Manager, Clinical Trial Disclosure

As a part of Bristol Myers Squibb, you will be engaged in work that is challenging, meaningful, and life-changing. Each day, you will experience uniquely interesting tasks across various departments, from optimizing production lines to contributing to the latest advancements in cell therapy. Your efforts will directly impact the lives of patients and shape your career in ways you never imagined possible. This is an opportunity for professional growth and development within high-achieving teams that offer unparalleled scale and scope. **Key Responsibilities:** - Develop training programs and drive change management initiatives for novel processes related to the EU Clinical Trial Regulation and other regulatory requirements. - Manage and coordinate the redaction of clinical documents in compliance with EMA Policy 0070, Health Canada PRCI, EU Clinical Trial Regulation, and global regulations. - Collaborate with cross-functional teams including Global Development Operations, Biostatisticians, Medical Writing, and Submission Managers to ensure operationalization of redaction requirements. - Provide oversight to vendors and CROs for data sharing and document redaction activities. - Implement technology solutions related to clinical trial disclosure in coordination with IT teams. - Maintain and track the redaction book-of-work, compiling and reporting on volume and performance metrics. - Support CT Results Managers operationally as needed. - Monitor global regulatory environment to stay informed of disclosure requirements. - Communicate with internal and external stakeholders to enhance processes and address unmet needs. - Train new staff and create job aids, work instructions, and user guides as necessary. **Qualifications:** - Deep understanding of US/Canada and EU requirements for clinical trial disclosure and related policies. - Comfort working with and discussing scientific data. - Experience in project and stakeholder management. - Ability to work independently and seek support when needed. - Excellent written and oral communication skills. - Strong organizational skills with the ability to multitask and prioritize. **Education/Experience/Licenses/Certifications:** - MA/MS in a scientific or medical field. - 2-3 years of transparency experience and 5 years of relevant work experience in a scientific or medical field with a BA/BS degree. At Bristol Myers Squibb, we encourage candidates to apply even if their background doesn't perfectly align with the job description. Your unique talents and perspectives are valued in our supportive culture where passion, innovation, urgency, accountability, inclusion, and integrity drive our shared mission of transforming patients" lives through science.,