Job Search Results
Regulatory Affairs
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.
Associate Director Commercial Regulatory Affairs
Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company’s objectives are met. Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
Responsibilities include:
- Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
- Provides solution-oriented and innovative advice to meet the company’s objectives and goals
- Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions
- Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
- Ensure regulatory compliance with subpart E/H and 2253 regulations
- Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion
- Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
- Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
- Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
- Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
- Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
- Provide input on process improvement and BMS guiding principles as needed
- Engages with colleagues within the department to help support them in their roles and development
- Provide direct management to individuals depending on assignment
- Proactively seeks opportunities to learn and develop leadership skills
Qualifications:
- BS required; advanced degree preferred (MS, PhD, PharmD, JD)
- Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
- Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
- Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
- Proven aptitude to analyze and interpret efficacy and safety data
- Experience communicating and negotiating with OPDP/APLB
- Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
- Excellent verbal, communication, and presentation skills
- Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
The Associate Director of Validation is responsible for leading the validation function to ensure that manufacturing facilities, utilities, equipment, processes, and computerized systems comply with regulatory and company standards for pharmaceutical/radiopharmaceutical production. This role oversees validation activities from initial planning through execution, manages a cross-functional team, and ensures alignment with regulatory requirements (cGMP, FDA, USP, and other relevant bodies). The ideal candidate has extensive experience in validation within radiopharmaceutical or pharmaceutical manufacturing and a strong technical background in process and facility qualification.
Key Responsibilities
Lead, plan, and execute the validation strategy for manufacturing facilities, utilities, equipment, process technologies, and computerized systems.
Develop and oversee validation master plans, protocols (IQ/OQ/PQ), and reports for new or expanded manufacturing capabilities (facility, equipment, utilities, and processes).
Direct and coordinate multidisciplinary validation teams, including hiring, mentoring, and professional development of validation personnel.
Collaborate closely with site leadership, engineers, QA/Quality, and external vendors and contractors to ensure timely and compliant validation delivery for expansion, renovation, and site build projects.
Ensure adherence to budget, schedule, and quality standards within validation scope across all site projects
Review and approve technical documentation, validation protocols, risk assessments, and qualification deliverables.
Manage and resolve deviations, CAPAs, and change controls related to validation and qualification activities.
Support regulatory inspections, audits, and responses by ensuring site validation compliance and documentation integrity.
Lead validation efforts to support site/facility strategic initiatives, new technology integration, and global harmonization as needed.
Drive continuous improvement of validation processes for enhanced site reliability and regulatory compliance.
Lead and mentor the deviation investigations team for the site.
Uphold all safety standards; ensure safe handling of radioactive materials and hazardous equipment throughout validation activities.
Education and Experience
Required: Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
Preferred: Advanced degree or professional certification in validation (e.g., IVT, PDA, or equivalent),
Minimum 8 years' experience in validation within pharmaceutical/radiopharmaceutical manufacturing, including large-scale capital project support (>$10M).
Demonstrated understanding and hands-on experience with radiopharmaceutical or pharmaceutical validation systems and compliance.
Direct experience managing validation or multidisciplinary project teams and external contractors.
Skills and Qualifications
Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirements.
Expert understanding of facility, utility, aseptic processing, and fill/finish equipment validation.
Advanced proficiency in authoring and managing validation documentation (master plans, risk assessments, protocols, and reports).
Familiarity with qualification of computerized systems and data integrity best practices.
Solid background in vendor management, contract review, and cost controls within validation scopes.
Excellent written, verbal, stakeholder, and team leadership communication skills.
Proficient in MS Office Suite, validation software/applications, and computerized maintenance management systems (CMMS).
Willingness to work in radioactive environments and follow strict safety requirements.
Ability to travel and support validation at multiple domestic or international sites.
Physical Demands
Ability to climb ladders and lift up to 25 lbs.
Frequent interaction within laboratory or manufacturing settings; PPE required in controlled environments.
Work Environment
Moderate noise levels.
Exposure to laboratory, pharmaceutical manufacturing, and radiopharmaceutical production areas.
#RayzeBio
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.
Compensation Overview:
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Responsibilities
Tracks, collects, and reviews all components for routine submissions to Health Authorities.
Interacts with responsible parties for quality submission documents for routine submissions.
Troubleshoots issues found in components received and interacts with responsible parties for clarification or revision.
Prepare Cover Letter, FDA Forms and submission content plan for routine submissions.
Perform submission verification on published submissions to confirm eCTD compliant
Update RIM system with US planned submissions and update entries with submitted submissions.
Participates in submission team meeting as applicable Coordinate non-eCTD submissions with International Regulatory Team lead.
Other miscellaneous regulatory operational activities as needed.
Qualification
0-2 years pharmaceutical experience
Foundational knowledge of global regulatory practices, submission guidelines and requirements.
Understands the importance of resolving issues in a timely manner.
Escalates questions and issues as they arise.
Engages relevant stakeholders to help address the problem, as appropriate.
Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.
Communicates project status and updates, as appropriate, to relevant stakeholders.
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives
Seeks to understand stakeholder needs, priorities, working processes, and activities.
Good understanding of desktop application software suites.
Practical knowledge of computer systems in an R&D environment.
Degree Requirement
BA/BS degree, science / technology field preferred.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Responsibilities
The Senior Specialist manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.
Tracks, collects, and reviews all components for submission to Health Authorities.
Interacts with responsible parties for quality submission documents for submissions.
Facilitate submission team meetings with team support.
May participate in focused projects related to their scope of work.
Prepare Cover Letter, FDA Forms and submission content plan for Investigational, Marketed Applications submissions (CSR, Variations, DSURs, PSURs, Initial IND Submission).
Attend Submission Team and kick off meetings, represent RISM and drive submission publishing timelines.
Coordinate Initial IND Kick off meeting submission.
Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
Develop/Update job aid documents for departmental process.
Build/Manage CARA/PRISM Structures for Global CMC Submissions (CMC Submission Specialist).
Coordinate non-eCTD submissions with International Regulatory Team lead.
Experience & Key Competency Requirements
3+ years relevant submissions experience
Foundational knowledge of global regulatory practices, submission guidelines and requirements.
Assists in the implementation of short- and long-term goals within own work group within RISM.
Come prepared with a solution to questions and issues as they arise.
Engages relevant stakeholders to help address the problem.
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers.
Demonstrates basic presentation skills needed to deliver content to a variety of audiences.
Demonstrates the ability to execute a non-complex project, including the ability to prioritize tasks with strong attention to detail.
Communicates project status and updates, as appropriate, to relevant stakeholders.
Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
Proposes alternative solutions for submission-related and/or project situations.
Seeks to understand stakeholder needs, priorities, working processes, and activities.
Good understanding of desktop application software suites.
Knowledge and some experience of computer systems in an R&D environment.
Degree Requirements
BA/BS degree, science / technology field preferred.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Position Summary
The Omnichannel Strategist acts as member of the Worldwide Commercialization Excellence (WCE) for brand teams, pulling in cross-functional resources to ensure successful delivery of omnichannel strategy and campaigns.
This role is deployed to brand teams with a focus on HCP, to lead digital and media channel planning in collaboration with our business partners, and leads cross-functional teams to execute and optimize campaigns, tactics, and programs to meet and exceed business strategy and objectives.
Position Purpose
- Pull through omnichannel brand campaigns, programs, media planning & campaigns and tactics - driving operational effectiveness, business impact and achievement of objectives.
- Partner with business and other WCE functions (e.g., Content Delivery and Customer Engagement Platform Team) on development of channel-agnostic engagement strategy followed by more specific digital channel strategy to meet business and customer needs.
- Deliver omnichannel insights and recommendations for ongoing optimization of business plans
- Leverage Digital Capabilities and Customer Engagement Excellence principles, standards, and best practices to drive results for the business, including
- Omnichannel and advanced analytics
- Content
- Web
- Interactive visual aids (IVAs)
- Other examples to be identified based on customer & business needs and prioritized according to the identified customer experience journeys.
- Identify and run experiments with capabilities team to pilot/scale future digital marketing capabilities.
- Act as a coach to brand teams to ensure adoption of new ways of working with specific focus on omnichannel strategy
Key Responsibilities
- Leads brand omnichannel planning and content strategies across multiple internal business partners including medical, commercial, access, and engaging with multiple customers as prioritized by the brand lead.
- Contributes to continuous improvement of engagement, channel, content and analytic planning frameworks and tactical templates to use across cross functional brand teams.
- Leads and coordinates regular insights and metrics discussions with business partners in partnership with the AIA team to ensure frequent optimization of the engagement, content and channel plans.
- Leads cross-functional matrix teams to enable seamless execution of business strategy and lead execution of digital campaigns/tactics
- Collaborates with AIA to ensure KPI identification, measurement plans and optimization of omnichannel campaigns and customer journeys
- Coordinates with Customer Engagement Platforms, IT, Digital Production, Content Delivery, and rest of WCE teams on the following activities:
- Prioritization of campaigns and tactics
- Definition of campaign/tactic success (e.g., development of metrics plan)
- Evaluation and optimization of tactics
- Driving tactical plan to accomplish KPI and business objectives
- Provides omnichannel subject matter expertise into the ongoing evolution of customer engagement model by working with business leads on critical business priorities
- Maintains view of the competitive landscape and has a broad perspective across BMS and pharma industry to identify and drive best practice around omnichannel expertise
- Drives innovation culture and coordinates with business and capability leads to develop innovative digital tactics and apply metrics, analytics, and insights
- Identifies long-term process needs of the business partners focused on omnichannel capabilities, developing, and executing a plan to address business requirements
- Identify opportunities for synergies and collaboration within and across markets within a therapeutic area
- Lead on the relationship with digital agencies/vendors to define project scope, costs, timelines, and deliverables
- Partner with content stewards P Production & Content Delivery to provide early insight into cross-market material creation to drive content/asset re-use
- Deliver campaign briefs and other necessary requirements documentation to support the development of programs Monitor, manage and provide regular updates on campaign/project financials
- Partner closely with Production and Content Delivery to provide direction, support to project teams, and implement changes when needed to achieve project objectives
- Monitor project status and budget and provide regular reporting on progress, challenges, and solutions
- Collaborate with other Omnichannel Strategy teams to enable consistency and best practice sharing across the enterprise
- Identify business process and capability improvement opportunities aligned to the needs of the business/customers
- Flex coverage across Omnichannel Strategy teams on as-needed basis
Required Qualifications & Experience
- Bachelor’s degree required; MBA preferred
- 8+ years' experience in Digital /Omnichannel Marketing leadership, including:
- marketing/customer engagement strategy, brand/business planning
- analytics
- multi-channel (digital and non-digital)
- marketing operations and campaign/tactic execution/management
- Languages: Fluent in English, Spanish. Additional European languages advantageous.
Key Competencies
Omnichannel excellence
- Strategic Thinking and Articulation
- Record of accomplishment of developing and executing omnichannel strategies and tactics (across personal, non-personal promotional channels)
- Considerable experience in omnichannel marketing in industries with high digital usage
- Experience working with external creative and media agencies
- Insight and Analytical fluency
- Financial and Business acumen
- Knowledge of industry trends and benchmarks for content and channel performance across different customer types
- Data-driven customer experience
- Understands media planning, buying and pull through
- Leverages creative and analytical approaches to identify and activate paid, earned and owned channels
Customer-backed performance management
- Adopts a customer-focused mindset in building strategy and tactics; understands unique customer preferences for omnichannel deployment
- Maintains a robust measurement framework in partnership with AIA to track omnichannel campaign performance by customer segment with feedback loop to inform on-going omnichannel strategies
- Drives trade-off decisions anchored in data
- Partners with AIA to understand omnichannel preferences for different customer segments
- Demonstrates ability to deliver on customer needs and optimize customer experience
Content production and deployment management
- Experience operating in agile teams; ability to coach teams on agile ways of working for content creation.
- Facilitates content delivery process for brand teams, enabling agile ways of working.
- Knowledge and experience with MLR processes for content production
- Knowledge of requirements for omnichannel pull through; adopts new technology and ways of working to enable content deployment faster (e.g., GenAI content)
- Experience using modular content creation (e.g., tagging, taxonomy)
Leadership and cross-functional collaboration
- Demonstrates ability to lead and influence a cross-functional team
- Has a record of accomplishment of fostering a collaborative environment and creating effective rapport
- Embraces changes and upskills teams.
#LI-Hybrid
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident – Employer
A UK Government scheme
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.
Signal Detection/Management & Safety Surveillance
- Drives core signal detection and assessment activities, in partnership with the SMT Chair, throughout product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates strong capability in using a wide range of tools/data sources to assess safety concerns, enabling informed decision-making and proactive risk management.
- Leads SDRMs by reviewing and evaluating clinical data to support signal detection. Appropriately escalates issues impacting key SMT activities, milestones, and documents to the SMT Chair, demonstrating sound judgment and strategic awareness.
- Drives the strategy and execution for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports with clear preliminary conclusions, and ensures timely tracking, stakeholder engagement, and documentation within the signal management system.
- Executes strategy and provides strong medical writing for safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Executes strategy, analyzes data, and writes ad hoc responses to health authorities (including supporting local markets in responding to risk management-related queries from local HAs), and mentors less experienced scientists in this area.
Clinical Development Product Support
- Leads the preparation, review, and strategic input for safety sections in key clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language.
- Represents Patient Safety and supports safety strategy preparation at internal and external meetings (pre-submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc.).
Submission Planning & Postmarketing Product Support
- Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Reviews and authors safety sections of marketing authorization applications (MAA), including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing book, and initial product labeling (USPI, CCDS, SmPC). Authors responses to ad hoc regulatory safety requests (e.g., 120-day safety updates), proactively sourcing and interpreting safety data to evaluate the impact of emerging safety issues on the product’s benefit-risk profile.
- Provides input into strategy, analyzes data, and authors documentation as needed to support safety labeling updates to adequately reflect emerging postmarketing safety profile.
- Supports the EU QPPV or other regional/local QP for safety issues on assigned products.
Risk Management Planning & Execution
- Responsible for creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS).
- Provides strategic leadership and is accountable for the development and maintenance of global and EU Risk Management Plans (RMPs), including understanding of in-licensing arrangements or pharmacovigilance agreements that may impact risk management activities.
- Leads and oversees the creation and revisions to core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Provides guidance to local markets and vendors for complex (eg, Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials).
Department Activities
- Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions.
- Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates.
- Cultivates effective collaboration by engaging regularly with all TA staff, serving as a role model in cross-functional interactions, and contributing to a culture of excellence, accountability, and continuous improvement.
Cross Functional Activities
- Leads or identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update and maintenance of procedural documents.
- Builds cross-functional partnerships with SMT/ACT stakeholders, exercising matrix leadership to drive alignment, accountability, and timely decision-making across functions.
- Possesses deep knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations and industry trends; shares with cross-functional teams as needed.
Degree Requirements
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
- Minimum of 6-8 years relevant pharmacovigilance/pharmaceutical industry/drug development experience; ability to mentor others
- Co-develops and executes safety strategies across programs by synthesizing complex data (clinical, nonclinical, postmarketing, literature) to inform decisions and influence stakeholders, leveraging deep understanding of medical concepts and safety activities.
- Effectively manages team priorities, timelines, and quality through strong communication, collaboration, and organizational skills, proactively escalating risks to timelines or deliverables. Consistently demonstrates initiative and professionalism to operate both independently and as a team player to resolve program-level challenges in dynamic, fast-paced environments.
- Makes sound decisions by integrating scientific knowledge, analytical thinking, experience, and judgment; applies exceptional attention to detail, conceptual thinking, and scientific training to interpret complex medical data across disciplines and drive strategic insights.
- Solid understanding of data analysis, interpretation, and presentation, including foundational statistical methods, with growing ability to integrate emerging technologies (AI, automation, digital platforms) to optimize workflows, enhance data analysis, and uphold scientific rigor and compliance.
Travel Required (nature and frequency)
- N/A
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Position Summary
- Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
- May lead or support trial level activities for one or more trials with the necessary supervision.
Duties/Responsibilities
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as requested.
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for specific trends.
- Contribute to the development of Data Review Plan in collaboration with Data Management.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- Submit clinical documents to TMF.
Qualifications
Specific Knowledge, Skills, Abilities:
- Basic planning/project management skills (develop short range plans that are realistic and effective).
- Basic knowledge of disease area, compound, current clinical landscape.
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism).
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools).
Education/Experience/ Licenses/Certifications:
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Knowledge and skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Travel:
- Domestic and International travel may be required (10 - 25%).
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
IO Account Executive 免疫肿瘤客户主任
主要职责 (岗位相关):
• 有深入的产品知识和疾病领域知识
• 达成/超越区域目标
• 执行市场经理阐明的市场战略。从恰当的细分市场里甄别出目标HCP并与之合作, 达成推广计划
• 充分了解所在地区和所负责区域的关键HCPs
• 更新客户数据
• 协调当地的“院内会议”
• 及时更新HCP的信息，根据计划进行拜访。
• 建立和维护和关键HCP的联系, 理解客户(医学)需求。
• 达成并保持公司关于拜访率、知识水平、能力、行为和个人形象方面的要求。
• 定期（每天）在ETMS 系统中报告拜访情况。
• 提供准确的报告，并且根据规定的流程联系直接主管。
• 提供给直接主管关于BMS 推广材料有效性的信息。.
• 通过参加培训、会议、和自学医学文献以发展和提高专业知识
• 和团队成员分享自己的知识和经验。
• 管理好专业设备和促销资料，确保完好。
岗位要求
• 具备医药，生命科学相关本科以上学历
• 熟悉当地医院的推广工作
• 1-3 年销售经验
• 有肿瘤经验者优先考虑
• 具备良好的人际沟通技巧，团队合作精神，能独立分析解决问题并在压力下工作。
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Signal Detection/Management & Safety Surveillance
- Performs core signal detection and assessment activities throughout the product life cycle (including review of safety-related literature and quantitative signal detection). Demonstrates solid capability in utilizing available tools and data sources to investigate safety concerns, contributing to safety assessments with increasing autonomy and analytical insight.
- Leads SDRMs by reviewing and evaluating clinical data to support signal detection and escalate issues impacting key SMT activities, milestones, and documents to the SMT Chair.
- Executes strategy for signal evaluation (e.g., case-series, literature review, health authority/claims databases), promotes cross-functional collaboration, authors comprehensive signal reports, and proactively manages and tracks signals within the signal management system, ensuring timely notification and engagement of all relevant stakeholders.
- Prepares/writes safety and risk management sections of aggregate safety documents (e.g., DSUR, PBRER, PADER).
- Analyzes data and writes ad hoc responses to health authorities, including supporting local markets in responding to risk management-related queries from local HAs.
Clinical Development Product Support
- Contributes to the preparation/review of safety sections in clinical trial documents, such as protocols, clinical study reports (CSR), investigator brochures (IB) including reference safety information (RSI), informed consent forms (ICF), and contraception language, with oversight.
- Represents Patient Safety and supports safety strategy preparation at internal and external meetings (pre-submission, Advisory Committees, Scientific Advice, data monitoring committee, publications, etc.).
Submission Planning & Postmarketing Product Support
- Executes on the safety strategy for regulatory filings, including contributing to safety strategy, key safety messages, and risk management approaches. Reviews and authors safety sections of marketing authorization applications (MAA), with oversight, including safety table shells, Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), clinical overview, briefing documents, and initial product labeling (USPI, CCDS, SmPC). Contributes to ad hoc regulatory safety requests (e.g., 120-day safety response updates) and obtains safety data to determine the impact of the safety issue on the product's benefit/risk profile.
- Analyzes data and authors documentation as needed to support safety labeling updates to ensure labeling adequately reflects the emerging postmarketing safety profile.
- Supports the EU QPPV or other regional/local QP for safety issues on assigned products.
Risk Management Planning & Execution
- Responsible for the creation and update of the EDSR to proactively characterize emerging safety concerns during asset development, support Structured Benefit Risk, and define the strategy for Company Core Risk Management and gaining alignment with SMT/ governance, including collaboration with Epidemiology on risk minimization effectiveness, non-interventional research (NIR) activities for post-authorization safety studies (PASS).
- Develops and maintains global and EU local Risk Management Plans (RMPs) and understands in-licensing or pharmacovigilance agreements that may impact risk management activities.
- Develops and maintains core additional Risk Minimization Measures (aRMMs) and additional Pharmacovigilance Activities (aPVAs) globally and locally. Coordinates with local markets and vendors for complex (e.g., Pregnancy Prevention Programs, Controlled Distribution Programs) and non-complex aRMMs (e.g., educational materials).
Department Activities
- Leverages automation and innovation tools into day-to-day work, with an understanding of current processes and ability to evaluate and suggest digital improvements. Uses multiple data sources and AI generated outputs to support decisions.
- Supports preparation for regulatory inspections and audits with evaluation of current processes and assesses alignment with regulatory expectations, guidelines, and mandates.
- Participates in team activities by engaging with TA staff and contributing to a collaborative working environment through consistent communication and professional conduct.
Cross Functional Activities
- Collaborates on and identifies opportunities for process improvement and cross-functional initiatives for Patient Safety Science, including update/maintenance of procedural documents.
- Builds cross-functional partnerships with SMT and ACT membership and stakeholders.
- Maintains solid knowledge of product goals, strategy, drug development milestones, partnership agreements, HA commitments, functional area responsibilities, and relevant global HA regulations; shares with cross-functional teams as needed.
- Scientific degree (e.g., BS, MS, RN, PharmD, PhD, MD) or other degree with the equivalent combination of relevant education and professional experience
- Minimum of 4-6 years of relevant pharmacovigilance/pharmaceutical industry/drug development experience
- Working understanding of medical concepts and familiarity with safety activities in drug development and postmarketing and global safety health authority requirements.
- Working understanding of team priorities and milestones. Ability to manage timelines and quality of work through communication, cross-functional collaboration, and organizational skills, appropriately communicating items that could impact timelines or quality.
- Adaptable / flexible; willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
- Applies attention to detail along with strong scientific, analytical, and conceptual skills and scientific training to understand complex medical-scientific data across disciplines (e.g., clinical and nonclinical data, postmarketing reports, scientific literature, and regulatory documents).
- Understands aspects and methods for data analysis, interpretation, and presentation, including an understanding of basic statistics, with basic ability to begin applying emerging technologies (AI, automation tools, and digital platforms) to streamline workflows, enhance data analysis, and reduce manual effort to ensure compliance with safety standards.
Travel Required (nature and frequency)
- N/A
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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.
Supporting People with Disabilities
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.
Candidate Rights
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/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.