Remote Medical Writer II — Global Clinical Docs Lead

Worldwide Clinical Trials

United States

Remote

USD 90,000 - 120,000

Full time

6 days ago
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Job summary

Worldwide Clinical Trials seeks a Medical Writer II to support Phase I–IV studies across the USA, Europe, and RoW. You will develop high-quality clinical and regulatory documents and translate complex data into clear, scientifically sound content for global programs.

You will lead writing activities, coordinate reviews with sponsors and cross-functional teams, ensure regulatory and quality standards, and manage multiple assignments in a dynamic, remote-friendly environment.

Qualifications

  • Bachelors degree or higher in Life Sciences or related field, or equivalent experience.
  • Minimum 3 years of medical writing experience or similar.
  • Proficiency in English with excellent written and verbal communication.
  • Strong ability to interpret clinical data and communicate findings clearly.
  • Proven project management, organizational, and time management skills.

Responsibilities

  • Lead the preparation of Phase I–IV clinical study documents, including protocols, amendments, ICFs, narratives, and Investigator Brochures.
  • Develop region-specific regulatory documents for global studies.
  • Interpret clinical data and translate findings into clear, accurate text.
  • Coordinate internal and sponsor review cycles to ensure timely deliverables.
  • Perform quality control reviews to maintain high standards of accuracy and consistency.
  • Collaborate with cross-functional teams across global programs.
  • Propose innovative ideas to improve document quality and efficiency.
  • Manage multiple writing assignments with regulatory timelines.

Skills

Lead writing
Study documents
Data interpretation
Regulatory documents
Quality control
Cross-functional collaboration
Process improvement
Project management

Education

Life Sciences degree

Tools

MS Word
PowerPoint
Excel
Outlook

Job description

Worldwide Clinical Trials seeks a Medical Writer II to support Phase I–IV studies across the USA, Europe, and RoW. You will develop high-quality clinical and regulatory documents and translate complex data into clear, scientifically sound content for global programs.

You will lead writing activities, coordinate reviews with sponsors and cross-functional teams, ensure regulatory and quality standards, and manage multiple assignments in a dynamic, remote-friendly environment.

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