WRITING CONSULTANT
SUMMARY:
12-month contractor need, with the possibility of extension. 100% remote. Approximately 3/4 time. Plan for 30 hours +/- per week, with ebbs and flows of workload. Variety of writing and editing projects including Clinical Study Protocols and Amendments, and regulatory responses and reports
DUTIES & RESPONSIBILITIES:
* Gathering relevant content, information and data from key personnel and departments
* Writing and editing:
- Clinical study protocols
- Protocol amendments
- Clinical Study Reports
- Investigator Brochures
- Regulatory submissions, responses and other regulatory documents, including DSURs
- Other content as needed
* Team communications
* Other duties, as required
QUALIFICATIONS & REQUIREMENTS:
* 10 years of relevant clinical, regulatory and medical writing experience in the drug industry, including substantial experience in small and midsize biotech companies
* Experience writing study protocols and amendments for complex multi-arm trials, CSRs for Phase I and Phase II trials, IBs, DSURs, regulatory responses, etc, and experience as a submissions lead
* Excellent written, verbal and interpersonal communication skills, and good computer skills including Microsoft Word and Veeva Vault
* Good project management, collaboration and persuasion skills, and proven performance working independently and remotely
