Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

Sr Medical Writer Publications - Sponsor Dedicated - Remote Based

- 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 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. - 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.

- 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. - Minimal travel may be required (less than 25%).