- Lead medical scientific affairs function, ensure its management of the affiliate adhering to the highest scientific and ethical standards and fulfilling all regulatory requirements. This position provides strategic directions and contributes to the collective medical management of the company and to the appropriate use of company products. It also represents Roche medical authority engaging with key external stakeholders.
- Develop and execute medical strategy through his / her medical expertise.
- Ensure affiliate medical plans optimally by integrating with life cycle team and affiliate objectives through an appropriate mix of BAs and affiliate clinical trials and investigator selection.
- Ensure strategic partnerships with TAEs, patient groups and scientific institutions and societies to enable optimal support for products throughout their lifecycles.
- Ensure medical and product information provided in compliance with Global SOPs and local regulatory requirements and that all data used in the provision of medical information are accurate and meet the needs of internal and external customers.
- Expand medical field as appropriate, develop feasible affiliate studies and enhance product knowledge.
- Ensure optimal investigators selection by a constructive dialogue between medical and clinical operations.
- Ensure all local clinical trials and contracts are appropriately approved; implemented within agreed timelines and budget; in accordance to ICH/GCP, SOPs, quality standards, and regulatory requirement.
- Develop and lead a highly motivated and well-trained team.
- Manage the budget/resources appropriately to ensure the prioritization and effectiveness.
- Build good relationships and interactions with key stakeholders of various functions, local/regional/global.
- Secure all medical activities comply with company policies, guidelines, SOPs, GCP and ethical standards and local legislation.
- Ensure medical review and approval of all promotional materials in compliance with codes of practice, company SOPs, and local regulations.
- Verify the accuracy of training material for scientific and product information and drug safety reporting requirements to the local organization.
- Ensure medical affairs are fully trained and compliant to company SOPs.
- Provide data and advice to support the creation of health economic data information for market access applications.
- Medical degree
- Pharmaceutical medicine training highly desirable
- Higher degree and / or specialist accreditation desirable
- Business qualification MBA desirable
- 15+ years of relevant experience
- Substantial experience of practicing clinical medicine
- Extensive experience in the medical function of the biotechnology / pharmaceutical industry, include clinical research, medical affairs, TAE, product launches
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Head of Medical Scientific Affairs - Shanghai, 中国 - Roche
描述
The Position
Job Summary :
Main Tasks & Responsibilities :
Medical strategies and tactics
Medical information
Clinical trial activities
Leadership and management
Compliance and training
Health Economics and Market Access
Other projects or tasks assigned by line manager
Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection
Basic Requirements of the Job
Education& Qualifications
Experience
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