Associate, Regulated Sample Manager

What You Will Achieve

This colleague will provide specimen logistics support for Pfizer's Early Clinical Development Precision Medicine Clinical Biomarker Technologies (CBT) labs. Primary logistics support is accomplished through the management of clinical samples, biological matrices, and data attributes to enable the bioanalysis studies that advance Pfizer's global portfolio. This role is a point of contact for sample submitting partners, receipt and storage of samples, and troubleshooting of sample-associated data discrepancies. The colleague is expected to conduct work in a manner that is compliant with applicable regulatory requirements.

How You Will Achieve

• Receive, login, and manage clinical samples of biological fluids and tissues in applicable LIMS
• Responsible for management of inventories of freezer/fridge assets, matrices, and data (sample manifests, electronic document system applications, and laboratory information management systems)
• Review and revise local sample management SOPs within scope of role
• Responsible for packing and initiating outgoing domestic and international shipment of biological samples
• Conform to appropriate regulatory requirements
• Support a dynamic portfolio and deal with changing priorities
• May order and confirm the destruction of biospecimens
• May direct and manage resolving discrepancies or gaps in documentation (e.g., rosters) and databases related to biospecimen sets
• May support quality control review of data exported from LIMS systems
• Assist with relevant process improvements and best practices related to biospecimen management
• May develop strategy for implementation of, and improvement to, informatics systems supporting department processes

Qualifications

Must-Have

• Bachelor's degree, preferably in the biological sciences or project management, with 0-2 years of experience in appropriate scientific area related to the position
• Demonstrated ability to work independently, think critically, prioritize tasks, have good organization skills
• Knowledge and proficiency in the use of MS Word, Excel, Power Point
• Excellent written, oral, and interpersonal communication skills

Nice-to-Have

• Experience in laboratory LIMS
• Working knowledge of biospecimen management principles
• Experience with regulated environments (such as GLP)
• Experience in the pharmaceutical industry

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.

Medical

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