Medical Writer II

Worldwide Clinical Trials; United States; Remote; USD 90,000 - 120,000; Full time

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

Make an Impact as a Medical Writer II at Worldwide

Bring your medical writing expertise to a role where accuracy, scientific integrity, and clear communication help support Phase I-IV clinical studies across the USA, Europe, and Rest of World regions. In this role, you will play a key part in developing high-quality clinical and regulatory documents that contribute to the successful execution of global research programs.

You'll have the opportunity to lead medical writing activities across a variety of study documents, collaborate with cross-functional teams and sponsors, and help ensure deliverables meet regulatory, scientific, ethical, and quality standards. Your ability to translate complex data into clear, meaningful content will directly support clinical research efforts and study outcomes.

Working both independently and as part of a global team, you'll bring innovative thinking, strong project management skills, and a commitment to quality while managing multiple priorities in a dynamic environment.

Where You'll Work

This is a REMOTE role open to candidates based in US. You will collaborate with global teams across multiple time zones.

Some domestic and international travel, including overnight stays, is required.

What You'll Do

• Lead the preparation of Phase I-IV clinical study documents, including protocols, protocol amendments, informed consent forms, assents, clinical trial reports, narratives, and Investigator Brochures.
• Develop region-specific documentation for global studies, including IMPDs, Protocol Lay Summaries, CTR Lay Summaries, and other required regulatory documents.
• Interpret clinical data and transform findings into clear, accurate, and scientifically sound written content.
• Coordinate internal and sponsor review cycles to ensure efficient document development and on-time delivery.
• Perform quality control reviews of medical writing deliverables to maintain high standards of accuracy and consistency.
• Collaborate with cross-functional teams and stakeholders from diverse professional backgrounds across global programs.
• Contribute innovative ideas and solutions that enhance document quality, efficiency, and overall project value.
• Manage multiple writing assignments while meeting deadlines, regulatory requirements, and quality expectations.

What You'll Bring

• University or college degree in Life Sciences, a related allied health discipline, or an equivalent combination of education and experience.
• Minimum of 3 years of medical writing experience or comparable experience demonstrating the knowledge and skills required for the role.
• Proficiency in English with excellent written and verbal communication skills.
• Strong ability to analyze and accurately interpret clinical data and communicate findings clearly and concisely.
• Proven project management, organization, and time management skills with the ability to work independently.
• Ability to manage changing priorities and deliver high-quality work across multiple projects with demanding timelines.
• Advanced Microsoft Office skills, particularly Microsoft Word, along with PowerPoint, Excel, and Outlook.
• Ability and willingness to travel domestically and internationally, including overnight stays; valid passport required.