Head of Medical Scientific Affairs Director

1 day ago


Shanghai, Shanghai, China Roche Full time
Job Summary

The Head of Medical Scientific Affairs will lead the medical scientific affairs function, ensuring its management of the affiliate adheres to the highest scientific and ethical standards and fulfills 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's medical authority, engaging with key external stakeholders.

Main ResponsibilitiesMedical Strategies and Tactics
  • Develop and execute medical strategy through medical expertise.
  • Ensure affiliate medical plans are optimized by integrating with life cycle teams 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.
Medical Information
  • 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.
Clinical Trial Activities
  • Expand medical field as appropriate, develop feasible affiliate studies, and enhance product knowledge.
  • Ensure optimal investigator 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 with ICH/GCP, SOPs, quality standards, and regulatory requirements.
Leadership and Management
  • Develop and lead a highly motivated and well-trained team.
  • Manage the budget/resources appropriately to ensure prioritization and effectiveness.
  • Build good relationships and interactions with key stakeholders of various functions, local/regional/global.
Compliance and Training
  • 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.
Health Economics and Market Access
  • Provide data and advice to support the creation of health economic data information for market access applications.
Basic Requirements of the JobEducation & Qualifications
  • Medical degree.
  • Pharmaceutical medicine training highly desirable.
  • Higher degree and/or specialist accreditation desirable.
  • Business qualification MBA desirable.
Experience
  • 15+ years of relevant experience.
  • Substantial experience of practicing clinical medicine.
  • Extensive experience in the medical function of the biotechnology/pharmaceutical industry, including clinical research, medical affairs, TAE, product launches.


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