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.
For More Information on Job Responsibilities and Requirements interested parties apply on line at: www.ardeabio.com/careers
• 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.