Medical Writer

Medical Writer

Medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects.

Job Responsibilities

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 moderate supervision.

• Completes a variety of documents that may include clinical study protocols and protocol amendments; clinical study reports; patient narratives; and investigator brochures.
• Adheres to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, 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.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency.
• Interacts and builds good working relationships 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.
• Continues professional development to grow awareness of industry standards and best practices to improve ability to meet client expectations.
• 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%).

Equal Opportunity Employer

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. The Company also complies with the EU Equality Directive in relation to the recruitment and employment of its employees.