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.
Primary Duties and Responsibilities
- 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 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; demonstrated ability in managing indirectly.
- 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.
To apply directly, please visit: www.ardeabio.com