莆田招聘

收简历邮箱为Chinajob-micstalent@pfizer.com

MAIN REPONSIBILITIES / DUTIES

The Study and Publication Manager (SPM) is responsible for overall Post marketing clinical trials operational management and related study result Publication operational management to ensure strategy implementation, high quality of clinical deliverables, and operation procedure compliance with GCP and company policy through the matrix leadership.

The SPM is the primary Medical Affairs point of contact for China projects and interface among all functional groups involved in the study. This person operates as a senior level operations liaison role, coordinating externally with some of Principle Investigators, research sites, relevant government agencies, alliance partners, vendors, and internally with Global IIR Team, Global Publication Team, Medical Affairs Team, CRDC, Regulatory, Supply Chain, Legal, Drug Safety, and Finance and is accountable for study delivery through internal and external resources.

The SPM will champion operational excellence to provide continuous improvement of processes and sharing of best practices. This person is responsible for leading to standardize and continuous improve projects procedures of medical related functions through designing and overseeing the implementation of projects specific procedures (such as the IIR & CTP & NIS & Phase IV & Publication) to ensure that the project goals are met.

1. Overall Investigator Initiated Research ( IIR) operation management

• Standardize and continuous improve China IIR management procedure through designing and overseeing the implementation of IIR conduction procedures to ensure that the project goals are met and prove project management efficiency.
• Communicate with Regional IIR team, Global IIR team to put constructive input into global IIR relevant SOP/Guideline development, better in accordance with china practice.
• Supervision hundreds of China IIR project management from reception to close, including operation in INSPIIRE and offline to ensure timely clinical deliverables per IIR contract and operation compliance with GCP, SOP and local laws.
• Coordinates and facilitates Regional/Global GRC meeting to ensures that China projects are timely and appropriate reviewed and efficient follow-up of Review Committee action items and decisions.
• Applies and provides training in IIR operational strategies and compliance regulations. Lead the training for medical affairs team timely to build their knowledge of IIR relevant SOP/IG/Working Instruction to make sure the whole IIR review and conduct process smoothly and compliance.
• Facilitate IIR Agreement templates for local practice through leading IIR Agreement templates translation and working with local legal and drug safety team to comply with company policy and Local Laws.
• Collaborates with internal and external partners and stakeholders

- 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;

- Interact with MAs 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.

- Works with the External Partner Liaison to process IIR requests and resolve issues and queries from internal or externals stakeholders regarding co-op or partnership group studies.

2. NIS & Phase IV Study management

• Leads the cross-functional integration of all components of a study by working with study team members (including but not limited to Medical Advisors, Study Project Managers, Study Managers, Data Managers, Clinical Programmers, Medical Writers and Project Planners, Study Clinicians, Statisticians, Pharmaceutical Sciences, Outcomes Research, Regulatory, Medical QA) both internal and external to Pfizer to ensure studies deliver to agreed goals.
• Optimise operational efficiency to ensure all those studies conducting smoothly and in accordance with SOP and maintain a consistent level of good quality through leading implementation of process design to increase productivity; Leading the team in managing issues and problem solving; Developing and updating related working model for NIS and Phase IV study operation and drive for continuous improvement to ensure cross-function cooperation well done.
• Responsible for the development and ongoing management of clinical trial budget for assigned studies.
• Partner with the Project Planners and Business Project Manager to ensure accurate schedule, cost, resource management and controls are established and maintained between clinical study activities and the development plan.
• Provide “Operational Review” updates/presentations to senior leadership as requested
• Ensure Program Alignment – through close liaison with Medical Advisor, Lead CPM and PM
• Ensure cross-functional awareness and buy-in to the risk/opportunities action plans and ensure communication and integration of study level risks/opportunities.
• Monitor Post marketing clinical trials report and publications are appropriate reviewed in accordance with SOP/IG/Working Instruction to ensure strategy implementation and project goals are met.
• Lead the related trainings for Pfizer colleagues to ensure compliance.

3. Publication management for all Pfizer Sponsored Studies

• Lead the therapeutic cross-functional cooperation and serve as chief publications liaison with Medical Advisor, CRDC and Global Publication Team for the publication management.
• Manage external publications agencies, including medical writers to develop timelines and manage the process for development, review, approval and submission of publications.
• Ensure that publications are developed in compliance with company guidelines and SOPs.
• Liaise with Life Cycle, Medical and Business/Commercial Teams, Public Relations and other functions to ensure proper internal communication on publication related competitive intelligence and upcoming publications/ presentations.
• Deliver appropriate training to cross-functional team member to improve their competency on publication.

4. Compound Transfer Program management

• Standardize and continuous improve CTP management procedure through designing and overseeing the implementation of CTP conduction procedures to prove project management efficiency.
• 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 MAs
• Provide CTP related training to CTP requestors and Pfizer colleagues.

5. Lead to establish appropriate clinical tools (such as IG &Working Instruction & working model) and processed for the MA team to support the execution of clinical deliverable and study timelines to continuous improve working efficiency

• Develop and update related working model & SOP&IG and drive for continuous improvement.
• Provide efficient SOP&IG &Working Instruction & working model training with high quality per request

6. Team Development

• Develop effective working model and build up a professional team to manage clinical projects, ensure its good performance, high standard and qualified result delivering.
• Develop team members to adapt to organization fast business growth, built their knowledge of clinical project management.

REQUIRED SKILL SET

· Technical

- Deep understanding of Medical functions operation and Medical business model.

- In-depth clinical research knowledge. Solid understanding of GCP, HCL, Regulatory, Safety, and laws applicable to clinical studies.

- Strong working knowledge of the scientific and operational issues relevant to study design, drug product(s), disease characteristics, and relevant scientific and operational aspects of drug development.

- Drug development experience including familiarity with:

· Clinical study management and monitoring

· Data management

· Clinical & regulatory processes

· Regulatory submissions

· Project/process management

· Budget / expense management

· Experience of Vendor Management(preferred)

- Language: excellent in oral and written English.

- Good understanding of other functional areas (e.g., Clinical Research, le publication management.fizer Sponsored StudiesClinical Supply, Finance)

- Excellent written and oral communication skills

- Excellent project management skills;

· Managerial

- Capabilities for making decisions that require choosing between multiple options to resolve complex problems, making decisions based on a high degree of integrity to ensure compliance with applicable healthcare laws and regulations.

- Exceptional influencing and interpersonal skills;

- Ability to manage multiple projects simultaneously；

- Strong Leadership capabilities, such as planning and results driving;

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

· Certifications

N/A

· Education

- Bachelors degree required with major in medical, pharmacy, life sciences, drug development, project management or business.

- Masters degree preferred

· Experience

- A minimum of 5 years projects management experiences in pharmaceutical industry is required.

- Extensive clinical operations and pharmaceutical business experience in order to have a thorough understanding of the processes associated with executing clinical development plans and addressing related regulatory issues. Leadership, project management, resource management, administrative and technical capabilities are required.

- Experience managing or reviewing research or clinical studies strongly preferred.

- Knowledge of Therapeutic Area(s) and international experience are plusses.

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.