Job Description

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: .BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.Position Summary
Ensure quality of clinical and regulatory documents through data verification, inter-document consistency and message clarity reviews.Key Responsibilities

• Critically review complex clinical documents for timely submission to health authorities worldwide ensuring:

o accuracy between in text tabular or graphical presentations and referenced source materials.
o consistency between text data and messaging to tabular presentations or graphical displays.
o inter-document consistency between data and messaging between submission level documents and referenced source documentation.
o accuracy in document cross-referencing including hyperlinks to sections, endnotes and data outputs.
o Adherence to acronym and abbreviation convention, reference format, and section/table sequencing.

• Participate in continuous improvement workstream to enhance quality and increase efficiency of document reviews.

Qualifications & Experience

• Minimum of BS/BA degree with 3+ years of regulatory documentation experience in complex quality review of clinical protocols, study reports and submission documents. Understanding of clinical protocol documentation is preferred.
• Demonstrated ability to interpret complex data from a broad range of scientific disciplines to enable critical scientific reviews for protocol and submission level documents.
• Familiarity with clinical protocol content and document organization.
• Thorough understanding of regulatory document review standards and QC processes.
• Thorough understanding of style guides and checklists usage for quality review.
• Specialized knowledge of proofreading techniques for clinical and submission documents.
• Excellent attention to detail in reviewing documents for data accuracy, consistency and pull-through.
• 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, facilitation, and interpersonal skills.
• Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

#HYDDD #LI-HybridIf 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol-Myers Squibb