Medical Writers create and write scientific documents that describe research results for drug or medical device use, promotional medical literature and website contents, articles for medical journals, while complying with regulatory and journal guidelines.
- Write SAE case narratives (CSR, DSMBs etc.)
- Write clinical study protocols
- Write clinical study reports (ICH-E3) and safety data reports
- Write IND Annual Reports (21 CFR 312.33)
- Prepare clinical summaries/Product Feasibility Reports for Medical Devices
- Create manuscripts and publications
- Create high quality submission-ready documents in accordance with regulatory document requirements
- Prepare Patient Diary Cards (PDC), Informed Consent Form (ICF), Case Report Forms (CRFs) and Subject Information Sheet (SIS)
- Assist in creating Investigator Brochure and Patient information leaflets
- Assist in medical translation services
- Coordinate and interact with study team, investigators and stakeholders to prepare publications
Eligibility: Bachelor’s degree and relevant experience or advanced scientific degree (MS, PhD, PharmD or MD), professional proficiency in written English.