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Medical Writer I (Ctt)

1+ years
Not Disclosed
10 July 30, 2025
Job Description
Job Type: Remote 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 I – Clinical Trial Transparency (Remote, India)

Job Summary

Syneos Health is hiring a Medical Writer I with experience in Clinical Trial Transparency (CTT) to support the development of key clinical and regulatory documents. This role is remote and suited for individuals with at least 1 year of experience in clinical trial disclosure activities such as protocol registration, results posting, and preparation of clinical study documents. Ideal for professionals aiming to grow their career in medical writing within a global biopharmaceutical organization.


Key Responsibilities

  • Prepare, write, and edit regulatory and clinical study documents including protocols, CSRs, patient narratives, and investigator brochures.

  • Participate in protocol registration and results posting for regulatory bodies.

  • Review statistical outputs and contribute to table/figure/listing specifications.

  • Collaborate with data management, biostatistics, regulatory affairs, and other departments.

  • Perform literature reviews and ensure adherence to ICH-E3, internal SOPs, and client templates.

  • Maintain timelines, quality, and compliance for all assigned writing deliverables.

  • Continue professional development to align with regulatory and client expectations.


Required Skills & Qualifications

  • Minimum 1 year of experience in clinical trial disclosure/CTT.

  • Experience with protocol registration and results posting.

  • Bachelor’s degree in Life Sciences, English, Communications, or related field.

  • Strong knowledge of ICH-E3, regulatory writing practices, and grammar.

  • Familiarity with AMA style guide and clinical data interpretation.

  • Proficient in Microsoft Word, Excel, PowerPoint, and web-based research.

  • Strong attention to detail and ability to work independently and cross-functionally.


Perks & Benefits

  • 100% Remote work flexibility from anywhere in India.

  • Opportunities for growth within a global pharma leader.

  • Ongoing technical training and development programs.

  • Collaborative and inclusive company culture.

  • Access to internal recognition and rewards programs.


Company Description

Syneos Health is a global biopharmaceutical solutions organization supporting clinical development and commercialization. With over 29,000 professionals across 110 countries, the company delivers high-impact solutions to pharmaceutical, biotech, and medical device companies by integrating clinical expertise with commercial innovation.


Work Mode

Remote – India


Call-to-Action

If you’re ready to contribute to global clinical research while building your expertise in medical writing, this role is for you.
Apply now and be part of a mission that truly changes lives.