"Alerted.org

General Description:

This position is 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 (eg, CIOMS).

Essential Functions of the job:

Narrative Writing** **:

+ Writes, edits, reviews, finalizes, and tracks patient safety narratives based on data listings and/or safety reports (eg, CIOMS) 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

+ Be able to handle multiple narratives at the same time 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

+ Ensure adherence to regulatory requirements and internal quality standards.

Project oversight:

+ 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, ensure

+ 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

Other Qualifications & Experience

+ Prior pharmaceutical, biotechnology, or contract research organization experience

+ Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process

+ Basic knowledge of electronic Common Technical Document (eCTD) requirements

+ 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

+ Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.

+ Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

+ Experience with automation tools for the development of narratives

Supervisory Responsibilities:

+ Manages and supervises staffing and performance management, including, but not limited to, hiring, training, coaching, and performance reviews for direct reports, if applicable.

Experience/Education Required:

+ Advanced degree (MS/PhD/PharmD/MD) in life science/pharmacy/medical/health-related science is preferred.

+ MS with a minimum of 5+years ofnarrativewriting (or equivalent) experience.

+ PhD/PharmD/MD with a minimum of 3+ years ofclinical safety narrative(or equivalent) experience. ​

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.