Medical Director, Medical Affairs, Orthopedics (Sports / Joints) ID-22025
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 https://www.jnj.com
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Job Function:
Medical Affairs Group
Job Sub Function:
Medical Affairs - MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America
Job Description:
Johnson and Johnson is currently seeking aMedical Director, Medical Affairs, Orthopedics (Sports located in West Chester, PA or Raynham, MA /Joints locatedin Palm Beach Gardens, FL)
About Orthopedics
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that's reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering State of the Art technology to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Medical Director, Medical Affairs, Orthopedics role provides medical affairs support within an assigned platform / sub-platform (Sports / Joints) within the Orthopedics Business Unit of Johnson & Johnson MedTech. Leading with both outside-to-inside vision to assimilate opportunities of unmet patient and provider needs, and inside-to-outside vision to communicate the medical, surgical, and scientific content. This role provides medical input throughout product development, Working closely with R&D Teams and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential patient safety issues. This position involves cross-functional collaboration with Clinical Affairs and HEMA teams generating and disseminating evidence, supporting market registration, access, and adoption. A key activity is to support medical education to internal and external stakeholders, and commercialization activities.
Tasks / Duties / Responsibilities
INTERNAL PROCESS SUPPORT
- 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 medical/surgical/scientific support for external regulatory inspections and audits, and internal audits.
- Provide expertise to support addressing complex medical information requests.
- Provide physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in matters requiring escalation or medical consultation.
- Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.
- Provide medical/surgical/scientific criteria in claims and collateral material review/approval.
LIFE CYCLE MANAGEMENT (LCM) SUPPORT
- 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 consults with Franchise Medical Director when needed.
- S/he will 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 risk evaluation (PRE or PRA) documents.
INSIGHT MANAGEMENT AND BUSINESS DEVELOPMENT SUPPORT
- Engage with omni-channel external sources of information (key opinion leaders, medical societies, literature, social media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/healthcare ecosystems.
- Support business leaders by providing medical and scientific expertise and omni-channel insights to help shape optimal business development strategy and targets, including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.
- Validate Target Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets.
- Provide strategic medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with medical teams) including to help drive global innovation agenda through leadership and partnership with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory, Clinical, Quality, & Supply Chain leveraging deep medical expertise.
EVIDENCE GENERATION SUPPORT
- Assist medical evidence generation leaders to develop and execute global strategies for evidence generation for new and existing products, including medical interpretation of clinical analyses, and in the review and approval of clinical study reports and scientific articles (abstracts, manuscripts, etc), in order to support regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing support.
Requirements
- Required Minimum Education: MD or equivalent
- Completion of an accredited orthopedic surgery residency and a minimum 1-year fellowship in joint arthroplasty, spine surgery, and/or orthopedic sports medicine surgery is required.
- Candidate must have a minimum of 10 years relevant surgical experience (beyond initial licensure) including clinical practice, dedicated research, or other related training/experience. Experience leading in medical affairs, clinical development, or related roles in research / medical device industry is preferred.
- Strong understanding of clinical trends and the related healthcare market environment, with deep connections in the digital-, med tech- ecosystem
- Background and medical expertise in assessment of clinical risk-benefit throughout product development and life-cycle management, with deep knowledge and understanding of all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
- Ability to be strong advocate for patient-centric decision making.
- Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators, investigators, etc.
- Strong business acumen
- US Board Certified Preferred
- 15% Travel Domestic and/ International
