Lead MSA SOP Strategy & External Envir

Johnson & Johnson MedTech

Leeds

On-site

GBP 90,000 - 120,000

Full time

14 days+

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Job summary

Johnson & Johnson in Leeds, UK is recruiting for a Lead MSA SOP Strategy & Compliance Leader. The role shapes SOP strategy across DePuy Synthes Medical and Scientific Affairs, focusing on clinical research, medical affairs, clinical evaluation, and evidence-generation processes in a highly regulated medical technology environment.

Applicants bring 6–8 years in clinical research/operations and strong experience in audits, CER/SSCP, PMCF, and governance.

Qualifications

Typically requires 6–8 years of progressive experience in Clinical Research/Operations, Medical Affairs, Clinical Evaluation, or a related clinical evidence function within industry.
Medical device or MedTech experience is strongly preferred.
Experience supporting clinical research, CER/SSCP, PMCF, or related evidence generation activities.
Strong understanding of global clinical regulations, standards, and guidance relevant to investigations and evidence outputs.

Responsibilities

Monitor external regulations, standards, and guidance related to clinical trial conduct and CERs/SSCPs.
Coordinate with Clinical & Medical Affairs SMEs to support audits and respond to observations with CAPAs.
Assess regulatory changes for applicability and impact; summarize implications for SOP strategy.
Serve as liaison between regulatory intelligence and internal SOP owners for timely decisions.
Govern the MSA SOP framework, including charter, roles, meeting cadence, and documentation.
Drive alignment with Clinical Research/Operations, CER strategy, and Medical Affairs across functions.

Skills

Regulatory compliance

SOP governance

Clinical research

Cross-functional leadership

Audit readiness

Global/regional experience

Communication skills

Strategic thinking

Project management

Education

Bachelor’s degree

Advanced degree preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Required

Experience and Skills

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 experience presenting to senior leaders.

Other Requirements

Language: Proficiency in English required.
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, career and life journey, please visit www.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.

#DePuySynthesCareers

Required Skills

Preferred Skills: