Expert Clinical Document Specialist
2 days ago
This is a Medical Writer role in the development and review of clinical and regulatory documents. The responsibilities include writing and reviewing various documents, ensuring adherence to established guidelines and regulations.
Responsibilities
- Write and review clinical/regulatory documents such as clinical trial protocols, clinical study reports, investigator brochures, and informed consent forms in accordance with ICH or other relevant guidelines.
- Draft and document CSR (Clinical Study) and CER (Clinical Evaluation) modules.
- Participate in the writing of publication manuscripts, abstracts, posters, and presentations.
- Conduct routine systematic literature reviews for specific medical device groups or subgroups, including screening articles against inclusion/exclusion criteria, extracting data from included studies, interpreting study results, and preparing summaries into formal reports.
- Develop templates for reports and other regulatory documents.
Education & Qualifications
- Bachelors or Masters degree in Life Sciences or BDS/MDS (Bachelors/Masters of Dental Surgeon)
- Minimum of 1-3 years of experience in Medical Writing (CSR/CER) or a related field.
Skills: csr,medical writing,clinical research,evaluation tools,investigator brochures,life sciences , healthcare , manuscript , abstracts , publishing
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