PRINCIPAL RESPONSIBILITIES may include but no limited to
1. Lead development and execution of medical strategy
1) Responsible for productive discussion with internal cross-functions including Global/AP, medical insights collection with key national external stakeholders including KOLs etc..
2) Responsible for exhaustive collection of information regarding the latest progress in therapeutic areas/products/competitors, existing knowledge gaps, scientific evidence gaps and clinical practice gaps.
3) Responsible for authoring the Medical Strategy after collection of input and insights from a wide cross-section of internal and external stakeholders.
4) Responsible for directing medical strategy and developing medical projects.
2. Lead clinical study management
1) Ensure the study is designed and operated in compliance with related SOP and other required regulations.
2) Design and compose clinical study protocols as required; submit concept/protocol for internal review and approval; manage the study budget and phasing; ensure the registration of the study online as required; present at investigator meeting if necessary.
3) Set up plan for CSR and publication; review study report; carry out medical monitoring during the clinical study.
4) MAO/CRO collaborations on study operation.
5) Collaborate with Statistician and Data Management team for SAP and data monitoring as required.
6) Ensure the AEs in the study are reported as required.
3. Determine the theme and high-quality medical content of national activities including advisory board and expert discussion; Contribute to the theme of medical educational activities and materials. Closely work with ME/MSL team when necessary.
4. Understand the recent progress in literature/congress in relevant therapeutic areas and products/competitors, HCP perceptions; Generate insights from the above resources, then integrate and share with cross-functional team.
5. Establish good communication and cooperation with internal and external customers, including Global and Regional (AP) MAF, R&D (CD, RA, CDTL et al.), ME, MSL, MKT, Sales, PR, BD, Strategic MKT, MKT Access, CRO etc.
6. Expert review and provision of careful, thoughtful input into the promotional/educational materials and other project-based activity materials from a scientific viewpoint.
7. Provide TA or product related training/support to Marketing/Sales and other departments.
COMPETENCY REQUIREMENTS
2-3 years clinical working experience on relevant therapeutic area/or 2-3years working experience on pharmaceutical industry is preferred.
Thorough understanding and command of GCP, HCC.
Good command of English, fluent at reading, writing, speaking and listening.
Being the expert of product and relevant therapeutic area.
Agile strategic thinking, leading and influencing the development of medical strategy/projects
Lead the strategic evidence generation with aligned medical strategy, providing constructive suggestions about study design/operation, and development of publication plan.
As a scientific partner, lead the efficient scientific communication with high-quality content and individualized communication ways.
Establish trust relationship and collaboration with cross functions, with aligned strategy/responsibilities, providing valued scientific suggestions for the high-quality output.
Lead the insight collection and engagement with external customers including KOLs, establish trust collaboration with external customers.
Others
Domestic and International travels are required.
试用期内按照公司要求完成入职培训、合规培训及考核并达到相关要求（该等条件和要求属于员工应满足的录用条件，如未能按照公司要求完成相关测试、培训并满足考核，将视为试用期内不符合录用条件。）
Required Skills
Preferred Skills
Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Critical Thinking, Cross-Functional Collaboration, Healthcare Trends, Leverages Information, Medical Affairs, Medical Communications, Medical Compliance, Organizing, Product Strategies, Scientific Communications, Strategic Thinking, Tactical Planning
