**local candidates only
The candidate will be expected to prepare and review contributions to Annual Reports (AR), Annual Report amendments, Periodic Adverse Drug Events Reports (PADER), and other required regulatory documents.
- Track and analyze analyses errors to identify root causes and to recommend remediation strategies aimed at reducing error rates
- Provide back-up support in the generation of the specified regulatory documents and the candidate will be fully knowledgeable of the process
- Provide highest level quality assurance of AR /AR Amendment/PADER documents and assistance in execution of the process for generating these documents. This role includes quality assessment of both the regulatory documents and the process to ensure the following:
- All studies are appropriately classified for inclusion/exclusion
- All reportable studies sponsored by the CLIENT are included in the report
- All comments in the spreadsheet are accurate
- Study synopses for completed clinical studies meet the established standards
- Validation of all documentation for the ARs and/or amendments, e.g., NDA (New Drug Application), PADER (Periodic Adverse Drug Experience Report), and PMA (Pre-Market Approval) for submission to the FDA.
- Bachelor’s Degree *required* in Life Science or related field
- Exceptional project management, including managing multiple complex projects from start to completion
- Demonstrated involvement in cross-functional teams and capabilities in planning, initiation, executing, and reporting activities.
- Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
- Ability to work under tight timelines and excellent attention to detail is essential.
- Strong skills in Excel, and the ability to work with databases, e-rooms, and clinicaltrials.gov, etc. in an electronic environment.
- Knowledge of the regulatory requirements for various periodic reports, including knowledge of pharmaceutical clinical trial process and AR documentation requirements
- Demonstrated superb organizational, time management and communication skills (verbal and written)
- Demonstrated experience working on multiple projects simultaneously
- Strong interpersonal skills with the ability to interact with all levels of the organization
- Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
- Proven ability to work both independently and in a team setting, and to meet goals by managing timelines
- Critical thinking skills, organizational skills.
- Must be able to take huge spreadsheets and filter down to about 10-15 lines.
- **The CLENT will train
- **Candidate will need to be on-site sometimes once they are allowed back to the office