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Clinical Project Leader - Packaging & Distribution

Posted by: Makro Scientific

Posted date: Mar-13-2015

Location: Northborough, MA

                                              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

 

 

Job Title Clinical Project Leader - Packaging & Distribution
Post Details
Email samer.mohd(at)makroscientific.com
Employer's Website http://
Category
Job Discipline Job Discipline -> Clinical Medicine
Job Classification Job Classification -> Other
Job Type Job Type -> Full-time
Location Northborough, MA
Key Words Clinical Project Leader
Start Date 3/2/2015
Deadline