Logistics and Licensing Project Coordinator

Logistics and Licensing Project Coordinator Location Hybrid work in Lincolnshire, IL : Description:

Nexus employees earn 4 weeks' vacation per year, and our benefits start on day 1!

Title: Logistics and Licensing Project Coordinator

Full Time

Location: Hybrid/ Lincolnshire, IL

Our Company

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they're needed most.

Summary

Nexus Pharmaceuticals, Inc. is seeking a proactive Logistics and Licensing Project Coordinator reporting to Senior Manager or Director, to oversee and manage logistics operations and project coordination throughout the product lifecycle. This role combines thorough project management with logistics oversight, ensuring that both operational logistics and project milestones align with Nexus's strategic objectives and compliance requirements.

The individual will ensure that shipments of raw materials, components, finished products, and samples for analytical analysis are planned and executed according to internal and external requirements. This role will also manage 3PL, Track and Trace Solution, and Nexus's downstream partners to ensure Nexus Pharmaceuticals, Inc. is compliant with Serialization and Track and Trace requirements. The role will require direct interaction with CMO partners, both national and international, and regulatory bodies (e.g., Customs, DEA, FDA, etc.) in order to ensure that all required documentation and applications are accurate, meet legal and regulatory obligations and are in place to meet shipping schedules.

The role will also manage all applicable state licensing functions to ensure new applications are accurately submitted and renewal licensing is maintained without interruption for Nexus. This activity will also be coordinated with a third-party agency to ensure state licensing requirements are fulfilled. In addition, the individual will be responsible for obtaining surety bonds, Certificates of Good Standing, inspection reports, etc.

Responsibilities:

• Coordinate the entire transportation and inventory management process for imported and exported products, ensuring compliance with national and international shipping regulations.
• Manage data related to domestic and international shipments, collaborating with customs agents, shipping companies, and external partners to support transportation logistics.
• Prepare and process import and export documentation according to customs regulations, laws, or procedures.
• Partner with third-party brokers to facilitate the clearance of goods through regulatory agencies (FDA/DEA) and ensure compliance to all relevant laws.
• Interface with 3PL, Track and Trace Solution, and Trading Partners to manage daily logistics responsibilities, communications, and ongoing integrations.
• Maintain the integrity of partner and product master data and systems related to Serialization and Track and Trace requirements; conduct analyses to ensure data integrity and compliance.
• Onboard and maintain master data for Nexus, direct customers, Contract Manufacturing Organizations (CMOs), and other partners in the Track and Trace Solution system.
• Provide regular status reports to communicate issues, exceptions, and progress within the supply chain.
• Collaborate with relevant departments to resolve packaging issues promptly and support additional relevant logistics needs for internal and external stakeholders.
• Act as the primary subject matter expert for supply chain planning and GS1 standards under the Drug Supply Chain Security Act (DSCSA).
• Create and manage documents for shipping restricted articles (dangerous goods) and resolve related shipment issues.
• Assist in the management of inventory transactions, including purchase orders, freight, and balances, and track and correct shipping errors.
• Manage distribution and shipment budgets to ensure the quality of all related services meets Nexus's standards.
• Assist third-party services with state licensing applications, renewals, and the gathering of all necessary information, including obtaining signatures, fingerprint cards, surety bonds, and Certificates of Good Standing.
• Maintain an updated spreadsheet of all states where Nexus is licensed, including pertinent details, and ensure all licenses are current and properly displayed.
• Schedule and conduct bi-weekly phone calls with State Licensing Service to discuss updates and maintain compliance.

Requirements:

Desired Characteristics:

• Strong analytical, organizational, team and project skills
• Strong knowledge of Serialization / Drug Supply Chain Security Act (DSCSA) / Track and Trace requirements
• Strong computer and problem-solving skills
• Strong communication skills, both written and verbal
• Ability to successfully handle multiple, competing priorities in a fast-paced, changing team environment; ability to prioritize and work within tight timeframes.
• Ability to facilitate discussions and know when to escalate
• Strength at troubleshooting and problem solving with data analysis skills

Education or Experience :

• Bachelor's degree required
• 1-2 years of Supply Chain/Logistics experience and 2+ years of experience in DEA/Licensing with pharmaceutical experience strongly preferred
• Experience in operating in an MRP system
• Experience with import/export licensing and managing customs related shipments
• Experience with managing DEA controlled substances, including quota directives
• Experience in Serialization and Track and Trace requirements

Travel Opportunity:

• 5% travel required for this role
• Physical Requirements
• Prolonged periods of sitting at a desk, working on a computer, and talking on the phone
• Must be able to lift up to 15 pounds at times
• Must be able to navigate various departments of the organization's physical premises

DISCLAIMER: The list under Role Responsibilities is not exhaustive, but is merely the most accurate lists for the current job. Management reserves the right to revise the and to require that other tasks be performed when the circumstances of the job change.

EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.