Principal Medical Writer Consultant needs 5 years medical writing experience in the biopharmaceutical industry with in-depth knowledge of Good Clinical Practices
Principal Medical Writer Consultant requires:
FDA regulations, ICH guidelines, and the drug development process.
Strong written and verbal communication skills, including fluency in oral and written English, with the ability to clearly present clinical data.
Regulatory submissions and knowledge of eCTD formatting preferred.
Bachelor’s degree in a relevant scientific field is required; advanced degree preferred.
Principal Medical Writer Consultant duties:
- Draft, edit, format, and finalize clinical regulatory documents including, but not limited to: clinical protocols and amendments, investigator’s brochures (IBs), and clinical study reports (CSRs).
- Provide quality control (QC) review of clinical regulatory documents, as appropriate.
- Produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function.
- Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
- Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.
- Assist in the development of templates and standard operating procedures (SOPs).
- Represent Medical Writing on one or more program teams
- Participate in Medical Writing initiatives, and process improvement, as appropriate