Shire Clinical Supplies Specialist in Lexington, Massachusetts
Utilizes the Clinical Supplies Management Database suite of software (CSMD) to facilitate the supply and distribution of clinical material to investigators. Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required.
Interfaces with Clinical Supplies Technologies Team to understand Shire IRT standards and CSMD requirements.
Provides input into Interactive Response Technology (IRT) design and development for return functionality if used.
Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate CSMD software or Interactive Response Technology (IRT) service.
Interacts with contractors and internal Shire customers to monitor progress and to troubleshoot when required.
Maintains Clinical Supply IMP project binders and product specification files in an “audit-ready” state ensuring inclusion of essential documentation and archiving of interim working notes. Coordinates pre-audit/inspection review.
Utilizes the Clinical Supplies Management Database suite of software (CSMD) to manage Clinical Supply inventory for projects assigned. Compares periodically to vendor inventory to ensure accuracy and that final product reconciliation is accurately completed.
Education and Experience Requirements
Scientific, technical degree (or significant progress toward achieving a degree) preferred.
0 - 3 years of related Pharmaceutical Industry or Contract Provider experience and applicable Clinical Supplies experience
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.