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