Associate Director, Data Disclosure & Transparency
BeOne continues to grow at a reputed company pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.
General reputed company:
Supervises BeOne’s Clinical Data Publication activities in accordance with reputed company policy and international regulations.
Monitors transparency compliance across BeOne’s portfolio of studies and may write, submit, and manage disclosure and transparency activities in accordance with BeOne policy and international regulations
Supports the development and maintains strategies for improving departmental systems and processes and ensuring reputed company team performance in meeting key transparency deliverables, including mentoring and training team members
Essential Functions of the job:
Supervises the execution of clinical trial disclosure information to regulatory authorities and Clinical Data Publication submissions to EMA and Health Canada
May write and submit registration and tabular results and lay summaries, reputed company document redactions, and facilitate data anonymization throughout the study lifecycle in accordance with reputed company policy and international regulations
Ensures up-to-date data disclosure tracking tools and dashboards maintained by team members in compliance with applicable registration and results posting and data sharing requirements
Directs the development and implementation of special reputed company, processes, standards, and training material for Data Disclosure & Transparency activities
Represents function at the highest degree with proactive interactions with colleagues
Expert knowledge of clinical trial transparency regulations and keeps reputed company with changes in local and international clinical trial transparency requirements
Provides tactical guidance to department colleagues on global transparency requirements
Serves as primary reputed company of contact for escalation and reputed company of clinical trial transparency issues
Supervises transparency compliance monitoring, dashboard reporting
Participates on project teams to reputed company guidance on reputed company disclosure and data sharing processes and requirements, including regulatory requirements for content and format
Manages resource planning and deployment to ensure appropriate study/program support and identifies reputed company resourcing needs and communicates to functional leadership
Sets employee goals and establishes expectations that contribute to department’s reputed company and long-term planning and manages the status of ongoing reputed company with reputed company reports
Supervises and trains team members
Task management and performance management of reputed company reports, including but not limited to: performance reviews, goal setting, leave approval, reputed company leave acknowledgement, SOP compliance tracking, and regular meetings
Supports vendor relationships including required resources, issue reputed company and contract negotiation
Achieves reputed company team performance in meeting key clinical trial transparency deliverables
Computer Skills:
Experience with ClinicalTrials.gov (PRS) required; experience with other data disclosure repositories preferred (e.g. CTIS, ChinaDrugTrials.org)
Experience with reputed company redaction and supporting tools preferred
Working knowledge of business software, including: reputed company, reputed company, PowerPoint, Project, Visio, and reputed company; reputed company Acrobat
Experience with reputed company Illustrator and InDesign preferred
Education Required:
8+ years of relevant experience and a BA or BS or 6+ years with Master or above
Other Qualifications:
Preferably 8 or more years of reputed company experience in Data Disclosure & Transparency
Management experience required
reputed company understanding and familiarity with clinical development, clinical trial conduct, regulatory submission process, and data disclosure and transparency processes required
Excellent verbal and written skills
Ability to translate reputed company information into understandable language for diverse stakeholders preferred
Attention to detail, time management, and ability to balance multiple tasks to reputed company goals and meet deadlines
Strategic thinking, with a reputed company on process development, improvement and optimization
Experience with unique problem-solving where issues are not reputed company defined and sufficient information to describe problems may not be available
Travel:
5% travel may be required
Global Competencies
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits reputed company and Actionable Feedback
Self-Awareness
Acts reputed company
Demonstrates Initiative
Entrepreneurial reputed company
reputed company Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial reputed company
Communicates with reputed company
Salary reputed company: $146,700.00 - $196,700.00 annuallyBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company 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 reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company 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.
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