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Quality Review Senior Specialist

1 month ago

hyderabad, India Bristol Myers Squibb Full time

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t 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. You’ll 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.

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.
 

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