MAIN REPONSIBILITIES / DUTIES
To advise and manage medical related activities in all operations of company with medical expertise and company policies, with the objective of ensuring the scientific validity and the ethics of operations.
Enhance local data generation and Product life-cycle management from medical perspective to maximize product’s value and long term development
- Evaluate new products, new indications, new research programs, new business potentials of defined therapeutic areas from medical perspective to support new product introduction and line extension
- Align with cross function team including marketing, CCO team, global team etc, develop post marketing research strategy based on Registration/Market needs
- Provide phase IV study direction and develop key elements
- Design and manage local Non-interventional Study (NIS) study as a clinician.
- Develop medical strategy and implement it to support product development
- Develop publication plan and implement it
- Evaluate and review Investigator Initiate research proposal to ensure its scientific standard and strategy fit
As a key partner to provide medical input on business decision making
- Co-develop product strategy, positioning, key message with Marketing team
- Provide medical support (topic design, KOL communication etc.) on key marketing activities
- Provide broad and deep medical insight/summary document of the defined therapeutic area to business partners to deal with key product issues such as bidding, RDL, new initiatives etc.
- Review and approve Local Standard Response Letter to HCPs
Develop sale force’s medical capability through training program design, Lecture Delivery and periodic medical knowledge update in different settings through various channel
- At Phase I sales training
- At National sales conference
- Field visit
- Special sales force program
- Give lectures or updates to other stakeholders to increase their disease and product knowledge in lung cancer
Support Drug Registration Activities
- Timely review and approval of local product labeling (LPD)
- Develop medical justification document to support LPD related queries from government
- Provide medical input in feasibility evaluation of studies for global trials
- Provide official input on study site selection from therapeutic prospective
- Provide input to registration protocol synopsis and study report as necessary
Academic communication to enhance the delivery of new concept and Pfizer products key message to key influencers and stakeholders, and Establish Cooperation and partnership with medical association to promote medical advancement.
- Set up national level KOL database, and keep medical communication with through various approaches
- Design educational programs for top KOLs and implement them
- Support on China treatment guideline development, scientific interpretation and promotion
- Publish or facilitate publication of medical paper in professional journals
- Cooperation with local medical societies to conduct medical programs/conference to facilitate new concept and state of art medical progress’ introduction to China
In order to maintain company’s image and protect patient’s welfare, MA act as a core member to work with cross function team on crisis management.
- Perform medical evaluation, explanation on the event;
- Develop medical justification or responding document.
- Provide medical expert opinion on company responding strategy
- Review and approve all external communication documents to make sure all delivered message are medically precise and consistent
- Communicate with external customers directly for medical issues as necessary
Provide medical expert opinion in safety events management to avoid negative impact.
- Provide professional medical consultation to Safety Officer to solve Pfizer products’ safety query
- If take clinician role: provide the clinical safety oversight including performing and documenting regular review of individual subject safety data and performing review of cumulative safety data with the safety risk lead (as delegated by the clinical lead).
- If take clinical lead role: consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinical lead may delegate these responsibilities to the study clinician identified in the SRP.The specific components of safety data review are detailed in the Safety Data Review Guide – for Clinicians and in SAF09 SOP. For all studies, clinical safety review should be performed in consultation with a designated medical monitorif neither clinical lead nor clinicians are medically qualified.
Ensure company’s medical compliance.
- Act as the sole reviewer to ensure educational grants within medical compliance
- Review and approve promotional materials and activities to ensure their scientific standard and medical compliance with external and internal requirements
**REQUIRED SKILL SET **
Technical
Therapeutic area knowledge: familiar with the disease knowledge and clinical practice of the therapeutic area
Language: Fluent in English (both spoken and written)
Primary Clinical trial knowledge
Computer: Familiar with Microsoft Office software
Ability to rapidly catch up global leading edge medical advancement
Strong business acumen
Strategic thinking and analytic skills
Good interpersonal communication skills
Proactive planning and result oriented
Customer focus
Excellent Teamwork/Collaboration
Managerial
Sustain Focus on Performance
Accountability
Manage Change
Align Across Pfizer
Certifications
N/A
Education
Clinical Medicine Background in the defined therapeutic area, master degree, Master above is preferred
Experience
3 years clinical practice in Tier 3 hospitals (corresponding specialty is preferred) or medical affairs experience in other multinational pharmaceutical companies
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical