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Senior Medical Writer

Company: Arcus Biosciences, Inc.
Location: Remote
Posted on: January 15, 2022

Job Description:

SummaryThe Sr. Medical Writer (SMW) will prepare clinical/regulatory documents to support regulatory submissions and contribute to the development of internal Arcus MW processes with input from a more senior medical writer. The SMW will help plan and have oversight (with guidance from a more senior medical writer) for medical writing deliverables for a wide variety of small-to-medium clinical/regulatory submissions from early-to-late phase development.ResponsibilitiesAll responsibilities will have input from a more senior medical writer, as needed.Prepare, edit, and finalize low-medium complexity protocols including amendments, original and updated investigator brochures, synopses, clinical study reports (full and abbreviated).Ensure appropriate and effective collaboration with key functional contributors and that all documents are authored according to regulatory requirements, internal Arcus document standards (utilizing the Arcus Manual of Style), and with adherence to timelines and team expectations.May serve on medium-to-large development programs supporting MW on cross-functional initiatives/teams supporting key objectivesParticipates in medical writing and cross-functional process improvement initiatives on clinical document standards, template development, and document or medical writing processesReviews documents written by contract medical writersQualificationsBA/BS and 4+ years of relevant experience (less with advanced degree and relevant industry experience); post-graduate degree preferredRelevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with 3+ years of direct experience in a medical writing/clinical submissions environment directing/preparing document for regulatory submissions; Medical writing experience in oncology or rare diseases is desiredExcellent verbal communication and technical writing skillsShows leadership and autonomy and has ability to negotiate and collaborate within a cross"-- - -functional team environment with minimal oversight from a more senior medical writerDemonstrates success in the preparation of clinical/regulatory documents at the individual document and submission levelA thorough understanding of industry regulations, guidance's, and regulatory documentation requirementsProvides medical writing expertise for clinical/regulatory documents and submissions of low to medium complexityExperience interacting and communicating timeline expectations with cross functional study team membersHighly proficient in the functionality of MS Word, Excel, Adobe Acrobat, and PowerPointExperience with electronic document management systems (e.g., Veeva Vault) preferredFamiliarity with statistical analysis concepts and techniques preferred-- -

Keywords: Arcus Biosciences, Inc., Eugene , Senior Medical Writer, Healthcare , Remote, Oregon

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