Loading some great jobs for you...
The Global MedicalAffairs Leader (GMAL) for erdafitinib will be responsible for leading theclinical-commercial optimization for erdafitinib product development and lifecycle management strategies and plans. S/he will partner closely with the GMAOperations Leader, Regional Medical TA/product leaders and Clinical DevelopmentLeader to develop an integrated global medical affairs perspectives, strategiesand plans.
The erdafitinib GMALwill be an integral member of the late stage development Compound DevelopmentTeams for erdafitinib.In addition s/he will participate on the GlobalCommercial Team and also as an ad hoc member of the clinical team. The erdafitinibGMAL will also be a core member of the erdafitinib SMT. The erdafitinib GMALwill be responsible for the development of the global medical affairs plan thatreflects prioritized regional needs, which are included in the overall CompoundDevelopment Plan. In addition, the GMAL will be accountable for the leading theglobal publication plans, global opinion leader relations, global medicaleducation (including symposia, speaker training) and global advisory boards forproducts starting in early development (phase IIA) and through launch of majorlife cycle management initiatives. The GMAL will also be responsible forfacilitating and ensuring a consistent approach to global late stage MedicalAffairs programs/activities globally.
Responsibilitiesinclude: Develop global medical affairs strategy and plan for the compoundbased on prioritized regional needs. In addition, partner closely with the VicePresident of Global Medical Affairs and other GMALs to ensure one franchisestrategy. Work with the CDTs to ensure integration with the overall globalcompound strategy, resulting in one global R&D and Medical Affairs compounddevelopment plan, inclusive of developing a Target Product Profile representingmedical affairs global and regional value needs. Provide single MedicalAffairs voice into the creation of compound development and LCM strategies,plans and trial design from phase IIa through phase IV. Responsible forpre-launch medical activities including product/ Therapeutic Area globaladvisory boards, medical symposia and congress activities, in collaborationwith functional leads of regional activity in these areas.
The GMAL will be anactive member of the core product CDTs and will lead a global Medical AffairsTeam consisting of regionally designated Therapeutic Area Medical AffairsLeaders to create one medical affairs perspective and one \"unified\"voice on the CDT. They will collaborate closely with the regional medicalaffairs representatives to develop integrated global medical affairs strategiesand plans and maintain open, two-way communication to ensure regional medicalaffairs is up to date on all plans, progress and decisions. Synchronizeinput and output of the Med Affairs plan with the strategic and business plancalendars. Lead global publications planning process oversight (with vendorsupport) including manuscripts, abstracts, posters and papers as well aspre-launch global KOL communications & speaker development. Review ofmanuscripts to ensure alignment with strategy and effectivecommunication/presentation in internal and external audiences (e.g.Symposia). The GMAL is responsible for review and approval of proposedevidence generation activities within Medical Affairs for oncology products.Responsible to ensure all global activities follow J&J Complianceprinciples, e.g. Health Care Compliance, etc.
Launch your career - Upload your resume now!Upload your resume
Loading some great jobs for you...