Contract Medical Writer

Ardea Biosciences
Job Location: 
San Diego
Job Description: 

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.

Contact Information: 

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