The Senior Associate, Trial Disclosure will be responsible for providing writing support to clinical trial registration and results postings including scientific study results and or protocol/results lay summaries and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. The Senior Associate, Trial Disclosure Associate will also support Agency Disclosure activities, companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Responsibilities
- Completes writing activities to assist in ensuring timely disclosure of accurate, consistent, aligned and complete information globally.
- Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
- Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes, creating efficiency improvements/system automation and communication and training activities.
- Communicates deliverables, writing process and timelines effectively across functional areas and within department to accomplish project objectives.
- Coordinates the review, approval, and other appropriate functions involved with the registration and writing of clinical trial results public postings and Agency Disclosure activities.
- Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
- Identifies conflicts and resolves or elevates them to management to ensure resolution.
- Provides writing support for unique registrations to global registries or websites, includes non-interventional safety studies
- Writes scientific study results and/or protocol/result lay summaries to registries and websites for multiple therapeutic areas with more complex study designs per global registry requirements
- Supports anonymization of Protected Personal Data (PPD) and redaction of Commercially Confidential Information (CCI) in clinical documents for submission to and public release by regulatory agencies. 6. Supports companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.