Medical Writer

 Posted 21 days ago
     
2-5 years experience
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AI Summary

The Medical Writer is responsible for developing high-quality clinical documentation, including site manuals and charters, while ensuring compliance with regulatory standards. They will review study protocols, eCRFs, and SOPs to maintain accuracy and consistency across clinical studies.

At Clario, a part of Thermo Fisher Scientific, we are committed to transforming clinical trials through technology and innovation. As a Medical Writer, you will play a pivotal role in developing high‑quality clinical documentation that supports critical research and regulatory success. This position ensures clarity, consistency, and compliance across clinical studies, directly impacting patient outcomes and organizational goals.

What We Offer

  • Competitive compensation
  • Comprehensive health and wellness benefits
  • Flexible work arrangements
  • Paid time off and company holidays
  • Engaging employee programs and professional development opportunities

What You’ll Be Doing

  • Review study protocols and contracts for inclusion/exclusion criteria, imaging objectives, endpoints, and indication‑specific requirements
  • Review study‑specific electronic Case Report Forms (eCRFs/CRFs) for accuracy and alignment with protocol requirements
  • Develop, write, and finalize study documentation including Site Manuals, Quick Reference Guides, Charters, and other study‑related documents or forms as requested
  • Review, update, and support Standard Operating Procedures (SOPs) related to Medical Communications
  • Manage the document development lifecycle, including version control, tracking databases, and template maintenance
  • Provide guidance to project teams to ensure timely delivery of final, approved documentation
  • Participate in internal and external meetings related to study documentation and deliverables
  • Ensure all documentation meets quality, regulatory, and internal compliance standards
  • Maintain accurate and organized documentation records in accordance with company policies

What We Look For

  • Bachelor’s degree in Life or Physical Sciences (e.g., Biology, Chemistry, Pharmaceutics)
  • 2+ years of medical writing experience preferred
  • 3+ years of experience in pharmaceutical, clinical, or imaging research environments required
  • Proficiency in medical, regulatory, and clinical writing
  • Strong working knowledge of clinical trial terminology and documentation standards
  • Proficiency with Microsoft Office Suite
  • Excellent attention to detail, documentation, and organizational skills
  • Strong written and verbal communication and interpersonal skills
  • Ability to manage multiple projects, prioritize effectively, and adapt to changing timelines
  • Ability to perform long‑duration computer‑based work
  • Minimal travel required (approximately 0–5%)

At Clario, a part of Thermo Fisher Scientific, our purpose is to transform lives by unlocking better evidence. It’s a cause that unites and inspires us. It’s why we come to work—and how we empower our people to make a positive impact every day. Whether you're advancing clinical science, building innovative technology, or supporting global teams, your work helps bring life‑changing therapies to patients faster.

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

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