Clinical Supplies Project Coordinator

Clinical Supplies Project Coordinator – Contract – Princeton, NJ – $57.00-$67.00/ Hr.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Clinical Supplies Project Coordinator in Princeton, NJ.

Role Description

• Supports delivery of clinical supplies through effective management of assigned projects. Manages multiple projects. Liaise with responsible Trial Supply on aspects of clinical supplies packaging and labelling design and study requirements. Ensures production schedules meet agreed upon on-time delivery date of finished supplies. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects. Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).
• Generates internal packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.
• Executes all required SAP transactions such as goods receipt and goods consumption. Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS). Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required. Executes TECO transaction on completed process orders. Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use. Liaises with Quality Assurance to secure release of finished supplies.
• Supports externally managed projects via outsourcing project management; generates and approves project specifications for label print and production. Manages external manufacturing transactions in SAP and sample execution. Manages and tracks all activities and milestones related to outsourced work and other departmental projects as assigned. Ensures pricing and terms in label vendor quotation is consistent with MSA. Circulates purchase justification memos and issues purchase orders in accordance with company policy.
• Reviews and approves vendor generated label proofs and other related documents. Reviews and approves vendor generated production orders and other related documents (i.e. change orders).
• Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit. May enter change controls and deviations into quality management system and conduct investigations as assigned.
• Works cross-functionally with individuals and project teams in various areas.
• Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
• Participates in assigned training including CGMP and safety training.
• Authors and reviews procedural documents.

Skills & Requirements

• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Strong project management skills.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
• Ability to understand and apply regulatory and CGMP principles.
• Knowledge of ERP/MRP systems and supply chain principles.
• Eager to learn and continuously improve.
• Bachelors degree or equivalent in pharmacy, engineering, business or life sciences
• 3 -5 years relevant experience in the pharmaceutical industry or related healthcare environment.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1142088


Job Type
Technology & Internet Services
Projects & Change Management
$57.00-$67.00/ Hr.

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