宜昌招聘

Responsibility

- Supports integration of regulatory solutions into business processes

- Investigates solutions to customer issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.

- Understands technical aspects of systems to aid in definition of business use

- Ensures that the company’s critical information and records stored within COE–owned repositories are managed in accordance with external regulations and internal processes, are protected and controlled over the long term and that content is available for critical business needs and is retained in accordance with established retention schedules.

- Support continuous improvement projects to simplify and improve system use and system management.

- Gather metrics and generate standard reports regarding usage or support of IM systems

- Update master data or other standard configuration data elements within IM systems in accordance with standard operating procedures

- Develop detailed requirements for implementation into Regulatory solutions

- Conduct and coordinate impact assessments across systems for change requests

- Contribute as appropriate to overall training program for content management systems and collaborate with business lines to ensure a consistent approach and minimal overlap with business process-specific training.

- Participate in and may lead small projects of short duration, following established methodologies

- Execute user acceptance testing during system releases to ensure high quality of Regulatory systems

- Complete training in accordance with WSR Regulatory Information Management curriculum, including Information Protection Management Guidelines (IPMG) and 21 CFR Part 11 training requirements.

Qualification

- Bachelor’s Degree in engineering, life sciences, information management, library science, information technology, computer science, business administration or related discipline required, master’s degree preferred.

- Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations.

- Demonstrated customer relationship skills and capabilities and collaboration on teams.

- Demonstrated ability to perform in a cross-functional environment.

- Strong verbal, written communication and presentation skills. Proficiency in Japanese is preferred.

- Ability to interact in a professional manner and build strong collaborative relationships with internal Pfizer teams.

- Ability to interface with international colleagues, understand the “big picture” in terms of potential implications of changes to systems and processes to sites and/or affiliates outside of home country/region

- Strong demonstrated project management and organizational skills

- Strong verbal, written communication and presentation skills.

- Training in current information management concepts and practices.

- Knowledge of document management practice and business processes in the pharmaceutical industry, including an understanding of the drug development process.

- Knowledge of document management systems, databases, business process management and electronic workflow/routing tools, regulatory submission and tracking systems.

- Knowledge of application system management and change control processes, application validation and implementation in a GxP environment

- Knowledge of Pharmaceutical metadata and standards

- Experience with VBA, Javascript, C#, Python, etc.

- Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS_Access)

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有约170年的历史，总部位于美国纽约，是目前全球最大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，并始终把“携手共创健康中国”作为在华的使命。在中国，我们拥有11,000多名员工， 分布于市场、销售、生产、研发等各个领域；在华累计投资超过15亿美元，拥有两所研发中心与四所工厂；业务遍及全国300多个城市。为了让中国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。
辉瑞生物制药集团（PBG）包含辉瑞旗下所有在专利期以内的创新药品，如抗感染、肿瘤、疫苗、炎症及免疫、抗凝、罕见病等产品线，致力于帮助人们享有更长久、更健康和更美好的生活。
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