Job Description
Job details
No matching job preferences
Job Type
100%
90-100%
Full Job Description
BeiGene 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.
This position will provide oversight of business processes and data stored in the l E2E RIM systems. Responsible for monitoring data quality and implementing data controls and remediating data quality issues. As the domain expert, this role will promote the value of centralized management and utilization of regulatory information and will collaborate cross-functionally to ensure compliant use of E2E RIM and champion data governance.
Primary Duties & Responsibilities:
- Ensure that standard project methodology are followed and that policies, procedures and metrics are established for maintaining and improving data quality and the creation and maintenance of metadata
- Support root cause analysis on data issues and recommend data quality controls to resolve gaps/issues
- Responsible for the successful implementation of the Data Governance (DG) framework and processes and effectively communicates importance of data standards and definitions. Act as the catalyst for change and champion for DG. Ensure DG Requests are resolved in a timely manner, and the details/decisions are fully documented
- Participates in cross functional identification and resolution of data definition, production, and usage issues. Support and manage routine and ad-hoc reporting requests from the RIM System
- Responsible for Master Data, data quality parameters, metric reporting, and workflows
- Supports any systems implementation and integration efforts with providing mapping of data and terminologies between systems and supporting interoperability
- Ensures system data formats & dictionaries remain current and compliant. Maintains and prepares documentation of RIM dictionary content. - Ensure Data Governance Job Aides are updated accordingly
- Guide and set standards 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, (ie. eCTD, IDMP, SPOR/DADI, PQ-CMC, SPL), and coordinates impact assessment relevant data changes impacting users.
Core Competencies, Knowledge, and Skill Requirements:
- Bachelor’s degree in a relevant discipline required (or equivalent in experience); Computer science field a plus
- 7+ years experience in working in a biotechnology or pharmaceutical Regulatory Affairs Operations environment with demonstrated ability to present and articulate requirements. Experience in systems management or implementation in the life sciences industry or regulated industry
- Knowledge of data management & data governance (DG) principles and methodologies
- 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; submissions publishing a plus.
- Thorough knowledge and practical experience with RIM technologies (e.g. Veeva, Calyx)
- 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
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
Computer Skills: Working knowledge of business software including MS Word, Excel, PowerPoint, Project, Adobe Acrobat, Smartsheet and Outlook.
Travel: 5-10% at most
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Response well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
About BeiGene
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com