Senior Medical Writer: Drive Global Clinical Documentation

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

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!