Johnson & Johnson MedTech
Medical Director, Medical Affairs, Johnson & Johnson MedTech
Johnson & Johnson MedTech, Washington, District of Columbia, us, 20022
Medical Director, Medical Affairs, Johnson & Johnson MedTech
Johnson & Johnson MedTech is recruiting a Medical Director, Medical Affairs. This is a fully remote role in the United States, reporting to the Senior Director, Medical Affairs, providing medical leadership globally for Johnson & Johnson’s MedTech Endomechanical and Energy Platforms. Overview
Join to lead medical affairs initiatives across the product lifecycle, collaborate with R&D, Global Strategic Marketing, Commercial, and Health Economics and Market Access (HEMA), and support evidence generation, dissemination, and education to enable product approvals, claims development, and adoption. Responsibilities
Work with partners including R&D, Clinical Research, Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, Health Economics & Market Access, and Professional Medical Education to lead product development, clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and training for key products within the portfolio. Lead the development and execution of product and procedural evidence generation and dissemination strategies for company-sponsored and investigator-initiated research, including registries. Participate in governance forums such as 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 care trends and uncover insights to support product innovation and portfolio strategies. Provide medical and scientific insights to guide business strategy, including product launches, major scientific meetings, and relationships with leading researchers and decision makers. Provide lifecycle medical affairs support (e.g., copy review, medical information requests, input into clinical evaluation reports). Provide medical oversight for development of study materials (investigator brochures, training materials, etc.). Work with Medical Safety to review, trend, and escalate adverse events from clinical studies as needed. Interpret study outcomes and help develop communication and education strategies for disseminating results. Collaborate with Regulatory and Clinical partners to prepare clinical investigation reports for regulatory submissions and publication to meet evidence requirements for new products and renewals. Contribute to medical input on risk management plans and post-market surveillance. Review and approve educational, promotional, and reporting materials for internal stakeholders; plan publication proposals with Clinical Science. Align strategy, budget, and resources with cross-functional partners. Attend key scientific meetings as an oral presenter; contribute to publications to establish leadership in the field. Safeguard patient safety and engage in environmental scanning, competitive analysis, and product development activities during trials and launches. Qualifications
MD/DO with a minimum of 5 years of post-graduate medical education and experience including specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or related experience. A current medical license is preferred. Board Certification and Fellowship in a surgical specialty is strongly preferred. Five or more years of clinical practice as an attending-level physician is preferred. Clinical research experience in medical devices, biologics, or drugs is strongly preferred. Experience supporting global regulatory submissions for medical devices, biologics, or drugs is desirable (e.g., PMA/BLA/NDA and equivalents). Experience in medical safety surveillance and/or quality improvement activities is preferred. Experience in medical product development and partnerships is desirable. Strong leadership, communication, and negotiation skills; ability to build global teams across diverse specialties is desirable. Demonstrated success in medical data generation, interpretation, and publication is preferred. Experience with natural language processing in research and literature reviews is desirable. Experience in product risk evaluation and mitigation is preferred. Academic mindset with ability to analyze data to inform decisions for clinical trials and innovation is desirable. Additional Information
The Johnson & Johnson Equal Opportunity Employer statement is provided to applicants. We are committed to inclusive hiring and to providing accommodations during the hiring process upon request. The anticipated base pay range for this position is 194000 to 334650. This position is eligible for an annual performance bonus and other company-sponsored benefits, as described in our benefits information. For benefits details, please refer to the company benefits page. Referrals increase your chances of interviewing at Johnson & Johnson MedTech.
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Johnson & Johnson MedTech is recruiting a Medical Director, Medical Affairs. This is a fully remote role in the United States, reporting to the Senior Director, Medical Affairs, providing medical leadership globally for Johnson & Johnson’s MedTech Endomechanical and Energy Platforms. Overview
Join to lead medical affairs initiatives across the product lifecycle, collaborate with R&D, Global Strategic Marketing, Commercial, and Health Economics and Market Access (HEMA), and support evidence generation, dissemination, and education to enable product approvals, claims development, and adoption. Responsibilities
Work with partners including R&D, Clinical Research, Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, Health Economics & Market Access, and Professional Medical Education to lead product development, clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and training for key products within the portfolio. Lead the development and execution of product and procedural evidence generation and dissemination strategies for company-sponsored and investigator-initiated research, including registries. Participate in governance forums such as 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 care trends and uncover insights to support product innovation and portfolio strategies. Provide medical and scientific insights to guide business strategy, including product launches, major scientific meetings, and relationships with leading researchers and decision makers. Provide lifecycle medical affairs support (e.g., copy review, medical information requests, input into clinical evaluation reports). Provide medical oversight for development of study materials (investigator brochures, training materials, etc.). Work with Medical Safety to review, trend, and escalate adverse events from clinical studies as needed. Interpret study outcomes and help develop communication and education strategies for disseminating results. Collaborate with Regulatory and Clinical partners to prepare clinical investigation reports for regulatory submissions and publication to meet evidence requirements for new products and renewals. Contribute to medical input on risk management plans and post-market surveillance. Review and approve educational, promotional, and reporting materials for internal stakeholders; plan publication proposals with Clinical Science. Align strategy, budget, and resources with cross-functional partners. Attend key scientific meetings as an oral presenter; contribute to publications to establish leadership in the field. Safeguard patient safety and engage in environmental scanning, competitive analysis, and product development activities during trials and launches. Qualifications
MD/DO with a minimum of 5 years of post-graduate medical education and experience including specialty residency, fellowship or subspecialty training, clinical practice, dedicated research, or related experience. A current medical license is preferred. Board Certification and Fellowship in a surgical specialty is strongly preferred. Five or more years of clinical practice as an attending-level physician is preferred. Clinical research experience in medical devices, biologics, or drugs is strongly preferred. Experience supporting global regulatory submissions for medical devices, biologics, or drugs is desirable (e.g., PMA/BLA/NDA and equivalents). Experience in medical safety surveillance and/or quality improvement activities is preferred. Experience in medical product development and partnerships is desirable. Strong leadership, communication, and negotiation skills; ability to build global teams across diverse specialties is desirable. Demonstrated success in medical data generation, interpretation, and publication is preferred. Experience with natural language processing in research and literature reviews is desirable. Experience in product risk evaluation and mitigation is preferred. Academic mindset with ability to analyze data to inform decisions for clinical trials and innovation is desirable. Additional Information
The Johnson & Johnson Equal Opportunity Employer statement is provided to applicants. We are committed to inclusive hiring and to providing accommodations during the hiring process upon request. The anticipated base pay range for this position is 194000 to 334650. This position is eligible for an annual performance bonus and other company-sponsored benefits, as described in our benefits information. For benefits details, please refer to the company benefits page. Referrals increase your chances of interviewing at Johnson & Johnson MedTech.
#J-18808-Ljbffr