Global Clinical Process Management Senior Specialist

BeOne 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.

General Description:

The role provides coordination and operational support to Process Leads and senior GCPM leadership to enable effective execution of process management activities, document control workflows, governance alignment, status oversight, and intake-driven insights. The incumbent supports the preparation, organization, analysis, and tracking of key inputs, project plans, stakeholder materials, approval activities, reporting outputs, and GCPM intake data to facilitate timely decision-making, process progression, continuous improvement, innovation consideration, and consistent delivery of GCPM-owned initiatives.

Responsibilities:

Coordination Support to Process Leads

• Support document review and approval workflows to enable timely progression, system/document governance, and completion of required approval steps.
• Coordinate document control activities, including initiating Document Control engagement, supporting QA alignment, submitting and facilitating DCC activities, and tracking approvals through completion.
• Support information gathering, preparation, tabulation, and organization of inputs to enable efficient Process Lead review and decision-making.
• Assist with the development, documentation, and maintenance of project plans, including regular status reviews, updates, and follow-up on outstanding information.
• Support the creation and maintenance of stakeholder lists, meeting planning materials, and project charter drafts.
• Provide administrative support for organizational change management activities, including preparing draft communications under Business Owner and Process Owner guidance.
  

Coordination Support to Senior Manager

• Compile data from Veeva Vault or equivalent source systems to support status reporting and periodic review of processes under GCPM leadership.
• Prepare and maintain QE CAPA tables and related tracking materials for periodic review by the Senior Manager and Head of GCPM.
• Prepare and analyze data from the GCPM intake form to support management review, process improvement planning, and evaluation of potential innovation opportunities.
  
  

Supervisory Responsibilities:  

• N/A
  

Computer Skills:   

• Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)

Other Qualifications:   

• Fluent English (Oral; Written)
• undefined
• Knowledge of ICH-GCP
• Excellent interpersonal and problem-solving skills
• Excellent organizational skills and a pre-disposition to quality management and process improvement
• Effective communicator (oral and written)

 Travel: 

• N/A
  

Education/ Experience Required:

• Bachelor’s degree required. 2+ years of experience in pharmaceutical and/or biotechnology sector preferred.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.