Bayer healthcare(要求：心血管，内分泌，抗感染，妇科，风湿免疫，外科，神内领域的硕士和硕士以上学位)
Medical Advisor/Medical Expert
1. Position
Position
Position Title: Medical Advisor
Position Title:
SAP position code:
Business Unit / Division: BSP Function / Department: Cilinical & Scientific Development / Medical
Jobholder: Supervisor: Medical affairs Manager / Senior Medical Advisor
2. Position purpose (A brief statement indicating the basic purpose of the position)
As an internal scientific expert throughout the new drug development progress, within relevant regulations, company SOPs and policies, to provide expertise to local trial, regional trial as well as global trial and medical support in the scientific promotion of products in the China market.
3. Major tasks and responsibilities of position (max. 8 key topics)
1. In clinical trials:
• Supports country selection, feasibility assessments, investigator identification and initial medical discussions with investigators
• Supports development of study specific documents such as protocol writing of specific sections including inclusion/exclusion criteria, amendments, review and approval of the PI/IC, and review of CRF and Statistical Analysis Plan
• Develops standard training material, is involved in training Study Team members and site staff on medical aspects of the study, and provides support for medical topics and questions
• Writes medical review plan, performs ongoing medical review of clinical data, Attends blinded review meeting, approves final patient validity, and provides final sign-off on unresolved data queries
• Reviews statistical tables, identifies additional analyses, interprets clinical data, prepares narratives for CSR and reviews final study CSR, writes Chinese Clinical Research Report
• Contributes to regulatory INA and NDA submissions and clinical publications
• Prepare the medical section of briefing documents for discussions/meetings with regulatory authorities
• Develop responses to study-specific medical issues that may be raised by regulatory agencies
2. In marketing support:
• Co-operate with marketing function to commercialize new products to the market.
• Review and provide medical information for marketing materials.
• Is the main point of contact between BSP and the Sponsor of a specific ISS, is responsible for the proper processing of local NIS data according to global standards or local procedure.
• Provide support for Publications of study
Value added to the success of the company – what are the main objectives of the function?
To ensure internal and external clinical trial related members conduct the trial with necessary medical knowledge and to ensure the product promotion under a scientific way.
5. Contribution context: Multiple choice of a pick list free text with limited characters
Individual Contributor others:
Team Member
Team Leader
Supervisor
Manage Supervisors
Manage Function / Department
6. Work relations
(List the most important work relationships with internal and external partners/customers)
Internal: External:
•
• SFDA (Sate Food and Drug Administration)
• CDE (Centre for Drug Evaluation)
• KOL/investigator
• Medical organizations/associations
• CRO
Global clinical development
• Local regulatory team
• Local clinical operation team
• Local project management
• Drug safety and information
• Regional medical affairs
• Global medical affairs
• Local BU colleagues
7. Qualifications
(Education, skills, experiences and personal characteristics necessary for success in this position)
Education:
• Master or above degree in clinical Medicine
Skills:
• Proficiency in Basic Microsoft Word, PowerPoint and Excel
• Fluency in English
• Excellent communication skill
Experiences:
• At least 2 years clinical experience in related therapeutic area;
• At least 2 year international pharmaceutical industry experience
Knowledge in :
• Oncology therapeutic areas, clinical experience is preferred
• Chinese/ICH GCP guidelines and SOPs
• Drug development process
• Clinical trial methodology
• China regulatory environment
• Pharmaceutical industry compliance rules
Personal characteristics
• Open and proactive
• Team work
Pfizer （要求：肿瘤，心血管，消化科，精神科，妇科领域的硕士以及硕士以上学位）
Regional Product Physician
Position: Regional Product Physician/Regional Medical Research Specialist
Working Location: Beijing(1)/Shanghai(2)/Guangzhou(1)
JOB SUMMARY
Regional product physician/Regional Medical Research Specialist (RPP/RMRS) –is the medical professional representing Pfizer in communicating with regional KOLs and academia for the defined therapeutic areas to serve the medical information need of regional key customers and the enhance the partnership with regional academia.
RPP/RMRS – is required to enhance medical communication between Pfizer and therapeutic experts and researchers in the region, timely communicate medical updates and product information, support medical program development, facilitate research proposal screening and study placement.
RPP/RMRS– serves as local medical resource for field force training to in defined therapeutic areas to improve the internal medical capability.
As such, good understanding and comprehensive knowledge of the defined therapeutic area, proactive attitude and professional behavior are mandatory.
KEY RESULT AREAS & JOB ACTIVITIES /TASKS
i) Field based medical to medical communication
a) Communicate complex cutting edge technical information, and product update to health care decision makers as aligned with Pfizer China's corporate goals and objectives.
b) Collaborate with Pfizer colleagues to actively support medical and scientific meetings by collecting and interpreting insights / presentations / results.
c) To speak at medical communication meeting.
d) Meet customer needs and expectations with regards to assigned Brand(s) for delivery of Product messages to key influencers (KOLs)
ii) Field based KOL Management
a) Contributes to mapping/ profiling of KOLs in line with segmentation (national, regional).
b) Work with product physician, product manager and sales manager proactively to ensure market preparation pre- and post-launch.
c) May function as the medical product champion. Work as strategic partner with Local Marketing for Pfizer China development project(s) and marketed product(s).
d) Support local medical association to standardize medical practice, facilitate doctor and patient’s education
e) Support publication plan- Follow up the implementation and timely publication of post marketing clinical activities including local profiling programs when applicable.
iii) Investigator Initiated Research Discussion and implementation
a) Discuss research concept with interested researcher, and communicated the nature and requirement of Pfizer’s IIR
b) Facilitate submission of investigator initiated pre-clinical and clinical proposals, and act as a Liason between Pfizer and IIR researcher
c) Facilitate research proposal screening and study placement, and follow up activities
d) Support Pfizer sponsored Non interventional study if applicable
iv) Medical Input in product commercial Activity
a) Collect, analyze and report local customer medical insights to assist business decision making
b) Report local competitive intelligence in clinical research and medical positioning to share internally and externally as post-meeting deliverables.
v) Medical Training
a) Provide internal therapeutic area or product training to Pfizer colleagues (i.e. sale force ongoing and new hire training programs).
b) Present at regional sales cycle meeting
Resolve medical questions related assigned products at field
BACKGROUND REQUIREMENTS
1. Education
Oncology Medical Background, Master Degree or above in the defined therapeutic area is preferred
2. Working Experiences
- At least 3 years clinical practice or medical affairs experience in other multinational pharmaceutical companies
- Good medical knowledge for the defined therapeutic area
- Good understanding about pharmaceutical business
- Proficiency in English and good computer usage
i.
3. Other competencies required
- Strong and continuous learning capability and adaptability.
- Good interpersonal communication skills.
- Good capability of strategic and analytical thinking.
- Proactive planning and result oriented.
- Customer focus.
- Excellent in teamwork.
E-mail: kellyguo@
Tel: 8610 59271344
MP: 13910519023
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