Job Description

Global Supply Chain Project Manager

Position Details:

Client Direct Client

Location Cambridge, MA

Duration 7 Months+

Job Summary:

This position within the Global Supply Chain is responsible for managing pharmaceutical labeling projects supporting international and domestic clinical trials. The individual is responsible for activities to develop, create, and implement clinical trial product labeling in over 50 countries. Other responsibilities include vendor management, authoring GMP documentation, working with electronic document management and change control systems and supporting and driving continuous improvement projects.

Responsibilities:

Managing the lifecycle of a clinical labeling project to meet production schedules and clinical trial start dates.

This role will define the label text, ensure regulatory compliance of the label content, and coordinate translation and typesetting.

The position is responsible for proofreading label copy, review and approval of label proofs, managing commercial printers, translation agencies, regulatory consultants and interfacing with the labeling departments of domestic and international contract manufacturing organizations.

Authoring and executing label specifications, SOPs and Work Instructions within EDMS and Change Control Systems is a routine part of the job.

The position will support continuous improvement projects by assessing processes, procedures and systems.

Maintain and foster key relationships with external contractors and suppliers through clear and concise communication.

The position plays a key role in clinical drug supply and must be proficient in gathering information to initiate and implement a project.

Must be able to identify and discuss potential issues with Clinical Planning and the Global Clinical Operations group.

Qualifications:

BA or BS degree required

The successful candidate will have 4 or more years managing commercial or clinical labeling projects within the pharmaceutical/biotech industry.

Excellent project management skills and experience in a GMP environment is essential.

This position is expected to work independently within a matrix organization.

Excellent written, presentation and verbal communication skills and the ability to communicate at all levels of the organization are essential.

The successful candidate must have excellent attention to detail and the ability to manage multiple projects and shifting priorities in a fast paced, fluid environment.

Comfort with ambiguity and aggressive timelines is essential.

Experience using Adobe InDesign and Illustrator desired but not required.

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