Easter Seals Jobs

General Description:

The RIMT function at BeiGene drives strategies, implementation and management of regulatory technology and information, by collaborating with cross functional teams (RA, IT, QA etc.). The Specialist/. Sr.Specilaist Data Management and Governance is responsible for managing and supporting central regulatory data entry into E2E RIM in compliance with internal/external data standards. This position is responsible for maintaining the data standards, controls and logic surrounding data fields in the BeiGene E2E RIM system and working closely with Data Governance team and other groups across the BeiGene. This role also has data quality and compliance responsibilities as assigned that could include the collection, maintenance, analysis, and reporting of metrics and data quality findings and to support ad-hoc reporting requests. This position will support and promote the value for centralized management and utilization of regulatory information/data.

Essential Functions of the job:

Primary Duties & Responsibilities:

• Responsible for management of all centralized RIM data entry needs for GRA.

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

• Supports Data Governance (DG) processes, and works to ensure DG Requests are resolved and, if approved, implemented correctly,

• Coordinates with Data Owners, Functional SMEs, System Owners, Business Admin (BA), vendors, IT, and DG teams to investigate, analyze and resolve the DG requests, impacts and related issues.

• Provides oversight for reporting and analytics activities of the RIM System.

• Manage and support ad-hoc reporting requests.

• Support to maintain 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.

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

• Monitors regulatory agencies and industry standards for data related regulatory requirements (eg: IDMP, PQ-CMC, DADI etc..), and changes and version status-controlled vocabularies. Works to ensure BeiGene RIM data formats and terminologies stay current and compliant

• Authors and maintain Data Governance Job Aides describing detailed Data Steward activities.

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

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

Core Competencies, Knowledge and Skill Requirements:

• 3+ years of experience in Pharmaceutical, Biotechnology, or Life Sciences, with a specific focus in Regulatory preferred, or at least 3+ years and working knowledge of Biopharma drug development and approval process preferred.

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

• Bachelor’s or Master degree preferred.

• Working knowledge of applicable Regulatory Agency regulations, guidelines, specifications and industry best practices pertaining to Regulatory Processes & Systems

• Regulatory operations experience, data management specific experience a plus.

• Knowledge and practical experience with RIM technologies (e.g. Veeva) is a plus.

• Knowledge of categorization and classifying information & Strong knowledge of relationships between key components of Regulatory Information a plus.

• Familiarity with Data Management & Reporting capabilities a plus.

• 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. Listening and facilitates discussion.

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

• Ability to solve problems and troubleshoot under pressure.

• Work independently under general supervision.

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

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

Supervisory Responsibilities:

None

Computer Skills: Working knowledge of business software including MS Word, Excel, PowerPoint, Project, Adobe Acrobat, Smartsheet and Outlook. Data Management or Veeva system experience preferred.

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.