishrequired.

• Travel: Up to 10%, domestic and/or international.

• Certifications: Clinical research, regulatory, quality, or compliance certifications preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visitwww.careers.jnj.com.

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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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