Head of Medical Affairs

Major Responsibilities

• To ensure medical leadership in generating marketing strategy and brand action plan on GM BU products
• To work with individual medical advisor to make sure medical plan in place and execution of the medical plan.
• To lead the full scope of Post Marketing Study (ISS, NIS, observation studies and so on)  in BSP China for delivery, growth and strategically be aligned with the company’s direction.
• Provide medical information services to BU
• Manage or provide support for scientific publications
• Provide support for in- and out-licensing activities
• Provide input and review MKT promotional material from medical aspect.
• Lead the medical activity in pre-launch period for new products.
• Provide support for sales training in the disease, products, clinical activities and relevant areas
• Supervise the implementation of post-marketing trials on all BSP launched products, not only limited in GM BU, but also all other BUs.
• Ensure all post-marketing studies’ implementation efficiently and in accordance with protocol, SOPs and timeline, throughout the whole process of trial, for example but not limited: investigator meeting, trial initiation, contract, recruitment, data clear, payment, close …..
• Identify the problem in trial operation aspect, and improve the process.
• To ensure the medical leadership on clinical development: 
• To work with individual medical advisor to ensure strategic medical input provided on the clinical development program, including registration strategy, study design and response to SFDA on medical issues during IND and NDA review.
• Prepare the medical sections of regulatory submissions
• Support to recruit clinical investigators.
• Coordinate and develop Chinese study reports submitted to the SFDA
• Act as project leader within country to make sure the project move forward.
• Support in resolving crisis resulting from clinical trials sites.
• To ensure the HEOR function to meet the business needs，
• To cooperate with internal & external client and experts to run HEOR studies on our products or run HEOR studies related to diseases treatment.
• To provide relevant supports to internal and external customers in HEOR field.
• Manage and develop Staff
• To recruit, develop and manage personnel.
• To set up annual target with team members, review the progress periodically, and conduct PMP.
• To provide capability & gap assessment on team members, identify the personal development and training plan, and follow up.
• To provide on-job training as required.
• Control Budget
• To prepare and control budgets for the team.
• To Manage the cost and payment for ISS and NIS

Requirement

• Medical  Doctor
• Fluency in English and Chinese,
• Excellent in oral presentation both in English and Chinese
• Excellent negotiation skill
• Strategic thinking
• Marketing sense
• Building relationship and trust with partners and customers
• Strong leadership
• Years of multinational pharmaceutical industry Experience: >8 years
• Clinical experience at least 5 years
• Leadership experience: > 5 years
• ICH GCP
• Compliance and Pharmacovigilance
• Pharmaceutical industry environment
• Clinical development process