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Johnson and Johnson Family is recruiting a Director, Medical Affairs, Orthopedics (Trauma) located in West Chester, PA

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 Director, Medical Affairs, Orthopedics role provides medical affairs support within an assigned platform / sub-platform (Trauma) 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 to drive market adoption.

Tasks / Duties / Responsibilities

• 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 technical 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.

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 technical/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 technical/surgical/scientific support for external regulatory inspections and audits, and internal audits.
• Provide expertise to support addressing questions from the medical information requests.
• Provide technical perspective, advice, guidance, and expertise as a Subject Matter Expert (SME)
• Provide expert technical / surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.

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.

Life Cycle Management Support

• Provide Lifecycle Management for marketed products including labelling updates, technical support and accountability for technical files and documents and technical 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.
• They 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 of risk evaluation (PRE or PRA) documents.

Requirements

• Minimum of a Master’
• Completion of an DPM -Doctorate of Podiatric Medicine and a Board certification from American Board of Foot and Ankle Surgery is required.
• Candidate must have a minimum of 10 years relevant experience 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 in assessment of clinical risk-benefit with deep knowledge and understanding of medical risk management, complaint management, reporting requirements, etc.
• Ability to be a strong advocate for patient-centric decision making.
• Demonstrated ability to build successful relationships & develop partnerships with key internal and external business stakeholders.
• Travel is required up to 15% Domestic and International.

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, please contact us via https: //www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.