莆田招聘

收简历邮箱pfizer_hr_north@pfizer.com

Role Description

The Regional Medical Monitor (RMM) represents BU Clinical and is dedicated to local/regional medical oversight in clinical trials of high medical risk. They also contribute to management of significant medical/safety issues in non high risk studies. RMMs ensure global consistency of medical oversight of study sites in their assigned region.

RMMs support Clinical Leads of a Study (CLS) with country intelligence input to any clinical development program, country strategy, and protocol design.

The RMM may also act as RMM Study Lead. In this role, the RMM is the main RMM point of contact to the CLS for overall study related issues, and representing the RMMs assigned to the study he/she leads.

Responsibilities:

As Individual Contributor RMM:

1. Program country strategy, pre-feasibility and site selection (all studies)

·Provide scientific and technical input, from a regional perspective, including input from Medical Affairs and external clinical experts, on the Program Feasibility, Country Strategy, and Protocol Design summarizing any country intelligence (e.g. standards of care, or other medical relevant information) through the CLS.

• Discuss about best sites to consider for planned clinical trials in the countries for which they are responsible (e.g. via Pfizer Site Recommendation/iMAP process), and supports the CLS in reviewing the proposed list of study sites for the relevant countries.

2. Medical issues

• Is responsible for medical issue resolution understood as:

o Significant medical issues (all studies)

- Potential/actual critical medical qualifying quality issues (QQIs, request of CLS for non high risk studies)

- Complex safety issues (request of the CLS for non high risk studies)

- Corrective And Preventive Actions (upon request of the CLS)

o Other medical issues (high risk studies)

- Reactive medical support to facilitate ethics/regulatory approvals

- Medical questions from investigator/monitor/Compliance Oversight Lead

- Protocol Deviations with potential medical/safety implications

- Addressing unusual data for major endpoints or for safety

- Study interruption relating to benefit/risk

- Review of study documents / translations (e.g. Informed Consent Document) only upon request due to significant changes to medical wording

- Helping investigators to understand how patients in their medical practice can be recruited ie. align with protocol inclusion/exclusion criteria

3. Training (high risk studies)

· Attends investigator meetings of the protocols he/she is responsible for when possible

o In agreement with the CLS, can present some agenda items (e.g. role of the RMMs, safety procedures)

· Address specific investigator knowledge gaps during site visit

· Provide the retraining associated with significant medical site quality issues (e.g. as part of site based Corrective and Preventive Activities), ensuring investigators are engaged with the protocol and understand the importance of quality and rigour in collection of key data supporting the integrity of the study

· Site initiation visits when associated with a specific need to address risk to quality / patient safety (agreed with clinician), eg. identified in the RMM Medical Oversight Plan (MOP)

4. Site Visits/contact with sites

Targeted site visit (or other contact forms as needed) to address specific medical issue or need (high risk studies – but also for all studies for critical medical issue)

- Follow up on Serious Adverse Events to enable clear narrative

- Potential / actual Qualifying Quality Issues

- Protocol Deviations and/or Site Visit findings with potential medical impact

- Identified specific investigator re-training need

- Accompany auditor on targeted audit where specific medical expertise is required

- Other (e.g. need for medical review of patient notes, audit findings)

· Proactive site visit (or other contact forms as needed) based on the relevant risk factors identified in the RMM MOP to address potential site based risk (high risk studies)

- When agreed with CLS

- When consistent with specific risk mitigation plans

- Ideally conducted in conjunction with site monitor

As RMM Study Lead:

1. As an RMM Study Lead (RMMSL), the individual is responsible globally for country-level medical oversight of a high medical risk study and represents the group of RMMs from different countries to the CLS/global Study Team.

2. The RMMSL ensures timely communication between CLS and all assigned RMMs (including occasional meetings) for overall study related issues. This may include presenting RMM activities to the CLS, sharing risk management tools (such as the RMM Medical Oversight and Integrated Quality Management Plans), study updates, safety reports, best practices and lessons learned, compiling from country RMMs local information requested by the CLS.

3. Provides effective and consistent inputs into protocol Quality Management Plans

4. Facilitates consistency and alignment of RMM medical oversight across countries, utilizing the RMMSL checklist including eg. creating and maintaining the RMM MOP, and ensuring systems are up-to-date with RMM role.

5. May provide training to other RMMs, on behalf of the CLS, when indicated.

6. Shared with the line manager, may coach/mentor less experienced RMMs.

Qualifications (Training, Education & Prior Experience):

Education

· The RMM must have a medical degree (MD or equivalent) and professional qualification from a recognized medical school, she/he must have training in ICH/GCP principles and in global and local policies relevant to the role (e.g. SOPs).

Experience

· Required: Be licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post “intern/houseman” year) and utilized that license to prescribe medicines in a patient care setting for an aggregate duration of at least one year, and always been in good standing with his/her licensing Health Authority. Experience in Phase 2 - 4 clinical development in the pharmaceutical industry and/or at a CRO, or in clinical / academic practice, including practical experience in clinical trial strategies, methods and processes.

· Preferred: Experience in regulatory audits.

Skills

· Deep knowledge of clinical development, principles of ICH/GCP, and experience in the management and reporting of adverse events (AEs) and serious AEs (SAEs).

· Thorough knowledge of local (and where appropriate) international regulations applicable to clinical development including Ethics Committees’ standards. Practical knowledge of clinical trial strategies, methods and processes.

· Be able to use various global computer system tools to facilitate medical oversight of clinical trials

· Ability to travel within region, area, as well as globally.

Competencies

· Clinical trial expertise

o Expert in full drug development processes from phase I to IV

o Extensive medical knowledge and AE/SAE expertise

o Good relationship with a wide network of Key Opinion Leaders in different therapeutic areas

o Thorough knowledge of the company direction, investigational product(s) and its development plan, the protocol, applicable SOPs, GCP, data privacy laws

o Demonstrated potential or ability to initiate and conduct clinical studies in industry, academic, or research clinic setting

o Knowledge of the conduct of regulatory audits and requirements

o Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents

o Deep knowledge of region, culture, patient populations, specific Therapeutic Area nuances/standard practices of medicine within the region

· Medical skills and Scientific excellence

Understanding of the complexities and recent developments in the relevant therapeutic/ technical area, and the ability to apply such knowledge to drug development

· Presentation and analytical skills

o Strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data

o Speaks and writes English fluently

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.