北京招聘

工作职责:

Identifying Job Information

JOB TITLE: (Title reflected Pfizer Org Chart)

Manger or Senior Manager

REPORTS TO: (Manager Title)

Associate Director or Director

DIVISION/BUSINESS LINE:

Global Product Development

VERSION DATE:

2 Mar 2020

SUB DIVISION:

GRA – Global Regulatory Affairs

DEPARTMENT NAME:

GCMC China

LOCATION(S): (indicate Pfizer "location"s)

Beijing or Shanghai, China

Organizational Relationship(s) including to whom the position reports (JD Job Title):

Organizational relationships include:

PGS functional leaders & site leaders

R&D (PTx, BTx, PCH) functional leaders & managers

WSR functional & regional leaders & managers

CMC Product & Regional Strategists

Regulatory authority reviewers, administrators &/or inspectors.

External partners, CMOs, CROs, consultant & contracted resources.

Position reports into a Director or Senior Director of GCMC China.

Job Summary

Collaborate with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.

Delivery of high quality regulatory submissions.

Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.

Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.

Possession of CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.

Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.

Leverage both technical & regulatory knowledge, to mitigate risks.

Execution of regulatory policies and operational processes.

Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.

Job Responsibilities

Responsibilities include:

Serve as a primary CMC representative on a core project(s) and provide CMC support for products at various stages including clinical trial application, NDA and post approval variations

Ensure high quality CMC submissions in compliance with China regulations and guidelines. Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

Manage and Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.

Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

Execute training related activities (e.g. compliance-related, HR policies…), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.

Develop effective relationships with local & global internal partners, e.g. GCMC, China RA, DC and PGS.

Technical Skill Requirements

Technical and/or other job-related skills:

Sufficient level of knowledge in development & commercial activities and cGMP’s is required.

An understanding of China, US and EU regulatory requirements & expectations and criteria for submission & approval globally.

Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.

Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

Good skills in written & oral communications in both Chinese and English are mandatory.

Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools

Qualifications (i.e., preferred education, experience, attributes)

Education:

BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.

Experience:

Technical discipline with 5+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 2+ years pharmaceutical regulatory experience are desired.

任职资格:

Desired / Required Competencies:

Decision Making

· Acts Decisively

Risk Mgt

· Ability to recognize risks across projects and programs.

· Manages regulatory risks & ambiguous situations under direct supervision.

Scientific & Regulatory Leadership

· Ability to contribute to projects or team initiatives to support short-term operational goals.

· Ability to influence at the work group project team level.

Teamwork/ Collaboration

· Ability to contribute to effective teams & implement change.

Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.

Communication

· Communication & Negotiation skills

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。