Sr. Medical Writer

Gandiv Insights LLC; Round Lake (IL); Remote; USD 80,000 - 120,000; Full time

Job summary

A dynamic company in healthcare is seeking an experienced Medical Writer to lead the development of clinical and regulatory documents. This role involves drafting, editing, and managing submissions while collaborating with cross-functional teams. Candidates should have over 6 years of medical writing experience, with familiarity in drug development and regulatory processes. Excellent project management and communication skills are essential. Apply now for this exciting opportunity!

Qualifications

• 6+ years of medical writing experience in the pharmaceutical/biotech industry.
• Strong understanding of drug development and regulatory documentation.
• Experience writing protocols, CSRs, INDs, BLAs/NDAs, PBRERs, and DSURs.

Responsibilities

• Draft and edit documents supporting clinical studies.
• Develop and review aggregate safety and efficacy reports.
• Prepare and manage regulatory submissions, including briefing books.

Skills

Medical writing

Project management

Communication

Leadership

Data interpretation

Education

Bachelor’s degree or higher

Tools

Microsoft Office

Veeva

SharePoint

LiveLink

Job description

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! [e-mail]

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