Medical Writer

We are hiring a Medical Writer (Clinical & Regulatory) with at least 2 years of experience to support clinical and regulatory documentation for pharmaceutical and biotech clients across Taiwan and the Asia-Pacific region.

Key Responsibilities

1. Author, review, and finalize clinical and regulatory documents, including but not limited to:

a. Clinical Study Protocols and Protocol Amendments

b. Investigator s Brochures (IB)

c. Clinical Study Reports (CSR)

d. Informed Consent Forms (ICF)

e. Common Technical Document modules (e.g., Clinical Overview, Clinical Summary)

f. Regulatory briefing documents and responses to health authority questions

2. Ensure documents comply with applicable regulatory requirements and guidelines.

3. Support document QC processes, integrate input from cross-functional teams and address reviewer comments in a timely and traceable manner.

4. Manage writing timelines and deliverables for assigned projects.

5. Participate in document review meetings and provide scientific and editorial guidance.

6. Support submission readiness activities, including document finalization and version control.

Qualifications

• Advanced degree (PhD, MD, PharmD, MSc, or equivalent) in life sciences, pharmacy, medicine, or a related discipline.
• Minimum 23 years of medical writing experience in the pharmaceutical, biotechnology, or CRO environment.
• Demonstrated experience authoring regulatory-grade clinical documents, preferably for IND, NDA, BLA, or equivalent submissions.
• Prior experience working on clinical trials (Phase 13) is preferred.
• Excellent written and verbal English communication skills, with the ability to produce clear, concise, and objective scientific text.