Medical Director, Medical Affairs, Johnson & Johnson MedTech

Johnson and Johnson Family is recruiting aMedical Director Medical Affairs Johnson & Johnson MedTech. This role is Fully Remote in the United States.

This is a remote role available in the Continental US. While specific cities are listed in the Locations section for reference please note that they are examples only and do not limit your application. We invite candidates from any location across the country to apply.

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at position will report into the Senior Director Medical Affairs and will provide medical leadership globally to Johnson and Johnsons MedTech Endomechanical and Energy Platforms.

The role will support products across the entire lifecycle in collaboration with R&D Global Strategic Marketing Commercial and HEMA (Health Economics and Market Access). This role will also provide strong input on long-term product opportunities and portfolio strategies.

The Medical Director will work closely with the Clinical Research team to drive evidence generation and dissemination activities that support product approvals claims development and product adoption. This role will also work closely with the R&D teams during product development and with marketing and commercial teams during product launches provide evidence based scientific support training and education.

The Medical Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders Surgeons Regulatory Agencies Professional Societies etc.) to anticipate industry trends understand clinical/medical insights unmet medical needs and global standards of care to deliver quality products/solutions.

• Work with business partners including but not limited to R&D Clinical Research Regulatory Affairs Communications Legal Quality & Compliance Preclinical Health Economics & Market Access and Professional Medical Education to provide leadership with product development pre- and post-approval clinical studies regulatory approval/clearance downstream claims safety assessments and product launch and training for key products within the franchise portfolio.
• Have a significant role in the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research including registries.
• Have a leadership role in governance forums including Business Unit leadership teams cross-functional product core teams EGS teams portfolio/strategy management teams and Safety and Quality Review Boards.
• Engage Key Opinion leaders Professional Societies Payers and Providers to understand trends in care and uncover critical insightsto support product innovation and portfolio strategies.
• Providemedical and scientific insights to drive optimal business strategic direction and business activitiesincluding product launches key scientific meetings relationship management with leading research physicians and medical delivery system or government decision makers.
• Provide lifecycle medical affairs support ( review medical information requests medical input into clinical evaluation reports etc.).
• Provide medical oversight for the development of materials to be used for study execution (investigator brochures training materials etc.).
• Work closely with Medical Safety team to ensure adverse events from clinical research studies are reviewedtrendedand escalated as needed.
• Provide medical interpretation of study outcomes and assist with the development of communication and education strategies for the dissemination of the results.
• Work with Regulatory and Clinical partners to prepare reportson clinical investigations in preparation for submission to regulatory agencies and/or for publication to meet evidence requirementsfor new products and for renewals.
• Contribute to medical input into risk management plans and failure mode analysis during product development and safety signal detection and post-market surveillance post-launch.
• Review and approve educationalpromotionaland reporting materials for use byinternal stakeholders. Strategize and prioritize publication proposals in collaboration with Clinical Science.
• Align strategybudgetand resource allocation in close partnership with the cross-functional partners.
• Attend key Scientific Meetings participating as an oral presenter. Write key scientific and clinical publications highlighting critical findings in the field and cementing role as KOL in the field.
• Safeguard patient safety.
• Engageinenvironmental scanning and competitive analysis new product development clinical research new business developmentproduct training during investigational trials as well as during product launches and may provide case coverage during trials.

Qualifications - External

Requirements

• An MD/DO and a minimum of 5years relevant experience in post-graduate medical education (beyond initial licensure) including: specialty residency fellowship or subspecialty training clinical practice dedicated research or other related training/experience required.
• A current license to practice is preferred.
• Board Certificationand Fellowshipinasurgicalspecialtyis strongly preferred.
• Five or moreyears experience in clinical practice as an attending-level physician preferred.
• Clinical research experience in medical devices biologics or drugs is strongly preferred.
• Experience in support of global regulatory submissions for medical devices biologics or drugs is desirable (including PMA/BLA/NDA and/or their global counterparts)preferred.
• Experience in medical safety surveillance (drugs biologics or devices) and/or quality improvement activities ispreferred.
• Experience in the process of new product development (internal development and external partnerships) isdesirable.
• Strong leadership skills and demonstrated ability to build successful relationships with internal and external partnersrequired.
• Strong communication and negotiation skillsrequired.
• Capabilityexpertiseand success in building teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areasis desirable.
• Demonstrated success in medical data generation interpretation and publication preferred.
• Experience with use of natural language processing in research and literature review is desirable.
• Experience in product risk evaluation and mitigation is preferred.
• An academic mindset capable ofanalyzingdata to build context for innovation find and analyze literature to inform decision making for clinical trials is desirable.

Additional Job Description

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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.