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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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.