20 days old

Global Medical Affairs Leader, Director - Rheumatology

Johnson & Johnson
Horsham, PA

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Medical Affairs Leader, Director - Rheumatology to be located in Horsham, PA.

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 Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information. 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Global Medical Affairs Leader (GMAL), Director of Rheumatology, is 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 Rheumatology TA. He/she will partner closely with Regional Medical TA/product leaders to develop integrated global medical affairs perspectives, strategies and plans for specified products/projects. The GMAL, Director of Rheumatology, will be a member of the Compound Development Teams, the Safety Management Teams and Global Commercial Teams 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. In addition, the GMAL, Director of Rheumatology will 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). The GMAL, Director of Rheumatology, will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally. 
*\tDevelop 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. \t
*\tProvide single Medical Affairs voice into the creation of compound development and LCM strategies, plans and trial design from phase IIa through phase IV.\t
*\tResponsible for pre-launch medical activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, coordination of regional activity in these areas.\t
*\tThe GMAL will 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.
*\tCollaborate 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.
*\tSynchronize input and output of the Med Affairs plan with the strategic and business plan calendars \t
*\tResponsible 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 \t
*\tManage the ReCAP process (review of all medical affairs sponsored clinical trials and Investigator Initiated Sponsored studies) for applicable products.
*\tSupport 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. \t
*\tResponsible to ensure all global activities follow J&J Compliance principles, eg. Health Care Compliance , etc.

*\tA minimum of a Ph.D or MD degree (or equivalent) is required with specialty training and certification in rheumatology preferred.
*\tExtensive clinical and/or pharmaceutical experience in Immunology is required. Experience in rheumatology disease area and an established network with medical experts/opinion leaders in rheumatology is highly preferred
*\tA minimum of 5 years of combined relevant experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with at least three years in the Medical Affairs environment is highly desireable.
*\tKnowledge of products, both J&J and competitors, in the Therapeutic Area
*\tA demonstrated track record of success within Medical Affairs and/or clinical R&D.
*\tIn-depth knowledge of study methodology, study data reviews and analysis
*\tExcellent knowledge of study execution, benefit risk management and regulatory affairs
*\tProven ability to act as a medical spokesperson for external audiences is required. Also required is strong experience developing and managing strategic relationships with medical experts/opinion leaders
*\tProven track record on ethics and Credo principles

Primary Location
United States-Pennsylvania-Horsham-
Janssen Global Services, LLC (6085)
Job Function
Medical Affairs
Requisition ID
Posted: 2018-12-26 Expires: 2019-01-25

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Global Medical Affairs Leader, Director - Rheumatology

Johnson & Johnson
Horsham, PA

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