เกี่ยวกับตำแหน่งงาน
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Job Description:
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Import/Export Coordinator – Licensed/Registered Pharmacist
Summarized Purpose:
Responsible and accountable for the planning and execution of moderate to complex Import & Export activities for assigned studies in Thailand, including coordination of import licence and regulatory requirements. The role also supports applicable Thai FDA clinical-trial regulatory activities requiring a qualified pharmacist and acts as a subject matter resource for regulatory requirements related to the importation of investigational medicinal products.
The position coordinates Import & Export transactions through delivery to depots/sites, supports import licence submissions and maintenance, maintains required documentation and metrics, and works closely with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, vendors and other stakeholders to ensure compliant and timely clinical trial execution.
Essential Functions and Other Job Information:
- Plan and execute Import & Export activities for assigned clinical studies in accordance with PPD, client, and applicable regulatory requirements.
- Ensure an appropriate Import & Export plan is established and maintained for assigned projects.
- Review, collect, prepare, and maintain documentation required for Import Licences, permits, customs clearance, and shipment activities.
- Support PPD Thailand's Importer of Record (IoR) operations, including application, maintenance, and compliance requirements associated with the Thai FDA Drug Importer Licence.
- Fulfil applicable responsible pharmacist responsibilities associated with PPD Thailand's Drug Importer Licence in accordance with Thai FDA requirements.
- Prepare, review, and coordinate applicable Thai FDA clinical trial applications and regulatory submissions, including relevant amendments, notifications, and responses to Thai FDA queries.
- Support applicable clinical trial regulatory activities throughout the study lifecycle, including assessment of regulatory requirements, maintenance of approvals/documentation, and study close-out activities within the scope of the role.
- Monitor Thai FDA, Import/Export, and relevant clinical trial regulatory requirements and communicate changes, requirements, or compliance risks to relevant stakeholders.
- Coordinate with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, Customs Brokers, Couriers, Depots, and other stakeholders to support timely and compliant clinical trial execution.
- Maintain accurate, traceable, and inspection-ready Import/Export, IoR, Drug Importer Licence, and clinical trial regulatory documentation and support applicable audits or Thai FDA inspections.
- Maintain applicable operational metrics, trackers, and reports, and support process improvements, SOPs/work instructions, and appropriate escalation of operational or compliance issues.
- Perform other Import/Export, logistics, regulatory-support, and administrative activities according to business and departmental needs.
Job Complexity
Works on assignments that range from semi-routine to moderately complex in nature and recognizes the need for deviation from established practices where required. Applies Import/Export, clinical supply and applicable regulatory knowledge to identify issues and support compliant solutions.
Job Knowledge
Applies acquired Import/Export, clinical supply, pharmaceutical and regulatory knowledge together with company policies and procedures to complete assigned responsibilities.
Supervision Received
Normally follows established procedures for routine work and requires guidance for new or complex assignments. Expected to independently manage assigned Import/Export and applicable regulatory activities and escalate issues appropriately.
Business Relationships
Contacts are typically with individuals within the Import/Export organization and regularly with Clinical Operations, Regulatory Affairs, Quality, Project Delivery, sponsors, Customs Brokers, Forwarders, Couriers, Depots and Thai regulatory authorities. Contacts involve obtaining, providing and interpreting information requiring professional judgment and explanation.
Qualifications (Preferred/Advantageous unless noted otherwise):
- Bachelor’s degree or higher in Pharmacy / Pharmaceutical Sciences from a recognized university.
- Valid professional pharmacist licence/registration in Thailand, as required for the responsible pharmacist role.
- Knowledge of Thai FDA requirements applicable to clinical-trial importation and investigational medicinal products.
- Knowledge of Import/Export requirements and clinical supply chain processes.
- Working knowledge of Good Clinical Practice and relevant clinical research requirements.
- Experience with Thai FDA applications, import licences or related regulatory submissions is advantageous.
- Experience in a pharmaceutical company, CRO, clinical research or other regulated healthcare environment is advantageous.
- Proficiency in Microsoft Excel, Word and other standard business applications.
- Good English communication skills, both written and verbal.
- Thai language proficiency required for local regulatory and stakeholder interactions.
- Strong organizational, documentation and timeline-management skills.
- Strong stakeholder management and problem-solving skills.
Knowledge, Skills and Abilities:
- Good awareness of the Clinical Supply Chain process, including Imports, Shipping, Delivery and Exports.
- Knowledge of local Import/Export and pharmaceutical regulatory requirements.
- Ability to review and maintain regulatory and Import/Export documentation in an inspection-ready manner.
- Ability to interact effectively with Thai FDA/regulatory authorities and internal/external stakeholders.
- Daily interaction with Customs Brokers, Forwarders, Couriers and Depots.
- Ability to identify compliance risks and recommend appropriate solutions.
- Strong attention to detail and ability to manage multiple priorities and timelines.
- Strong written and verbal communication skills.
- Customer-focused approach aligned with high standards of quality and excellence.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
