Principal Medical Writer - Regulatory Submission Documents

Benefits

Qualifications

• •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…

Responsibilities

• •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
• •10 more items(s)