Global Medical Affairs Manager – Respiratory
GSK
Full time- 1+ years
- Not Disclosed
- Mumbai, India
- Post Date: Nov 11, 2022
- End Date: Jan 11, 2023
- 1+ years
- Not Disclosed
- Mumbai, India
- Post Date:Nov 11, 2022
- End Date: Jan 11, 2023
Skills:
- Quality control
- bpharm
- Operations
Job Description:
Responsibilities
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Support in developing and co creating Global medical affairs strategies including campaigns, data dissemination plan, Integrated Evidence Plan (IEP) and external engagement plan for the relevant Respiratory assets/ indication(s) for their respective brands/TA.
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Get trained and certified on the GSK code and ABPI-code under a global mentor before signing off global contents.
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Understand and conduct the copy approval process e2e including the systems i.e. Content Lab.
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Develop and review/approve promotional, scientific, and training content/materials ensuring excellence in compliance to relevant SOPs, policies and GSK Code of practice.
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Support relevant License Maintenance activity for CEP assets
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Ensure there is a seamless collaboration within the Therapy Area (TA) global medical affairs team, global commercial team, region and MCT LOCs in gathering insights into the strategy development following the co creation model in identifying opportunities, creating strategies and delivering the plan with impact.
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Providing medical/ scientific input to brand campaigns and launches and other commercial activities to global and MCT LOCs
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Understand the evidence / data gaps for the relevant assets in partnership with LOCs, R&D colleagues and other stakeholders, including:
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Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need;
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Developing assigned study protocols.
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Reviews study proposals as a part of the Evidence Generation & Life-Cycle Management (LCM) activities for their respective brands/TA
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Maintains a high level of scientific knowledge of the assets/ indication, the disease area and competitive insights.
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Supports the Global Medical Affairs Leaders (GMAL) and Global medical leads in executing the global Sci Communications and external engagement plan for their respective assets.
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Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DPP) is maintained in Datavision.
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Provide scientific inputs to the design and delivery of phase 3b/ 4 studies, coordinating with relevant R&D technical experts e.g. GHO and Epidemiology as required. Tracks implementation status and keeps the GMD informed.
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Supports preparation of Global Brand & Medical business Planning processes.
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Provides medical/ scientific input to co create promotional materials, ensuring compliance with all relevant codes and system requirements (ABPI, Copy Approval system, MPs etc.) and that materials are adequately and correctly referenced.
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Supports in providing medical governance oversight for the assets, including assisting in the management of product-related issues/ crises.
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Supports the GMD in authoring and providing support to R&D technical experts to deliver License Maintenance activity.
Qualification & Experience
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Medical degree, PharmD, PhD or equivalent.
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Experience in Medical Affairs and Life Cycle Management preferred, including understanding of launch support requirements.
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Robust understanding of promotional codes/ regulations; previous involvement in review and approval processes.
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Understanding of copy approval process, authoring requirements and drug development process and GCP principles.
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Salary
Not Disclosed
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Role
Others
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Area of Practice
- Medicine
- Hospital Operations
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Experience
1+ years
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