Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
We are seeking a medical writer who will be responsible for writing and/or revising regulatory documents in support of drug development, including clinical protocols, clinical study reports, patient narratives and investigator brochures.
• Write and/or update clinical protocols, clinical study reports, investigator brochures, safety narratives, and other clinical regulatory documents in accordance with predefined, aggressive timelines.
• Support the timely generation of high-quality regulatory documentation by assuming other duties, including document editing, QC and formatting.
• Bachelors, Masters or PhD in a scientific or medical field.
• Minimum of 5 years of regulatory medical writing experience in the biotech/pharmaceutical industry.
• Experience writing clinical protocols, clinical study reports (ICH E3) and Investigator Brochures for the biotech/pharmaceutical industry.
• Excellent writing and interpretive skills.
• Working knowledge of ICH E2, E6, and M4E plus CFR 312 and 314.
• General knowledge of applied clinical medicine and laboratory interpretation.
• Experience with small-molecule drug development is preferred.
• Experience with an electronic document control and management system.
• Team-oriented with excellent communication and interpersonal skills.
• Ability to manage multiple projects and adapt to changing priorities.
• Extreme competence in MS Word with experience adhering to templates and styles; overall high proficiency in MW Office Applications, including Excel and PowerPoint.
Interested parties please apply today at: www.ardeabio.com/careers
Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA. We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases