Lead MSA SOP Strategy & External Envir

Job description

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: Leeds, West Yorkshire, United Kingdom Job Description: DePuy Synthes is recruiting for a(n) Lead MSA SOP Strategy & Compliance Leader, located in in West 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 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. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and 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 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 Required Qualifications Bachelor’s degree required (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 is required. 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 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