• Leads and embeds the GSK Governance Framework in country, Area or Region.
• Ensures compliance with industry and corporate ethics and with regulatory and legal framework.
• Ensures excellence in execution of all governance processes, including oversight of all studies, medical information, scientific engagement and promotional practices.
• Ensure high standards of ethic in clinical, medical and commercial strategies and practices.
• Provide strategic and operational medical input to Medical – Marketing Business development, build external relations and develop professional connections with medical communities, and provide medical information on therapeutically assigned product support to achieve GSK Vietnam business objectives.
• Assist the MD in developing strategic medical input in collaboration with Commercial team for Commercial strategy, Clinical operations, Market research, Opinion Leader development, Conference organizations, overseas speaker’s advice/contact and development of Continuing Medical Education Programs to ensure GSK prominence in the market.
• To provide strong technical, medical information to GSK Rx’s interaction with external experts and stake holders. To develop and reinforce the external scientific standing and credibility of GSK Rx among HCP and EE(s) by scientific engagement.
• Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific and medical understanding. Ensures timely, professionally and appropriate scientific engagement events 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 Reps. and/or Sales managers 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 Clinical Regulatory meetings and other ad hoc Sales/Marketing meetings to provide relevant and latest medical information that would benefit commercial as well as to alert Commercial colleagues to key issues which could impact our products.
• Responsible for medical review, prior to Medical Director’s final approval according to GSK and local Regulatory codes of Marketing Practice 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 / clinical study SOPs and embedding SOPs in daily medical and commercial practices. Update local medical / clinical study SOPs in a timely manner.
• Provide training on Promotion and Marketing 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 L1 inspection of relevant business operation aspects. To contribute in department risk management process.
2. As Clinical Study Support Specialist: To support clinical team/CRO on relevant clinical study:
• To review/input for study designs, protocols, and selection of study sites, principal investigators for clinical studies planned in assigned therapeutic areas. To support clinical team in preparing final report, presentation and publication, in compliance with disclosure requirements.
• To support relevant study results presentations at selected conferences
3. Assist Medical Director in developing and managing cross functional projects and other projects such as: Patient Focus Selling; Emerging Leader Forum; Polyclinic; Nurse Training and Respiratory Rooms in selected hospitals and Medical Centers, and all projects assigned for VPLT
4. Being a Internal medical Speaker for in SE and promotional setting .
5. As a champion of Medical Information Inquiry:
o WISDOM system: attend monthly MI network meetings to update/ to be updated on MI system and relevant tasks
• Update/modify the MI local SOP when needed.
• Provide the training MI local SOP to all new GSK staffs.
6. As a champion of SE activities:
• Update SE activities to AP SE Champion when requested
• Update/modify the SE local SOP when needed.
• Provide the documents of SE activities to auditors when requested
• Provide the training SE local SOP to all new GSK staffs.
• 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.
8. Regulatory input:
• To provide medical input into assigned product-related regulatory issues and submissions;
• To review product prescribing information for regulatory submission.
9. Fulfill any additional task (individually based) if requested by Medical Director.