Job Description

At [Employer hidden — sign up to reveal], we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions. Learn more at jnj.com.

As guided by Our Credo, [Employer hidden — sign up to reveal] is responsible to our employees. We provide an inclusive work environment where each person is considered as an individual. At [Employer hidden — sign up to reveal], we respect the diversity and dignity of our employees and recognize their merit.

[Employer hidden — sign up to reveal] 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. [Employer hidden — sign up to reveal] announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as [Employer hidden — sign up to reveal]. The process of the planned separation is anticipated to be completed within 18 to 24 months.

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 [Employer hidden — sign up to reveal] Medical and Scientific Affairs (MSA), with a strong focus on external regulatory, industry, and compliance environments.

Key Responsibilities

• Continuously monitor the external environment for global regulations, standards, and guidance related to clinical trial conduct, 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 to support internal and external audits, including providing SOP documentation and evidence, coordinating responses, and ensuring timely completion of CAPAs.
• Assess regulatory and guidance changes for applicability and business impact; summarize implications and recommended actions for MSA SOP strategy.
• Serve as the primary liaison between external regulatory intelligence and internal SOP owners.
• Establish, operationalize, and oversee the MSA SOP governance process.
• Drive strategic input and alignment from key governance functions.
• Maintain a forward-looking SOP update roadmap and prioritize revisions.
• Oversee end-to-end logistics and project management for SOP updates.
• Coordinate communication and implementation support for SOP changes.
• May be assigned responsibilities related to study resourcing and project management as required.
• Provide input on study specific documents as requested.

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.

Experience and Skills

Required:

• 6-8 years of progressive experience in Clinical Research/Operations or Regulatory, with exposure to SOP governance, quality systems, regulatory strategy, or related functions.
• 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.

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 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.

Other

• Language: Proficiency in English required.
• Travel: Up to 10%, domestic and/or international.
• Certifications: Quality, Regulatory, or Compliance certifications preferred.

[Employer hidden — sign up to reveal] is an Equal Opportunity Employer. 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.

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