SUMMARY:

Contractor needed to provide clinical, regulatory and medical writing support for a thriving biotech organization.

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 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

• 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