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.

Ardea Biosciences is searching for a Contract Medical Writer to join the team.

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 clincial 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: 

Apply online at: www.ardeabio.com/careers