Kristen D Kris Hawley
Senior Manager, Nonclinical Writing @Alnylam Pharmaceuticals
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WORK HISTORY
Senior Manager, Nonclinical Writing @Alnylam Pharmaceuticals
Cambridge, MA, US
Nonclinical Writing lead on project teams, specializing in CNS targets, working directly with scientists within Research and Early Development (ReDEV) and collaboratively with Program Management, Clinical, Medical Writing, Regulatory Affairs/Operations, and Pharmacovigilance, to lead the authoring of high-quality nonclinical regulatory submission content for global regulatory filings.• Lead nonclinical writer in conjunction with scientists and project team members for pre-development candidates, Phases 1 to 2, and late stage programs in the preparation of nonclinical content in support of regulatory submissions (eg, nonclinical protocols/reports, Briefing Documents, Investigator’s Brochures, Clinical Trial Applications, Responses to Regulatory Authorities, INDs, DSURs, PBRERs, NDAs/MAAs).• Develops and maintains timelines for authoring, review/revision, and completion of Modules 1, 2, and 4 nonclinical documents in collaboration with other project team members and Regulatory Affairs/ Operations.• Coordinates and manages review cycles of Modules 1, 2, and 4 nonclinical documents and leads round tables for comment resolution.• Edits/authors Module 2 summary documents from templates and interprets data, as needed.• Edits/authors Module 4 nonclinical study report drafts from templates and interprets data, as needed.• Performs QC verification of all nonclinical content using final reports and Electronic Laboratory Notebook source material.• Orders and obtains copyright clearance for literature used in nonclinical Regulatory documents and uploads to document libraries.• Reviews and edits nonclinical portions of Notes to Reviewer and White Papers used in Regulatory Submissions.• Independently manages and/or mentors junior writers and scientists.• Developed and leads annual training on Regulatory Submission Requirements for FIH Clinical Trials.• Identifies and proposes solutions to problems within a fast-paced dynamic environment.
EDUCATION
Ripon College
Bachelor's degree, Biology, General
Michigan State University
Master's degree, Pharmacology & Toxicology
SKILLS
ABOUT KRISTEN D KRIS HAWLEY
Highly motivated and experienced Laboratory Animal Technologist (LATG), Board-Certified Editor in the Life Sciences (ELS), and Nonclinical Regulatory Writer with an accomplished career working in the pharmaceutical industry. Skilled in Common Technical Document (CTD), Good Laboratory Practice (GLP), Standard for Exchange of Nonclinical Data (SEND), and Nonclinical Regulatory Writing. Extensive experience working cross-functionally and globally across project teams including Regulatory, Medical Writing, Pharmacovigilance, Clinical Science, and Drug Development partners with a Master\'s degree focused in Pharmacology & Toxicology from Michigan State University.
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