更新于 3月21日

辉瑞制药-高级医学顾问 Sr.MA-抗感染

2.1-2.7万
  • 上海静安区
  • 1-3年
  • 博士
  • 全职
  • 招1人

雇员点评标签

  • 同事很nice
  • 团队执行强
  • 工作环境好
  • 人际关系好
  • 氛围活跃
  • 实力大公司

职位描述

药企

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.

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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 monitor if neither clinical lead norclinicians are medically qualified.

8. 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


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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工作地点

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职位发布者

刘一飞/人事经理

刚刚活跃
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辉瑞投资有限公司公司标签
辉瑞公司(Pfizer Inc.)创建于1849年,总部位于美国纽约,是一家以科学为基础的、创新的、以患者为先的生物制药公司。辉瑞的使命是“为患者带来改变其生活的突破创新”。在辉瑞,我们通过科学和全球资源为人们提供治疗方案,以延长其生命,显著改善其生活。在医疗卫生产品的探索、研发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。我们在全球的产品组合包括创新药品和疫苗。每天,辉瑞在发达和新兴市场的员工都在推进人类健康,推动疾病的预防、治疗和治愈,以应对挑战我们这个时代的顽疾。辉瑞还与医疗卫生服务方、政府和社区合作,支持并促进世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家全球卓越的创新生物制药公司的责任是一致的。170余年来,辉瑞一直致力于为所有依赖我们的人带来改变。辉瑞于1989年进入中国市场。扎根中国30余年,辉瑞已成为在华主要的外资制药公司之一。2021年是辉瑞新征程的开始。迄今已有170余年历史的辉瑞正在迈入全新时代,成为一家以科学为基础的、创新的、以患者为先的生物制药公司。目前辉瑞在中国业务覆盖全国300余个城市,累计投资超过15亿美元,并设立了1家先进的生产设施,2个研发中心(分别位于上海张江高科技园区和武汉光谷),在华有近7,000名员工分布于业务、研发和生产等领域。辉瑞在华上市了五大领域的高品质创新产品,包括肿瘤、疫苗、抗感染、炎症与免疫、罕见病等多个领域的处方药和疫苗,强大完善的产品线旨在满足生命各阶段的健康需求。
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