Project Coordinator II

Location
San Francisco, CA, United States
Posted
Jul 31, 2018
Ref
2-3339-370-2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

The Project Coordinator will be responsible for supporting the Clinical Supply Management team to ensure IP are prepared and distributed on time to support clinical programs. All applicable documentation received is processed and filed appropriately. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities' regulations / guidelines and Nektar's SOPs. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with Clinical Trial Managers, therapeutic area Project Managers, Medical Monitors, as well as staff from Quality, Clinical Compliance, Regulatory, Formulations, CMC, External Manufacturing, and Stability. Effectively meets the customer expectations in the delivery of Clinical Supply Management to support the key Nektar Clinical milestones for study starts and patient resupply.

Responsibilities:

• Support scheduled labelling & packing operations for clinical studies and named patient programs by reviewing, verifying & filing documentation.
• Coordinate distribution of Investigational product to depots and sites for clinical studies and IRR programs.
• Coordinate development of product labels for clinical supplies including development of master label text and subsequent reviews and approvals.
• Coordinate and process documentation for expiry updates of Investigational products.
• Coordinate depot shipments, track and follow up on receipt and release to ensure supplies available to sites.
• Assists with monitoring and maintaining IWRS and runs reports from IWRS to provide weekly drug projection summary data.
• Verifies status of clinical study enrollment, depots inventories and at sites to monitor drug supply with demand.
• Tracks shipments and lot retest dates to ensure timely product release and receipt.
• Tracks shipment temperature monitors and shipments to ensure timely and acceptable drug receipts. For deviations, coordinates documentation and product release resolution as per SOPs.
• Supports maintaining and archiving documents related to IP from an administrative perspective.
• Attends and is responsible for generating, maintaining and archiving of CTM meeting / or related meeting minutes.
• Supports activities related to the CMO, as assigned.
• Other logistic activities, as assigned.
• Follows policies, procedures and material control systems
• Ensures compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory authorities
• Organizes and prioritizes numerous tasks and completes them under time constraints
• Multitasking over cross functional groups and concurrent projects
• Understanding of area of specialization, Clinical Supplies or Materials Management
• Clear verbal and written communication skills
• Familiar with Microsoft office, Excel in particular; IVRS/IWRS knowledge is key
• Works on problems of diverse scope in which analysis of data is required

Requirements:

• BS/BA degree in related discipline and/or two years of related industry experience.
• Requires a minimum of two years of related experience and/or combination of experience and education/training.
• Knowledge of GxPs and particularly GMPs.
• Knowledge in supply chain, planning or materials management, inventory management, eSystems and business process facilitation.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.