- Entry level
- No Education
- Salary to negotiate
Clinical Supply Packaging (CSP) is part of the Medicinal Sciences Global Clinical Supply (GCS) Group. Our purpose is to provide packaging solutions based upon a commitment to reliability, trust, confidence and ease of customer interaction to deliver quality packaged clinical supplies to the patient. The incumbent is responsible for the Clinical Supplies Packaging External Operations group encompassing the External Vendor Packaging Coordination, Special Projects and Local Scheduling at Groton. Responsible for the timely and accurate packaging of Investigational Medicinal Products for clinical programs that also meet regulatory and clinical requirements. Responsible for ensuring that the people within the department are appropriately trained for the duties they carry out. As a member of leadership teams, including, Global Clinical Supply, Clinical Supply Operations and Clinical Supply Packaging, the incumbent is responsible for facilitating cross functional collaboration and ensuring strategic and operational alignment across GCS and with other business partners. The position requires a customer focused individual with a continuous improvement mindset and operational acumen to manage our third-party vendors. The position requires excellence in project management, supply chain management, documentation management, communication and relationship building.
- Maintain GMP compliant business practices; ensure compliance with all legal requirements for packaged clinical supplies.
- Achieve Operational and Vendor excellence; collaborates with Sandwich External Operations Group Lead, CSP-LT and vendors to manage and develop a sustainable future-state model for external operations.
- Direct accountability for the team’s performance against defined Global Clinical Supply delivery commitment targets and strategic goals.
- Provides strategic direction and operational leadership for External Operations packaging functions within GCS, partnering with Sandwich External Operations Group Lead.
- Manages relationships for key strategic external partners for packaging.
- Defines, tracks, and is accountable for key performance metrics for packaging operations.
- Identifies and leads key strategic initiatives focused on continuous improvement opportunities across External Operations.
- Support workload distribution with global vendors.
- Contributes to strategic direction for the ongoing management of the global packaging vendor network.
- In partnership with Procurement, Finance, and other key stakeholders, identifies cost saving opportunities.
- Establishes and implements optimized packaging strategies.
- Leads the generation and design of standard business practices, workflows, and performance reports for External Operations.
- Partners with senior leadership in Medicinal Sciences, partner lines, and customer groups to ensure customer needs are understood and well considered in the design and implementation of practices and procedures.
- Ensures compliance with all legal requirements (e.g., EHS, GMP and Quality Standards).
- Provides leadership in all aspects of packaging compliance by providing training, procedures, audits, and support and by interaction with regulatory agencies and legal counsel.
- Supports the Clinical Supply Operations (CSO) Strategy Lead in addressing issues.
- Partners with the Internal Operations Global Lead to provide site-based leadership support for Groton Internal Operations.
- Interacts regularly with key leadership in customer/partner organizations to assess performance, initiate improvement efforts, resolve specific project issues and develop the organization.
- Participates, as needed, in process improvement efforts in WRD and Medicinal Sciences and other partner groups.
- Maintains familiarity with relevant academic and industry scholarship in supply chain management, packaging, clinical trial design and execution and/or other disciplines relevant to GCS. Leverages this knowledge to educate staff within and across GCS functional teams.
- Recruits and develops colleagues to achieve and maintain the highest possible talent.
- Actively coaches colleagues to improve performance.
- Develops both high-quality leaders and high-quality technical staff through training, development experiences, job rotations and other means.
- Works independently on highly complex activities, business processes, and systems issues.
- BS, MS, Phd degree (including environmental sciences, pharmaceutical sciences, supply chain planning).
- 8-10 years relevant experience.
- Operational management experience.
- Relevant experience in clinical supply chain with extensive knowledge of clinical trial designs, packaging operations and technologies and GMP documentation.
- Demonstrates strong understanding of the different types of packaging operations.
- Working knowledge of functions outside of the supply chain.
- Demonstrated ability to manage people with strong leadership skills.
- Demonstrates advanced project management and prioritization skills within Clinical Supply Packaging and with external vendors and uses these to develop options for project (e.g. technical, process, plan or system) progression.
- Demonstrates advanced understanding of complex clinical study designs and GMP documentation.
- Excellent planning, prioritization and organizational skills; certification preferred, e.g. PRINCE2, PMP.
- 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.
- 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.
- Advanced degree in life sciences or business administration with significant experience in the regulated pharmaceutical industry—GMP space is preferred.
- Continuous Improvement mindset; Lean or Sigma training.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Role requires Pfizer Site presence.
- Travel would be expected in this role.
- Travel to vendor sites will be required.
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.
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.
Other Job Details:
- Eligible for Relocation Package
- Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
About the company
Pfizer, is an American multinational pharmaceutical corporation headquartered in New York City, New York, with its research headquarters in Groton, Connecticut. It is among the world's largest pharmaceutical companies by revenues.
Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin for neuropathic pain/fibromyalgia); Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil, for erectile dysfunction); and Celebrex/Celebra (celecoxib), an anti-inflammatory drug.