Johnson & Johnson Innovative Medicine, Immunology Global Medical Affairs, is recruiting for a Global Medical Affairs Leader (GMAL), Director, Dermatology, located in Horsham, Pennsylvania or Spring House, Pennsylvania.
The Global Medical Affairs Leader (GMAL), Director, Dermatology, under the direction of the Head of Global Medical Affairs for Dermatology, 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 Immunology TA. The GMAL will 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 for specified products, assets, and projects. The GMAL, will be a member of the Compound Development Teams (CDTs), the Safety Management Teams (SMTs) and Global Commercial Teams (GCTs), 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 are included in the overall compound development plan. In addition, the GMAL will be accountable for the global publications plans, global opinion leader relations, global medical education (including symposia, speaker training) and global advisory boards for assets starting in early development (phase IIA) and through launch of major life cycle management initiatives (earlier or later as needed). The GMAL will also be responsible for facilitating and ensuring a consistent approach to Medical Affairs programs/activities globally.
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 a 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 Affairs activities including product/Therapeutic Area global advisory boards, medical symposia and congress activities, and coordination of regional activity in these areas.
Be an active member of the CDT and lead a Global Medical Affairs 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.
Synchronize input and output of the Medical Affairs plan with the strategic and business plan calendars.
Maintain responsibility for the development and execution of global publication plans as well as review and approval of publications for marketed products and specified compounds in clinical development
Lead 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.
Maintain responsibility for ensuring that all global activities follow J&J Compliance principles (eg. Health Care Compliance etc.)
Read Full Description