Senior Manager, Narratives, Medical Writing

BeiGene

5d

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. 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).

Requirements

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

Responsibilities

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

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree