Primary job function:
- To support Medical Affairs function for medical activities administrative and clinical research activities.
- To support Quality Assurance function for maintaining quality related documents, coordinating with cross-functional teams for training assignment, complaint registering, material controls, supplier management and quality documentation control.
Responsibilities:
Medical Affairs and Pharmacovigilance
- Provide administrative support for medical activities, including vendor creation, payment processing, and related documentation (e.g., contracts, agendas, thank-you letters).
- Serve as the SAP creator and DocuSign coordinator for Medical Affairs.
- Manage iREQUEST system user tasks and assist with clinical research administrative activities.
- Archive and organize documentation for clinical studies and publications, including Trial Master Files.
- Handle pharmacovigilance (PV) processes and support SOP sign-offs for local stakeholders via ISOtrain.
- Manage IT equipment orders and stationery supplies.
Quality Assurance
- Support the implementation and maintenance of the quality management system.
- Handle administrative tasks related to vendor and purchasing processes for quality-related activities.
- Prepare and submit advertising and promotional materials, ensuring compliance with local and global regulations.
- Archive quality documents and manage document lifecycle processes.
- Assist in internal audits, inspections, and supplier performance reviews.
- Translate and prepare Certificates of Analysis (COA) for customs clearance.
- Provide support for product releases, labeling materials, and complaint sample deliveries to manufacturing sites.
- Maintain training assignments and reconcile past-due training.
Qualifications:
- Bachelor's Degree, preferably in a scientific field.
- 2-3 years of experience in secretarial or administrative support (preferably in medical, quality, or regulatory roles within a pharmaceutical company or a related field).
- Strong English communication skills (written and verbal).
- Proficient in computer skills and adaptable to technology.
- Highly organized, detail-oriented, and capable of managing multiple tasks with urgency.
- Strong work ethic, excellent time management, and ability to work independently.
- Strong interpersonal skills with a commitment to self-improvement and development.
- Thai nationality
Remark: Location: Q House Lumpini
