Medical Writer II (CSR Safety Narratives)

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: