Medical Writer II
2 days ago
Role & responsibilities:
Main experience in CSR safety narratives writing (authoring, addressing review comments, collaborating with teams)
- Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate 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; 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 document reviews, reviews documents as needed, and resolves comments from client.
• 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.
• Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve document issues, escalating as appropriate.
• Mentors less experienced medical writers on projects, as necessary.
• Maintains a strong working knowledge of drug development process, regulatory guidelines,industry standards, and best practices.
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
Preferred candidate profile: Candidate must have experience with CSR Safety Narratives drafting.
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