Bristol Myers Squibb

Medical writer

• Author, edit, QC, and publish high-quality clinical and regulatory documents in accordance with ICH, GCP, and company standards including: Clinical Study Protocols and Amendments, Informed Consent Forms (ICFs), Investigator Brochures (IBs), Clinical Study Reports (CSRs), Clinical sections of regulatory submissions (e.g., INDs, CTAs, NDAs, MAAs, briefing documents), Patient narratives and safety summaries.
• Ensure all documents comply with regulatory guidelines (ICH, FDA, EMA), internal RayzeBio SOPs, and company style guides.
• Interpret and present clinical data in a clear, concise, and scientifically accurate manner for internal and external stakeholders.
• Coordinate with cross-functional teams (clinical, regulatory, biostatistics, data management, pharmacovigilance, clinical operations and other departments) for source data, input, and review.
• Oversee planning, timelines, and resource management for medical writing deliverables across clinical programs.
• Organize and facilitate document review cycles, manage version control, and oversee quality assurance for document finalization and submission.
• Track writing assignments and ensure timely execution in line with program milestones and regulatory submission deadlines.
• Serve as the primary point of contact for cross-functional teams regarding medical writing deliverables.
• Manage outsourcing partners and medical writing consultants, when applicable.
• Lead regular status meetings, provide risk mitigation strategies, and communicate project status to cross-functional teams.

Senior Manager, Clinical Medical Writer

Risk

• Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
• Partner with Drug Development to embed Quality by Design principles and identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
• During trial conduct, provide feedback on risks to study specific critical to quality factors and adjust mitigation strategies when new or unanticipated issues arise.
• Conduct quality assurance spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
• Assist in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
• Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
• Provide regulatory intelligence on current and upcoming regulations to ensure compliance with requirements.
• Partner with stakeholders to manage significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Ensure rapid communication and escalation of quality issues to the business and Health Authorities as needed.
• Drive quality into the business through proactive quality support, mentoring and/or coaching.

Associate Director, Quality Risk Specialist

Full-stack Engineer

• Senior Software Engineer responsible for Pharmacometrics product suite development within the Clinical Pharmacology and Pharmacometrics (CPP) product team.
• Tap into your curiosity and collaborate with some of the most innovative and diverse product team members.
• Make an impact by developing software solutions by understanding information needs of the Pharmacometrics scientists.
• Work under the direction of the Product Owner, Clinical Pharmacology and Pharmacometrics.
• Responsible for the overall technical deliverables of the various tools/applications/platforms used within Clinical Pharmacology and Pharmacometrics.
• Work on enhancement requests within release schedules, interim workaround, application life-cycle management and assist with new product evaluations and deployments.
• Develop documentation, flowcharts, layouts, diagrams, charts, code comments, and clear code
• Utilize available internal training opportunities
• Collect, analyzes, and summarizes development and service issues.

Senior Software Engineer, Clinical Pharmacology and Pharmacometrics

Business Analyst

• Collaborate regularly with a diverse range of internal teams including scheduling, partners, product management and provide guidance on documenting business requirements in user stories.
• Requirement gap analysis and contribute to user stories functional risk assessment.
• Functional verification of user stories before passing it to the testing team.
• Collaborate with BMS Hyderabad team on user stories, requirements clarification, in-sprint refinement, sprint demos.
• Collaborate with technical and integration team on integration mapping.
• Salesforce and Integration defect triage and helping technical resources on defect management.
• Assess user stories with deep understanding of salesforce and assign appropriate size and complexity.
• Author GxP documentation like configuration specification, data dictionary, user access and permissions as well as contribute to user requirement specification.
• Assess new requirement impacts to translation and manage end to end translation process from IT.
• Build strategy and execution for translating cell therapy 360 portals into new languages / markets.
• Collaborate with production support team on priority defects.
• Mentor and guide the team on requirement management, sprint & release demos.
• Keeps continuous improvement and process efficiencies in mind when evaluating releases and enhancements.

Manager, Business Analyst – Patient Operations Product Team

Business Development Rep

• Lead S&E efforts for BD opportunities in HOCT and ICN areas.
• Manage the internal strategic prioritization of opportunities within business development with input from key stakeholders from research, development and commercial.
• Manage and direct strategy of scientific diligence on priority active opportunities and challenge teams on key assumptions/takeaways as appropriate.
• Oversee and direct talent allocation and prioritization of effort spent on various S&E priorities.
• Keep up frequent strategic dialogue with key stakeholders in research, development and commercial, to anticipate evolving priorities.
• Keep up to speed and influence enterprise/TA priorities based on input from external biotech ecosystem globally.
• Manage scientific conference focus and team travel priorities to ensure enterprise 'follows the data' and positions BD and enterprise to be tactically in a position to 'win' in competitive BD processes.
• Keep current on scientific / clinical data trends in biopharma in core therapeutic areas of focus and key adjacencies.
• Closely interact and collaborate with SVP Business Development and other BD leadership to make sure information and priorities are shared in real time thereby facilitating work-flow prioritization and escalation of key strategic opportunities.
• Present and articulate merits, diligence findings related to strategic opportunities to C-suite audience.
• Serve as thought partner to key stakeholders in research, development and commercial bringing in scientific perspectives from the external environment and be able to lead cross-functional teams.
• Shape S&E focus strategy in close collaboration TA leadership, formulate external point of view on emerging mechanisms of action and new modalities, and develop concrete and tangible action plans to support execution of the strategy.
• Demonstrate strong leadership and scientific rigor while collaborating closely with internal BD, R&D and Commercial stakeholders and potential external partners.
• Develop talent within the S&E team, coach team members on core skill set, and demonstrate a genuine interest in fostering their growth and career development.
• Champion continuous improvement of the S&E process and lead change management when needed.

Vice President, Business Development, Search & Evaluation

Director

• The GCO is responsible for delivering new and improved capabilities across People, Process, Technology, and Data, for their assigned area of responsibility.
• Serves as the Conductor, aligning all sections of the Supply Chain to play together.
• Leads cross-pillar end-to-end process standardization and transformation, enabling pillar specific customization where required by business needs.
• Defines process improvement and capability evolution roadmap across people, process, technology and data.
• Use benchmarking and process KPI’s to define opportunities for capability improvement, bringing outside-in perspective to drive best-in-class capabilities.
• Provides leadership for large and complex capability programs, including matrix leadership of sub-programs, as applicable.
• Develop training content, key performance indicators (KPI’s) and change management to ensure user adoption and adherence to standard ways of working for deployment of new or uplifted capabilities.
• Provides dotted line leadership to capability leads supporting their area of responsibility, including providing coaching and guidance for successful execution and sustainment of capability enhancements.
• Manage relationships with key stakeholders both within & outside of GSC.
• Provides process expertise, as required, and ensures accuracy of accompanying business process models within their capability scope.
• Help organization transition through disruption at a faster pace and enable accelerated change management with digital evolution.
• Ensure compliance with regulatory requirements and company policies, maintaining robust governance and data integrity.

Director, Global Demand Capability Owner

• The Sr. Director, Analytical Science and Technology (ASAT) Analytical Excellence is responsible for defining and driving strategic Quality Control (QC) Excellence programs across BMS’s global cell therapy network.
• This role will be responsible for driving alignment and harmonization of analytical method performance, execution, and efficiency improvements, partnering closely with QC, Quality, and Analytical Development stakeholders.
• The individual will champion initiatives that improve analytical method performance, facilitate best-in-class operational practices, and optimize the use of analytical instruments and software platforms.
• Develop, implement, and continuously improve the QC Excellence strategy for global QC sites, focusing on method harmonization, performance optimization, and operational efficacy.
• Lead cross-functional teams to establish standardized procedures, tools, and metrics for routine QC testing.
• Partner with site QC, Quality (GPQ and QA), and ASAT functions to assess current practices, identify gaps, and drive alignment.
• Champion data-driven decision-making and continuous improvement principles for analytical method execution.
• Own and evolve business processes for QC-related analytical instruments and software systems, coordinating with IT and site SMEs.
• Benchmark industry best practices and implement innovative approaches to process efficiency, regulatory compliance, and quality improvement.
• Monitor performance indicators, compliance metrics, and operational dashboards, using findings to inform global improvement initiatives.
• Prepare and present strategic plans, performance updates, and improvement proposals to executive leadership.
• Mentor and develop team members, fostering a high-performance and collaborative culture.
• Ensure robust change management and stakeholder engagement throughout all initiatives.
• Foster a culture of excellence and accountability for cell therapy across all partners and stakeholders.

Senior Director, Analytical Excellence

Manager

• Act as key treasury liaison to APAC markets.
• Understand legal entities' financial statements, key drivers of cash flow, and forex exposure to proactively address international markets’ cash needs.
• Work with International markets to understand statutory accounts and identify opportunities to maximize cash repatriation to the US.
• Develop and implement strategies to optimize treasury operations and improve financial performance.
• Monitor and analyze market trends, economic conditions, and regulatory changes to inform treasury decisions.
• Collaborate with internal stakeholders, including finance, accounting, and legal teams, to support business objectives.
• Prepare and present regular reports on treasury activities, financial performance, and risk management to senior management.
• Ensure compliance with all internal controls, policies, and procedures related to treasury operations.
• Provide guidance and support to junior team members, fostering a culture of continuous learning and development.
• Participate in special projects and initiatives as required.

Senior Manager, International Treasury

• Lead business development and external innovation strategy development and prioritization of external investments across Oncology, Hematology/Cell Therapy, Cardiovascular Disease, Immunology, and Neuroscience for drug development.
• Develop data-driven objective frameworks to drive decisions on external investments connected to disease area, therapeutic area, and enterprise strategy.
• Accountable for developing and executing strategies to expand drug development effort into priority markets such as China.
• Ensure external and competitive insight is incorporated into all disease strategies.
• Drive enterprise portfolio value creation by guiding external investments and implementing cost efficient strategies to accelerate cycle times through external innovation and geographic expansion.

Executive Director, External Insight & Innovation, Drug Development

• Develop proactive policy solutions to address emerging trends and risks in reimbursement and coverage.
• Identify gaps and opportunities for policy innovation that align with organizational objectives.
• Analyze legislative and regulatory developments impacting the IRA and Medicare Part D and develop BMS positions.
• Identify and commission research to strengthen advocacy campaigns and inform policy positions.
• Translate complex data and evidence into compelling narratives for policymakers and stakeholders.
• Collaborate with internal teams to integrate research findings into advocacy strategies.
• Drive policy strategies to protect innovation and patient access under Part D.
• Collaborate with internal teams (legal, government affairs, market access) to align advocacy efforts.
• Lead cross-functional workgroups to develop proactive solutions for pricing and reimbursement challenges.
• Represent the organization in industry coalitions, trade associations, and stakeholder forums.
• Build and maintain relationships with policymakers, regulators, and advocacy groups.
• Prepare and deliver testimony, comments, and briefing materials for legislative and regulatory processes.
• Develop clear messaging on Part D and drug pricing policy priorities for internal and external audiences.
• Provide training and updates to senior leadership and business units on policy changes and implications.

Director, U.S. Policy – Drug Pricing, Part D

Artificial Intelligence

• Leads the execution of strategic projects and programs to ensure alignment with defined business outcomes, financial objectives, and operational priorities.
• Applies standardized project management practices, including methodologies, tools, and governance models, to promote consistency, transparency, and accountability.
• Coordinates cross-functional delivery by managing resources, timelines, budgets, and risk mitigation strategies from initiation through completion.
• Establishes and tracks performance indicators and quality benchmarks to support data-informed decision-making and continuous improvement.
• Identifies, evaluates, and integrates emerging tools and methodologies to enhance delivery efficiency and execution maturity.
• Develops and supports high-performing teams by fostering skill growth, leadership readiness, and alignment with long-term strategic goals.

Executive Director – Drug Development AI Enablement

Therapist

• Develop strategy for the product franchise by representing Drug Product on product strategy teams and leading a cross-functional team that manages the Drug Product technical project portfolio.
• Be the primary owner of the Drug Product process, and leads or participates in process validation, regulatory filings, regulatory inspections and responses, technology transfers, troubleshooting, change management, process monitoring and robustness, continuous improvement, and other initiatives.
• Interact regularly with product development to ensure process readiness for commercialization, assess resources required, communicating progress and risks, and presenting timelines and strategies for endorsement.
• Represent the Drug Product manufacturing process in regulatory interactions such as inspections and other meetings.
• Work with Drug Product manufacturing site teams to troubleshoot manufacturing issues and develop process improvements.
• Collaborate closely with analytical, quality, regulatory, operations, development, supply chain, program strategy, third-party manufacturing, and manufacturing sciences to drive the franchise strategy.

Associate Director, Product Technical Steward – Cell Therapy Technical Operations

• Oversight of China Production team
• Ensure alignment with brand strategy
• Collaborate with teams to plan executions
• Accountable for content timelines and delivery
• Actively involved in China platforms
• Lead and participate in status meetings
• Manage multiple tasks and prioritize workload
• Identify and drive innovation initiatives
• Implement best practices in marketing operations

Senior Manager, China and Asia Cluster – Omnichannel Production Lead

• Lead a cross functional matrix team (CTTO, Development, Analytical, Quality, External Manufacturing, and Regulatory) to create an integrated technical roadmap for Key Vector assets.
• Develop CMC technical strategy for life cycle or pipeline programs; secure stakeholder endorsement at governance forums.
• Partner with matrix team leads to build project schedules, charters, budgets, and resourcing plans.
• Define and drive global process control strategies, including risk-based parameter classification, lifecycle justification of ranges, and Continued Process Verification (CPV) alignment.
• Develop end-to-end project to portfolio execution, focused on supply stabilization, business continuity projects, and pipeline launch programs.
• Represent CTTO in regulatory discussions and serve as a technical leader for INDs, and BLAs.
• Participate in global change control management to ensure product quality, compliance and supply.
• Author, review and approve regulatory CMC submission sections.
• Drive continuous improvement initiatives to improve lifecycle management and process robustness.
• Actively manage technical risks & risk register, charter priority projects to manage high risks to the brand, and support business continuity initiatives.
• Escalate risk and develop contingency plans through proactive stakeholder engagement.

Director, Vector Technical Program Lead

Program Manager

• The Program Manager will orchestrate cross-functional delivery of the Benchling platform across BMS Research.
• Partnering with product owners, capability leads, site leaders, scientists, and IT teams to align strategy, scope, timelines, and resources.
• Driving critical path management, cross-team dependency tracking, and fast escalation paths.
• Establishing an executive communication cadence with clear status narratives, KPIs, and decisions needed.
• Defining and instrumenting adoption and data-quality KPIs and ensuring role-based enablement, champion networks, and hypercare plans are embedded in each wave.