Johnson and Johnson Family is recruiting a Medical Director, Medical Affairs, Johnson Johnson MedTech located in Cincinnati, OH

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through 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 humanity.Learn more athttps://www.jnj.com/.

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson Johnson, we all belong.

This position will report into the Senior Director, Medical Affairs and will provide medical leadership globally to Johnson and Johnson’s MedTech Endomechanical and Energy Platforms.

The role will support products across the entire lifecycle in collaboration with RD, 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 RD 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 RD, 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 insights to 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 (e.g.copy 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 reviewed,trendedand 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 educational,promotionaland reporting materials for use by internal stakeholders. Strategize and prioritize publication proposals in collaboration with Clinical Science.Align strategy,budgetand 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 development,product training during investigational trials as well as during product launches, and may provide case coverage during trials.

Johnson and Johnson Family is recruiting a Medical Director, Medical Affairs, Johnson Johnson MedTech located in Cincinnati, OH

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through 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 humanity.Learn more athttps://www.jnj.com/.

For more than 130 years, diversity, equity inclusion (DEI) has been a part of our cultural fabric at Johnson Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson Johnson, we all belong.

This position will report into the Senior Director, Medical Affairs and will provide medical leadership globally to Johnson and Johnson’s MedTech Endomechanical and Energy Platforms.

The role will support products across the entire lifecycle in collaboration with RD, 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 RD 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 RD, 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 insights to 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 (e.g.copy 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 reviewed,trendedand 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 educational,promotionaland reporting materials for use by internal stakeholders. Strategize and prioritize publication proposals in collaboration with Clinical Science.Align strategy,budgetand 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 development,product 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 5 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 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.Capability,expertiseand 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.

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 corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).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
- Work, Personal and Family Time - up to 40 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visitwww.careers.jnj.com.

Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Requirements

An MD/DO and a minimum of 5 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 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.Capability,expertiseand 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.

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 corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

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 Company’s consolidated retirement plan (pension) and savings plan (401(k)).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
- Work, Personal and Family Time - up to 40 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visitwww.careers.jnj.com.

Johnson Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability

Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits