Safety Narrative Writer

Working with Us Challenging Meaningful Life-changing Those arent words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here uniquely interesting work happens every day in every department From optimizing a production line to the latest breakthroughs in cell therapy this is work that transforms the lives of patients and the careers of those who do it Youll get the chance to grow and thrive through opportunities uncommon in scale and scope alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives Read more Key Responsibilities Writes edits reviews finalizes and tracks clinical study report CSR patient safety narratives Serves as primary contact for narrative writing for an assigned study deliverable timelines and addressing resolving any narratives related issues as required Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness Ensures the work is complete and of high quality including final quality control checks compilation and formatting Participates in process improvement activities to develop patient safety narratives Qualifications Experience College or university degree preferably a Bachelors Masters degree in biomedical or life sciences fields Minimum 2-5 years of experience working with clinical documentation and data 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 unambiguous medical text Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews Ability to manage timelines and quality of work using strong organizational communication and facilitation skills Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization Why You Should ApplyAround the world we are passionate about making an impact on the lives of patients with serious diseases Empowered to apply our individual talents and diverse perspectives in an inclusive culture our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits services and programs that provide our employees with the resources to pursue their goals both at work and in their personal lives HYDDDIf you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture promoting diversity in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50 onsite at your assigned facility For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations