BeOne Medicines

Operations

• 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.

Manager, Talent Acquisition

Sales

• Develop and implement the Benelux sales strategy in line with the global and regional marketing strategy
• Ensure consistent, high-quality and compliant execution of promotional activities across all identified customer segments
• Build and lead a strong performance culture focused on accountability, continuous improvement, and results
• Lead, inspire, and develop a high-performing team of KAMs
• Work in close partnership with Market Access to align sales and access strategies
• Own and lead the sales forecasting process, ensuring accuracy, transparency and timely updates
• Act as a core member of the Benelux LT, actively contributing to overall business strategy, culture and decision making

Sales Director

Procurement

• Lead the strategy, execution, and oversight of vendor management and GCP audit activities to ensure compliance with GCP regulations.
• Ensure clinical trials and all vendors adhere to internal quality standards, regulatory requirements, and contractual agreements.
• Audit planning, preparation, conduct, and reporting for R&D GCP audits.
• Develop and implement a robust audit strategy for vendors involved in clinical trials.
• Lead GCP audits of vendors, identifying gaps and implementing corrective and preventive actions.
• Develop and manage performance metrics and vendor scorecards.

Associate Director, Good Clinical Practice – Audit and Vendor Management

• Attend and actively contribute to discussions and decisions at the affiliate Leadership Team meetings, providing sound and highly responsive legal and business partner support.
• Act as a subject matter expert on French healthcare laws and related business operations, staying abreast of evolving local healthcare legislation and regulations.
• Advise business colleagues on various initiatives to advance the Company’s strategy while addressing legal risks and protecting BeOne’s integrity and reputation.
• Provide local and regional legal advice on promotion, market access, pricing and reimbursement, employment, the use of social media, dissemination of scientific information, product liability, competition, and other matters relevant to the development, regulatory approval, and commercialization of prescription drugs.
• Serve as a “wise counsel,” offering good judgment and practical legal solutions to challenges faced by BeOne in France, maintaining a thoughtful risk-taking mindset in all areas of the Life Sciences industry.
• Draft, negotiate, and manage a high volume and wide variety of complex contracts and documents.
• This includes the review of Review and revise employment agreements, consulting agreements, and HR-related contracts, support of the clinical operations team to draft and review patients informed consent forms before and after EC review.
• Develop local policies, procedures, and processes for France adapted from global SOPs that ensure compliance with local laws, regulations, and codes while driving consistency.
• Conduct training as needed.
• Build relationships and influence at all organizational levels, demonstrating a flexible approach to connect with colleagues across the broader organization and engage with multiple stakeholders to drive projects and cultural change.
• Provide practical, solution-oriented legal support to BeOne internal clients during business projects lifecycle, from project definition, through contract preparation and negotiation, to project management.
• Train and educate local and regional stakeholders on the use of contract templates, relevant legal issues, and best contracting practices.
• Manage external counsel effectively, build effective relationships, and monitor legal spending.
• Exhibit excellent verbal and written communication skills, developing and providing clear direction to the business and pragmatic solutions to complex legal and compliance challenges.
• Demonstrate sound judgment and self-confidence to identify, assess, and mitigate legal and compliance risks, delivering effective recommendations on diverse legal and business matters.
• Handle and resolve disputes and claims including pre-litigation and litigation disputes and government audits.
• Assist in internal investigations related to employment issues.
• Monitor pending and new laws, regulations, decisions and government enforcement activities, also in those related to employment issues, and provide proactive, strategic advice to relevant stakeholders.
• Generate reports, presentations, spreadsheets, memos, and other documents for the Legal and Compliance Department, internal/external clients, and the senior management team as requested.
• Complete special projects and responsibilities as requested in other markets in Europe and the New Markets region.
• Provide expert legal guidance on employment matters, including hiring, terminations, compensation/benefits, union relations, contingent workers, safety and health requirements, performance management, internal investigations, and leave of absences.
• Advise and implement proactive strategies for labor risk prevention and compliance with local labor codes.

Senior Legal Counsel – France Lead

Risk

• Develop, maintain and implement assigned GxP/Quality incident management processes that align with organizational goals and latest regulatory requirements on global level.
• Manage and oversee the intake, triage, investigation, documentation, and resolution of GxP and quality-related issues and incidents in an end-to-end process.
• Partner with manufacturing, quality assurance, quality control, regulatory affairs, clinical operations, development, patient safety and other stakeholders to ensure timely and thorough management of GxP and quality incidents.
• Drive and support comprehensive root cause investigations and the development of corrective and preventive actions plans and lessons learned related to escalated GxP and Quality incidents.
• Ensure that the activities and documentation meet the relevant regulatory agency and other relevant requirements for the industry; prepare for and support inspections and audits.
• Develop and deliver training on incident management procedures and promote a culture of quality and accountability across the organization.
• Ensure meeting of key performance indicators (KPIs), track incident trends, and provide regular reports.

Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge

Compliance

• Serve as the regulatory CMC representative on project teams.
• Provides CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, Supply Chain and Regulatory colleagues, as well as third party laboratories, global collaborations partners and contract manufacturers.
• Manage interactions with FDA and other global regulatory authorities for assigned project(s) to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information.
• Author and lead CMC content for Health Authority meeting briefing packages, including development of CMC strategy, preparation of CMC-related questions, supporting data summaries, and responses to Health Authority feedback, in collaboration with Global Regulatory and cross-functional teams.
• Develop and implement effective regulatory CMC strategies for global submissions knowing the life cycle of drug product from R&D through commercialization and can interpret and apply local regulations and guidance’s to the life cycle of a drug product.
• Actively participate as a member of global regulatory teams and CMC subteams.
• Support and manages regulatory aspects of CMC Operations including authoring, reviewing and or approving SOP’s, CAPA’s, etc.

Associate Director, Regulatory Affairs, CMC

Business Development Rep

• Partner with business development to evaluate external opportunities, conduct due diligence and financial modelling for evaluating the business/investment case
• Serve as the finance lead for BD transactions and be responsible for engaging the broader finance organization in executing transactions
• Coordinate payment processes for executed transactions and support post-deal activities
• Track and forecast expected milestones under BeOne’s existing collaborations and work with treasury and accounting functions to ensure payments are accrued and processed on time
• Track and manage reporting on our portfolio of external early-stage equity investments
• Establish financial processes to support investment analysis for BeOne’s corporate venture activities
• Support corporate FP&A processes for quarterly reporting, forecasting and long-range financial planning
• Responsibility for business development & alliance management forecasting and reporting
• Provide benchmarking support for FP&A, investor relations or business development transactions as needed
• Support process improvement and documentation work to improve efficiency and alignment within the finance organization and with business partners.

Associate Director, Business Development, Alliance Management, Finance

Manager

• Responsible for designing, governing, and evolving enterprise data models for R&D
• Define the enterprise modeling roadmap
• Lead design of advanced frameworks that span multiple domains
• Ensure models support analytics, reporting, machine learning
• Develop and oversee governance frameworks ensuring regulatory compliance
• Collaborate with GTS/IT and business sponsors on modeling initiatives
• Publish best-practice frameworks and mentor modelers and analysts