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Global Medical Affairs Leader, Director- Gastroenterology

Company: Disability Solutions
Location: Horsham
Posted on: February 1, 2025

Job Description:

Johnson and Johnson is recruiting for a Global Medical Affairs Leader (GMAL), Director- Gastroenterology within our Global Immunology Medical Affairs organization located in Horsham, PA.\rAt 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/. \rFor 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.\rThe GMAL - Gastroenterology (GI), under direction of the Head Global Immunology Medical Affairs - Gastroenterology, is responsible for leading certain aspects of the clinical-commercial optimization for asset development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology- Gastroenterology TA. S/he will partner closely with the GMA Operations Leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans. He/she will be a member of the Global Medical Affairs Team (GMAT) and partners closely with Regional Medical TA/product leaders to develop to support the Head Global Immunology Medical Affairs - Gastroenterology in the building global medical affairs perspectives, strategies. The GMAL GI acts as a member of the Safety Management Team, Global Commercial Team as well as an ad hoc member of the Clinical Team and Global Market Access Team. The GMAL GI will be responsible for development of the Global Medical Affairs (GMA) plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL GI will be accountable for the global publication plans, global opinion leader relationships, and global advisory boards. The GMAL has primary medical responsibility in responding to requests and representing clinical aspects to external stakeholders including governments, health authorities, KOLs, NGOs, and supra-governmental organizations, such as WHO, CDC etc.

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  • Development of GMA strategy and plan for the assigned compounds (whether in development or marketed) based on prioritized regional needs in alignment with defined global medical objectives
  • Collaborate closely with the regional medical affairs and maintain open, two-way communication to ensure regional medical affairs is up to date on all plans, progress and decisions
  • Responsible for internal training strategy to assure continuous education of global and regional market access and medical affairs teams
  • Responsible for global publications planning process oversight (pre-launch and throughout lifecycle) including manuscripts, abstracts, posters and papers as well as pre-launch global KOL communications & speaker development
  • Review of manuscripts to ensure alignment with strategy and effective communication/presentation in internal and external audiences
  • Responsible for pre- and post-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas
  • Responsible for medical education strategy as well as creation and approval of medical material for external use (e.g. HCP education)
  • Responsible for opinion leader relations product/Therapeutic Area global advisory boards
  • Responsible to provide medical input into market research and health outcomes research conducted by commercial and market access teams, respectively
  • Responsible to support commercial teams in the creation of promotional material
  • Will lead/participate to create one Medical Affairs perspective and one "unified" voice on the CDT
  • Responsible for the Management of the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products
  • Supporting development of the company risk management strategy and plan as well as author and review specific sections of the Periodic Benefit-Risk Evaluation Report for compounds. Performance of Medical Impact assessments as required
  • Responsible to ensure all global activities follow J&J compliance principles, (e.g. Health Care Compliance, etc.)\r\r

Keywords: Disability Solutions, East Orange , Global Medical Affairs Leader, Director- Gastroenterology, Executive , Horsham, New Jersey

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