Gandiv Insights LLC is hiring: Sr. Medical Writer in Round Lake

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

• Bachelors 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! anupam@gandivainsights.com

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