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Medical Writer Ii (Clinical Trial Transparency)

2-5 years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Medical Writer II (Clinical Trial Transparency) – Syneos Health, Gurugram [Hybrid]

Job Summary:

Syneos Health is hiring an experienced Medical Writer II with expertise in clinical trial transparency for its Gurugram office. This hybrid role focuses on developing regulatory and scientific documents, including clinical study protocols, reports, investigator brochures, and patient narratives. The role requires strong knowledge of ICH guidelines, FDA regulations, and regulatory medical writing, along with cross-functional collaboration.


Key Responsibilities:

  • Prepare, review, and revise medical writing deliverables such as protocols, CSRs, and narratives

  • Ensure compliance with ICH-E3, FDA regulations, and client SOPs

  • Conduct literature reviews and verify statistical content

  • Participate in peer reviews and address scientific and formatting feedback

  • Mentor junior writers and provide writing leadership within the team

  • Collaborate with regulatory, biostatistics, data management, and clinical operations teams

  • Maintain high standards of quality and consistency across documents

  • Adhere to budget and project timelines


Required Skills and Qualifications:

  • Bachelor’s degree in Life Sciences or related field

  • Strong command of English and medical writing style (e.g., AMA style)

  • Experience with ICH, FDA, and clinical research regulations

  • Proficiency with MS Office and web-based literature research

  • 2 to 5 years of experience in regulatory or clinical trial medical writing

  • Ability to manage writing projects independently and work collaboratively


Perks and Benefits:

  • Hybrid work model based in Gurugram

  • Competitive salary and benefits

  • Learning and development programs

  • Inclusive and collaborative work culture

  • Opportunity to work on global clinical trials


Company Overview:

Syneos Health is a global biopharmaceutical services organization with over 29,000 employees in more than 110 countries. The company supports clinical development and commercialization across all therapeutic areas. It has worked with 94 percent of novel drugs approved by the FDA. Syneos Health is recognized for its innovation and results-driven approach to improving healthcare outcomes.


Work Mode: Hybrid (Gurugram)
Preferred Experience: 2 to 5 years in regulatory or clinical medical writing
Salary/Compensation: Not disclosed in the job description


Call to Action:

If you are a dedicated medical writer with a passion for transparency and regulatory compliance, apply now to join Syneos Health and contribute to meaningful clinical research.