Freelance Medical Writer- Clinical Evaluation Reports (CERs
Cactus offers medical writing services to multinational biopharmaceutical and devices companies, clinical research organizations, and researchers worldwide. We work with clinicians and researchers to help them communicate their science to the world. We are currently looking to add to our team, experienced medical writers who have exposure to regulatory writing as well as hands-on experience of writing on medical devices or Clinical Evaluation Reposts (CERs) writing experience, and who aspire to be part of a world-class delivery team, and work in an exciting, fast-paced global environment.
As a Freelance CER writer in the Cactus team, you will:
- Ensure timely production of high quality CERs for devices across therapeutic areas
- Screen and summarize literature for relevant clinical data
- Review literature to elucidate the clinical problem and current treatment techniques
- Study and report device characteristics and instructions for use
- Evaluate data for similar competitor devices
- Summarize post-marketing surveillance and risk management data for the target device
- Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation
Qualification: PhD (preferably in the pharmaceutical sciences)/MBBS/MD with knowledge of clinical research, and first-author publications in international peer-reviewed journals. A Master’s degree with clinical research exposure and significant publications experience can also be considered.
- 1-3 years of CER writing experience
- Advanced knowledge of clinical research processes and drug development, as well as ICH, GCP, and other such industry guidelines
- Experience across document types and therapeutic areas/diseases/drug classes
- Ability to understand and interpret complex clinical trial data
- Clear, concise scientific style of writing with a high level of attention to detail
- Excellent written and oral English language skills
- Ability to work under tight timelines and manage multiple tasks
To apply, you can send in your application to firstname.lastname@example.org.