Acumen Medical Communications

Acumen seeks an experienced Medical Narrative Writer as a contract role to develop patient-level narratives and related clinical documentation in support of regulatory submissions. This position requires a strong understanding of clinical data, regulatory requirements, and scientific communication principles. The writer ensures that all narratives are accurate, complete, and aligned with Acumen’s quality standards and client specifications.

The role operates within Acumen’s established framework for quality, consistency, and compliance, contributing to the company’s broader goal of delivering world-class medical writing that reflects scientific rigor and operational excellence.

Core Responsibilities:

• Draft and finalize patient narratives for clinical study reports and related deliverables in accordance with global regulatory standards.
• Review clinical data listings, patient profiles, and source documents to accurately summarize individual patient events and outcomes.
• Ensure all narratives are scientifically sound, internally consistent, and compliant with client templates, style guides, and regulatory guidance.
• Collaborate with internal project managers, medical writers, quality reviewers, and external clients to clarify requirements and resolve discrepancies.
• Participate in internal quality control and review cycles, incorporating feedback and maintaining full version control throughout the document lifecycle.
• Support the development and refinement of narrative templates, SOPs, and style standards to improve efficiency and consistency.
• Maintain accurate project tracking, document logs, and correspondence in alignment with Acumen’s internal documentation protocols (e.g., SharePoint, Smartsheet).
• Contribute to team discussions regarding process improvements and best practices for narrative development.

Qualifications

• Advanced degree (PhD, PharmD, MD, or MS) in a life sciences discipline (e.g., pharmacology, biomedical sciences, toxicology).
• Minimum of three years of experience in medical or regulatory writing, with specific experience in narrative preparation for regulatory submissions.
• Demonstrated ability to interpret clinical data accurately and summarize complex information clearly and logically.
• Comprehensive understanding of regulatory submission components and applicable guidelines.
• Proficiency in Microsoft Word and experience using document management tools (e.g., SharePoint, Smartsheet, Box).
• Strong attention to detail, with the ability to manage multiple projects and maintain accuracy under tight deadlines.
• Excellent written and verbal communication skills and the ability to collaborate effectively within cross-functional teams.