兰州招聘

Email: tacandidate.china@pfizer.com

MAIN REPONSIBILITIES / DUTIES:

1. 1Overall investigator initiated research ( IIR) operation management in assigned TAs to ensure timely clinical deliverables per IIR contract and operation compliance with GCP, SOP and local laws

• Provide hotline help for investigator to submit IIR request via IIR submission portal.
• Completing the IIR submissions in INSPIIRE to address missing information and ensures compliance to Pfizer’s policies on Safety Reporting, FCPA, HCP and Privacy.
• Timely send acknowledgement letter, approval letter, closure letter, site information sheet, study closure certificate etc. to PI and collect site information sheet and study closure certificate back from PI.
• Quality check for IIR local review documents and contracts to ensure IIR local review process and contract review process smoothly and contact with legal and drug safety team.
• Timely send reminding letters to MA according to phases in, so as to ensure working process efficient.
• Timely uploaded documents to INSPIIRE and archived in binder and drive P in accordance with CT-25.
• Interact with MA to manage financial payments and track study progress and close, to secure and manage clinical supplies and vendors, to facilitate and monitor the efficient and accurate creation of contracts and amendments for IIR studies – new or ongoing – with Legal, and Regulatory colleagues.
• Oversees study progress and coordinates with Finance to initiate payments in response to milestones.
• Monthly send IIR and Publication tracking log to MA and get study status timely updated.
• Response to queries about specific IIR status, IIR details summary, and IIR policies and procedures from Global IIR Team, Medical lead Team and other internal and external stakeholders, as required.

2. Compound transfer program management

• Supervision Compound Transfer Program (CTP) overall management to ensure timely clinical deliverables per CTP contract and operation compliance with GCP, SOP and local laws. Coordinating investigators, Global CTP group, and supply chain to ensure drug release and delivery process smoothly.
• Initiate and coordinate CTP local review process to ensure projects goals and timeline are met by communication with MA.

3. Coordinates and facilitates IIR GRC review

• Monthly support Regional IIR GRC review meeting to ensure China projects are timely and appropriate reviewed.
• Efficient follow-up of Review Committee action items and decisions.

4. Support for PCO Audit regarding the IIR to help ensure the satisfied audit result

• Help to implement the IIR Quality Review Plan in accordance with requirement of CQP 2013.
• Help to prepare the 2013 PCO audit.

REQUIRED SKILL SET

· Technical

- Good communication skills

- Proficient with computer based tools and systems to support IIR study management.

- Completes study-specific tasks and contributes to the delivery of milestones.

- Identifies when issues are beyond own expertise and seeks input from appropriate team members (e.g., more senior colleagues).

- Performs assignments using established procedures and general instruction on the process and desired outcome;

- Full proficiency in English (oral & written) and Chinese mandarin.

· Certifications

N/A

· Education

- Bachelor’s degree required,

- Mayor in Medicine or Pharmacology or English is preferred.

一周至少三天，持续六个月以上

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持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。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.