Director, Medical Affairs, Orthopedics

Johnson and Johnson Family is recruiting a Director, Medical Affairs, Orthopedics located in Raynham, MA or Palm Beach Gardens, FL.

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 at https://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 role provides medical affairs support within an assigned platform / sub-platform within the Business Unit. Leading with both outside-to-inside vision to assimilate opportunities of unmet patient and provider needs, and inside-to-outside vision to communicate the medical, surgical, and scientific this role provides strategic input to inform the innovative agenda within the Platform Portfolio. This role provides medical input throughout product development and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential patient safety issues. This role collaborates cross-functionally to support product development, including evidence generation and dissemination to drive market registration, access and adoption. This role supports medical education to internal and external stakeholders, and commercialization activities to drive market adoption.

Tasks / Duties / Responsibilities

• Engage with omni-channel external sources of information (key opinion leaders, medical societies, literature, social media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/healthcare ecosystems.
• Support business leaders by providing medical and scientific expertise and omni-channel insights to help shape optimal business development strategy and targets, including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.
• Validate Target Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets.
• Provide strategic medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with medical teams) including to help drive global innovation agenda through leadership and partnership with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory, Clinical, Quality, & Supply Chain leveraging deep medical expertise.

Internal Process Support

• Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA) and Marketing to provide leadership with product development and commercial plans to support product launch, training content and delivery.
• Provide medical/surgical/scientific insights into design requirements, concept and prototype testing.
• Provide input into risk management processes for hazard/harm identification & risk mitigation.
• Assess device performance, including clinical benefits and safety profile, to evaluate the appropriate Risk-Benefit balance to support market registration and throughout life cycle.
• Work with Medical Safety and Post-Market Surveillance to assess, analysis and interpret events, complaints, signals and trends from clinical studies, literature, complaints, etc.
• Provide medical/surgical/scientific support for external regulatory inspections and audits, and internal audits.
• Provide expertise to support addressing complex medical information requests.
• Provide physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in matters requiring escalation or medical consultation.
• Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.

Evidence Generation Support

• Assist medical evidence generation leaders to develop and execute global strategies for evidence generation for new and existing products, including medical interpretation of clinical analyses, and in the review and approval of clinical study reports and scientific articles (abstracts, manuscripts, etc), in order to support regulatory approval/clearance, health technology assessment, customer access, medical safety and post-marketing support.

Life Cycle Management Support

• Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.
• Research, prepare and document responses to Medical Information Requests from Healthcare providers; review and approve medical content in Copy Approval process; and consults with Franchise Medical Director when needed.
• They will provide consultation in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER) and provide review of CERs and assists in preparation of periodic safety reports for assigned products.
• Assist in reviewing of risk evaluation (PRE or PRA) documents.