"Work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives.
Responsibilities:
- Person will be responsible for coordinating the posting of registration and disclosures on clinicaltrials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure).
- Database proficient with registrations and disclosures preferred.
- Has the ability to work cross-functionally and meet required deadlines.
- Ensures trial disclosure is in compliance with applicable regulations globally.
- Develops and maintains strong internal relationships across all levels of the clinical organization.
- Escalates issues to management in an expedient manner.
- Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures.
- Reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion
- Coordinates all clinical disclosure activities, acting as primary intermediary between the disclosure vendor and contacts 30
- Works with contacts to identify and resolve compliance gaps 30 •Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20
- Maintains disclosure trackers and produces metrics reports for management 10
- Maintains product information for use in disclosure activities 10