Lead MSA SOP Strategy & External Envir

Johnson & Johnson Innovative Medicine•Warsaw, IN

4d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree required (e.g., Business, Science, Engineering, Quality, Regulatory, or related field).
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.
Proficiency in English required.

Nice To Haves

Advanced degree (e.g., Master’s, MBA, or equivalent) 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 experience presenting to senior leaders.
Clinical research, regulatory, quality, or compliance certifications preferred but not required.

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.