Position Details:
Client Direct Client
Location Cambridge, MA
Job Title Global Supply Chain Project Manager
Duration 7 Months+
Must have skill-set [Job Description] 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.