Senior Medical Writer - Regulatory Documents - CSR​/Protocol - Late Phase

Benefits

Responsibilities

• •Leads the clear 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 clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and 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 operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget
• •Coordinates quality and editorial reviews
• •Ensures source documentation is managed appropriately
• •Leads team document reviews, and reviews documents as needed
• •Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
• •Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
• •Provides feedback to further define statistical output required and document needs
• •Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables
• •Performs online clinical literature searches and complies with copyright requirements
• •Identifies and proposes solutions to resolve issues, escalating as appropriate
• •Provides technical support, training, and consultation to department and other company staff
• •May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities
• •Mentors and leads less experienced medical writers on complex projects, as necessary
• •Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that…
• •15 more items(s)