Sr Mgr/Associate Director, Medical Affairs, LCM

Senior Medical Affairs Manager, Craniomaxillofacial

D ePuy Synthes is recruiting for a Senior Medical Affairs Manager, Craniomaxillofacial, located in Raynham, Massachusetts or West Chester, Pennsylvania or Warsaw, Indiana or Palm Beach Gardens, Florida.

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 Senior Medical Affairs Manager, Craniomaxillofacial, provides medical affairs support for the Craniomaxillofacial platform within DePuy Synthes. This role delivers medical and surgical input across product development and life-cycle management, including regulatory documentation, clinical risk assessment, and patient safety considerations. The role collaborates cross-functionally to support evidence generation, dissemination for market registration, access and adoption, and provides medical education to internal and external stakeholders to support commercialization and market adoption.

Key Responsibilities

• Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA) and Marketing to provide leadership with product development and commercial plans to support product launch, training content and delivery.
• Provide medical/surgical/scientific insights into design requirements, concept and prototype testing.
• Provide input into risk management processes for hazard/harm identification & risk mitigation.
• Assess device performance, including clinical benefits and safety profile, to evaluate the appropriate Risk-Benefit balance to support market registration and throughout life cycle.
• Work with Medical Safety and Post-Market Surveillance to assess, analysis and interpret events, complaints, signals and trends from clinical studies, literature, complaints, etc.
• Provide expertise to support addressing complex medical information requests. Provide clinical perspective, advice, guidance, and expertise as a medical expert for non-clinical colleagues in matters requiring clinical consultation. Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.
• Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.
• Research, prepare and document responses to Medical Information Requests from Healthcare providers; review and approve medical content in Copy Approval process; and consult with Clinical Medical Directors when needed.
• Provide consultation in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER) and provide review of CERs and assists in preparation of periodic safety reports for assigned products.
• Assist in reviewing of risk evaluation (PRE or PRA) documents.

Qualifications

Education:

• Medical Doctor (surgeon) or Physician Assistant with demonstrable, strong clinical hands-on surgical experience in craniomaxillofacial, oral and maxillofacial, plastic/craniofacial, or ear, nose and throat / head and neck surgery; United States board certification is not required.
• Candidate must have a minimum of eight years of relevant experience in the pharmaceutical or medical device sectors, including clinical practice, dedicated research, or other related training or experience.
• Experience in medical affairs, clinical development, or related roles in research or the medical device industry is preferred.

Experience and Skills:

• Minimum of 8 years' relevant experience across pharmaceutical or medical device sectors, clinical practice, dedicated research, or equivalent related training/experience.
• Demonstrated experience in medical affairs, clinical development, or related roles within medical device or life sciences industry preferred.
• Strong clinical hands-on surgical background relevant to craniomaxillofacial indications.
• Proven ability to assess clinical risk-benefit and provide medical input during product development and lifecycle management.
• Experience collaborating with cross-functional teams (R&D, Regulatory, Quality, HEMA, Marketing) in a matrixed or multinational environment.
• Track record of supporting evidence generation, clinical study interpretation, and medical communications (abstracts, manuscripts, CERs).
• Excellent written and verbal communication skills; ability to present complex medical/scientific concepts to diverse audiences.
• Strong stakeholder engagement skills and the ability to build trusted relationships with KOLs and internal partners.

Preferred

• Deep understanding of clinical trends, healthcare market dynamics, and connections within the digital and med-tech ecosystem.
• Strong expertise in clinical risk assessment, complaint management, reporting requirements, and applicable standards/regulations requiring medical input.
• Demonstrated patient-centric approach and advocacy for patient safety in decision making.
• Relevant medical license (as applicable) and current clinical credentials.
• Professional affiliations with relevant surgical or medical societies preferred.
• Ability to travel domestically up to 20% as needed.

Languages: Fluent in English required.

The anticipated base pay range for this position is: $137,000.00 - $235,750.00