Writing Consultant

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
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

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