Sr Mgr/Associate Director, Medical Affairs, LCM

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Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs

Job Category:

People Leader

All Job Posting Locations:

Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

DePuy 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.