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General Description:

The RIM function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA, IT, QA etc.). The Manager/Sr. Manager Data Management and Governance is responsible for oversight of central regulatory data entry into RIM, compliance with internal data standards and management of data governance needs for establishing or updates to Regulatory data, formats, standards, and controlled vocabularies within BeiGene E2E RIM system. This role will also be responsible for addressing all ad-hoc reporting requests in collaboration with internal or cross-functional teams. As the domain expert, this role will promote the value for centralized management and utilization of regulatory information. As well, this role will ensure compliant use of RIM and champion data governance. Successful cross-functional collaborations with SMEs/Data owners across GRA, other R&D organizations and the data governance committee for data input, compliance, decisions, and issue resolutions, will be key.

Primary Duties & Responsibilities:

• Responsible for management of centralized submission and correspondence data entry needs for the RIM system via Data entry requests.

• Ensure adherence to RIM data quality standards and compliant platform use through routine verifications, audits, resolution, and reporting.

• Support and manage ad-hoc reporting requests off the RIM System.

• Own, build and maintain the Master Data, data quality parameters, important metric reports and workflows to ensure that data is governed, consistent, reliable, and easily accessible.

• Supports any systems implementation and integration efforts with providing mapping of data and terminologies between systems, supporting interoperability.

• Governs and supports business data model, data business rules, data flows, data lineage mapping, objects and fields, formats, definitions, and dictionaries, picklists, controlled vocabularies.

• Promotes data literacy and understanding of data, definitions and standards with cross-functional stakeholders/SMEs.

• Works to ensure data formats & dictionaries in RIM System stay current and compliant. Maintains RIM data dictionary, which can be used for traceability, audits, and for QC of the RIM database configuration.

• Provides guidance and sets standards of functional excellence in methodologies, processes, and SOPs to enable improvement of Global & Local BeiGene data operations

• Support BeiGene Enterprise Master Data Management program (MDM).

• Develop and/or maintain up-to-date knowledge of existing/emerging global standards and procedures for regulatory technology and submissions (e.g., eCTD, IDMP, SPOR/DADI, PQ-CMC, SPL) and coordinate impact assessment on systems and relevant data elements used within BeiGene.

• Collaborate with Regulatory Operations (RO) Business Processes and Standards team on identifying and addressing process and/or systems gap affecting RO, SOM, RIMT or RA.

Core Competencies, Knowledge and Skill Requirements:

• 5+ years of experience of experience in Pharmaceutical, Biotechnology, or Life Sciences, with a specific focus in Regulatory of at least 5+ years and working knowledge of Biopharma drug development and approval process.

• 3+ years’ experience in Regulatory Information Management (RIM), Regulatory EDMS capabilities, or operations in a similar capability model in GxP/Regulated Systems

• Knowledge of data management & data governance (DM&G) principles and methodologies is preferred.

• Working knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g. FDA/EMA, ICH, eCTD, IDMP) and industry best practices pertaining to Regulatory Processes & Systems

• Understanding of Regulatory end-to-end process from document authoring and management, submission publishing and validation, to regulatory information management and archive.

• Regulatory operations experience a plus.

• Thorough knowledge and practical experience with RIM technologies (preferably Veeva systems)

• Strong knowledge of categorization and classifying information & strong knowledge of relationships between key components of Regulatory Information

• Familiarity with MDM & enterprise reporting capabilities a plus (e.g. Power BI, Qlik, Tableau or Smartsheet dashboard)

• Project Management skills and competencies a plus.

Communication & Interpersonal Skills:

• Ability to collaborate and communicate globally and be respectful of cross-cultural norms.

• Excellent interpersonal, communication, analytical and organizational skills.

• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.

• Team player capable of managing multiple projects and complex timelines in a dynamic environment

• Ability to problem solve and troubleshoot under pressure.

• Work independently under general supervision.

• Ability to prioritize and handle multiple projects simultaneously and work in a global environment across several time zones.

• Clear and effective communication to stakeholders on project expectations and timelines.

Supervisory Responsibilities:

None

Qualifications:

Bachelor’s degree required with 5+ years of relevant experience. Master’s degree (Information Systems or life sciences preferable.

Computer Skills: Excellent knowledge of business software including MS Word, Excel, PowerPoint, Project, Adobe Acrobat, Smartsheet and Outlook. Knowledge of Veeva RIM Vault preferred.

Other Qualifications:

Travel: 5-10% at most

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.