Medical Writer II/ Sr Medical Writer

Job Responsibilities Senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents while serving as the primary technical contact with the internal team and the client. Core 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 activities within and across departments with minimal supervision. Resolve client comments and coordinate revisions. Prepare a variety of documents including clinical study protocols, protocol amendments, study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, safety update reports, development plans, IND/IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations. Adhere to regulatory standards (ICH E3, ICH guidelines, company SOPs, client standards, approved templates, authorship requirements, style and formatting guides) and deliver on time and on budget. Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately. Act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format. Review statistical analysis plans, tables, figures, and listings for content and grammar, providing feedback to define statistical output and document needs. Collaborate with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables. Perform online clinical literature searches and comply with copyright requirements. Identify and propose solutions to resolve issues, escalating as appropriate, and provide technical support, training, and consultation to staff. Contribute to internal materials and process improvements. Mentor and lead less experienced medical writers on complex projects. Develop deep expertise on key topics and regulatory requirements affecting medical writing. Monitor budget specifications, work within budgeted hours, and communicate status and changes to leadership. Complete required administrative tasks within specified timeframes. Perform other work-related duties as assigned. Qualifications 4-year Bachelor’s degree in a relevant discipline; graduate degree preferred. 3–5 years of experience in science, technical, or medical writing. Experience in biopharmaceutical, device, or CRO industry required. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices. Experience writing the document types listed above. Extensive knowledge of English grammar and the AMA Manual of Style. Travel Minimal travel may be required (less than 25%). Compensation Salary Range: $70,100.00 – $145,000.00 (base salary; actual salary varies by qualifications, skills, and performance). Benefits Company car or car allowance. Medical, dental, and vision benefits. Company match 401(k). Employee Stock Purchase Plan eligibility. Commissions/bonus based on company and individual performance. Flexible paid time off (PTO) and sick time; eligibility varies by jurisdiction. Legal and Equal Employment Opportunity The Company is committed to compliance with the Americans with Disabilities Act, including reasonable accommodations, and the EU Equality Directive, ensuring no discrimination in recruitment and employment. #J-18808-Ljbffr