Lead MSA SOP Strategy & External Envir

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function Discovery & Pre-Clinical/Clinical Development Job Sub Function Clinical Development & Research – Non-MD Job Category People Leader All Job Posting Locations Palm Beach Gardens, Florida, United States of America; Raynham, Massachusetts, United States of America; Warsaw, Indiana, United States of America; West Chester, Pennsylvania, United States of America Job Description DePuy Synthes is recruiting for a (Lead MSA SOP Strategy & Compliance Leader), located in West Chester, PA, Raynham, MA, Warsaw, IN, Palm Beach Gardens, FL or Leeds, UK. This role is available across multiple countries and may be posted under different requisition numbers. 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 to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. 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 external regulatory, industry, and compliance environments. This role plays a leadership function in ensuring SOP strategies remain aligned with evolving global regulations, industry standards, and business priorities while enabling operational excellence across the organization. This is an impactful role for a strategic leader who enjoys operating at the intersection of regulatory intelligence, enterprise SOP governance, and cross‑functional collaboration in a highly regulated medical technology environment. Key Responsibilities Continuously monitor the 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 and evidence, coordinating responses to audit observations, and ensuring timely completion 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 ensure timely awareness, 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 regulatory change drivers, risk, and business needs. Oversee end‑to‑end logistics and project management for SOP updates, including coordinating drafting, redlines/markups, version control, and consolidation of feedback. Coordinate communication and implementation support 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, as required. Provide input on study specific documents as requested, such as protocol, informed consent, ISO 14155 gap assessments, etc. Qualifications Education Bachelor’s degree required (e.g., Business, Science, Engineering, Quality, Regulatory, or related field). Advanced degree (e.g., Master’s, MBA, or equivalent) preferred. Required Experience and Skills Typically requires 6-8 years of progressive experience in Clinical Research/Operations or Regulatory, with exposure to SOP governance, quality systems, regulatory strategy, or related functions (e.g., medical devices, pharmaceuticals, life sciences). Experience supporting external audits and inspection readiness. Demonstrated experience leading SOP or management system strategy at an enterprise or global level. Strong understanding of global regulatory and external compliance environments. Experience working in complex, matrixed organizations. Knowledge and application of clinical regulations and standards applied in different clinical areas and regions is required. Preferred Experience within a medical device or MedTech organization. Familiarity with global quality system standards and regulatory frameworks. Experience supporting large‑scale transformation or system implementation initiatives. Demonstrated ability to interpret external regulations or guidance documents, and translate them into practical SOP strategies. Experience working in global or multi‑regional roles. Proven ability to lead cross‑functional initiatives and influence stakeholders without direct authority. Excellent strategic thinking, problem‑solving, and decision‑making skills. Strong written and verbal communication skills, with experience presenting to senior leaders. Other Language: Proficiency in English required. Travel: Up to 10%, domestic and/or international. Certifications: Quality, Regulatory, or Compliance certifications preferred but not required. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit 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 internal employees contact AskGS to be directed to your accommodation resource. #DePuySynthesCareers Required Skills Clinical Data Management Clinical Evaluations Consulting Developing Others Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Inclusive Leadership Leadership Medicines and Device Development and Regulation Operational Excellence Regulatory Affairs Management Relationship Building Safety‑Oriented Scientific Research Strategic Change Study Management Team Management Preferred Skills Clinical Data Management Clinical Evaluations Consulting Developing Others Drug Discovery Development Entrepreneurship Good Clinical Practice (GCP) Inclusive Leadership Leadership Medicines and Device Development and Regulation Operational Excellence Regulatory Affairs Management Relationship Building Safety‑Oriented Scientific Research Strategic Change Study Management Team Management #J-18808-Ljbffr Johnson & Johnson MedTech