Job Description
Are you a passionate medical communicator looking to shape the future of healthcare? NovaCare Solutions is seeking a Senior Medical Writer to lead our scientific communications team. You will translate complex clinical data into compelling narratives for regulatory submissions, peer-reviewed publications, and internal stakeholders.
Why Join Us?
- Work on groundbreaking medical technologies.
- Competitive salary and benefits package.
- Remote-first culture with flexible hours.
Apply today to make a difference in patient outcomes.
Responsibilities
- Develop high-quality clinical study reports (CSRs), protocols, and regulatory submissions (e.g., INDs, NDAs).
- Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Medical Directors.
- Ensure all written content adheres to regulatory guidelines (FDA, EMA) and internal quality standards.
- Edit and review manuscripts for accuracy, clarity, and compliance.
- Manage multiple concurrent projects while meeting strict deadlines.
- Conduct literature searches and synthesize findings for background sections.
- Mentor junior medical writers and provide feedback on their drafts.
Qualifications
- Master’s degree in Medicine, Pharmacy, Life Sciences, or a related field.
- Minimum of 5 years of experience in medical writing or scientific communications.
- Deep understanding of clinical trial phases and regulatory frameworks (FDA 21 CFR Part 11, ICH E6).
- Excellent command of the English language with a strong focus on grammar and style.
- Proficiency in Microsoft Office Suite and DTP tools (e.g., InDesign, FrameMaker).
- Ability to work independently in a fast-paced, deadline-driven environment.