BeOne Medicines

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

Manager

• 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

Director

• 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

Associate Director, Digital Quality Management Systems – Change Management, Digital Adoption

• Support the implementation and maintenance of efficient, effective, and compliant QMS processes that align with BeOne’s quality and business objectives
• Collaborate with the QMS Process Oversight and Performance Management team and BPOs to define, track, and analyze key performance indicators (KPIs), identify trends, and recommend actions to enhance process performance
• Support Quality Council, Management Review, and other governance meetings by ensuring KPIs, clear summaries of process performance, and effective communication of risks, trends, and required actions
• Contribute to digital transformation initiatives by supporting the implementation of tools, automation, and analytics that modernize QMS processes and improve data visibility and system performance
• Collaborate with process owners and governance teams to review and enhance QMS policies and enterprise SOPs, ensuring clarity, consistency, and compliance with regulatory expectations
• Partner with functional teams to improve the technical accuracy and clarity of documentation within Deviations, Complaints, Change Controls, and other QMS records
• Lead or contribute to cross-functional improvement projects to streamline QMS workflows, enhance user experience, and improve right-first-time execution of quality records
• Support internal and external audit and inspection readiness by ensuring QMS documentation and records are complete, current, and easily accessible
• Work cross-functionally with Quality, Technical Operations, Regulatory, and other business partners to promote alignment and continuous improvement across QMS processes

Associate Director, QMS Process Improvement and Analytics

Medical Director

• Provide local input into global and regional product strategies
• Drive local go-to-market strategy
• Support development of local and regional Medical strategies
• Lead a team of Medical Associates
• Establish relationships with opinion leaders and key organizations
• Facilitate local medical meetings
• Collaborate with local, regional and global teams
• Develop educational and training materials
• Monitor strategic partnerships with scientific experts
• Support local Medical Affairs budget planning

Medical Director, BENELUX

Clinical Operations

• Contribute to the development and implementation of global clinical operations training projects
• Work closely with Senior Learning Business Partners to create learning materials
• Develop systems such as data trackers to assist in enhancing departmental procedures
• Support in scheduling global and regional training sessions
• Analyze data and present findings
• Effective time and project management, as well as communication and collaboration skills

Global Clinical Operations Excellence Learning and Development Intern

Medical writer

• Lead the tactical execution of publications stemming from our global medical affairs publication plans
• Develop strategic, high-impact scientific publications and congress materials in oncology
• Collaborate with cross-functional teams and external experts in a biotech or pharmaceutical setting
• Ensure data are communicated with clarity, accuracy, and impact through high-quality publications and congress materials
• Establish and maintain professional relationships with internal colleagues, external authors, journal editors, publishers, and other professional bodies

Associate Director, Medical Writer – Publications

General Counsel

• Provide comprehensive legal support to the global R&D function.
• Partner with R&D leaders to implement strategies aligning with company objectives.
• Advise on regulatory matters affecting R&D, including clinical trials and submissions to regulatory authorities.
• Negotiate and draft a variety of R&D agreements, ensuring compliance with legal standards.
• Collaborate with other departments to offer integrated legal support.
• Build, lead, and mentor a high-performing legal team.

Associate General Counsel – Head of R&D Legal

Strategy

• Support the identification and thorough evaluation of strategic initiatives
• Enhance the team's understanding of industry trends and market analysis
• Conduct deep diligence of potential ideas
• Assist in preparing presentations for team discussions and leadership meetings
• Create and maintain a robust database to guide idea generation
• Engage with team members and other stakeholders to gather insights

Manager, Corporate Strategy

Systems Engineer

• Support the execution of TMF department activities related to the eTMF system and associated processes.
• Assist with monitoring document flow and basic oversight activities within the eTMF system.
• Support User Acceptance Testing (UAT) activities, including documentation and test execution under supervision.
• Assist in creating and / or updating system-related documentation such as Quick Reference Guides.
• Assist in maintaining and updating TMF reports and dashboards.
• Help analyze TMF metrics and prepare summary reports for review by senior team members.
• Support end‑user inquiries by assisting with ticket triage, access requests, and basic metadata corrections.
• Assist with centralized mailbox monitoring to ensure inquiries are logged and routed appropriately.
• Participate in department meetings and end‑user forums to build understanding of TMF systems and processes.
• Follow established procedures with a strong focus on data integrity and quality.

Systems Analyst Intern

Recruitment

• Manages the Recruitment / Selection process and systems for Europe and New Markets.
• End-to-end management of the recruiting process.
• In partnership with the recruiting team, HRBPs, and hiring managers, develops job descriptions, sources candidates, and drives the recruiting process for teams that they support.
• Pre-screen resumes, complete candidate evaluations, and schedule interviews for key positions.
• Must have the ability to recruit passive candidates.
• Delivers against and provides guidance to continually deliver quality candidates and hires.
• Develops, motivates, and coaches hiring managers and interview teams to ensure that proper interviewing practices are being implemented.
• Drives adoption of consistent recruiting, interviewing, and hiring practices across the organization to facilitate talent acquisition productivity and predictable quality.
• Develops creative sourcing strategies for hard-to-fill positions, including direct sourcing, internet recruiting, networking, utilization of external search firms, etc.
• Assess internal and external recruiting resources and recommend solutions that will best meet the recruiting demands of the organization.
• Ensures recruiting and hiring practices are in compliance with local country regulations and organizational policies and procedures in the pre-screening and post-employment process.
• Maintains current knowledge in business, marketplace, legal, and recruitment trends and requirements.
• Identifies and shares best recruitment best-practices across the organization.
• Initiates and maintains a network of contacts to help identify qualified candidates and increase applicant tools for hiring needs.
• Ensures end-user education and training (hiring managers) within the business.