Senior Manager Benefit Risk Assessment operations

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The Senior Manager of Benefit Risk Assessment Operations will be responsible for collaboratively authoring and revising key drug safety-focused for risk management related documents to support upcoming submission documents to Regulatory Health Authorities worldwide. This role will work closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information to support development of new treatments as well as support post-marketing safety activities for approved agents relating to risk minimization strategy. 

Principal Responsibilities:

Includes but not limited to (based on role/functional allocation): 

• As a part of structured benefit risk assessment (SBRA), attend meetings to understand the approaches being considered and data presented plus contribute.
• Schedule meetings accordingly to discuss risk management strategy to support upcoming authoring of various risk management documents
• Facilitates meeting with SBRA team, records and distributes meeting minutes and follows up on all action items accordingly.
• Produces a detailed timeline for Core SBRA document (and ensures this fit with Clinical overview timelines)
• Project management to ensure timelines are met and follow-up on deliverables
• Authoring and editing sections based on source documents like clinical study reports (e.g. investigator brochures, etc) for the structed benefit risk assessment
• Manage documents related to SBRA for document review and adjudicate comments accordingly plus facilitate approvals
• For various risk management documents including but not limited to internal purposes and as non-submission risk management documents (e.g. core additional risk minimization measures or regional additional risk minimization measures), support with authoring and formatting including coordination/project management, compliant to BMS style guide and core template as applicable, outreach to the appropriate stakeholders that require review and approval and dissemination to LMs.
• Support with communications to local markets or other key internal stakeholders on releases of various risk management documents and rationale for updates as applicable
• Understand relationships and dependencies between documents and ensure consistency in information presented in program documents (e.g., IBs,) to ensure alignment of safety messaging across all safety risk related documents.
• Perform quality review of the document against the source documents and ensure internal consistency and high quality  
• Ensure assigned documents are produced in accordance with relevant internal SOPs and BMS style guide and core template
• Contributes to and participate in internal audit as needed.
• Support other tasks as assigned

Required Qualifications by Level: 

• PharmD/PhD or equivalent with a minimum of 5 years' experience in Pharmacovigilance/Pharmaceutical Industry or equivalent.
• Thorough understanding of requirements for complex strategic documents and PBRER (Periodic Benefit-Risk Evaluation Report).
• Strong experience in Clinical overview and Clinical documents - protocol, submission documents.

Preferred Qualifications

• Experience with Risk Management Plans (RMPs) and Clinical Overviews. 
• Collaborative writing experience. 
• Excellent project management to meet timelines agreed upon, written and verbal communication skills, with the ability to interpret and present information to varied audiences.
• Ability to coordinate and prioritize multiple projects in a fast-paced matrix environment with limited to little supervision. 
• Knowledge of FDA and EMA regulations, Guideline on Good Pharmacovigilance Practices Module V and XVI, ICH guidelines, Good Clinical Practices, and the drug development process. 
• Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat. 
• Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical industry deliverables. 
• Demonstrated ability to analyze and interpret complex data from a broad range of scientific disciplines.
• Good understanding of global pharmaceutical drug development and requirements for documentation authoring supporting regulatory submissions.
• Working knowledge of a document management system and basic knowledge of the document publishing process.
• Prior Therapeutic Area experience in solid tumor oncology, cell therapy, hematology, immunology, cardiovascular, and neurology  
• Interpersonal skills that promote a collaborative and productive team environment.

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 Visit 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: 

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