Manager, Data Disclosure & Transparency

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:

• Writes, submits, and manages data disclosure and transparency activities in accordance with BeOne policy and international regulations.
• Maintains and updates data disclosure tracking tools and dashboards to comply with applicable registration and results posting and data sharing requirements.
• Leads and manages special projects involving transparency or other BeOne activities.
   

Essential Functions of the job:

• Writes and submits clinical trial registrations, tabular results and lay summaries, performs maintenance updates throughout the study lifecycle in accordance with BeOne policy and international regulations
• Manages redaction and anonymization of personal data and confidential information in clinical documents and the preparation of anonymization reports and justifications according to applicable guidelines for EMA Policy 70 and Health Canada PRCI
• Facilitates cross-functional team review and approval of transparency submissions on time and within compliance with regulatory and BeOne requirements
• Advanced knowledge of clinical trial transparency regulations and keeps current with changes in local and international clinical trial transparency requirements
• Maintains and updates data disclosure tracking tools and dashboards to comply with applicable registration and results posting and data sharing requirements
• Leads and may manage special projects and provides updates on the status of ongoing projects
• Supports Data Sharing Coordination activities
• Maintains constructive and positive interactions with colleagues
• Supports the development, and implementation of projects, processes, standards, and training material for Data Disclosure & Transparency activities
• Provides guidance to Department colleagues in the execution of day-to-day activities
• Ensures that applicable policies, procedures, and quality standards are adhered to
   

Supervisory Responsibilities:  

• May include task management and monitoring of studies assigned to employees for writing clinical trial disclosure submissions or other transparency activities and ensuring submission compliance
• May include performance management of employees including but not limited to performance reviews, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings
• Manages vendor relationships if applicable
   

Education/Experience Required:

• 5+ years of relevant experience and a BA or BS, or 4+ years with a MA or MS

Other Qualifications:   

• Preferably 5 or more years of direct experience in Data Disclosure & Transparency, Regulatory Affairs, or Medical Writing.
• Experience with Veeva RIM
• Core understanding and familiarity of clinical trial development process and Data Disclosure/Transparency processes.
• Excellent verbal and written skills.
• Attention to detail, time management, and ability to balance multiple tasks to achieve goals and to meet deadlines.
• Strategic thinking, with a focus on process development, improvement and optimization.

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.