Lead MSA SOP Strategy, External Environment

Johnson & Johnson

Lead MSA SOP Strategy & Compliance Leader at DePuy Synthes shaping SOP direction for clinical research. Ensure alignment with regulatory standards and oversee SOP governance.

Posted 7/29/2026full-timeWest Chester • Florida, Massachusetts, Pennsylvania • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in shaping and governing Standard Operating Procedures (SOPs) in alignment with global clinical regulations and medical device standards. Proven ability to lead cross-functional initiatives and manage complex projects within the medical device or MedTech industry.

Highest-signal resume keywords

SOP Governance StrategyClinical Research OperationsRegulatory ComplianceMedical Device StandardsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical EvaluationEvidence GenerationAudit ReadinessRegulatory StrategySOP DevelopmentRisk AssessmentISO 14155 KnowledgePMCF ExperienceCER/SSCP FamiliarityClinical Trial Conduct

Soft Skills

Strategic ThinkingProblem-SolvingDecision-MakingInfluencing StakeholdersCommunication Skills

Certifications & Qualifications

Clinical Research CertificationRegulatory CertificationQuality CertificationCompliance Certification

Industry Keywords

Medical DeviceMedTechClinical AffairsScientific OperationsGlobal RegulationsQuality System StandardsClinical InvestigationsMatrixed OrganizationsTransformation InitiativesStakeholder Engagement

About the role

Key responsibilities & impact

Responsible for shaping and governing the strategic direction of Standard Operating Procedures (SOPs) across DePuy Synthes Medical and Scientific Affairs (MSA)
Ensure SOP strategies remain aligned with evolving global clinical regulations, medical device standards, industry guidance, and business priorities
Monitor the external environment for global regulations, standards, and guidance related to clinical trial conduct
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
Assess regulatory and guidance changes for applicability and business impact
Establish, operationalize, and oversee the MSA SOP governance process
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
Coordinate communication and implementation support for SOP changes
Provide input on study specific documents as requested, such as protocol, informed consent, ISO 14155 gap assessments, etc.

Requirements

What you’ll need

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
Direct experience within a medical device or MedTech organization, especially in clinical research, Medical Affairs, clinical evaluation, or clinical evidence strategy preferred
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 preferred
Experience supporting large‑scale transformation or system implementation initiatives preferred
Demonstrated ability to interpret external regulations or guidance documents, and translate them into practical SOP strategies
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.
Proficiency in English required.
Clinical research, regulatory, quality, or compliance certifications preferred but not required.

Benefits

Comp & perks

Flexible work arrangements
Professional development opportunities