Clinical Supplies Lead - San Diego
Amylin Pharmaceuticals - San Diego, CA

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<p>Provide technical expertise to coordinate all areas of clinical supplies including protocol interpretation, kit configuration, distribution strategy, study logistics and timelines, packaging and labeling, etc.<br /><br /><strong>ESSENTIAL JOB FUNCTIONS</strong></p><ul><li>Interpret clinical protocols to determine and forecast drug product, devices, ancillary supplies and budget requirements.</li><li>Design kit configuration and label text, meeting country-specific requirements.</li><li>Develop and establish an efficient distribution strategy to support Ph I to Ph IV worldwide clinical trials.</li><li>Manage complex study logistics and timelines to meet study start date.</li><li>Manage packaging, labeling, and distribution activities to ensure on-time availability of clinical trial materials (CTM) for worldwide clinical trials.</li><li>Ensure the CTM and associated documentation comply with regulatory requirements and Amylin quality standards.</li><li>Manage CTM returns and reconciliation activities.</li><li>Manage contract packaging, distribution facilities and in-country depots as required by the study.</li><li>Assist with identification and evaluation of contract service providers.</li><li>Coordinate efforts with other Amylin development groups to achieve project objectives.</li><li>Provide input and support department initiatives.</li></ul><p><strong>QUALIFICATIONS</strong><br /><br /><strong>Education</strong></p><ul><li>BS or MS degree in science, pharmacy or equivalent field.</li></ul><p><strong>Experience</strong></p><p>8-12 years of experience in biotechnology or pharmaceutical industry, with a minimum of 5 years' specific experience in clinical trial materials, including CTM distribution using IVRS/IWRS. General understanding of regulartory guidelines impacting clinical supplies (i.e., GxP, ICH guidelines, Clinical Trial Directive).</p><p><strong>Skills</strong><br /><br />Excellent organizational skills and attention to detail, as well as strong influence and cooordination skills. Strong verbal and written communication skills. Must be able to effectively interact with people at many levels.

Strong computer skills, especially in MS Word and MS Excel. Must be able to manage multiple tasks, be flexible to changing project priorities and meet deadlines.</p>

About this company
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Amylin Pharmaceuticals helps diabetics gain the upper hand in their battle with the disease. The company makes and markets injectable...