Strategic Initiatives & Compliance Professional

ROLE SUMMARY
We are seeking a collaborative, detail-oriented, highly organized Strategic Initiatives & Compliance Professional to join our Drug Safety Research and Development (DSRD) team. You will play a critical role in ensuring adherence to applicable regulatory standards while performing records management, archival, transfer, and retrieval of preclinical records for out-license, acquisitions, and ingestions.
Responsibilities will also include assisting in SOP administrative functions and using your experience in quality & records management to maintain the highest level of compliance and efficiency.
RESPONSIBILITIES
All responsibilities require strict adherence to local compliance with applicable regulatory requirements (FDA, EU, etc.) document management policies, procedures, and industry standards.
Quality and Compliance

• Provides leadership and support for compliance activities, relevant committees, and related initiatives
• Supports internal and external inspections and audits interfacing with company and agency professionals as appropriate
• Team member who delivers technical and operational solutions to implement consistent quality standards
• Provides support for the effective execution and delivery of strategic imperatives related to quality and/or compliance processes
• Serves as site Master Schedule administrator & GLP Archivist by delegation
• Involved in all aspects of Controlled Document management

Records Management

• Maintains and improves information management for the historical collection of nonclinical records, including application of retention and record destruction, to assure compliance with corporate retention schedule and external industry/health authority requirements
• Searches across various Pfizer systems to ensure retrieval of complete and accurate information as appropriate for customer requests and/or audits
• Serves as point of accountability for management of nonclinical records during licensing and/or divestiture projects

QUALIFICATIONS
Must Have

• BA or BS in a relevant science with 2- 3 years relevant GXP compliance experience or MBA/MS with 0 to 2 years of experience in a related field
• Detailed oriented with exceptional organizational skills and the ability to prioritize tasks efficiently.
• Excellent written and verbal communication skills.
• Proficient in using record management systems, electronic document management tools, and Microsoft365 applications.

Nice to Have

• Understanding of the nonclinical drug development process and supporting information repositories
• Knowledge of records management in a regulated environment
• Experience hosting internal and external audits/inspections and proven negotiation skills and ability to reach a successful outcome
• Demonstrated ability to manage complex/global projects and to manage several projects simultaneously
• Understanding of licensing and/or divestiture projects as they pertain to records management

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional travel may be required
• Designated on-site presence required for archive management.

Work Location Assignment: Hybrid
The annual base salary for this position ranges from $77,100.00 to $128,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
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.
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. This position requires permanent work authorization in the United States.
Regulatory Affairs