Medical Affairs Manager
Site Name: Hanoi, Ho Chi Minh City
Posted Date: Dec 20 2019
- Provide strategic and operational medical input/action plan to Medical - Marketing Business development, build external relations and develop professional connections with medical communities and relevant stake holders, provide medical expertise/ medical information on therapeutically assigned product support to achieve GSK Vietnam business objectives.
- Ensures compliance with industry and corporate ethics and with regulatory and legal framework.
- Ensures excellence in execution of all governance processes, including medical information, scientific engagement and promotional practices.
- Ensure high standards of ethic in clinical, medical strategies and practices.
As a medical governance and medical affairs specialist:
- Develop medical strategy and action plan for assigned product, TA (therapeutic area) strategic medical input and execution in collaboration with Commercial team for Brand/portfolio strategy, New product launch, Market research, Opinion Leader development, Conference organizations, speaker's advice/contact and development of Continuous Medical Education Programs to ensure GSK prominence in the market.
- To provide strong technical, medical expertise to GSK 's interaction with external experts (EEs) and other relevant stake holders (Medical associations, government officer, payer...) To develop and reinforce the external scientific understanding and credibility of GSK Rx among HCP and EE(s) by scientific engagement.
- Identifies and engages the external stake holders appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding. Understanding regulatory environment and related requirement for new product access opportunity. Coordinate with relevant cross-funtional team and liaise with above country resource for support and responsible for conducting HTA/HEOR for new product (if applicable) for evidence generation and reimbursement enlisting purpose when required. Ensures timely, professionally and appropriate scientific engagement in strict adherence with Global Scientific Engagement Principles and Standards.
- Development and implementation of assigned TA and products and other relevant training activities.
- Keep up to date medical literature/ information on assigned therapeutic areas, competitor products and related scientific data for communication to other Medical, Commercial and Regulatory personnel to ensure prompt dissemination and awareness of information to all concerned. To support marketing team to deliver scientific presentations where appropriate.
- Ensure medical affairs support to local business in cases where medical rep have medical queries - with accompanied field visits and external presentations as appropriate in order to facilitate understanding and solve issues.
- To actively participate in Commercial meetings and other cross-function meetings to provide relevant and latest medical information and insights for our product opportunities as well as to alert colleagues to key issues which could impact our products.
- To coordinate with the local Named Safety Contact (NSC) in the reporting and follow-up Rx product complaints received in Vietnam.
- To co-ordinate with NSC in liaison with regional and central safety officers on relevant pharmacovigilance matters
- To provide medical input/medical assessment into assigned product-related regulatory issues and submissions;
- To review product prescribing information for regulatory submission.
- Assist Medical Director in developing and managing cross functional projects and other projects
- Being a Internal medical Speaker for Scientific engagement (SE) and promotional setting
- Fulfill any additional task (individually based) if requested by Medical Director.
- Responsible for medical review according to GSK Code of practice and local regulation for all medical documents/tools used in promotion and SE to ensure the highest standards of medical and scientific accuracy and integrity.
- Assist the Medical Director in developing local medical SOPs and embedding SOPs in daily medical and commercial practices.
- Assist in training on Promotion Code and relevant SOPs to those involved in medical and promotional activities. Acts as a partner to compliance to ensure efficient ABAC process and support training.
- To perform periodic management monitoring of relevant operation aspects as required and to contribute in department risk management process.
- Medical graduate with specialist post-graduate degree (Internal Medicine or Public Health or related specialty preferred)
- Knowledge about GCP and medicine based evidence
- Good understanding of Vietnam medical practice
- Working experience in Pharmaceutical industry (Medical affairs role).
- Health economic/Outcome research knowledge preferred
- Pharma Marketing/Market research knowledge preferred
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