Senior Medical Writer (Regulatory) - Taiwan/ United States/ South Korea/ Europe - fully remote
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
Our extensive expertise can cover all phases of drug related trials in all the therapeutic areas as well as clinical investigations for medical and diagnostic devices, Investigator Initiated Trials (IITs), and compassionate use programs.
We offer a great opportunity for someone with previous substantial Regulatory Writing (minimum 2 years) experience, focused on Clinical Trials.
The Senior Medical Writer is responsible for producing a variety of clinical and regulatory materials/ documents, always working in compliance with relevant practices and standards. Takes ownership of a given assignment, proactively consulting with Biometrics staff, Pharmacovigilance and Clinical Operations Units.
Main tasks & responsibilities:
- Draw up, edit and review preclinical/clinical documents such as clinical study reports, study protocols, patient information and informed consent forms and other medical and regulatory documents;
- Prepare regulatory and preclinical/clinical documents for drug development and registration activities;
- Review the quality and accuracy of documents in English.
- Be familiar with, and works in accordance with Regulations, Good Clinical Practices and ICH guidelines and Company Standard Operating Procedures
- At times, prepare medical communications materials: manuscripts, abstracts, posters, etc.
What we are looking for:
- Life Science degree is mandatory
- At least 2 years of experience as medical writer;
- Knowledge of medical concepts and terminology; of the clinical trials phases
- Good knowledge of the drug development process, ICH-GCP guidelines and the methodology of clinical research;
- Fluent in English, specific knowledge of biomedical English is required;
- Must be based in one of the selected regions/ countries: Taiwan/ South Korea, United States/ Europe
What we offer:
· Flexible hours
· Fully remote
· Holiday entitlement
· Salary + benefits