Pfizer Manager Information Management in Sandwich, United Kingdom

Manager Information Management

ROLE SUMMARY

Individuals filling the position listed are responsible for providing subject matter expertise in the management of the Information Management (IM) owned applications as well as associated system change requests and requirement elicitation activities for the IM Regulatory Solutions portfolio. Incumbent will partner with Business Technology and business lines to ensure system enabled solutions and data integrity through robust requirements, testing and implementation

ROLE RESPONSIBILITIES

  • Supports integration of IM Regulatory focused solutions into business processes

  • Liaise with WSR business to define or gather business requirements, define new business and support processes or improve existing processes.

  • Liaise with business and technical groups to provide/review impact assessments of business requirements and technical change which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.

  • Maintain a collaborative program of continuous improvement within the organization.

  • Elicit and Develop Use Cases in support of business requirements

  • Develop detailed requirements for implementation into Regulatory solutions

  • Provide guidance and coordinate risk assessments and risk based approach to requirements and testing

  • Conduct and coordinate impact assessments across systems for change requests

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

  • Lead small projects of short duration, following established methodologies

  • Participate in system release activities

  • Contribute as appropriate to overall training program and collaborate with business lines to ensure a consistent approach with business process-specific training.

  • Participate in development of solution test strategies and author/execute user acceptance testing during system releases to ensure high quality of systems

  • Participate in and lead quality oriented projects intended to ensure high quality data in our regulatory tracking systems

  • Provide data analysis support ongoing to key stakeholders for data

  • Develop and execute ad hoc or standard queries and follow established procedures to validate queries/results in support of business requirements

  • 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

BASIC QUALIFICATIONS

  • Bachelor's Degree in life sciences, engineering, or information management related discipline required.

  • Demonstrated ability to generate Use cases, requirements and subsequent test strategies.

  • 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.

  • 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

  • Proven experience in business processes in the pharmaceutical industry, including an understanding of the drug development process.

  • Strong demonstrated project management and organizational skills

  • Experience with systems management and maintenance including 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

PREFERRED QUALIFICATIONS

  • Knowledge of Pharmaceutical metadata and standards

  • Experience with SDLC tools (HP ALM, UML, City Planning)

  • Experience with query tools/data extraction techniques (e.g., SQL, PL/SQL, Brio, MS Access)

  • Extensive experience in a business analysis role for computer systems in a pharmaceutical environment

  • In-depth knowledge of Drug Regulatory process and Systems (Insight) desired

  • In-depth knowledge of electronic submission formats a plus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.