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Senior System Analyst


Andover, MA
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Job Details


This position will be responsible for creating a System Compliance Gap Assessment and Remediation Plan for all of the DSRD GLP systems. In partnership with the Systems Enabling Lead, Business Technology partners and Medical Quality Assurance colleagues, the plan will be prioritized, managed, and executed to ensure system compliance with all quality and regulatory requirements.

This position is primarily responsible for providing Pristima and Pristima/Cerner interface GLP System Management and Administration support as well as providing overall quality and regulatory system compliance expertise and education across all DSRD GLP systems.

He/ She will become a subject matter expert in the business processes associated with Pristima and the Pristima/Cerner interface; other systems and projects as needed to support the business. He/ She will work alongside the system users to gain an in-depth knowledge of the business processes and how the systems support those business processes. He/ She will collaborate with system owners, system users, Business Technology and the Systems Enabling team to recommend and implement changes to processes or systems to increase productivity and ease of system use. This position will be accountable for creating/ updating business process and data flow maps.


**Quality and Compliance Function**

+ Ensure compliance with all quality and regulatory requirements, including data integrity, system validation, change control and applicable Pfizer Quality Standards (PQS) and DSRD Quality System requirements.

+ Ensure that appropriate and compliant system training/ education exists to enable colleagues to perform assigned system functions/ roles to support the business. May author training material or may manage a vendor to create and deliver the training.

+ Ensure that appropriate record keeping and documentation of application training is maintained to meet regulatory guidelines. Ensures regulatory compliance and archival of system records

+ Ensure that applicable DRSD applications remain in GLP and 21 CFR 11 compliance and remediate any deficiencies either procedurally or work with BT to remediate technologically when appropriate

+ Provide guidance to team members and customers regarding system compliance with quality and regulatory requirements

**Senior System Analyst and Administrator Function**

+ Plan and manage DRSD assigned projects and programs of work

+ Practice effective Project and Organizational Change Management skills to ensure project timelines are met and quality technical solutions are implemented

+ Act as point person to ensure system availability for all assigned critical systems. Work with BT to identify resources and actively participate in trouble shooting and contingency planning activities for critical systems.

+ Responsible for the integrity, administration, operation, maintenance, and decommissioning of systems throughout the systems' lifecycle. Subject matter expert for the business processes and systems assigned. Collaborate with system users to recommend and implement changes to processes or systems to increase productivity and ease of system use. Utilize Business Process Management tools and methodology to document business processes to help assess change and identify impact.

+ Author, review and ensure adherence to department SOPs pertaining to DSRD systems

+ Responsible for authoring change controls, user acceptance test scripts and execution when appropriate


Minimum Requirements

+ Bachelor's Degree in a business administration, science or technology field

+ 9-12 years of experience managing systems in a regulated environment

+ Advanced understanding of Software Development Lifecycle methodologies is required

+ 9-12 years of relevant experience working in a GxP environment with a comprehensive understanding of regulatory requirements as they relate to systems is required.

+ Familiarity with the drug development process, DRSD Business Processes and the organization's strategic direction for technology

+ Strong/ Innovative problem solving skills (e.g.; root cause analysis, creative solution space)

+ Demonstrated Compliance, Data Integrity and Information Management experience

+ Project and/or Organizational Change Management expertise

+ Business Process Management experience

+ Knowledge and adherence to regulatory guidelines

+ 10-30% travel to the global sites in order to effectively partner with system users

Highly Desirable

+ Master's Degree in business administration or technology field

+ Project and/or Organizational Change Management certification

+ InfoPath and SharePoint experience

+ Previous experience with using or supporting one or more of these business critical systems: Pristima, Cerner, Ponemah, Columbus, Biobook, Visiopharm, system interfacing tools (e.g.; Mulesoft, Iguana, Infosphere)

+ Experience with VBA, .NET, SAS, SQL Server, Oracle, MS Access, CDISC Standards (SEND), Spotfire, Crystal Reports, Trackwise, Application Lifecycle Management - Quality Center


10-30% travel to the global sites (Groton CT, La Jolla CA) in order to effectively partner with system users

Additional Details:

+ Eligible for Employee Referral Bonus

+ Pfizer US Exempt Grade 11

**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.
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