Senior Medical Writer – Regulatory
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Job Description
Medical Writer leading the accurate completion of medical writing deliverables for Syneos Health. Collaborating with clinical solutions team members to meet customer needs and expectations.
Responsibilities:
- 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
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