Senior Manager, System and Standard
BeiGene
Wuhan Office, China
3天前

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.

Job Description : Lead cross-functional working groups to develop and update GSDS process Oversee process development from a draft concept to release Participate in task-forces and initiatives around standardization and technology Develop and deliver GSDS online and instructor led training courses Manage training curriculums in LMS Collaborate effectively with others in GSDS to improve process and training Develop and / or perform quality oversight to find risks and report them to functional leads.

  • Provide feedback and training to functional leads on inspection readiness Provide support for inspections by providing inspection expertise including mock interviews Provide support for submissions by providing PDF submission expertise Participate and provide leadership for department wide initiatives and forums Identify and troubleshoot operational problems, issues, obstacles, and barriers department process with input from project team members and other stakeholders Review and provide feedback on other departments process and training Qualification Required : 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.

    Other Qualifications : 5+ years of experience in the pharmaceutical / biotechnology Submission and Inspection Experience Proficiency in the areas of clinical data collection, cleaning and analysis Excellent experience working in cross-functional team-oriented environments Strong project management skills Understanding of ICH and regulatory environment as it pertains to Statistics and Data Science Working knowledge of one or more EDC systems, Medidata Rave preferred Travel : Minimal travel, 1-2 times per year Follow Us on MoSeeker!

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