Directly supporting EM MD and DVP China functionally on daily basis, the Medical Affairs Director will lead the strategies and goals for medico marketing activities across China, ensuring compliance with all applicable Company policies and industry standards in the affiliate. The incumbent will provide scientific and medical liaison to the DVP China.

The result of execution of the medical strategy will support the transformation and growth of the China business. Keen knowledge of the country with a medical affairs network in the Medical Affairs Community is critical.

Working seamlessly cross functionally to prepare and execute initiatives will help shape the future of the China business. Working efficiently and effectively with relevant HQ partners will also be key to success.

Executive effectiveness

• Play an active part in the activities of the Senior Management team relating to the running of the business and development of the company.
• Play an active part in the strategic and business planning process and the development of company policies fully align with Global guidance.
• Comply with all policies to ensure company activities are ethical, not environmentally harmful and are beneficial to customers. Lead affiliate medical compliance process.
• Maintain levels of personal development and training.
• Provide information to media and act as Company spokesperson align with PA.
• Provide liaison between the company and health professionals, medical organizations, patient organizations and learned colleges

Departmental Administration

• Ensure adequate staffing levels, staff training and compensation are available appropriate to the levels required of departmental activity needed for excellent customer service.
• Ensure active forward planning in order to cope with the demands and needs of customers internally and externally.
• Provide appropriate and timely financial planning.
• Liaise with other companies, the corporation and regional offices and supply such services as required.
• Provide direct contact with customers as required align with PV guidance.
• Ensure compliance with Standard Operating Procedures (SOPs) and Policies and ensure Medical Services have input into such systems.
• Ensure Departmental resources are adequate to function efficiently in the interests of the company and the customer.

Product Lifecycle Management

• Direct operations of the logging, tracking and reporting of adverse events and provide a system capable of ensuring accurate and timely communications with corporate Pharmacovigilance and local regulatory authorities. Implement global Med Ops requirements to the affiliate with local legal guidance.
• Chair China vetting committee to ensure all promotional materials are properly reviewed and align with the company policy
• Provide a system of logging tracking, reporting and investigation of product complaints with timely responses to customers.
• Provide liaison between the company and legal representatives both locally and overseas and to provide timely notifications of potential situations which may lead to litigation.
• Provide a service capable of accurate and timely information to customers relating China products.
• To provide services to customers relating to literature searches article retrieval and supply of products for late stage research.
• Provide education on matters relating to products of China or their therapeutic areas to external health bodies as required.
• Provide services to other departments as required relating to education, medical opinion or expertise.
• Actively provide liaison between Sales/Marketing and Medical Services as required.
• Liaising with Key Opinion Leaders and government bodies.

Product Development

• Provide liaison between Clinical Research and Regulatory Departments and Medical Services as required.
• Provide input into clinical operations, including: Clinical trial site selection & Global trials to be executed in country or kick off local trials upon the need of the affiliate align with Global.
• Oversee the operation of the clinical trials under responsibility

REQUIREMENTS:

• Industry experiences: A minimum of 8-10 years experience required in Medical Affairs, Clinical Operation or related area

• Position experiences:

• Minimum of 6 years experience of clinical research in other multinational pharmaceutical company with proven proficiency in trial execution, lifecycle management of established molecules and drug development

• Having more than 5 year experience on people management or 2 year experience as medical head in with pharmaceutical R&D or clinical operation function
• Having experience and proven track record of success in clinical research and drug management with PV requirements as well.
• Expect relevant experience of a broad range R&D work in the ethical pharmaceutical industry

• Biologics experience a plus. Experience in Women Health, Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus

• Language Skills: Fluent English in reading, writing and oral communication
• Computer Skills: Microsoft Office software, SPECTRA (or ZINC etc.) Scientific database searching
• Mobility: Is willing to travel
• Certificate Required:
• Other Special requirement:

• Experience working in a complex and matrixed environment is required.
• Demonstrated ability in leadership
• Excellent communication, social intelligence, networking and people skills
• Ability to interact effectively with various stakeholders and management levels in a highly competitive and rapidly growing area including Regional and Global proactive routine interactions
• Rapidly adaptable to a changing environment and willing ness to assess and implement new ideas and opportunities
• Self-starter with vision and initiative and the ability to work unsupervised towards the achievement of challenging goals
• Sound judgment, strong planning and organizational skills, and the ability to achieve commonly identified goals