Senior Medical Writer – Regulatory

Role Overview

• Leads the clear and accurate completion of medical writing deliverables.
• Manages medical writing activities associated with individual studies.
• Completes a variety of documents including clinical study protocols and reports.
• Adheres to established regulatory standards and guidelines for medical writing projects.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Acts as a peer reviewer for internal team documents for clarity and format.
• Reviews statistical analysis plans for appropriateness and provides feedback.
• Interacts and builds relationships with clients and peers in various fields.
• Mentors and leads less experienced medical writers on complex projects.

Requirements

• 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.
• 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.

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time