Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
Ardea is seeking a full-time, senior-level medical writer who will be responsible for writing regulatory documents in support of drug development, as well as assisting with the oversight of writing projects assigned to contractors and CROs. This individual will responsible for writing and overseeing the production of regulatory documents in support of drug development programs, including protocols, study reports, investigator brochures, and summary documents.
• Write and/or update clinical protocols, clinical study reports, Investigator Brochures, safety narratives, IND annual updates, and other clinical regulatory documents in accordance with predefined, aggressive timelines.
• Write and/or update nonclinical documents and summaries as well as regulatory submission components from other disciplines, as needed.
• Assist the department head in overseeing projects assigned to contractors and CROs, including timeline development and management.
• Evaluate draft documents and draft statistical output for accuracy and consistency.
• Represent department and provide status updates at internal meetings and meetings with external collaborators.
• 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 with regulatory submissions (IND, NDA, MAA, NDS, etc.) in eCTD format.
• 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.
• Strong facilitation, organizational, analytical, and time management skills.
• Extreme competence in MS Word with experience adhering to templates and styles; overall high proficiency in MW Office applications, including Excel and PowerPoint.
• Ability to apply knowledge and experience to new situations.
• Task-oriented view of work with a commitment to timelines and
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.