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.
General Description:
The Senior Manager, Global Clinical Process Governance is responsible for the implementation and maintenance of the Global Clinical Process Management Governance Framework; Working collaboratively with cross functional stakeholders, to ensure the decisions pertaining to BeiGene GCO standards are appropriately governed and processes are maintained in compliance with ICH-GCP and regulatory requirements.
Essential Functions of the job:
Governance Framework: Primary GCOE point of contact for GCO process governance.
Continuous Process Improvement: Supports Global Clinical Process Management Leads with document review and continuous process improvement.
Stakeholder Management: Manages stakeholder review, consultation and endorsement of changes to process under the responsibility of Global Clinical Process Management OR processes under the responsibility of other functions that impact GCO.
Communication and Learning: Supports Global Process Management Leads with timely creation, revision, release or retirement of communication and learning materials and associated content.
Audits and Inspections: Supports process related audit and inspection commitments for Global Clinical Process Management.
Documentation and Reporting: Maintains performance and quality metrics related to processes under the responsibility of Global Clinical Process Management.
Establishes successful partnerships with relevant GCO and cross-functional groups and other stakeholders as required.
Education Required:
Bachelor’s degree required, Master’s or other relevant post graduate qualification advantageous.
Requirements:
Fluent English (Oral; Written)
Relevant Bachelor’s degree or higher – preferred science/healthcare discipline
Minimum of 5 years relevant experience in pharmaceutical and/or biotechnology sector
Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s
Experience working in matrix environment and in global teams
Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
Excellent organizational skills and a pre-disposition to quality management and process improvement
Effective communicator (oral and written)
Strong presentation skills
Computer Skills:
Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)
Other Qualifications: Six sigma certification and/or experience with process mapping desirable.
Travel: N/A
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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.
Cryptology
Stavreska Recruiting
Welo Data
Welo Data Talent
Talent Shore
