Medcial manager-FMI
Roche
Shanghai,上海,中国,
3天前
  • Job facts
  • Principle Roles & Responsibilities / Accountabilities

    Development and execution of Regional Medical Plans in line with Regional / Global medical strategy to support FMI service strategy

  • Development, execution and continuous review of the China FMI Medical Plan, including gap analysis and development and alignment of the Global / APAC FMI Medical Plans with China medical plan
  • Design, oversight, execution, and reporting of clinical trials according to ICH-GCP, Roche SOPs and local regulations
  • Development of effective interactions with Clinical Operations, including but not limited to placing studies, provide input on feasibility, sites and investigators selection
  • TAE engagement plan to support medical objectives : identification, development, and establishment of scientific relationship with TAEs
  • Support for pharmacovigilance activities, including assurance of appropriate adverse event reporting in coordination with Local Safety Responsible (LSR)
  • Support for Regulatory, Market Access and Medical Information activities for selected products
  • Review of promotional and other external communication materials
  • Medical knowledge and customer insights to the Brand Team

  • Offer expert opinion aligned with LCT / IMT / DST medical recommendations on scientific / medical information to identify and develop effective TAE relationships to execute Roche FMI strategies, while holding high ethical standards, compliance to SOPs and local / international regulations
  • Research, collate, present and offer data insights related to the dedicated therapeutic area and product(s) associated with FMI services
  • Manage the integrity and accuracy of scientific and medical data communicated both internally and externally for promotional and non-promotional purposes.
  • Contribute to Medical Information activities in accordance with regional / local model, referencing global standard responses
  • Manage publication related activities according to Roche policies and SOPs
  • Develop a customer-centric culture, making sure promotional / medical / scientific communications address HCP needs and optimize patient benefit and safety while keeping a fair balance and compliance with local affiliate regulations and SOPs
  • Identify, develop, maintain and expand communication with key investigators and key accounts to facilitate appropriate research on pipelines and marketed services
  • As appropriate, support in the design and development of clinical studies.
  • Contribution to local Clinical Operations activities

  • Oversee the China FMI study program by maintaining effective relationships with the Clinical Operations teams and external investigators or sponsors
  • Provide early insights on new products and indications in close collaboration with the Clinical Operations group
  • Inform other MI functions on Global planned studies
  • TAE engagement plan and execution

  • Maintain regular contacts with investigators for key studies
  • Identify and develop scientific relationship with external TAEs who are sources of insight and advice and plan and execute relevant scientific advisory boards and expert meetings
  • Ensure that activities towards external experts / TAEs are coordinated across the affiliate
  • Identify and work with external experts on medical education activities to facilitate improved patient outcomes
  • Train and support internal Roche FMI staff in affiliates to support customer queries

  • Deliver updated training information from Global / Regional FMI channels to train China FMI staff on latest services, data, trial strategy and customer support.
  • Ensure customers receive timely responses to their queries about individual patient reports.
  • Implementation of Roche SOP, GCP and local policies to ensure medical initiatives to comply to related SOP and regulations

  • Understanding and acting in line with legal, regulatory and company standards and codes of practice (such as Roche / GNE Code of Conduct and any other directives, SOPs and guidelines)
  • Inform Local Safety Responsible of safety issues according to Roche / GNE safety SOPs; and provide scientific support and follow-up on product safety issues
  • Other Regional Responsibilities as Assigned

  • Support regulatory activities, including preparation of relevant data for new products / indications’ application and label updates
  • Provide medical / scientific support and training for internal staff or vendors
  • Act as medical expert for requests from external organisations, e.g. media (via Corporate Affairs department)
  • Qualification and Experience

    Education / Qualifications

  • Medical or PhD / PharmD degrees preferred. Other graduate health science degrees, or equivalent with strong proven therapeutic area experience considered.
  • 3 or more years' experience as an MSL, Biomarker Science Liaison, MM, Clinical Scientist or related roles in industry.
  • Strong, relevant therapeutic or pathology laboratory track record (typically demonstrable over 2 or more years' relevant experience).
  • Has extensive knowledge of diagnostics’ application to clinical practice, ideally with relevant publication history.

  • Demonstrates deep knowledge of the Medical Manager function, medical planning and TAE / Pathologist engagement
  • Strong relationships with TAEs / Pathologists, and external professional, disease, and research organizations.
  • Proven track record of meeting or exceeding objectives and goals
  • Strong interpersonal, communication and influencing skills : can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
  • Job Required Competencies

  • Strategic Agility & Managing Change : strategic thinking and flexibility to overcome unfamiliar challenges
  • Team work and Collaboration : excellent collaboration skills
  • Inspiring and Influencing : relationship, presentation, communication, interpersonal and networking skills
  • Knowledge of clinical oncology diagnostics and sequencing highly desirable
  • Knowledge of data analysis and statistics for purpose of understanding clinical study results
  • Compliance with local laws, regulations and Codes of Practice
  • Computer literacy (MS office, Google, etc.)
  • Functional business English required.
  • Analytical skills
  • Who we are
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