Job Title: Medical Writer II (Clinical Trial Transparency)
Job Location: India - Asia Pacific - Home-Based
Company Overview
Syneos Health is a leading integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into actionable outcomes. The company operates in 110 countries with a mission to bring customers and patients at the center of everything they do.
Role Summary
As a Medical Writer II, you will be responsible for producing a variety of clinical and regulatory documents including clinical study protocols, reports, patient narratives, and investigator brochures. You will work with cross-functional teams, adhering to regulatory standards and ensuring high-quality content.
Key Responsibilities
Mentor less experienced medical writers and support them on projects.
Develop, write, and edit medical writing deliverables including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Annual reports
Investigator brochures
Review statistical analysis plans and table/figure/listing specifications.
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams to produce high-quality deliverables.
Serve as a peer reviewer, ensuring scientific content, clarity, consistency, and proper formatting.
Ensure adherence to regulatory standards like ICH-E3, SOPs, client standards, and approved templates.
Conduct online clinical literature searches when required.
Maintain a good understanding of the drug development process and regulatory guidelines.
Manage project budgets, working within the allocated hours and communicating any changes.
Complete administrative tasks in a timely manner.
Minimal travel may be required (less than 25%).
Qualifications
Required
Education:
Bachelor of Science with relevant writing experience or Bachelor of Arts in Social Sciences, English, Communications, or related fields, with relevant scientific/medical knowledge.
Experience:
Strong understanding of English grammar, FDA/ICH regulations, and AMA style guide.
Ability to interpret and present clinical data.
Strong proficiency in Microsoft Word, Excel, PowerPoint, and email.
Excellent presentation, proofreading, and leadership skills.
Work Environment
Syneos Health fosters a Total Self culture, where employees are encouraged to be their authentic selves. The company provides career development opportunities, technical and therapeutic area training, and a peer recognition program.
How to Apply
Interested candidates can apply through the Syneos Health career portal.
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