Janssen Global Services, a member of Johnson & Johnson’s family of companies, is recruiting for a Global Medical Affairs Leader (GMAL) - Rheumatology, to be located in Horsham, PA or Titusville, NJ.
At the Janssen Pharmaceutical Companies of 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.
Janssen Global Services, LLC encompasses groups that provide leadership across critical business areas for Janssen including, Global Commercial Strategy Organization; Global Pharmaceuticals Communication and Public Affairs; U.S. Pharmaceuticals Procurement Group; and Pharmaceuticals Group Business Development.
We are Janssen. 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) – Rheumatology will:
• Be responsible for leading the clinical-commercial optimization of product development and life cycle management strategies and plans for the assigned marketed compounds and compounds in clinical development within the Immunology TA.
• Lead the Global Medical Affairs Team and partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans.
• Be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams, Labelling working group, as well as an ad hoc member of the Clinical Team and Global Market Access Team and 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.
• Be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for products starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed).
• Be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.
• Represent global medical affairs on the Rheumatology Disease Area Stronghold team.
• Develop global medical affairs strategy and plan for the assigned compounds based on prioritized regional needs, Working with the CDT ensures 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.
• Provide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.
• Be responsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.
• Be an active member of the CDT and will lead a global Medical Affairs TA Team consisting of regionally designated Therapeutic Area Medical Affairs Leaders to create one medical affairs perspective and one “unified” voice on the CDT.
• Collaborate closely 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
• Be responsible for the development and execution of the global publication plan as well as review and approval of publications for marketed products and specified compounds in clinical development
• Manage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
• Support development of the Company risk management strategy and plan as well as author and review specific sections of the Periodic benefit-risk assessment report for compounds. Perform Medical impact assessments as required.
• Be responsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance , etc.Qualifications
• A minimum of a MD or equivalent degree is required with specialty training and certification in rheumatology is preferred
• A minimum of 10 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with a minimum of 5 years in the Medical Affairs environment preferred.
• Previous clinical and/or pharmaceutical experience in Immunology is preferred
• Previous experience in rheumatology disease area and an established network with medical experts/opinion leaders in rheumatology is preferred
• A demonstrated track record leading highly matrixed, cross-functional work teams comprised of high-level contributors is required.
• In-depth knowledge of study methodology, study data reviews and analysis is required
• Proven ability to act as a medical spokesperson for external audiences is required
• Strong experience developing and managing strategic relationships with medical experts/opinion leaders is required
• This position is located in Horsham, PA or Titusville, NJ and will require up to 35% domestic and international travelPrimary Location
United States-Pennsylvania-HorshamOther Locations
North America-United States-New Jersey-TitusvilleOrganization
Janssen Global Services, LLC (6085)Job Function