Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
Complete a variety of documents, including clinical study protocols, amendments, 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, and abstracts, posters, and presentations for scientific meetings
Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
Perform online clinical literature searches and comply with copyright requirements
Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
Mentor and lead less experienced medical writers on complex projects
Develop deep expertise on key topics in the industry and regulatory requirements
Work within budget specifications for assigned projects
Qualifications
Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
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
