Medical Director, Global Medical Affairs, Biosurgery
Medical Director, Global Medical Affairs, Biosurgery
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Medical Affairs GroupJob Sub Function:
Medical Affairs MDJob Category:
People LeaderAll Job Posting Locations:
Raritan New Jersey United States of AmericaJob Description:
Johnson and Johnson is currently seeking aMedical Director Global Medical Affairs Biosurgery locatedin Raritan NJ
About Surgery
Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.
The Medical Director will help shape the industry and build strong relationships externally with key customers and stakeholders (Key Opinion Leaders KOLs Surgeons Health 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 studies (IIS) including registries.
- Have a leadership role in governance forums including Business Unit leadership teams cross-functional product core teams EGS (evidence generation strategy) teams portfolio/strategy management teams and Safety and Quality Review Boards.
- Engage KOLs 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 clinical 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.
- Collaborate with Pre-clinical team on clinically relevant ex-vivo and in-vivo models development for evaluation of Biosurgery products
- Provide medical interpretation of preclinical and clinical 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 Sr. Medical Director in Pharmacovigilance activities reviewing periodic safety reports and adverse events assessment related to biologics.
- 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.
Requirements
- An MD/DO and a minimum of 10 years 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 IDE/PMA/BLA and/or their global counterparts)is strongly preferred.
- Experience in medical safety surveillance (drugs biologics or devices) and/or quality improvement activities isstrongly preferred.
- Experience in the process of new product development (internal development and external partnerships) ispreferred.
- 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 the 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.
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.
The anticipated base pay range for this position is :
The anticipated base pay range for this position is 194000 to 334650.Additional Description for Pay Transparency:
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Please use the following language: Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. Experience:Exec
Employment Type
Full-Time
Key Skills
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