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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
Job Description:
DePuy Synthes is recruiting for a Senior Medical Affairs Manager, Craniomaxillofacial, located in Raynham, Massachusetts or Raritan, New Jersey.
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 proto@type 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:
Required
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.
Other
Languages: Fluent in English 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.
LI-Hybrid
DePuySynthesCareers
Required Skills:
Preferred Skills:
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
