Responsible for development and execution of regional medical plans for Therapeutic Area (TA)/Brands by partnering with GEM Portfolio Management, Market Access, Evidence Generation and Medical Excellence teams.
Provides up-to-date, fair-balanced product-related and clinical expertise to internal and external stakeholders as the in-house scientific expert to Therapeutic Area (TA)/Brands within Growth and Emerging (GEM) markets with focus on defined key countries.
Establish, develop and foster relationships with key external stakeholders including Global, Regional, local levels through scientific discussions to facilitate and contribute to insight generation, in-depth understanding of the patient journey within TA that eventually guides the creation of medical and brand plans.
Support TA head on all matters related to medical strategy, medical governance, and compliance within the medical function, by putting the patient\xe2\x80\x99s needs and safety into focus.
Ensure compliance with regional directives for, amongst others, the release of promotional material, medical representative training materials and medical information.
Major activities
Develops and execute regional strategic communications plans in line with product life cycle management plan.
Collaborates with Area/Local medical teams to build medical capabilities and to ensure strategic relevance, timeline and delivery of medical activities.
Support key countries with the development of local evidence generation activities with focus on RWE.
Apply scientific expertise and customer (patient and prescriber) insights to contribute to the development of the Brand Strategy and develop a Medical Plan for each assigned product.
Ensure excellence and timeliness in implementation of the therapeutic area specific medical plans.
Formulate strategic KOL/Stakeholder engagement plans to inform and assist in evaluating innovative ideas in development of the medical strategy.
Review and approve promotional/non promotional materials per Takeda policies.
Develop medical/scientific materials and slide decks as needed (e.g. Advisory board slides/symposia etc) and ensure the content is appropriately reviewed and approved as per Takeda policies.
Support/Lead scientific training of internal stakeholders and provide ongoing support and education as needed.
Co-create GEM brand plan development, in close collaboration with global, regional, area and LOC Medical Directors, TA leads and cross functional teams.
Ensure integrity and correctness of the analysis, interpretation, scientific and marketing validity of the publications produced.
Lead and provide support to all the data generation activities and publications generated within GEM.
Ensures the scientific integrity, GCP adherence, (global) strategic alignment and safety design of clinical studies undertaken by their regional or LOC medical affairs teams.
Have a clear understanding of external stakeholder mapping, which will enable development of appropriate and relevant relationships and build networks to meet business objectives.
Review of research proposals (include IIR, Collaborative Research, etc.) to ensure global alignment and execution of this research within Takeda standards of compliance.
Ensure that all scientific-medical communications are fair-balanced, based on appropriate scientific evidence, and compliant with local regulatory norms and internal compliance policies.
Review of early access requests (Named Patient Program, Individual Patient Request) from GEM LOCs and support program manager on operational oversights
Assist the TA head in proactive risk management and recognize when appropriate actions need to be put into place or highlighted.
Qualification and Experience
MD (preferred) or PhD human sciences / pharmacology/Bio Sciences
Minimum of 5 years of experience in pharmaceutical industry (including medical affairs and/or clinical development) at country and preferably above country levels
Experiences in Rare disease and new product launch experiences would be asset
Regional / international experience working in a cross-cultural environment preferred
Good knowledge of the international healthcare market, able to identify healthcare trends and the related commercially opportunities
Excellent skills in oral and written communication
Travel requirement: 30-40%
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