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Senior Manager, Global Labeling Compliance
44 minuti fa
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.BeOne is a global biopharmaceutical company dedicated to the discovery and development of innovative drug therapies for the treatment of cancer.This role will support global commercial labeling projects and programs connected to labeling process effectiveness, efficiency and compliance, including external collaboration initiatives (SDEA labeling compliance) and internal collaboration initiatives across the broader BeOne organization. This role will support the development, planning, coordination, implementation, and tracking of various labeling deliverables and initiatives within the Global Regulatory Affairs Labeling Group. This role will support cross-functional working groups to identify, assess, design and/or implement improvement opportunities to measure and reduce compliance risk and increase efficiency of the end-to-end Labeling process.It requires effective cross-functional collaboration, detailed analyses, and understanding of interdependencies to support a wide-range of project planning/management and infrastructure/process activities.This is a unique growth opportunity for professional development, with potential to expand to management of labeling documents such as CCDS and regional commercial labeling and other areas within regulatory.ResponsibilitiesMonitor and update labeling provision of SDEA labeling contracts, including coordinating with legal and country representatives on updates and taking action if non-compliance occurs.Data remediation activities.Records quality events for regulatory labeling team and monitors assigned CAPAs until issue resolution and closure. This includes the provision of guidance to labeling team to reduce instances of recurrence.Drives cross-functional working groups to identify, assess, design and/or implement improvement opportunities to measure and reduce compliance risk and increase efficiency of the end-to-end Labeling process. Demonstrates strong leadership and problem-solving skills and ability to gather relevant facts and distill information.Assists with development, revision and maintenance of departmental SOPs, WIs and non-governance documents.Prepares necessary training and communication to relevant stakeholders to ensure the proper process execution.Reporting out of or coordinates the timely availability of metrics and KPIs to demonstrate labeling process compliance and efficiency.Serves as strategic regulatory partner and a liaison between the Global Labeling Business Users of the Systems to IT for new or enhanced technical solutions. Experience in systems (e.g., document management systems, labeling systems, etc...) to meet regulatory requirements is a must.Serves as global regulatory labeling representative in company initiatives, as assigned by management.Identifies industry trends and evaluates impact on BeOne labeling policies and practices. Supports development of project strategies within teams and the department.On an ad-hoc basis, supports the preparation of labeling deliverables, for submission to Health Authorities, implementation on market, inspection or audit.Communicates with and provides services to a wide range of internal and external contacts. Anticipates and resolves problems, updates supervisor on status of projects.Experience7 + years pharmaceutical or industry related labeling experience, including significant examples of involvement in regulatory labeling updates and/or process.Direct working experience with labeling process, document management, international labeling differences in execution such as translations, readability, harmonization etc..Strong aptitude for authoring documentation such as User Guidance and Standard Operating Procedures (SOP) and change control management is desirable.Familiarity with Regulatory Information Management systemsEffective communication skills (verbal and written).Ability to work cooperatively with others and provides significant contributions as a member of a team in addition to serving in a leadership capacity.Strong organizational skills. The ability to be flexible and handle multiple tasks well, under pressure while demonstrating strong attention to detail.Proficiency in MS Office and Project Management tools is mandatory.Familiarity of GMP requirements and working in a highly regulated industry. Good understanding of GxP/GMP applications.QualificationsBachelor’s degree in Project Management, Life Sciences, or other related area, with at least 7 years of applicable experience in pharmaceutical or biotechnology/device industry.Preferred Education: - Advanced degreePrior commercial regulatory labeling required. Project management a plus.Skills & ToolsComputer Skills: Ability to work in a strong technical environment, MS office Suite, knowledge of Project Management tools, Labeling implementation and tracking systems, Document Management Systems, Packaging and Artwork Management Systems, Veeva Vault, Change Management Systems, SharePoint and other technical applications used in the regulatory environment.TravelInfrequent; national travel for team meetings and conferences, infrequent international travelCore Competencies, Knowledge & Skill RequirementsAnalytical and process minded with a short learning curve for systems and processes to drive results based on specified objectives.Strong planning, organizing, and execution skills.Ability to proactively manage workload and meet deadlines.Ability to provide and apply creative solutions to maintain workflow.Ability to work collaboratively within a global team setting, and with staff of different backgrounds and experience levels, listen to and consider stakeholder feedback.Logical problem-solving skills, looks beyond immediate problems to consider root causes and addresses them.Excellent verbal and written skills with great attention to detailPossess a high degree of personal responsibility, proactivity and agility.Communication & Interpersonal SkillsFosters open communication. Listens and facilitates discussion.Strong negotiating skills and ability to think creatively and develop creative solutionsProven ability to build trust and respect within the organization.Ability to prioritize and handle multiple projects simultaneously.Interacts with internal stakeholders and cross-functional team members, as requiredGlobal CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.#J-18808-Ljbffr
