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Job Details

Location
Singapore
Salary
SGD150000 per annum
Job Type
Permanent
Ref
BH-161669-3
Contact
Angela Poh
Posted
25 days ago
Medical Lead

We have the opportunity to unlock the potential of our medicines across their lifecycle successfully on global basis - with patient safety being at the heart of everything we do. Our focus will be on supporting the Regions to fully realize the potential of all our medicines. This role will require close collaboration with co-creation markets to deliver business needs for the Classic & Established Products (CEP) portfolio and be the study accountable person for the various phase 3b and IV studies

Responsibilities
• Contributing to the Integrated Evidence Plan (IEP) for the relevant asset/ indication(s) under the direction of the Global Medical Director, identifying data generation gaps that have potential to meet patient needs.
•    Delivering the evidence needs of that asset in partnership with CEP and R&D colleagues, including:
o Supporting the efficient working of the Integrated Evidence Team and be the study accountable person ( SAP) 
o Reviewing local GSK-sponsored and Investigator Sponsored Study (ISS) proposals to assess their scientific merit and strategic need; 
o Developing assigned study protocols, as part of the proactive life cycle management of the established portfolio
•     Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained in Datavision
•    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.
•    Supports preparation of materials for the CEP Portfolio Investment Board (PIB) review/ Brand Planning processes.
•    Maintains a high level of knowledge of the assets/ indications, the area and competitors.
• Supports the Global Medical Director in communicating the clinical / market access data, ensuring a robust understanding of the asset risk: benefit profile. 
• Leads designated aspects of Advisory Board design/ execution, ensuring compliance with all SE governance and documentation requirements (SE Approval Templates; GLASSES etc).
Provides medical input, reviews and approves Clinical R&D activities including risk-benefit assessment, participation in PIRC (Product Investigation Report Committee) meetings, synchronizing labels, PBRER safety reports, clinical overviews and central clinical response to questions from national regulatory agencies.
Provides medical/ scientific input to promotional campaigns. Approves promotional materials, ensuring compliance with all relevant codes and system requirements

Requirements
•    5-7 years of experience in Clinical trials and Medical affairs 
•    Medical or Post Graduation Science degree
•    Experience in above country medical role
•    Therapy knowledge 
•    Copy approval knowledge / experience in the pharmaceutical industry, ideally at final or near to signatory status
•    Strong familiarity with and confidence in implementing compliance frameworks
•    Clear communicator with sufficient business acumen and experience to enable communication and engagement with key stakeholders supported by influencing, challenging and negotiating skills.
•    Knowledge and experience in phase 3b and 4 trials

•  Study accountable person for deliver the clinical programme
•    Provides medical/ scientific input to promotional campaigns. Develops promotional materials, ensuring compliance with all relevant codes and system requirements (ABPI, Zinc MAPs etc) and that materials are adequately and correctly referenced.
• Develops and reviews publications/ abstracts/ posters related to the product, key competitors and relevant disease area(s). Ensures the Data Dissemination Plan (DDP) is maintained in Datavision.
• Supports the GMD in providing medical governance oversight for the asset, including assisting in the management of product-related issues/ crises including medical input into manufacturing issues. 
• Leads license maintenance activities by providing strategical and technical expertise to support marketed portfolio for PREPS/ global regulatory filings/commercial interactions/new formulations/ indications/SKU reduction/authoring of regulatory responses/medical affairs.
• Provides medical input, reviews and approves Clinical R&D activities including risk-benefit assessment, participation in PIRC (Product Investigation Report Committee) meetings, synchronizing labels, PBRER safety reports, clinical overviews and central clinical response to questions from national regulatory agencies.