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|Temperature Excursion Project Manager|
Location: New York City, NY
Employment Type: Full Time
Date Posted: 04/10/2021
Expire Date: 06/14/2021
Job Categories: Biotechnology and Pharmaceutical, Computers, Software, Government and Policy, Information Technology, Legal, Executive Management, Logistics, Research & Development, Medical
Temperature Excursion Project Manager|
The colleague responsible for temperature excursion management will lead the Pfizer clinical supply operation in the optimization of associated processes and the creation of digital tools to automate the process. It is envisioned that this optimization will include the design and creation of digital tools that rely on cloud-based solutions with electronic data capture. Creation of the tools will be performed by a cross functional team lead by the Temperature Excursion Project Manager and the team will include Pfizer's Global Clinical Supply Data and Business Operations group, clinical pharmacists, clinical operations colleagues and Pfizer's Business Technologies group.
The Temperature Excursion Project Manager has ownership of Pfizer's clinical supply temperature excursion management systems and support. The scope of responsibilities includes oversight of contract operations staff adjudication of drug supplies that undergo a deviation from labeled storage conditions either during shipment or storage. The shipments can be between clinical supply depots or from depots to clinical sites. The storage excursions may also happen at the depots or during supply storage at clinical study sites.
+ Oversite of contract staff responsible for adjudication of supplies that have undergone an excursion from labeled storage conditions.
+ Partnering with clinical operations colleagues to foster more robust clinical site storage practices.
+ Tracking temperature excursion adjudication metrics, e. g., cycle time, required staffing levels and external spend.
+ Documentation of temperature excursion management as needed to support regulator inspections.
+ Development of digital tools to automate receipt of excursion data with the goal of reducing cycle time and resource requirements.
+ Gathering input from stakeholders to develop specifications for digital system development.
+ Oversight of digital solution implementation which includes liaising with clinical operations colleagues to facilitate clinical site staff system utilization and compliance.
+ B.S. degree within a scientific discipline required with 8+ years of industry experience with clinical operations, clinical supply chain or pharmaceutical sciences experience.
+ Management of multi-disciplinary teams that includes project management, negotiation, and conflict management.
+ Proven ability to effectively develop, communicate, and execute project plans Development and implementation of digital tools is a plus.
+ Experience with d evelopment and implementation of digital tools, that includes 21 CFR Part 11 compliance assessment and software development life cycle planning.
+ Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
**Other Job Details:**
+ **Last Date to Apply for Job: May 25, 2021**
+ **Eligible for Employee Referral Bonus: Yes**
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.
Logistics & Supply Chain Mgmt