Pfizer Director, Repository Management Lead in Groton, Connecticut

Job Summary

Individuals filling the position listed are responsible for providing leadership and deep subject matter expertise in the enterprise content management and business process management solutions as well as associated change management and support activities for the Information Management, Operations Center of Excellence Content Management and Authoring portfolio. Incumbent will partner with Business Technology and business lines to ensure timely system(s) functionality, data integrity and compliance.

Responsibilities

  • Facilitate the integration of content management and business process management solutions into business processes

  • Collaborate with other leaders to define strategies, best practices, and sustainable solutions that ensure the quality and compliance of the content management solutions.

  • Drive innovation in content management practices by leading a collaborative program of continuous improvement for enterprise content and business process management within the organization.

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

  • Determine strategies and implement improvements to enhance end user experience

  • Lead programs to establish content standards in all repositories and ensure content standards are defined and maintained in close collaboration with business process owners

  • Participate in governance, change management, roadmap and budget planning activities for the portfolio of content management applications.

  • Lead teams of information management professionals and liaise with business and technical groups to define or gather business requirements, define new business and support processes or improve existing processes.

  • Provides solutions to complex operations' issues and communicate these solutions in an influential manner to relevant stakeholders resulting in appropriate decisions.

  • Coordinates participation in system release activities.

  • Interface with strategic products and services vendors to understand and influence products and platforms direction, usability, features and performance to assist business efficiency and quality.

  • Take maximum advantage of new technology by proactively engaging in partner groups to explore new solutions.

  • Lead/facilitate development of solution test strategies and user acceptance testing approaches during system releases to ensure high quality of GPD and WRD systems

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

  • Serve as a subject matter expert and content interface for regulators plus provide Inspection Readiness consultation POC and provide in-room support during Inspections or Audits

  • Represent Pfizer in industry forums on content management topics (e.g. DIA TMF Reference Model)

Basic Qualifications

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

  • Graduate Degree is preferred.

  • Minimum of 10 years content management experience in the pharmaceutical industry, including an understanding of the drug development process.

  • Demonstrated, in depth knowledge of Pharmaceutical drug development environment and regulations related to document and records management.

  • Demonstrated experience with identifying inefficiencies and/or gaps in processes as well as the ability to propose solutions and/or lead teams challenged with delivering process improvement initiatives or associated system/technology enhancements

  • Demonstrated ability to make appropriate business decisions in evolving business environment, as well demonstrate flexibility and tolerance for ambiguity & uncertainty.

  • Experience working with international colleagues, with demonstrated facility to understand the "big picture" in terms of potential implications

  • Strong demonstrated project management and organizational skills.

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

  • Demonstrated experience leading teams in a cross-functional environment.

  • Strong verbal, written communication and presentation skills.

Technical Skills Required

  • Experience with document management systems, databases, business process management systems, electronic workflow/routing tools, regulatory submission and tracking systems.

  • Significant experience in application system management and change control processes, application validation and implementation in a GxP environment

  • Knowledge of Pharmaceutical metadata and standards

  • Experience with query tools/data extraction techniques (i.e. SQL, PL/SQL)

  • Experience with and understanding of collaboration tools (e.g., SharePoint).

  • Experience leading system release activities

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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