ProClinical is advertising a vacancy for a Supply Coordinator position with a leading pharmaceutical company. The organization is a speciality injectable pharmaceutical company, focusing on developing innovative products in an injectable and ophthalmic space. The company is seeking an applicant to join their office in New Jersey.
The Supply Coordinator will manage and oversee shipments of API, standards, excipients, components, drug product samples intended for GMP/GCP activities across company development and manufacturing partners (e.g., API manufacturers, Drug Product CMOs, laboratories, and clinical packaging partners, etc.). They will also manage clinical packaging and logistics of Drug Product intended for use in clinical studies according to forecasts, budget, and specifications provided by Clinical Operations.
- Managing shipments of analytical standards, componentry, drug substance, drug product, and excipient based on shipment specifications (including shipment conditions) from internal department or external party; determining types of transportation needed and choses carrier.
- Managing clinical packaging of investigational medicinal drug products (including comparators and placebo) at external vendors according to specifications and forecasts established by Clinical Operations.
- Managing shipments of drug products, placebos, or comparator drugs from their source to the clinical packaging vendor according to specifications provided by Technical Operations.
- Preparing shipment documentation (e.g. invoices, bill of material, importation letters, USDA letters etc.) for domestic and international shipments and ensuring compliance with DOT designated hazardous materials, 49 CFR, DEA, and IATA regulations.
- Tracking shipments, maintaining logs of all shipments, documenting proof of delivery, and resolves any courier/customer issues regarding the shipments.
- Supporting supports departments as necessary in the preparation of shipments from companies (primary responsibility for proper packaging lies with sending department).
- Establishing Requests for Proposals, assesses vendor proposals, and invoices for final approval by the Head of Technical Operations.
- Tracking packaging campaigns and ensuring that the inventory of packaged and unpackaged product is in line with forecasts established by Clinical Operations.
- Resolving issues, including integrity, quantity, description, and documentation from the shipping/receiving process and providing communication to all affected internal customers (R&D, Tech Operations, Clinical Operations, Project Management, and Finance).
- Ensuring the accuracy of all shipping documents and maintaining all data/documents relative to shipping activities.
Skills and Requirements:
- Bachelor's Degree preferred or equivalent through work experience.
- Hands-on experience with management of pharmaceutical shipments preferred.
- Knowledgeable with UPS, FedEx, DHL, freight forwarding procedures.
- Training/certifications in Dangerous Goods and/or those related to international shipping preferred.
- Federal Express Dangerous Goods Certified.
- Minimum of three-year experience in a position of comparable nature.
- Knowledge of Good Distribution Practice regulations and requirements.
- Background in warehouse operations and logistics, including shipping, receiving, and delivery.
- Experience with clinical packaging and clinical supply management.
- Experience with IVRS systems
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at + 267-477-4800 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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position to join an internationally known pharmaceutical organisation.