Clinical Project Leader - Packaging & Distribution

Company: makroscientific
Date Posted: 03-12-15
Category: Biomedical
Location: Massachusetts - Northern
Education:Bachelor's Degree


Clinical Project Leader - Packaging & Distribution

Location: Northborough, MA
Contract: 7 months

Responsibilities overview:

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 (Interactive Voice Response System) 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



Qualifications & Skills
Education Bachelor of Science (BS) degree in a related discipline or Masters of Science (MS) degree in a related discipline with pharmaceutical industry experience.
Skills Excellent knowledge of Projects Development and Clinical Development -Generalist profile combining a good knowledge on Preclinical Activities, Clinical Operations, Clinical Supplies Production and Distribution activities.
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

Contact Information
Company: makroscientific
Address: New Jersey, New Jersey
Website: samer.mohd@makroscientific.com



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