Senior Medical Writer

Role Overview

• 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
• Coordinates quality and editorial reviews
• Ensures source documentation is managed appropriately
• 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
• 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 affect medical writing.
• Completes required administrative tasks within the specified timeframes

Requirements

• 3-5 years of relevant experience in science, technical, or medical writing
• Experience working in the biopharmaceutical, device, or contract research organization industry required
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
• Experience writing relevant document types required
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Benefits

• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program