Kristen D Hawley Email and Phone Number

Represents Nonclinical Writing on project teams, working directly with scientists within the Early Development and Research departments, and collaboratively with Clinical, Medical Writing, Pharmacovigilance, and Regulatory Affairs and Operations functions to lead the preparation of high-quality submission content for nonclinical summary document sections in support of global regulatory filings.• Leads nonclinical writing assignments in conjunction with scientists and project team members for early development/late stage programs in the preparation of nonclinical content in support of regulatory submissions (eg, nonclinical protocols and reports, Investigator’s Brochures, Briefing Documents, INDs, IMPDs, annual reports/DSURs, NDA/MAAs).• Leads document writing and review processes within department for individual projects.• Develops and maintains timelines for document generation, revision, and completion, in collaboration with other project team members and Regulatory Affairs/Operations.• Coordinates and manages review cycles for nonclinical documents in collaboration with subject matter experts, and leads discussions when needed. • Edits/writes nonclinical study report drafts from templates and interprets data as needed.• Reviews and/or edits internal and external publications (eg, manuscripts, abstracts, poster presentations, white papers).• Independently manages outsourced writing staff and projects.• Contributes to the development and maintenance of SOPs, templates, and style manuals.• Provides communication and training on writing requirements and processes, templates, style guides, and SOPs within the department and cross-functionally, as required.• Provides QC review of various regulatory and nonclinical documents as needed.• Independently solves problems, exercising sound judgment, appropriate interfacing, and flexibility within a dynamic environment.

Led nonclinical document preparation and review strategy for regulatory submissions and timeline strategy for key documents. Provided functional and cross-functional guidance on nonclinical issues related to document preparation and QC, including US and international regulatory guidance requirements. Authored and performed QC checks on nonclinical regulatory documents: IND Applications, Clinical Trial Applications, IMPD, NDA (US), MAA (EU), DSURs, PBRERs, PIPs, and scientific white papers. Authored, edited, and QCd tabular summaries of nonclinical Pharmacology, PK, and Toxicology data.

Guided nonclinical document preparation and review strategy for regulatory submissions and formulated timeline strategy for key documents. Performed QC checks on nonclinical regulatory documents: IND Applications, IMPD, NDA (US), MAA (EU), IND annual reports and scientific white papers. Prepared and QCd tabular summaries of nonclinical Pharmacology, PK, and Toxicology data.

Analyzed system solutions and authored validation plans, reports, and other SDLC documentation. Participated in the delivery of system solutions by ensuring validation activities were conducted in a cost effective and compliant manner.

Reviewed submission documents to ensure consistency between the nonclinical, clinical, and CMC sections of the document. Ensured that data presented in the nonclinical sections of the submission documents (tables and text) accurately reflected the final study reports.Ensured consistency within the nonclinical sections of the submission documents.

Acted as Study Director on regulatory safety studies conducted in compliance with GLP and OECD standards. Designed studies to meet scientific objectives and ensured that the results were accurately represented and interpreted in the report. Managed the placement, monitoring, and reporting of contract laboratory studies.

Acted as Study Toxicologist on studies to evaluate preclinical safety assessment. Designed studies to meet scientific objectives, ensured that the study results were accurately represented and interpreted in the final report. Ensured studies were conducted in compliance with SOPs and governmental regulations.

Acted as Study Supervisor or Study Director on reproductive studies. Performed mating, dosing, visceral examinations, and skeletal examinations. Ensured that the study met the scientific objectives and the results were accurately represented and interpreted in the final report.

Acted as Study Supervisor on studies by overseeing daily activities. Performed technical tasks as defined by study protocols and regulations.