Address
Form of workResponsibilities:
- Author and analyze technical data pertinent to clinical operations, including CMC, non-clinical toxicology, and pre-clinical efficacy data, to support the development of regulatory documents such as Pre-INDs, INDs, BLAs, and IMPDs.
- Collaborate with regulatory partners to prepare Orphan Drug Designation (ODD) requests based on pre-clinical efficacy data and disease prevalence, submitting them to FDA. Conduct quality control and editorial review of documents prepared by team members to ensure completeness, accuracy, consistency, structure, and grammar.
- Assist in responding to requests for information from regulatory agencies.
- Manage the review and approval of documents required for regulatory filings. Support the drafting of presentations, papers, and publications related to clinical studies.
- Creation of detailed documents outlining the procedures and guidelines for conducting various scientific experiments, clinical trials, or research studies.
- Conduct literature searches on new discovery programs and contribute to the development of project proposals.
- Communicate document-specific timelines to team members to ensure timely completion of deliverables.
- Synthesize complex scientific information into clear, concise, and well-structured documents that can be easily understood and followed by researchers, clinicians, and other stakeholders involved in the studies.
