Contract Medical Writer

Organization: 
Ardea Biosciences
Job Location: 
San Diego, CA
Job Description: 

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

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.

Responsibilities include:
•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.

Requirements: 

•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.

Contact Information: 

Interested parties please apply today at: www.ardeabio.com/careers