Job Description We are seeking a highly skilled and experienced ICF Developer/Writer and Reviewer to join our team. As a key member of our clinical trial operations department, you will be responsible for developing, reviewing, finalizing, and maintaining clinical trial documents such as informed consent forms. You will apply your knowledge of GCP Guidelines, regulatory requirements, and therapeutic area(s) to review and develop Informed Consent Forms (ICF). Your primary goal will be to ensure that the content of the Master Informed Consent Form is consistent with the corresponding protocol and fully informs the subject of all information about the research study. Your responsibilities will also include ensuring that research participants can easily understand the content and the scientific and medical language of the consent form. Additionally, you will ensure that documents are written/edited in compliance with global industry standards. Required Skills and Qualifications - Strong knowledge of the drug development process - Good understanding of FDA IND/NDA requirements - Strong understanding of regulations, policies, and procedures concerning the conduct of clinical trials including FDA regulations, biological samples regulations, GDPR, and GCP guidelines - Excellent customer service/management skills - Excellent proficiency in MS Word Benefits This role offers the opportunity to work in a fast-paced, dynamic environment and contribute to the success of our clinical trials. You will have the chance to work with a talented team of professionals who share your passion for delivering high-quality results. Others This position requires a University/College Degree (medical degree preferred) and at least 5 years of experience in writing and editing master informed consent forms and other clinical trial-related documents. Advanced English (oral and written) skills are essential. If you have relevant domain knowledge and experience, we encourage you to apply.