Medical Writer

San Francisco, CA; Boulder, CO; or Cambridge UK | Full Time | Clinical Development

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Job Description

Job Summary
The medical writer will be responsible for authoring, editing, formatting, QC review, and/or assisting with the writing of clinical and regulatory documents, including clinical study reports, clinical summaries, clinical protocols, Investigator’s Brochures, annual safety reports, and patient safety narratives. The medical writer will provide medical writing support for medical writing activities and clinical development programs.

Job Responsibilities
• Author, edit, and/or assist with the writing of clinical, regulatory, and other supporting documents for assigned studies and indications.
• Format and perform QC review of clinical and regulatory documents.
• Generate document templates and other materials to support medical writing activities.
• Maintain version control of documents, as needed.
• Work under general supervision to manage and prioritize workload to ensure deliverables are completed per time and quality goals.

Skills & Requirements

Qualifications
• A clinically-related science degree is preferred.
• Experience with writing clinical and regulatory documents within the pharmaceutical or biotechnology industry
• Clinical oncology experience is preferred. Familiarity with standard oncology clinical study endpoints and terminology is preferred.
• Understanding of clinical study design and the drug development process
• Ability to comprehend and present clinical data in a clear and concise manner
• Excellent writing skills, meticulous attention to detail
• Familiarity with GCP and ICH guidelines
• Expertise in MS Word; Good working knowledge of MS PowerPoint and MS Excel; Familiarity with ISIWriter preferred.
• Flexibility to work with colleagues in a global setting

Education and Experience

A degree (MS or PhD is preferred) in a scientific discipline is required. A minimum of 2 years of medical writing experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment is required.

Working Conditions

Office-based position. Limited travel required; estimated 10% of time or less.