Global Medical Affairs Leader, Gastroenterology - Horsham Pennsylvania

Company: Disability Solutions
Location: Horsham, Pennsylvania
Posted On: 05/17/2024

Johnson and Johnson Family is recruiting a Global Medical Affairs Leader, Gastroenterology located in Horsham, PA. 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 Johnson and Johnson Innovative Medicine is recruiting for a Global Medical Affairs Leader (GMAL) Gastroenterology. The position will be located in Horsham, PA. At Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. At J&J Immunology, our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. The Global Medical Affairs Leader (GMAL) Gastroenterology, under direction of the Head of GMAF Gastroenterology, is responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans (ie the Medical Affairs Strategy) for the assigned marketed compounds and compounds in clinical development within the Immunology TA. He/she will lead or be a key participant in the Global Medical Affairs Strategy Team (G-MAST) and partner closely with Regional Medical TA/product leaders to develop integrated Global Medical Affairs (GMAF) perspectives, strategies and plans. The GMAL will be a member of the Compound Development Team, the Safety Management Team and Global Commercial Team as well as an ad hoc member of the Clinical Team and Global Market Access Team for assigned product. The GMAL will be responsible for development of the Global Medical Affairs plan that reflects prioritized regional needs and which are included in the overall Compound Development Plan. In addition, the GMAL will be accountable for the global publication plans, global opinion leader relationships, and global advisory boards. The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally. The GMAL will be responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance, etc. The Global Medical Affairs Leader will be responsible for but not limited to the following:

• Development of Medical Affairs Strategy and plan for the assigned compounds based on global and prioritized regional needs. Working with the CDT to ensure integration with the overall global compound strategy, resulting in one global R&D and Medical Affairs compound development plan, inclusive of developing a Target Product Profile representing Medical Affairs global and regional value needs.
• Pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.
• Active membership of the CDT and will lead/participate in the GMAST, consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one Medical Affairs perspective and one "unified" voice on the CDT.
• Close collaboration with the regional Medical Affairs representatives to develop integrated global Medical Affairs strategies and plans and maintain open, two-way communication to ensure regional Medical Affairs is up to date on all plans, progress, and decisions.
• Development and execution of the global publication plan as well as review and approval of publications and Congress displays for assigned products, marketed or in clinical development.
• Management of the ReCAP process (review of all Medical Affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for assigned 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. More...

      

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