Responsibilities

• Leads the transparent and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard oper...