北京招聘

Essential Functions of the job:

• Manage and maintain controlled documents in Veeva Vault QualityDocs (VVQD) including creating draft documents, maintaining profile card metadata, and linking supporting documents

• Track Document Change Requests and Document Change Controls within VVQD to ensure reviews and approval are completed within strict timelines

• Coordinate the review, approval, and archival of BeiGene’s controlled documents in accordance with GxP regulations

• Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures

• Implement and utilize advanced word processing and automation features of Microsoft Office software

• Build and Run reports in Veeva Vault QualityDocs to ensure accuracy and completeness of the document control process

• Participate in validation testing for system implementations and updates

• Manage Document Control email inbox with prompt responses to internal customers

• Create learning content such as pre-recorded videos, PowerPoint presentation, and other classroom-style trainings.

• Build and maintain items in the LMS such as training items, curricula, user groups, quizzes, SmartForms and assignments

• Provide training to LMS and VVQD customers/users as needed on variety of technical and quality related topics

Other duties as assigned

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; Responds 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.

Computer Skills:

· Advanced experience using Microsoft Word, with an emphasis on document formatting

· Experience with Adobe Acrobat · Experience using an electronic document management system required, Veeva Vault preferred.

· Excellent attention to detail · Proven ability to work under tight deadlines and pressure in a composed manner

· Experience Using Microsoft SharePoint

Other Qualifications:

· Knowledge of GxP concepts and guidelines

· Experience with document control activities required

· Requires strong written, oral, interpersonal and communication skills

· Demonstrated ability to perform detail-oriented work with a high degree of accuracy and completeness

· Spoken/Written fluency in Mandarin/Chinese required

· Spoken/Written fluency in English required

Travel, physical demands and work environment: Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

· Ability to work on a computer for extended periods of time.

· Regularly required to sit for long periods of time, and occasionally stand and walk.

· Regularly required to use hands to operate computer and other office equipment.

· Close vision required for computer use

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