WRITING CONSULTANT (12-month - Potential for extension)
SUMMARY:
Contractor needed to provide clinical, regulatory and medical writing support for a thriving biotech organization.
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 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 multi-arm trials, CSRs for Phase I and Phase II trials, IBs, DSURs, regulatory responses, etc.
* 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
* Relevant Degree
