Manager, Clinical Trial Disclosure

Job Description

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: careers.bms.com/working-with-us . 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 needed" Specific 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 prioritize Education/Experience/ Licenses/Certifications: MA/MS in scientific or medical field 2-3 years of transparency experience and 5 years relevant work experience in a scientific or medical field with BA/BS If you come across a role that intrigues you but doesn't 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 a supportive culture, promoting global participation 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 Protocol BMS has an 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 adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility 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: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.