Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The successful candidate will be responsible for managing and directing the medical writing function as well as producing documents for regulatory submission, and assisting with the development of clinical documentation. This individual will be responsible for final compilation of INDs, BLAs and NDA’s and may also support Clinical Operations in creating and adhering to a template/style-guide for clinical protocols, investigator brochures, and study reports.
• Direct the medical writing function, including management of in-house and contract medical writers, to create and/or update Investigator Brochures, clinical protocols, clinical study reports, safety narratives, and correspondence with regulatory agencies in agreement with predefined, aggressive timelines.
• Organize the production of INDs, BLAs, or NDAs in collaboration with Regulatory Affairs and other team members.
• Evaluate draft documents and draft statistical output for accuracy and consistency.
• Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.
• Coordinate a multi-disciplinary team to develop formats and guidelines for clinical documentation.
• QC tables, listings and figures, and clinical study reports provided by the CRO.
• Other duties as may be necessary.
• Bachelors, Masters, or PhD in a relevant field.
• Minimum 10 years of regulatory medical writing experience.
• Minimum 8 years experience in the biopharmaceuticals industry, with at least 2 years managing staff.
• Experience with producing IND and NDAs in CTD format
• Excellent writing and interpretive skills.
• Must have working knowledge of ICH E2 and E6 plus CFR 312 and 314.
• Knowledge of Canadian and/or EU regulatory requirements is preferred.
• 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.
• Proficiency in strategizing, planning, monitoring and problem solving.
• Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.
• Ability to manage multiple and diverse issues.
• Strong facilitation, organizational, analytical and time management skills.
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project.
• Ability to apply knowledge to new situations.
• Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement. Special Considerations
• Some travel is to be expected up to 25% to visit key sites, travel to investigator meetings, etc.
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.