Pfizer CSO Label and Systems Specialist in Collegeville, Pennsylvania
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Global Clinical Supply (GCS) manages the execution of supply chain strategies to deliver Investigational Medicinal Product to patients involved in Pfizer's clinical research trials across the globe.
Clinical Supply Operations (CSO) is part of the Medicinal Sciences Global Clinical Supply (GCS) Group. Our purpose is to provide packaging, labeling, and logistics solutions to deliver quality patient-focused clinical supplies to the patient. We provide quality clinical supplies in a compliant, timely, innovative and cost-effective manner. We continuously strive to improve our systems, processes and capabilities in collaboration with our Pfizer and external partners in support of developing breakthroughs to change patients' lives.
The Label and Systems Specialist is a member of the Clinical Supply Operations (CSO) team within Global Clinical Supply (GCS), this role will start in the area responsible for stock management, design, initiation, approval and production of labels intended for clinical trial supplies in accordance with Good Manufacturing Practices (GMP). Role may lead to other opportunities in the GCS area based on development planning and business needs.
How You Will Achieve
Engage with other in Global Clinical Supply (GCS) or vendors to understand the label design requirements for a clinical study.
Be competent in the use of the PRISYM360/other labelling system(s) in order to add new label stock types and manage the timely oversight of the label design/approval/printing process.
Using Global procedures, design labels for clinical trial supplies; create the labels in the requested languages and ensure they meet the requirements as defined in the Label Request documents and the country specific Regulatory Templates.
Liaise with GCS colleagues and suppliers as needed to request the translation for any phrase that is not currently available in the Phrase Library to enable the design of labels.
Liaise with label approvers to ensure the timely approval of labels. Action any changes requested to ensure the final approved label artwork meets study/regulatory requirements.
Create documents that contain approved label designs for export to external label vendors.
Generate label approval reports to support documentation required for the Trial Master File.
Generate/approve Print Requests in PRISYM360 for approved label designs to enable internal label production.
Print, re-print and inspect printed labels/blinding disclosures
Monitor usage of label media used for label production and liaise with Inventory Management to order label media.
Support the Phrase Library Administrator with the routing of phrase translation requests and management of the bi-annual review of Regulatory label templates.
Support the collection and reporting of labeling operations metrics to enable better decision making
Build collaborative partnership and maintain strong relationships with internal and external partner lines (CSSM, PSQA, Vendors, etc.) by continually evaluating opportunities for process improvement
Perform various tasks and support initiatives and projects as assigned by Sr. Director of Labels and Systems
Deliver excellent customer service and consistently strive to meet commitments to customers and optimize operational effectiveness.
Demonstrate a 'patient focused' and 'quality culture' approach to label operations and subsequent Clinical supply packaging operations.
Contribute to continuous improvement initiatives and support internal GMP audits and GMP facility/process inspections, where applicable.
Support the creation/revision of label related Standard Operating Procedures (SOPs) / label guidance documents.
Act as Responsible Person for Quality investigations, where applicable.
Bachelor's degree with 2-3 years of relevant clinical supply chain experience.
Must be proficient in Microsoft Office programs.
Knowledgeable about project management and prioritization within Clinical Supply Packaging and/or labelling and/or Distribution along with external vendors and uses these to support project progression (e.g. technical, process, plan or system).
Demonstrates general understanding of clinical study designs and GMP documentation.
Articulate in both verbal and written communication. A strong presenter that can deliver messages within the internal organization and externally with our partners.
Excellent customer focused communication and listening skills.
Proven interpersonal, facilitation, customer relations and negotiation skills.
Demonstrated ability to learn fast and foster a CSO culture of innovation.
Continuous Improvement mindset; Lean or Sigma training.
Prior experience with supply chain enterprise supply chain systems
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel to vendor sites may be required
Role requires Pfizer Site presence
Other Job Details:
- Last Date to Apply for Job: November 30th, 2021
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.
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
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