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Project Lead
Ref No.: 15-03660
Location: Northborough, Massachusetts
Manages the Demand for Packaging & Distribution of Investigational Products for International Clinical Trials as well as for any other services proposed by the Clinical Supplies SCP to any customers.
Act as single interface with customers and the Clinical Supplies SCP
Represents the Clinical Supplies at the Project Team level.
Lead the Clinical Supplies Project Team.
Based on the customer project development plan, build the business plan for the project he/she is accountable for
Estimate IP need with customers and consequent DP need and share at Project team level.
Generate a service agreement for a program/study with the customer, containing technical specifications (packaging & labeling), IP Needs, timelines and related costs.
Manage any change impacting the allocated budget, revise the business plan and service agreement accordingly.
Establish comparator Supply strategy with customers.
Establish Distribution Strategy with customers and IVRS providers
Review and comment Project & Study documents (CIB, protocol, Monitoring Plan, IND/IMPD dossier
Set-up and maintain customer services relationship to gain and retain long term customer loyalty

Skills
Excellent knowledge of Projects Development and Clinical Development -Generalist profil combining a good knowledge on Preclinical Activities, Clinical Operations, Clinical Supplies Production and Distribution activities. -Excellent oral and written communication skills -Excellent negotiation skills: -Excellent skill in Project Management: ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization -Ability to organize and lead meetings -Experience with MS Office Suite (Excel, Word, PowerPoint), flow diagramming and project management software required

Education
Bachelor of Science (BS) degree in a related discipline or Masters of Science (MS) degree in a related discipline with pharmaceutical industry experience. The individual must be well versed in all aspects of the project development and clinical supplies process, GMP, GCP and other regulatory requirements as they pertain to clinical supplies