Jessi Lee

• Prepared/reviewed scientific summaries, regulatory, and submission documents, including nonclinical summaries for IND, CTA, NDA, BLA, and MAA, following eCTD specifications/formats for Health.
• PMO/primary contact for toxicology compliance monitoring, including tracking, monitoring, and reporting study reports, achieving program goals, and documenting good-faith efforts.
• Review various sources, including authorities, white papers, Investigator Brochures, company data sheets, product monographs, SOPs, and health authority responses.
• Draft IND Annual Reports, DSURs and IND/IMPD Amendments
• Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
• Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
• Lead study timelines for regulatory documents and regulatory submission strategy
• Act as a functional area representative and lead on product teams
• Collaborated with Document Specialist and Regulatory Operations to manage electronic study reports and literature repositories, contributing to document authoring, review, and approval.
• Provided technical writing assistance for GLP exploratory toxicology and nonclinical pharmacology studies.

• Creates accurate, professional, and style-guide-compliant technical publications through planning, writing, editing, reviewing, and coordination
• Documents activities, services, and outcomes, and submits confidential reports as needed
• Ensures Section 508 compliance by evaluating, analyzing, and correcting electronic documents
• Collaborates with project managers, SME's, and solution architects to write and edit program and system documentation, proposals, technical manuals, release notes, grants, project management plans, and SOPs
• Attend agency consultations, project meetings, and client communications
• Document nonclinical processes and procedures, create new SOPs and update a library of existing SOPs
• Edits and rewrites draft documents to industry and government standards using style guides and other document procedures
• Ensure contract compliance, reviewed and validated quality requirements for manufacturing planning, supplier purchase orders, and engineering specifications
• Supported technical or functional meetings between government and contractors, including agendas, note-taking, and action follow-up with responsible action owners
• Converts technical discussions into documentation, procedures, and instructions
• Develops documentation processes, templates, and oversees document lifecycles
• Develops project business cases based on risk assessments and collaborates with stakeholders to implement mitigation methods.
• Create a wide range of high-quality documentation using clear and concise language
• Proofreads documents for accuracy and consistency. Coordinates and communicates with other word processing team members for consistency for all documents. Imports and routes documents in the submission system ensuring proper naming conventions and document properties.

• Produce, deliver, and archive finished publications and ensure version control and necessary stakeholder review and approval
• Submitted professional proposals to publishers, detailing works, promotional talents, and literary experience
• Global Regulatory Strategy Documents, CTD sections for dossier distribution, review and approval
• Create, amend, and prepare pharmaceutical CMC submissions using paper and eCTD templates
• Review CMC submissions, technical reports, and data entry content for technical consistency, data transcription accuracy, and technical consistency
• Regularly reviewing and updating 100+ SOPs
• Meet with supervisors, managers, compliance, and process owners to determine SOP needs and questions
• Create new SOPs across departments to learn how to complete SOP requests
• Helped marketing team turn product features into customer value propositions for consumer messaging
• Writes functional specification documents and helps create commissioning and validation methods for plant startup
• Writing SOPs or manufacturing batch records for new processes
• Validates protocols, deviation reports, and change controls per cGMP
• Author/review/improve SOP's, batch records, protocols, and technical reports Author/review/improve validation procedures, deviation reports, and change controls in compliance with cGMP's

• Revised client-specific research reports 510(K), NDA, ANDA, BLA, and OTC premarket FDA applications met timeframes and reports
• Modified Sponsor update report tables, report templates and client data tables
• Performed internal compliance audits for key QMS components
• Investigated Quality Event/Deviation Management deviations, CAPAs, and change controls with operations staff
• Technical literature edited
• Ensured reports properly reflected raw data and met QA standards
• Recommended changes to SOPs and guidelines for internal audits, system monitoring, Quality Assurance plans, and improvement and corrective action plans for all QA tasks
• Make manuals and electronic documents
• Verified report matches third-party testing site audit
• Peer-review data for scientific accuracy and documentation
• Managed project timelines and deliveries
• Tracked and informed project stakeholders
• Keeping Principal Scientists and Project Managers informed of report status and delays.