Bristol Myers Squibb - Manager - Clinical Trial Disclosure

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. 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 Develop training and drive change management for novel processes related to the EU Clinical Trial Regulation"and other regulations.
• Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
• Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements.
• Provide vendor oversight to support data sharing and document redaction, as appropriate.
• Provide CRO oversight to support document redaction.
• Work with IT, as needed, to implement technology solutions related to clinical trial disclosure.
• Manage and track redaction book-of-work; compile and report on volume and performance metrics.
• Provide operational support to CT Results Managers, as required.
• Assist in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
• Communicate with internal and external stakeholders to improve on processes and manage unmet need".
• Train new staff and develops job aids, work instructions, and user guides, as Knowledge, Skills, Abilities
• Deep understanding of US / Canada and EU requirements for clinical trial disclosure as well as other related policies
• Familiarity and comfortability working with and discussing scientific data.
• Project and stakeholder management experience
• Demonstrated ability to work independently and seek out support when needed
• Exceptional written and oral communication skills
• Strong organizational skills with the ability to multitask and MA / MS in scientific or medical field.
• 2-3 years of transparency experience and 2 years relevant work experience in a scientific or medical field

(ref : iimjobs.com)