The primary purpose of this job role is to function as a senior member of the Sample Management (SM) operations within Pfizer Vaccine Research and Development (VRD). The incumbent will be responsible for adherence and compliance to established Vaccines documentation and records management practices and will manage the organization and archival of SM documentation. The candidate will implement process improvements in the general daily lab flow activities. In addition, the candidate may manage direct reports as needed.
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.
- Authors Standard Operating Procedures (SOPs), Planned Deviation Notes (PDNs), and Laboratory Deviation Reports (LDRs) and other compliance related documents.
- Manage direct reports as requested by immediate manager. This includes, managing the employee's growth and career development, and giving guidance on VRD aligned goals.
- At the request of manager, the incumbent may act in the role of study point of contact for assigned studies in Pfizer's vaccine portfolio. This entails acting as an intermediary between SM lab analysts and clinical study teams and Clinical Research Organizations (CROs) in resolving sample shipment discrepancies and representing the SM team at cross-functional study team meetings. This also involves providing relevant updates to clinical study teams as needed.
- The incumbent will manage sample management's documentation and archival in accordance with established VRD processes.
- The candidate will work with a team of managers and collaborate across functional lines to develop and implement process improvements and build efficiencies for daily lab activities.
- Help to improve the process flow for daily lab activities of the sample management team.
- The colleague will participate in the hiring process (resume reviewing, interviewing, and scheduling) and the onboarding process for new and incoming SM colleagues.
- Carries out other duties as assigned.
- Bachelor of Science Degree in Biology or related scientific field. (Advanced Degree a plus)
- At least 5+ years experience in the pharmaceutical industry
- Proficient in Microsoft applications including Word Processing, Excel, PowerPoint
- Strong interpersonal skills and ability to communicate well within the team and across different functional units
- Strong organizational and coordinating skills
- Proven track record of effectively leading teams of individuals. Prior managerial experience 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.
- Needs to have solid decision-making skills and be able to resolve moderately complex problems
- Able to work in a fast paced, rapidly changing environment.
\nRelocation support available\n
Work Location Assignment: On Premise
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