Senior Manager Benefit Risk Assessment operations

As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk management strategy and support the authoring of various risk management documents. - Produce detailed timelines for Core SBRA document and ensure alignment with Clinical overview timelines. - Project management to ensure timelines are met, follow-up on deliverables, and author/edit sections based on source documents. - Manage documents for review, adjudicate comments, facilitate approvals, and ensure compliance with BMS style guide. - Support authoring and formatting of risk management documents, coordinate with stakeholders, and communicate updates to internal stakeholders. - Ensure consistency in information presented in program documents and perform quality reviews to maintain high standards. - Produce documents in accordance with internal SOPs and guidelines. **Required Qualifications by Level:** - PharmD/PhD or equivalent with a minimum of 5 years" experience in Pharmacovigilance/Pharmaceutical Industry. - Thorough understanding of requirements for complex strategic documents and PBRER. - Strong experience in Clinical overview and Clinical documents. **Preferred Qualifications:** - Experience with Risk Management Plans and Clinical Overviews. - Collaborative writing experience and strong project management skills. - Knowledge of FDA and EMA regulations, ICH guidelines, and drug development process. - Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. - Prior Therapeutic Area experience in oncology, cell therapy, hematology, etc. - Interpersonal skills for a collaborative team environment. If you are intrigued by this role and believe you can contribute, we encourage you to apply regardless of how closely your experience aligns with the requirements. Bristol Myers Squibb offers a supportive work environment where every employee plays a vital role in transforming patients" lives through science.,