Senior Regulatory Medical Writer

Ionis is seeking a Senior Regulatory Medical Writer to lead, write, and manage completion of clinical regulatory documents. The successful candidate will have a minimum of 5 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry and a deep understanding of relevant FDA, EMA, and ICH guidelines.

Requirements

• Bachelor’s Degree required, advanced degree a plus
• Minimum 5 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry
• Experience writing, as lead and/or contributor, important regulatory and clinical documents
• Solid working knowledge of relevant FDA, EMA, and ICH guidelines
• Deep understanding of the drug development process
• Strong ability to assimilate and analytically interpret scientific data
• Excellent written, oral (including presentations), and project management skills

Benefits

• Health Insurance
• 401(k) Matching
• Retirement Plan
• Generous Paid Time Off