Associate Director, Global TMF Management & Records

General Description:

Provides leadership, management, and/or mentorship to Global TMF team members. Collaborates effectively with global internal and external stakeholders to ensure the needs of the business are met. Contributes to overall Global TMF Management & Records strategy and is accountable for performance against key metrics for TMF area. Ensures alignment of regional and global resources and deliverables with overall portfolio goals. Sets the strategy for enhancements to TMF process. Represents TMF Management in internal and external meetings involving management of TMF processes. Interfaces with external parties and vendors, and internal stakeholders and other functional groups throughout BeiGene to resolve TMF process issues.

Essential Functions of the Job:

Assesses global impact of standards and requirements.
Leads TMF process improvements and establishes repeatable processes utilizing key technologies.
Drives the application of standards and requirements.
Communicates and actively collaborates with managers and leaders concerning the TMF process and communicates organizational goals and objectives.
Implements strategic and tactical decisions regarding TMF.
Interprets and applies TMF knowledge with little to no guidance.
Oversees the evaluation of processes to ensure organizational responsibilities are met.
Leads the development of business process improvement opportunities.

Quality
Ensures team members are trained on and are adhering to required processes and SOPs.
Supports the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work.

Works to develop KPIs to ensure TMF compliance.
Budget and Resources
Manages the resourcing process for Global TMF Management & Records.
Identifies budgetary needs for TMF processes and staff with rationale ahead of yearly planning to ensure business needs are met.
Supervisory Responsibilities:
Conducts performance appraisals for direct reports which includes providing feedback.
Supports development plans for direct reports.
Contributes to the hiring of new talent into the global team.
Manages contractors and their workload/assignments as applicable.

Qualifications

8+ years of progressive experience within biotech, pharmaceutical or CRO industry.

Role Competencies:

• Embraces Change
• Communicates Effectively
• Drives Excellence
• Provides Leadership
• Team Player
• Mentors
• Manages Stakeholders
• Strategic Thinker
• Creates Innovation
• Learning / Growth Mindset

Computer Skills: MS Office, Project Planning Applications, Veeva Vault (eTMF) experience, as well as other Clinical Systems knowledge, such as CTMS.

Other Qualifications:

• Solid leadership and management experience either as direct line manager or as cross functional team lead
• Strong written, verbal communication, and presentation skills
• Exercises sound judgement and discretion in matters of significance
• Ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Excellent interpersonal skills, strong organizational skills, and ability to influence and lead.
• Strong vendor management expertise.

Travel: Required as per business need.

BeOne 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

百济神州全球胜任力 当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。 ●团队协作 ●提供并征求坦诚及可行的反馈 ●自我认知 ●兼容并蓄 ●积极主动 ●开拓精神 ●持续学习 ●拥抱变化 ●结果导向 ●分析性思维/数据分析 ●卓越财务 ●清晰沟通 BeOne 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.