Position Purpose

Individuals filling the position listed are responsible for providing subject matter expertise in the management of the regulatory information management applications as well as associated change management and support activities for the Information Management, Operations Center of Excellence Regulatory Solutions system portfolio. Incumbent will partner with Business Technology and business lines to ensure timely support for systems, help ensure data integrity and compliance.

Primary Responsibilities ·

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. ·

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 ·

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

Technical Skill Requirements

. 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
  

Qualifications

• 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.
  

上班地址：张江高科