Medasource is hiring: Technical Writer in Indianapolis

Job Title : Technical / Medical WriterLocation : Indianapolis, INDuration : 12 monthsStart Date : ASAPJob Description : The technical writer will be supporting the client's Medicines Quality Organization team to deliver high quality documents in the Safety and Efficacy Quality System. The medical writer will support document changes within the Safety and Efficacy Quality Systems, working closely with colleagues in the Quality Systems, Global Patient Safety, and other components of the Research and Development organization.The writer is responsible for developing and maintaining accurate, clear, and concise procedures, required tools, and resource documents. The role is also responsible for quality checks of the quality system documents to ensure compliance with the client's standards and procedures. The role manages workflows and metadata in the document control system using Veeva QualityDocs.Job Responsibilities : 1.) Quality Systems Document ManagementEnsure timely delivery of error-free, high-quality documents that meet international standards of written EnglishDevelop and maintain accurate, clear, and concise procedures, required tools, and resource documents using appropriate technical writing standards templates, and style guidesVerify quality system architecture accuracy and consistency of content within and between related documentsDocument ArchitectureDesign and implement document architecture for Safety and Efficacy Quality System safety documents (procedures, required tools and resource documents), ensuring clarity, coherence, and adherence to regulatory requirementsDocument ControlLaunch templates and manage document metadataSupport MQO Quality Systems with editing, Quality Checks, and data integrity reviewEnsure the accuracy and completeness of document control records, including document revision histories. revisions, approvals, and related metadataTrack status, milestones, and associated documentation throughout the workflowGeneral ExpectationsMaintain a strong customer focusCommunicate effectivelyManage activities efficiently and proactively to achieve timelinesCross-functional collaboration : work closely with the Global Patient Safety Team to gather information and incorporate feedback into the Safety & Efficacy Quality System document developmentTimeline management : develop and manage timelines for document creation, ensuring timely completion and delivery of high-quality documentsMaintain proficiency in applicable software, tools, processes, and workflowsRequirements : Understanding of routine medical writing / surveillance activities3 yrs direct experience with medical writingPharma / industry experience is a plusPharmacovigilance / Safety experience a huge plusAbility to draft and control document flow for process ownerExperience using Veeva QualityDocs and electronic document management systemsAbility to work cross-functionally between safety, regulatory, clinical teams