- Prepare, compile, and send regulatory submissions to the US FDA, Health Canada, and NIH Office of Biotechnology Activities (OBA). Submissions have included IND updates, Annual Reports, meeting requests and briefing documents, Orphan Drug Grant and Breakthrough Therapy applications, new Clinical Trial Applications (CTA), CTA updates, and initial protocol applications for review by NIH.- Manage regulatory submission timelines.- Create and maintain a filing system for organizing and… Show more - Prepare, compile, and send regulatory submissions to the US FDA, Health Canada, and NIH Office of Biotechnology Activities (OBA). Submissions have included IND updates, Annual Reports, meeting requests and briefing documents, Orphan Drug Grant and Breakthrough Therapy applications, new Clinical Trial Applications (CTA), CTA updates, and initial protocol applications for review by NIH.- Manage regulatory submission timelines.- Create and maintain a filing system for organizing and archiving all Regulatory submissions and correspondence in both paper and electronic format.- Prepare final, submission-ready Clinical documents, such as Protocols, Amendments, and Investigator Brochures.- Regulatory representative on program project teams.- Assist Quality Assurance department with Document Control activities which include processing controlled documents, updating change control logs, issuing effective documents, routing documents for signature, issuing Document Change Request numbers, etc.- Generate, revise, and implement Standard Operating Procedures (SOPs). Show less

- Prepared, compiled, and sent regulatory submissions to the US FDA and Health Canada. - Generated and maintained a filing system for organizing and archiving all Regulatory submissions and correspondence in both paper and electronic format.- Established and maintained paper and electronic filing systems for Nonclinical, CMC, Business Development, and Legal.- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.-… Show more - Prepared, compiled, and sent regulatory submissions to the US FDA and Health Canada. - Generated and maintained a filing system for organizing and archiving all Regulatory submissions and correspondence in both paper and electronic format.- Established and maintained paper and electronic filing systems for Nonclinical, CMC, Business Development, and Legal.- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.- Maintained a Nonclinical and CMC report filing system. Process included issuing internal report numbers, scanning to PDF, logging into the report database, and archiving the paper originals into a central filing system.- Generated, revised, and implemented Standard Operating Procedures (SOPs).- Assisted in the preparation and facilitation of several due diligence reviews of the Regulatory, Clinical, and Quality data for a possible partnering with a large pharmaceutical company. Show less

- Prepared, compiled, and sent regulatory submissions to the US FDA.- Generated and maintained a filing system for organizing and archiving all Regulatory submissions and correspondence in both paper and electronic format.- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.- Generated, revised, and implemented Standard Operating Procedures (SOPs).- Assisted in the preparation and facilitation of several due… Show more - Prepared, compiled, and sent regulatory submissions to the US FDA.- Generated and maintained a filing system for organizing and archiving all Regulatory submissions and correspondence in both paper and electronic format.- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.- Generated, revised, and implemented Standard Operating Procedures (SOPs).- Assisted in the preparation and facilitation of several due diligence reviews of the Regulatory and Quality data which led to a successful merger with a large pharmaceutical company. Show less

- Prepared, compiled, and sent regulatory submissions to the US FDA. Submissions have included new INDs, IND amendments, Annual Reports, and a Project Bioshield Grant application.- Provided administrative support to the Medical Affairs and Quality Assurance teams by preparing submission-ready Protocols and Amendments, maintaining version control, and writing Standard Operating Procedures (SOPs).- Maintained the Regulatory Affairs submission archives, as well as the Clinical Trial… Show more - Prepared, compiled, and sent regulatory submissions to the US FDA. Submissions have included new INDs, IND amendments, Annual Reports, and a Project Bioshield Grant application.- Provided administrative support to the Medical Affairs and Quality Assurance teams by preparing submission-ready Protocols and Amendments, maintaining version control, and writing Standard Operating Procedures (SOPs).- Maintained the Regulatory Affairs submission archives, as well as the Clinical Trial Master Files (TMFs). Show less

- Prepared, compiled, and sent regulatory submissions to the US FDA.- Established and maintained a central filing system for Regulatory Affairs, Medical Affairs, and Quality Control. - Served as the System Administrator in the implementation, configuration, and validation of an Electronic Document Management System (EDMS) - Generated, revised, and implemented company-wide Standard Operating Procedures (SOPs) to govern and facilitate the use of the EDMS system.

- Generated and maintained the Clinical Trial Master File (TMF) for all clinical trials- Tracked the receipt of clinical study documents and filed accordingly.- Processed and monitored clinical drug requests. - Monitored patient enrollment in 2 clinical studies and tracked the enrollment progress. - Assisted in the preparation and facilitation of an FDA audit of the Clinical data to support a Biological Licensing Application (BLA).

- Organized, compiled, and sent regulatory submissions to the US FDA. Submissions included an initial IND application, IND amendments, Annual Reports, and one approved New Drug Application (NDA).- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.- Generated the Clinical Trial Master Files (TMFs) for all clinical trials- Tracked the receipt of clinical study documents and filed accordingly.- Created and… Show more - Organized, compiled, and sent regulatory submissions to the US FDA. Submissions included an initial IND application, IND amendments, Annual Reports, and one approved New Drug Application (NDA).- Prepared submission-ready final Clinical documents which included Protocols, Amendments, and Investigator Brochures.- Generated the Clinical Trial Master Files (TMFs) for all clinical trials- Tracked the receipt of clinical study documents and filed accordingly.- Created and maintained a filing system for organizing and archiving all Regulatory submissions and correspondence.- Assisted in the preparation and facilitation of an FDA audit of the Clinical data to support the NDA application.- Designed Case Report Forms using PageMaker. Show less

- Administrative Assistant to the Director of Pharmaceutical R & D, Director of Preclinical Development, Department Head of Drug Delivery, and Director of Human Resources- Drafted and formatted memos, letters, faxes, reports, and journal abstracts.- Created employee training files.- Arranged travel for all personnel within the Pharmaceutical R&D department, as well as coordinated travel for guest speakers.- Coordinated in-house meetings and maintained multiple calendars.-… Show more - Administrative Assistant to the Director of Pharmaceutical R & D, Director of Preclinical Development, Department Head of Drug Delivery, and Director of Human Resources- Drafted and formatted memos, letters, faxes, reports, and journal abstracts.- Created employee training files.- Arranged travel for all personnel within the Pharmaceutical R&D department, as well as coordinated travel for guest speakers.- Coordinated in-house meetings and maintained multiple calendars.- Entered all personnel data into the Human Resources database.- Managed the USDA inspection files and animal protocol files.- Transcribed meeting minutes from the company’s Institutional Animal Care and Use Committee (IACUC) and maintained the archive files. Show less