Oncology Medical Writer
A company is looking for a Senior Medical Writer (Oncology). Key Responsibilities Prepare initial IND applications, clinical study protocols, investigator brochures, and clinical study reports Provide guidance and support for the preparation or review of manuals and training guidelines Support 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/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
A company is looking for a Senior Medical Writer (Oncology).
Key Responsibilities
Prepare initial IND applications, clinical study protocols, investigator brochures, and clinical study reports
Provide guidance and support for the preparation or review of manuals and training guidelines
Support 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/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
