Susan Wilt Gillette
Director Medical Writing @Regeneron
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WORK HISTORY
Director Medical Writing @Regeneron
NY, US
Medical writing manager with multiple direct report- supervise reports and other writers (medical/scientific) assigned to clinical documents -provide leadership and guidance for effective team communication to resolve or escalate issues-work with leadership to develop the strategy & direction for the writing function, eg, guidelines, templates, timelines, and SOPs that comply with regulatory guidance-accountable for tracking document projects for my reports and programs to anticipate the need for writers or prioritization for projects-responsible for management, development, and mentoring for direct reports and internal writers, including performance evaluation and training -develop the medical writing function by recruitment, interviewing, and hiring writersMedical writing lead for early phase drug candidate programs -Prepares/ supervises document preparation to facilitate quality and consistency for a program -Manage writing projects: create timelines, conduct reviews and resolution meetingsMedical writing lead for BLA/MAA submission activities -define scope of content, strategy for modules, and submission timeline with the submission team -manage the writing team (medical and scientific writers)Clinical Trial Disclosure and Data Transparency-Serve on the cross-functional workgroup to ensure we meet global clinical trial transparency requirements. Document experience:BLAs/MAA CTD modules (initial and updates)- Summaries: 2.7.1 Biopharmaceutics, 2.7.2 Clinical Pharmacology, 2.7.3 Clinical Efficacy, 2.7.4 Clinical Safety- Safety update reports and Integrated Summary of Immunogenicity-Overviews: 2.5 Clinical Overview-Clinical study/registry protocols (phases 1 to 4) & amendments -Clinical study reports (CSRs; phases 1 to 4)-Clinical document template updates (protocol and CSR) in collaboration with functional area leads.
EDUCATION
Penn State University
PhD, Biological Chemistry
Penn State University
BS, Biochemistry
SKILLS
ABOUT SUSAN WILT GILLETTE
A scientific professional with experience in pharmaceutical drug development (20 years) and government/academic research (13 years). I have a passion for medical and scientific writing that clearly and accurately communicates complex scientific information to diverse audiences. I am a skilled medical writer and problem solver with proven ability to work collaboratively with clinical and nonclinical program teams to deliver complex regulatory documents that meet firm project deadlines. I have an extensive experience in developing study protocols, study reports, or summaries/overviews for global regulatory submissions (BLA/NDA/MAA, IND/CTA). This broad backgroud supports my ability to successfully manage direct reports and writing teams, train and mentor writers, develop and maintain document processes, including document templates My interest in process development led me to join the cross-functional Clinical Trial Disclosure and Data Transparency team which successfully developed our processes and implemented systems to ensure that we meet global regulatory requirements. I have established and lead cross functional workgroups for submission modules 2.7.2, 2.7.1, and Integrated Summary of Immunogenicity.My high job satisfaction is due to seeing that my work directly benefits patients. I am also a genealogist who uses DNA data to uncover the history of my family.Therapeutic areas: rare diseases, infectious disease, ophthalmology, inflammation, cardiovascular, metabolism, and neuroscience. Research techniques: in vitro primary cell culture models for rat, mouse, and human brain, and animal models, mouse, rat, and hamster. Keywords: medical writing, scientific writing, management, direct reports, process development, clinical and nonclinical regulatory submission summaries (IND, CTA, NDA, BLA, MAA, ISI), eCTD compliance, project management, clinical trial disclosure and data transparency, ICH, 21CFR 314.50
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