- Contract Duration 12 Months
- Pay rate up to $36.46/hr
Job Summary:
- The Project Coordinator provides organizational support to the Global Program Management Organization (PMO) by working directly with PMO Managers, project specialists, and cross-functional teams to coordinate and execute PMO activities associated with regulatory compliance, product launch, and end-of-life and maintenance of Client Diabetes Care products.
Main Duties:
- Coordinate, drive, and track internal reviews, approvals, and inputs with cross-functional teams, such as Commercial, Regulatory, Quality, Supply Chain, R&D, Artwork & Labeling Development (ALD), and others on assigned projects and responsibilities.
- Issue Engineering Changes (ECs) and modify Bill of Materials (BOMs) in Agile ERP change management system for materials, components, and products.
- Coordinate project initiation assessments.
- Coordinate UDI (Unique Device Identifier) data collection in Agile ERP system and global databases to support UDI compliance requirements.
- The Project Coordinator assists with the creation and maintenance of the Global Trade Identification Number (GTIN) for UDI.
- Assist with coordinating and creating enhancements to the Agile System to align with future global regulations.
- Assist in establishing work processes to incorporate the global UDI process.
- Responsible for updating data records and country database with inactivating and obsoleting end-of-life SKUs.
- Responsibilities may include estimating and managing budgets and schedules for PMO projects.
- Conduct daily activities of assigned job responsibilities and projects as assigned.
Job Qualifications:
- Four (4) year degree is required, preferably with scientific, engineering, regulatory, quality systems, or general business core concentration.
- Work experience including coordinating and executing project activities.
- Understanding of AGILE (or similar) ERP change management system.
- Familiar with Engineering Change Orders (ECs) and Bills of Materials (BOMs).
- Understanding of FDA regulatory issues related to medical device products and/or diabetic disease states is helpful but not required.
- Background in manufacturing/operation is preferred but not required.
- Good time management skills; ability to set priorities and remain flexible to changes.
- Experience and knowledge of labeling, packaging, regulatory compliance, and barcodes are helpful but not required.
- Software literacy levels desired: Microsoft Office Suite – Mid-level experience.
- Able to read and interpret project schedules.
- Strong proofreading ability and attention to detail are required.
- Must demonstrate strong problem-solving techniques.
- Solid written and oral communication skills.
- Strong interpersonal skills. Must be service-oriented.
- Able to receive and execute instructions quickly and accurately.
- Able to work on premises for core working hours of the department.
- Able to work in a culture with fast-paced work demands.
Benefits:
- Medical, Vision, and Dental Insurance Plans
- 401k Retirement Fund
About the Company:
- Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
- If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees who have written positive reviews on Glassdoor and Indeed.
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