长沙招聘

工作职责:

Why Patients Need YouWe

re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will AchieveYou will help us in preparation, publication, tracking and quality control of our submissions to the regulators in compliance with document management standards. You will be responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical submissions on time. Your innovative use of communication tools and techniques will facilitate in addressing difficult issues and establishing consensus between teams.

It is your focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve ItContribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

Execute, through use of standards and tools, designated operational tasks or through the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.

Support the interpretation of regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local/regional level.

Work with the team managers to effectively forecast and manage project specific resources utilizing flexible resourcing and global load sharing as normal business practice.

Operate as Subject Matter Expert in dossier types and processes with responsibility for training and mentoring fellow colleagues.

Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional partners or Health Authorities.

Lead the implementation and execution of withdrawal strategy in partnership with regulatory strategy.

Responsible for updating the Regulatory parameters for monthly reports to local and global customers.

Supports allocated region/countries, with additional responsibility to support other "location"s through utilization of global tools.

Able to follow scientific arguments and ensure data is complete and sound.

Ensure maintenance of product and license information in the tracking database.

Responsible for curriculum and training assignments and assist in the collection of training metrics and produces compliance figures for distribution.

任职资格:

Qualifications

Must-HaveBachelor

s Degree

1+ year of experience

Relevant experience in electronic submissions build within the Pharmaceutical Industry

Strong knowledge of the drug development process, regulatory affairs, and submission management

Understanding of systems and electronic technologies used to support submission and planning activities

Attention to detail and exceptional organizational skills

Presents scientific data effectively, in verbal and written in a logical and persuasive manner

Proven experience managing or delivering through others in a team environment

Proficient in English, verbal and written

Nice-to-HaveMaster

s degree

Relevant pharmaceutical experience

Familiarity with pharmaceutical organizational structures, systems, and culture

#LI-PFE

On October 31, 2005, Pfizer announced the official opening of China Research and Development Center (CRDC) in Shanghai. Pfizer Global Research and Development’s Center is mainly engaged in drug development activities. Much of the facility's capacity is devoted to the study design, data management and statistical analysis of global phase I-IV clinical trials, as well as the clinical study report process. In addition, CRDC is a part of Pfizer global Safety and Risk Management and covers the functions of safety data processing and assessment. The center also trains Pfizer employees in China and throughout the Asia region in internationally recognized Good Clinical Practice standards.
辉瑞公司于2005年10月31日宣布辉瑞中国研发中心正式在上海揭幕。辉瑞中国研发中心主要为全球辉瑞药物开发提供支持工作。大部分的功能是围绕在I-IV期临床试验研究设计、数据管理和生物统计分析、以及临床试验报告的部分准备工作。此外，该中心是辉瑞全球安全和风险管理部的一个分支，负责安全数据处理和评估工作。研发中心还将为辉瑞公司在中国及亚洲的其它运营部门的员工提供国际标准的临床试验管理规范(GCP)的技术培训。