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.
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