BeOne Medicines

Compliance

• Work on programs and strategies for compounds in multiple stages of development
• Gain experience and exposure in drug development intended to address unmet medical needs
• Use creative problem-solving skills to develop new ideas and insights
• Partner with other regulatory team members in building solutions for real-life business challenges
• Collaborate with the US Regulatory Affairs team members
• Support and attend Regulatory Team meetings
• Participate in cross-functional team meetings and support the drafting, review, and approval of regulatory deliverables
• Support colleagues in handling submissions as needed and tracking documents’ status

Regulatory Affairs Intern – Summer Internship

Clinical Operations

• Identifying and anticipating potential issues impacting business goals
• Leading global initiatives and working groups
• Collaborating with study teams to ensure quality compliance
• Designing study documents to ensure quality by design
• Developing risk identification and management strategies
• Consulting on business initiatives and tools for compliance
• Maintaining expertise in global GCP guidance and regulations
• Conducting quality issue trending and root cause analysis

Director, Clinical Operations Compliance, GCP

Manager

• Developing and executing clinical pharmacology strategies for small molecules and biologics assets
• Providing clinical pharmacology expertise in characterizing pharmacokinetics and absorption, distribution, elimination profiles
• Justifying dose selection
• Assessing drug/food interaction potential
• Characterizing QT prolongation potential
• Planning and reviewing study designs & analysis plans
• Analyzing & interpreting pharmacokinetic and pharmacodynamic data
• Developing clinical pharmacology study designs and collaborating with CROs and Clinical Operations
• Contributing to the design and analysis of PK data from patient clinical studies
• Performing population PK (PPK) analyses
• Conducting exposure–response (ER) analyses
• Analyzing, interpreting, summarizing and presenting data to internal project teams and to senior management
• Assisting in authoring relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions

Manager, Clinical Pharmacology – Pharmacometrics

Communications

• Setting and executing the Corporate Affairs strategy for BeOne in Spain and Portugal
• Establishing and maintaining relationships with various stakeholder groups
• Steering the planning and execution of strategic initiatives and programs
• Building a positive BeOne image/brand and awareness in the haemato-oncology market
• Managing the expense budget for all Corporate Affairs activities
• Identifying agencies/vendors/technologies/tools for execution of strategy
• Developing stakeholder-centric communication tools/materials
• Keeping management informed of healthcare developments

Director, Corporate Affairs – Communications

Account Manager

• Promotes BeOne’s Solid Tumor products through calls on targeted physicians in assigned territory
• Trains and educates physician support staff on the proper use and handling of BeOne’s Solid Tumor products
• Maintains communication and integrates activities, when appropriate, with BeOne’s Market Access, Field Reimbursement and Contract Account Teams
• Identifies customer changes and ensures, through coordinated communication and planning, that appropriate people and resources are allocated to address the change
• Performs all administrative functions required of the position, including reporting call activity and customer information

Account Manager – Solid Tumor

Administration

• Administration of the company's equity programs
• Ensure accurate processing and settlement of equity transactions
• Act as a liaison with stakeholders on SOX compliance
• Collaborate on employee education/communication initiatives
• Maintain daily recordkeeping of equity data
• Reconcile transactions, termination dates, and tax withholding
• Generate and review reports for Finance, Payroll, HR, and Legal
• Assist with regulatory filings related to equity

Senior Manager, Global Stock Plan Administration

Director

• Define and execute the global technology strategy aligned with business objectives and regulatory requirements.
• Establish governance frameworks for technology services, ensuring compliance with data privacy/residency laws, GxP and other industry standards.
• Partner with senior business and technology leaders to drive digital transformation initiatives and operational efficiency.
• Lead global support services, including Microsoft 365 administration, end user computing, enterprise collaboration platforms, and communication tools.
• Oversee global helpdesk operations, ensuring high-quality, timely support for end-users across all regions.
• Manage IT Service Management (ITSM) processes and platforms, driving continuous improvement and automation.
• Ensure reliable conference room technology and site support services for global offices and facilities.
• Drive the deployment of ServiceNow to support enhanced ITSM process and procedures.

Executive Director, Global Technology Service Delivery

Business Development Rep

• Maintain and develop commercial forecasts for pipeline assets including assumptions, methodologies, and documentation
• Assess forecast risk and uncertainty, run sensitivities analysis and scenarios
• Conduct primary and secondary market research to understand disease epidemiology, patient segmentation, treatment paradigm, unmet medical needs, competitive landscape, etc.
• Translate insights from market research to both qualitative and quantitative commercial assessment
• Support major planning processes such as LRP, portfolio prioritization and strategic planning cycles with forecast submissions, scenarios, and narratives
• Coordinate inputs and data from internal sources and external datasets; ensure data quality and consistent use of definitions/assumptions across teams
• Support commercial/business case assessment to inform pipeline programs’ go-no-go and critical investment decisions
• Collaborate with peers and support cross-functional teams to establish Target Product Profiles and develop market positioning strategies for early-stage pipeline programs
• Collaborate with peers and support cross-functional teams to establish relevant Disease Area Strategies

Senior Manager, Pipeline & Business Development Valuation

Operations

• Management of in-house medical communications projects from inception to completion
• Key contact for GPMS operations and governance across BeOne publications
• Support the maintenance of the GPMS; facilitate all internal efforts for vendor enhancements
• Provide GPMS onboarding and training for internal team members and partners to ensure compliance
• Ensure publications/communications are archived appropriately to document compliance

Senior Manager, Publications Systems – Operations

Business Operations

• Support the Pharmacovigilance Quality Assurance (PVQA) team within the R&D Quality organization
• Lead and optimize day-to-day business operations to ensure efficient functioning
• Develop and maintain operational frameworks, governance structures, and standard processes
• Identify opportunities for simplification, automation, and process improvement
• Partner with Audit & Inspections teams to provide operational coordination and documentation support
• Support oversight activities prioritizing patient safety and adherence to global PV regulatory requirements
• Help maintain and strengthen a culture of compliance, quality, and continuous improvement
• Facilitate information flow, meeting management, and leadership routines
• Manage and optimize internal websites for effective information sharing

R&D Quality Business Operations Intern

• Responsible for facilitating continued access to sponsor medications for patients transitioning out of parent protocols through Patient Programs and PTS pathways
• Collaborate cross-functionally to ensure compliance with PTS processes
• Streamline operations and enhance patient access globally
• Support implementing new or revised Global Clinical Operations policies
• Provide guidance and support to cross-functional teams
• Collaborate with key stakeholders and external vendors
• Set up and maintain CyberGrants and manage budgets
• Ensure pharmacovigilance compliance by maintaining project documentation
• Manage program milestones and timelines
• Identify emerging risks and regulatory concerns

Senior Manager, Post Trial Supply

• Owns the process which captures and examines BeOne’s product knowledge throughout the commercial lifecycle
• Maintains oversight on process capability through data trending and statistical analysis of critical variables
• Ensures process(es) are robust and in a continued state of validation
• Provides second line technical/scientific process support
• Support cross-functional collaboration and drive process improvements
• Collaborate with R&D, manufacturing (CMC) and regulatory teams to ensure quality considerations are embedded in new product development and lifecycle management
• Manage change tracking and implementation for actions related to Regulatory CMC commitments
• Lead or participate in cross-functional teams to improve quality systems and address systemic challenges
• Represent the Quality Organization at platform level in molecule level governance meetings and forums
• Support regulatory inspections and audits, ensuring alignment with global quality standards and best practices
• Actively mentor new and existing team members to develop core Product Quality skills and leadership skills

Associate Director, BPO, Global APQR, Product Data Quality

Business Analyst

• Serve as the business System Owner for assigned Quality GxP digital systems (e.g., eQMS, QualityDocs, etc)
• Lead and manage full lifecycle of system implementations and enhancements
• Gather and translate complex business needs into functional and technical requirements
• Drive process mapping, continuous improvement, and digital transformation initiatives across Quality
• Collaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors to align systems with business strategy
• Develop and maintain strong relationships with business process owners and ensure systems meet evolving needs
• Plan and lead UAT, training, and change management activities for new system features or implementations
• Manage project scope, timeline, resources, budgets, and risks, escalating issues as needed
• Ensure ongoing system compliance with applicable GxP, FDA, EMA, and ISO standards
• Prepare and deliver high-quality project updates, stakeholder communications, and system documentation
• Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS, ensuring alignment with organizational policies and compliance standards while optimizing system functionality to enhance user experience and operational efficiency
• Develop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools, facilitating informed decision-making and compliance with regulatory requirements

Senior Manager, Digital Quality Management Systems, Business Analyst

Research Analyst

• Execute clinical monitoring activities and ensure compliance with regulations
• Collaborate with clinical study teams and manage site performance
• Conduct monitoring visits and maintain study documentation
• Mentor junior staff and evaluate site practices

Senior Clinical Research Associate

• Develop and implement effective communication strategies to inform and engage users before, during, and after the adoption of new digital quality tools and processes
• Collaborate with key stakeholders to understand their needs, expectations, and concerns regarding digital adoption and changes
• Build and maintain strong relationships with various departments to facilitate open communication and support for initiatives
• Create informative materials such as newsletters, presentations, and other communication assets
• Design and deliver comprehensive training programs tailored to different user groups based on their roles and levels of digital proficiency
• Prepare user guides, FAQs, and other relevant documentation to support ongoing learning and development
• Monitor the progress of digital tool adoption and identify potential barriers to usage
• Conduct surveys and feedback sessions to assess user satisfaction and engagement
• Identify and mitigate risks associated with the change process
• Develop risk assessment plans and implement risk mitigation strategies
• Create dashboards, KPIs, and metrics to evaluate adoption effectiveness and overall success of digital initiatives
• Provide regular reports to management highlighting progress, challenges, and recommendations for improvement
• Maintain thorough documentation of change management processes, methodologies, and lessons learned to ensure consistency and efficiency in future initiatives
• Gather and analyze feedback from users to identify opportunities for continuous improvement in systems training and adoption strategies
• Stay current with industry best practices and emerging trends in digital adoption and change management
• Support the optimization of digital adoption tools like WalkMe, ensuring they are effectively utilized to enhance user experience
• Serve as the Business Process Owner for AI capabilities within Global Quality, driving cross-functional alignment on requirements, governance, and standards for AI-enabled workflows
• Define, maintain, and continuously improve AI-enabled business processes, including governance models, RACI, decision workflows, and process controls related to AI use in Quality Systems
• Lead the evaluation, prioritization, and intake of AI opportunities within Global Quality, maintaining an AI capability roadmap that supports efficiency, automation, and predictive insights
• Represent Global Quality in cross-functional AI governance bodies, ensuring Quality requirements are embedded in enterprise AI frameworks and decision-making