Senior Medical Writer, Clinpharm – CSR, IB, Protocol

Job Description: • 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 affect medical writing. • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. • Completes required administrative tasks within the specified timeframes. • Performs other work-related duties as assigned. 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: • Health insurance • Professional development opportunities • Total rewards program Apply tot his job Apply To this Job