Sr. Medical Writer

2 days ago Be among the first 25 applicants Are you an experienced Medical Writer passionate about delivering high-quality clinical and regulatory documentation? Join our growing team and play a key role in driving excellence in medical and scientific communications that support global drug development programs. Responsibilities Draft and edit documents supporting clinical studies — including protocols, amendments, informed consent forms, and clinical study reports (CSRs) . Develop and review aggregate safety and efficacy reports (IBs, PBRERs, DSURs, etc.). Prepare and manage regulatory submissions , including briefing books and eCTD Module 2/5 clinical summaries . Manage timelines, meetings, and document reviews across cross-functional study teams . Represent Global Medical Writing at cross-functional meetings and collaborate closely with clinical, regulatory, and biostatistics teams. Provide peer review, editing, and process improvement support to ensure consistency and quality across documentation. Qualifications Bachelor’s degree or higher (scientific background preferred). 6+ years of medical writing experience in the pharmaceutical/biotech industry (or 10+ years in medical/scientific writing roles). Strong understanding of drug development , clinical study design , and regulatory documentation . Experience writing protocols, CSRs, INDs, BLAs/NDAs, PBRERs, and DSURs . Familiarity with AMA, CBE, and Chicago style guides and medical dictionaries (MedDRA, WHO Drug). Skilled in Microsoft Office , document management systems (Veeva, SharePoint, LiveLink), and data interpretation (tables, figures, and clinical data presentations). Excellent project management, communication, and leadership skills. This is an exciting opportunity to shape medical writing excellence, streamline global documentation, and collaborate across multidisciplinary teams in a fast-paced, mission-driven environment. Apply now or DM me for more details! View email address on click.appcast.io

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• J-18808-Ljbffr Gandiv Insights LLC