General Description:
Writes, submits, and facilitates data disclosure and transparency activities and/or redacts clinical study documents in accordance with BeiGene 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
Supports special projects involving transparency or other BeiGene activities
Essential Functions of the job:
Writes and submits transparency submissions, including clinical trial registrations, tabular results, plain language results summaries and/or performs document redactions throughout the study lifecycle in accordance with BeiGene policy and international regulations
Facilitates cross-functional team review and approval of transparency submissions on time and within compliance with regulatory and BeiGene requirements
Maintains and updates data disclosure tracking tools and dashboards to comply with applicable transparency requirements
Supports and may lead special projects as assigned and provides updates on the status of ongoing projects
Basic knowledge of clinical trial transparency regulations, tracks and inform DDT colleagues about new requirements, developments, and latest updates as appropriate
Monitors applicable DDT mailboxes and provides timely replies as required and in compliance with applicable guidance and regulations
Supports team trainings related to regulatory and BeiGene requirements
Maintains constructive and positive interactions with colleagues
Qualifications:
Excellent verbal and written skills.
3+ years of experience
Attention to detail, time management, and ability to balance multiple tasks to achieve goals and to meet deadlines.
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.