The Medical Lead is responsible for the Medical Affairs Tactics in line with the overall strategy for the Therapeutic Area as well as the Medical Engagement plans. Further, the Medical Lead is the subject matter expert (SME) within specified therapy area having in-depth scientific knowledge and scientific leadership when collaborating with cross-functional colleagues and leading cross-functional team(s) throughout the product life cycle.
Key responsibilities:
Acts as the SME for relevant TA(s)
•Has an in-depth knowledge and understanding of the unmet medical need, SoC (standard of care), competitive landscape and external stakeholder views within TA as well as collaborates and co-develops Country value proposition (including reimbursement dossiers) with Market Access.
•Develops and executes the Medical Affairs Tactics for the Therapy Area aligned with the overall TA strategy.
•Ensures that all Adverse Events (AEs) are brought to attention to the Patient Safety department and Product Complaints to Quality organization within 24 hours after received, as well as provides scientific and medical input as well as guidance and review for post-launch marketing materials and concept generation for prioritized brand.
Therapy Area accountabilities
•Adapts and executes initiatives for life cycle management plans of the Therapeutic area(s) as well as understands Therapy area (TA) and collects insights. Discusses data in relation to TA externally and is mainly external and customer facing in engaging HCPs as well as having a patient centric mindset according to TA strategy.
•Responsible for compliance to global/regional medical excellence guidelines, including applicable SOPs, regulations and performance indicators (metrics).
•Plans and implements advice seeking plans and activities including running advisory boards and the systematic collection of field medical intelligence (FM-IQ) and together with cross-functional team propose actions based on FM-IQ.
Medical Expert (ME) Engagement and development:
•Plans and implements the aligned ME engagement strategy for the relevant TA(s) as well as maps all prioritized MEs within TA(s) and builds strong and sustainable relationships with key healthcare providers and medical societies.
•Responsible for medical segmentation process based on cross-functional input from all relevant stakeholders, and governs and follows up the ME engagement activities for the Therapeutic area(s)
Data Generation and dissemination:
•Plans and deploys the Data Gap Assessment process in the Therapeutic area(s), as well as the alignment with Nordic, Regional and Global data gaps and integrated evidence plans.
• Develops and implements Country data generation plans based on Country data gap analysis as well as provides up to date and in-depth medical and clinical knowledge to external and internal stakeholders.
•Has oversight of registries with the potential to generate relevant data supporting the Health Technology Assessment (HTA) and other activities throughout the life cycle.
Patient, digital and other initiatives:
•Knows, plans, effectively uses and contributes to development of digital channels and digital solutions to engage with stakeholders and influencers.
• Sets up and deploys digital initiatives for the TA(s) together with other colleagues as well as maps relevant patient associations and if relevant collaborates with them to identify gaps in treatment of patients.
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