Title: Senior Medical Writer
Company: Pharma / Biotech Company
Type: Permanent Role
Notes: No Corp to Corp
- Draft, edit, format, and finalize documents including, but not limited to: clinical protocols and amendments, investigator's brochures (IBs), clinical study reports (CSRs) and development safety updatereports (DSURs).
- Provide quality control (QC) review of clinical and regulatory documents including data output.
- Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
- 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.
- Assisting in the development of templates and standard operating procedures (SOPs).
- Representing Medical Writing on one or more programs
- Advanced degree (MS or PhD) in a relevant scientific field.
- A minimum of 3 years medical writing experience in a pharma, biotech, or a combination of CRO and pharmaceutical setting with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Strong written and verbal communication skills, with the ability to clearly present clinical data.
- Regulatory submissions and knowledge of eCTD formatting preferred.
- Oncology experiencepreferred.