With over 16 years of experience as a regulatory writer and 11 years focused in the Transparency and Disclosure (T&D) space, Kim provides strategic regulatory writing and guidance to multiple clients on T&D activities to ensure compliance with global health authorities. She established a successful T&D service offering, which included registrations and disclosures, redaction services, and plain language summaries. She trained and managed a global team of writers and editors on how to provide T&D strategic writing to Sponsors of all sizes. She has extensive management experience with multi-functional, global teams in the development, authoring, and filing of multiple regulatory documents for eCTD submissions to Food and Drug Administration (FDA), Health Canada, and European Medicines Agency (EMA) as well as T&D deliverables.
Brenda has over 27 years of experience in regulatory writing with a focus in Clinical Trial Transparency and Disclosure. She has a strong knowledge of regulatory agency requirements, including EMA Policy 0043, EMA Policy 0070, and United States (US) FDA and International Conference on Harmonization (ICH) standards for safety documents. Additionally, she has extensive experience in clinical trial disclosure and led a team responsible for summarizing and processing clinical trial protocols and results for database disclosure. Additionally, Brenda has experience with document redaction and writing anonymization reports, clinical study reports (CSRs), regulatory response, modules of the common technical documents (CTD), and investigator brochures.
Courtneay has 18 years of experience as a medical writer, editor, and team leader. Her areas of expertise span regulatory documents, medical affairs, transparency and disclosure, and medical communications, with a focus on plain language summaries. She has worked in several therapeutic areas, including oncology, psychiatry, sleep disorders, rheumatology, diabetes, hematology, cardiology, neuroscience, gastroenterology, urology, rare diseases, managed care, pediatrics, geriatrics, and primary care.
Eti has over 10 years of industry experience, including 7 years working in the regulatory writing field. Her expertise includes authoring and quality check (QC) of clinical trial disclosures (protocol registrations, maintenance, results postings, and redaction). She has experience authoring documents in multiple therapeutic areas, including oncology, respiratory, diabetes, endocrinology, rheumatology, hematology, cardiovascular, vaccines, infectious diseases, rare diseases, and central nervous system. She is well-versed with the disclosure regulations, including US FDAAA (2007), evolving disclosure requirements of NIH and EMA. She has good understanding of AMA manual of style and ICH-E3 and E6 guidelines.
Eti is a post graduate of pharmacy with specialization in Pharmaceutical Chemistry. She has also obtained Masters in Business Administration.
Mary has more than 23 years of experience in the regulatory writing industry as a project coordinator and technical editor in editing and writing medical, regulatory, and technical documents. She has a strong background in developing documents in compliance with regulatory and style guidelines as dictated by the ICH and specific clients. Among the many types of documents, she has developed and edited are submissions, briefing documents, clinical study reports, and narratives. Mary is a quality control (QC) expert, who routinely examines documents for consistency and accuracy. She has developed document templates and boilerplate language for a variety of pharmaceutical and technical documents.
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