Medical Affairs Operation Assistant (1-year contractor)

Job Title: Medical Affairs Operation Assistant

Working model: Office based in global pharma, Taiwan, Taipei office, Flexible WFH

We are seeking a detail-oriented and proactive Compassionate Use Program MA Operation Assistant to support the coordination, documentation, and communication processes related to compassionate use (expanded access) programs. This role involves working closely with physicians, hospital pharmacies, internal teams, and regulatory authorities to ensure timely access to investigational medicines for patients with unmet medical needs.

• Assist in the preparation, collection, and submission of required documents for compassionate use/expanded access applications in accordance with TFDA regulations and internal SOPs
• Liaise with physicians and hospital staff to support the application process, including informed consent forms and medical justifications
• Prepare and coordinate IRB submission packages, and track approval status for each case
• Support contract communication with hospital or clinical sites, including reviewing contract templates, coordinating signatures, and maintaining document records
• Coordinate with hospital pharmacies on drug dispensing and record-keeping
• Support investigational drug importation process, including invoice review, customs clearance, and shipment tracking
• Work with regulatory teams, supply chain, and vendors to ensure timely delivery and documentation of imported drug products
• Maintain accurate records and databases of program activities, application status, and patient-level tracking
• Monitor regulatory timelines and ensure all approvals and renewals are submitted in a timely manner
• Prepare internal reports, summaries, and communications regarding program status and metrics
• Provide administrative support for compassionate use projects, including meeting scheduling, document translation, and filing
• Ensure patient safety documentation (e.g., adverse event reports) are submitted and archived properly

Required experience and qualifications

• Bachelor’s degree or above in a Life Sciences-related field (e.g. Biology, Biotechnology, Biomedical Science, Biochemistry)
• 1–3 years of experience in clinical research, regulatory affairs, medical affairs, or a related healthcare/biopharma setting
• Familiarity with TFDA regulations, GCP, and expanded access program requirements is a strong plus
• Strong attention to detail and organizational skills
• Ability to work independently and manage multiple priorities under tight deadlines
• Comfortable communicating with physicians, internal teams, hospital pharmacies, and external vendors

Benefits of Working in ICON:

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

#LI-ST1

#LI-Hybrid