G&L Scientific’s medical writing team provides integral support to our clients’ drug development program and regulatory submission activities, from protocol development to the authoring of non-clinical and clinical regulatory submission documents.
Our globally-renowned team has an industry-leading reputation for excellence in conveying data in understandable and transparent terms which streamlines the drug submission process.
Our accomplished medical writers have a minimum of 8 years of writing experience, with many having at least 15 years. Our writers are all active contributors to the medical writing community and are members of the American Medical Writers Association (AMWA) and/or the European Medical Writers Association (EMWA).
Upholding the highest quality and scientific standards, our writers apply current guidance and regulations in writing global regulatory documents for all product types and therapeutic areas.
Adept in close collaboration with diverse cross-functional clinical teams, our writers possess strong project management skills. As a result, they manage project timelines, lead cross-functional teams, and drive critical content decisions, review processes, and comment adjudication.
Our teams have a mastery of English composition, grammar, spelling, punctuation, and medical/scientific vocabulary.
They are highly proficient in the use of MS Word, formatting, eCTD authoring templates, and document software platforms such as Adobe Acrobat Pro, PerfectIt, EndNote, EDMS (e.g., Veeva Vault, Documentum), all of which ensure the submission-readiness of authored content.
The medical writers on our team pay meticulous attention to detail, maximizing the submission outcomes and related ROI.
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