Oncology Senior Medical Writer

A company is looking for a Senior Medical Writer (Oncology). Key Responsibilities Prepare regulatory documents such as IND applications, clinical study protocols, and investigator brochures Provide guidance and support for the preparation or review of manuals and training guidelines Support the electronic submission of regulatory documents to the FDA and serve as a resource for new medical writers Required Qualifications Bachelor's degree required; advanced degree preferred 5+ years of experience in a CRO or pharmaceutical environment 3+ years of regulatory medical writing experience, preferably in oncology Lead writer experience on at least 3 key regulatory documents Familiarity with eCTD modules and industry regulatory guidelines

Mar 27, 2025 - 22:54

A company is looking for a Senior Medical Writer (Oncology). Key Responsibilities Prepare regulatory documents such as IND applications, clinical study protocols, and investigator brochures Provide guidance and support for the preparation or review of manuals and training guidelines Support the electronic submission of regulatory documents to the FDA and serve as a resource for new medical writers Required Qualifications Bachelor's degree required; advanced degree preferred 5+ years of experience in a CRO or pharmaceutical environment 3+ years of regulatory medical writing experience, preferably in oncology Lead writer experience on at least 3 key regulatory documents Familiarity with eCTD modules and industry regulatory guidelines