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ROLE SUMMARY
The primary purpose of this job role is to function as a member of the Sample Management (SM) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for managing incoming and outgoing external sample shipments to support internal/external testing labs and research collaborations across multiple vaccine programs. The candidate will implement a system of continuous improvements in coordinating and tracking incoming and outgoing shipments working closely with select specialty couriers.
The candidate will work in a team setting and will share roles and responsibilities as assigned by the team leader/manager.
ROLE RESPONSIBILITIES
The candidate will perform job responsibilities in compliance with GxP and all other regulatory agency requirements.
Manage the import and export of biological samples according to local, federal, and country specific guidelines, regulations, and requirements.
Assist VRD sample management and various research groups in determining permit requirements to import/export biological materials for vaccine clinical trials and research collaborations.
The incumbent will be responsible for applying for permits with various US agencies (i.e. CDC) and tracking and/or renewing open permits as needed.
Coordinate required International Air Transport Association (IATA) training for VRD colleagues involved in shipping biological samples.
The incumbent will ensure a system of continuous improvements and efficiencies with specialty courier to improve shipment delivery/tracking and will communicate cross-functionally to implement process improvements.
At the request of manager, the incumbent may represent the SM team at cross-functional study team meetings with specialty couriers to define shipment requirements based of study specific details.
The candidate may oversee the SM sub team responsible for shipping samples and supplies to external testing laboratories.
Authors Standard Operating Procedures (SOPs), Planned Deviation Notes (PDNs), and helps to investigate shipment deviations and write Laboratory Deviation Reports (LDRs) and other compliance documents
Help to improve the process flow for daily lab activities of the sample management team.
Carries out other duties as assigned.
QUALIFICATIONS
Bachelor of Science Degree or Bachelor of Arts Degree in a relevant scientific discipline
1-5 years of experience in the pharmaceutical industry, or logistics and operational field
Proficient in Microsoft applications including Word Processing, Excel, PowerPoint
Strong interpersonal skills and ability to communicate well within team and across different functional units
Strong organizational and coordinating skills
Proven track record to effectively lead teams of people. Prior managerial experience a plus
Previous experience and direct knowledge of local, federal, country, and international requirements necessary to import/export biological materials.
Previous experience working directly with specialty couriers to implement process improvements to support the movement of clinical trial samples a plus.
Should be self-motivated, taking the initiative to lead projects and develop and execute a pre-determined plan.
Should possess the ability to multi-task and align priorities with program objectives.
Need to have solid decision-making skills and be able to resolve moderately complex problems
Able to work in a fast paced, rapidly changing environment.
Relocation support available
Work Location Assignment: On Premise
This job is a US/PR Exempt Grade: 004
US/PR colleagues who are issued an Incident Final Warning (IFW) disciplinary action are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
US/PR colleagues who are on an active Performance Improvement Plan (PIP) are not eligible to post and compete for a position for the duration of the Performance Improvement Plan (PIP).
Relocation assistance may be available based on business needs and/or eligibility.
Relocation support available
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
Research and Development
