Senior Manager, Narratives, Medical Writing

Role Summary

Senior Manager, Narratives, Medical Writing responsible for the development of patient safety narratives for Phase 1-4 clinical trials in accordance with the client’s controlled processes based on data listings and/or safety reports (e.g., CIOMS).

Responsibilities

• Writes, edits, reviews, finalizes, and tracks patient safety narratives based on data listings and/or safety reports provided by the client.
• Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness.
• Identifies crucial discrepancies between the clinical and safety databases, investigates discrepancies and provides recommendations regarding relevance and resolution.
• Handles multiple narratives simultaneously to provide finalized documents which incorporate client/vendor medical review as well as any Quality Control (QC) findings.
• Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.
• Participates in or leads process improvement activities to develop patient safety narrative capabilities.
• Ensures adherence to regulatory requirements and internal quality standards.

Responsibilities

• Ability to manage timelines and quality of work using strong organizational, communication, and facilitation skills.
• Builds connection with study team(s) and other related departments to develop safety narrative scope, provide and maintain narrative tracker for each project/study.
• Responsible for leading and coordinating external vendors to ensure successful delivery of projects within defined timelines, budgets, and quality standards.
• Involved in strategic planning, financial oversight, and proactive risk management to support organizational goals.
• Support for medical review and accuracy of narratives, as appropriate.

Qualifications

• Required: Prior pharmaceutical, biotechnology, or contract research organization experience.
• Required: Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process.
• Required: Basic knowledge of electronic Common Technical Document (eCTD) requirements.
• Required: Demonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write concise unambiguous medical text in English.
• Required: Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.
• Required: Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.
• Preferred: Experience with automation tools for the development of narratives.

Education

• Preferred: Advanced degree (MS/PhD/PharmD/MD) in life science/pharmacy/medical/health-related science.
• Required: MS with a minimum of 5+ years of narrative writing (or equivalent) experience.
• Required/Preferred: PhD/PharmD/MD with a minimum of 3+ years of clinical safety narrative (or equivalent) experience.

Additional Requirements

• None specified beyond the above qualifications.