Category

Description

Job description

Responsibilities

Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio

Governance and alignment with Global strategy

Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global

Supporting clinical trial conduct

Participating in engagement of external key stakeholders (often in partnership with other functions)

Participating in development of data communication strategy (including congress)

Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data

Supports implementation of Medical governance for respective product, which includes:
Safety and pharmacovigilance as a key and effective partner with GRAAS
Clinical trial conduct
US risk management/minimization in collaboration with GRAAS
Subject matter appropriateness (medical/scientific) of external interactions (e.g. copy review, multichannel, congresses, 1-1 interactions, etc.)

Ensuring appropriate medical support of compliance

Key Activities

Maximizes Amgen

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