Shire Clinical Supplies Project Lead in Lexington, Massachusetts
20 % of Time
Works with Clinical Supplies Planning function to interpret clinical trial drug requests and clinical protocols and to develop supply packaging strategies, timelines and budgets.
Utilizes the ClinApps Clinical Supplies Management Database (CSMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.
Interfaces with Clinical Supplies Technologies Team to understand Shire IRT standards and CSMD requirements and proactively designs database methodology and/or trouble-shoots potential challenges.
Interfaces with appropriate QA/QP personnel to help plan work activities and to facilitate expeditious release of IMP for shipment to sites.
Interfaces with Product Development group to ensure that trial supplies are appropriately supported and that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.
- Works with Clinical Supply Specialists to manage and troubleshoot shipment requests, drug returns, CSMD, and IRT processes. Works with them to ensure creation and maintenance of Clinical Supply IMP documentation and product specification files (where required) according to established procedures and to manage IMP inventory for projects assigned.
- Coordinates primary and secondary packaging, labeling, testing, distribution, return drug management activities with contract providers according to approved budget. Ensures that activities are performed in accordance with statements of work, packaging requests, job orders, regulations and established quality and service level agreements. Processes compliant invoices promptly to ensure optimal value to Shire.
Education and Experience Requirements
Degree in Pharmacy, other scientific/technical degree, or significant job related experience.
5-8 years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred.
Experience with Medical Devices a plus.
Strong understanding of cGMP requirements
Proficiency in computer software applicable to IVRS/IWRS, Excel and MS Project or equivalent project management software is a plus
Key Skills, Abilities, and Competencies
Excellent communication, organizational, and team collaboration skills.
Must work effectively with global work associates.
Ability to interact effectively at high levels, between customers and suppliers, and to manage and resolve issues and to provide effective feedback.
Must be able to handle multiple projects simultaneously while maintaining high quality results.
Must provide and implement innovative solutions to unique situations.
Must be able to recognize potential conflict and escalate when necessary.
Must be aware and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s and Annex 13 and EU CT Directive, and DEA or local controlled-substance regulations as required.
Complexity and Problem Solving
Ability to work independently on projects assigned however project work is routinely reviewed by CS group management.
Must deliver Clinical Research goals with high precision.
Seeks innovative solutions to complex problems. Shares information freely within own workgroup and rest of Clinical Supplies team. Communication between customers and suppliers is generally not monitored.
Required to project annual budget for IMP preparation and fulfillment for assigned project for review by CS management prior to agreement. Able to authorize spending up to established DOA.
Must immediately escalate decision making or preparation challenges impacting on agreed timelines and or budget.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.