Johnson & Johnson MedTech
Medical Director, Medical Affairs, Johnson & Johnson MedTech
Johnson & Johnson MedTech, Anaheim, California, United States, 92808
Overview
Johnson & Johnson MedTech is recruiting a Medical Director, Medical Affairs. This role is fully remote in the United States. Reporting into the Senior Director, Medical Affairs, this position provides medical leadership globally to Johnson & Johnson’s MedTech Endomechanical and Energy Platforms and supports products across the lifecycle in collaboration with R&D, Global Strategic Marketing, Commercial, and Health Economics and Market Access (HEMA). Responsibilities
Work with cross-functional partners (R&D, Clinical Research, Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, HEMA, and Professional Medical Education) to provide leadership on product development, pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and product launch/training for key products within the portfolio. Lead the development and execution of product and/or procedural evidence generation and dissemination strategies for company-sponsored and investigator-initiated research, including registries. Participate in governance forums (Business Unit leadership, cross-functional product core teams, EGS teams, portfolio/strategy management, Safety and Quality Review Boards). Engage Key Opinion Leaders, Professional Societies, Payers and Providers to understand trends in care and uncover insights to support product innovation and portfolio strategies. Provide medical and scientific insights to drive strategic direction, including product launches, scientific meetings, and relationships with leading physicians 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 and escalate adverse events from clinical studies as needed. Interpret study outcomes and assist with communication and education strategies for disseminating results. Collaborate with Regulatory and Clinical partners to prepare reports on clinical investigations for regulatory submissions and publications to meet evidence requirements. Contribute to medical input for risk management and post-launch surveillance. Review and approve educational, promotional and reporting materials; prioritize publication proposals with Clinical Science. Align strategy, budget and resources in partnership with cross-functional teams. Attend key scientific meetings, participate as an oral presenter, and contribute to publications to establish leadership in the field. Qualifications
MD/DO with a minimum of 5 years of post-graduate medical education and related experience (residency, fellowship, subspecialty training, clinical practice, research, or equivalent). Current medical license preferred. Board Certification and Fellowship in a surgical specialty strongly preferred. Five+ years’ clinical practice as an attending-level physician 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. Experience in medical safety surveillance and quality improvement activities is preferred. Experience in new product development and partnerships is desirable. Strong leadership, communication, and negotiation skills; ability to build global teams across multiple specialties is desirable. Demonstrated success in medical data generation, interpretation, and publication is preferred. Experience with natural language processing in research and literature review is desirable. Experience with product risk evaluation and mitigation is preferred. Academic mindset with ability to analyze data to inform clinical trial decisions and innovation is desirable. Additional Information
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. The anticipated base pay range for this position is 194000 to 334650. This position is eligible for an annual performance bonus based on the applicable plan. Benefits may include medical, dental, vision, life insurance, disability, retirement savings, and time off; for full details see the Company’s employee benefits information.
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Johnson & Johnson MedTech is recruiting a Medical Director, Medical Affairs. This role is fully remote in the United States. Reporting into the Senior Director, Medical Affairs, this position provides medical leadership globally to Johnson & Johnson’s MedTech Endomechanical and Energy Platforms and supports products across the lifecycle in collaboration with R&D, Global Strategic Marketing, Commercial, and Health Economics and Market Access (HEMA). Responsibilities
Work with cross-functional partners (R&D, Clinical Research, Regulatory Affairs, Communications, Legal, Quality & Compliance, Preclinical, HEMA, and Professional Medical Education) to provide leadership on product development, pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments, and product launch/training for key products within the portfolio. Lead the development and execution of product and/or procedural evidence generation and dissemination strategies for company-sponsored and investigator-initiated research, including registries. Participate in governance forums (Business Unit leadership, cross-functional product core teams, EGS teams, portfolio/strategy management, Safety and Quality Review Boards). Engage Key Opinion Leaders, Professional Societies, Payers and Providers to understand trends in care and uncover insights to support product innovation and portfolio strategies. Provide medical and scientific insights to drive strategic direction, including product launches, scientific meetings, and relationships with leading physicians 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 and escalate adverse events from clinical studies as needed. Interpret study outcomes and assist with communication and education strategies for disseminating results. Collaborate with Regulatory and Clinical partners to prepare reports on clinical investigations for regulatory submissions and publications to meet evidence requirements. Contribute to medical input for risk management and post-launch surveillance. Review and approve educational, promotional and reporting materials; prioritize publication proposals with Clinical Science. Align strategy, budget and resources in partnership with cross-functional teams. Attend key scientific meetings, participate as an oral presenter, and contribute to publications to establish leadership in the field. Qualifications
MD/DO with a minimum of 5 years of post-graduate medical education and related experience (residency, fellowship, subspecialty training, clinical practice, research, or equivalent). Current medical license preferred. Board Certification and Fellowship in a surgical specialty strongly preferred. Five+ years’ clinical practice as an attending-level physician 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. Experience in medical safety surveillance and quality improvement activities is preferred. Experience in new product development and partnerships is desirable. Strong leadership, communication, and negotiation skills; ability to build global teams across multiple specialties is desirable. Demonstrated success in medical data generation, interpretation, and publication is preferred. Experience with natural language processing in research and literature review is desirable. Experience with product risk evaluation and mitigation is preferred. Academic mindset with ability to analyze data to inform clinical trial decisions and innovation is desirable. Additional Information
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. The anticipated base pay range for this position is 194000 to 334650. This position is eligible for an annual performance bonus based on the applicable plan. Benefits may include medical, dental, vision, life insurance, disability, retirement savings, and time off; for full details see the Company’s employee benefits information.
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