Precision for Medicine is the first global, precision-medicine, biomarker-driven contract and clinical research organization, with expertise in today’s most advanced techniques for deeply interrogating samples to better understand patient biology. Our translational solutions begin with biospecimens, through a spectrum of laboratory services from biomarker identification, to clinical immune monitoring, to companion diagnostics development and more. With teams of responsive industry veterans, we support you by solving complex challenges to fuel breakthroughs at every development stage

The Translational Science Global Logistics Documentation Specialist will be responsible for the creation of commercial invoices and shipping documentation for all global precision for medicine locations. This role involves setting up international logistic documents for global and regional studies, ensuring that documents and set up activities align with all participating country regulations, ensuring carrier service align with requested services, and adherence to IATA standards. The Global Logistics Documentation Specialist will play a key role in study design and setup, logistic service offerings, cross-functional communication with project management, study set up, and day to day shipping and logistics functions.

Essential functions of the job include but are not limited to:

• Create customs documents use to apply for importation permits, commercial invoices, certificate of origin documentation and CDC declaration
• Provide technical advice on importation process and carrier capabilities for the setup of awarded studies.
• Guide and mentor team members on technical aspects in collaboration with the director.
• Have active knowledge of HTS system and ensure that all study setup items have correct HTS codes for the customs process.
• Stay abreast of all regulation changes that could affect import/export processes utilizing carriers, internet, and government websites.
• Responsible for updating commercial invoice templates, ensuring all active documents conform to the newest templates being utilized.
• Participate in EKOM and IKOM meeting providing guidance as SME and insight to ensure logistics setup is completed in the manner of logistics and business strategy.
• Create study folders per protocol and sponsor with all customs information so that operational logistics team can proceed with shipments utilizing created templates.
• Aid with other department tasks including but not limited to providing rates, helping with SOP’s, resolving courier issues, providing KPI metrics, tracking shipments, etc.
• Manage shipment tracking and support clinical sample receiving.
• Communicate with couriers, vendors, internal teams, and customers effectively.
• Coordinate with other team leaders and participate in process improvement activities.
• Identify and escalate risks/issues promptly and seek mitigation guidance.
• Participate in project reviews and provide input on scope, feasibility, and resources.
• Aid in investigation of new and emerging processes for the processing and handling customs documentation.
• Any additional assignment or task assigned by the Global Director.

Qualifications:

Minimum Required:

• Bachelor’s Degree or equivalent experience in Logistics, Supply Chain, Science, Business, or related field.
• 8-10 years of experience in Global Logistics and Shipping, including temperature-controlled shipping.
• Minimum 2 years of experience in Clinical Trials (GxP).
• Experience in Supply Chain Management, ERP systems, and warehousing procedures (incoming goods, inventory).

Other Required:

• Exceptional time management and leadership skills.
• Ability to collaborate effectively across teams and departments.
• Work well under pressure and meet deadlines with attention to detail.
• Proficient in English (and German for EU positions).
• Strong computer skills including Excel, Word, and Outlook.

Preferred:

• Ability to multitask and prioritize in a fast-paced environment.
• Direct experience in the creation of customs documents and interacting with brokers/customs personnel.
• Familiarity with courier online tools.
• Knowledge of GxP or CAP/CLIA/ISO standards and IATA training.
• Background in a laboratory setting with Clinical Trial regulatory guidelines (cGMP, cGLP, ISO) and SOPs.
• Strong oral and written communication skills.
• Excellent organizational and people management skills.
• Advanced proficiency in MS Office products (Teams, Word, Excel, PowerPoint, Outlook).