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Medical Writer I (Ctd/Ctt)

0-2 years
Not Disclosed
10 Sept. 17, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 (CTD/CTT)

Location: IND-Gurugram-Hybrid
Updated: August 29, 2025
Job ID: 25101317


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into outcomes.

  • Patient- and customer-centric Clinical Development model

  • Agile, collaborative, and innovative teams

  • 29,000 employees across 110 countries

Global Impact:

  • 94% of novel FDA-approved drugs and 95% of EMA-authorized products in last 5 years

  • 200+ studies across 73,000 sites and 675,000+ trial patients

Learn more: www.syneoshealth.com


Why Syneos Health

  • Career Development: Training, mentorship, and progression opportunities

  • Inclusive Culture: Total Self culture fostering authenticity and belonging

  • Collaboration: Cross-functional teamwork to achieve customer goals


Role Summary

The Medical Writer I (CTD/CTT) supports clinical and regulatory writing projects, assisting in preparation, review, and coordination of deliverables under moderate supervision.

  • Focused on Clinical Trial Disclosure (CTD/CTT) and protocol/result registration

  • Assists senior writers in producing high-quality clinical and regulatory documents


Core Responsibilities

Medical Writing & Document Support

  • Compile, write, and edit documents, including:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Patient narratives

    • Investigator brochures (IBs)

  • Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency

  • Perform online clinical literature searches, ensuring copyright compliance

Collaboration & Client Interaction

  • Interact with department heads and staff in:

    • Data management, Biostatistics, Regulatory Affairs, Medical Affairs

  • Communicate effectively with clients and internal teams

Compliance & Standards

  • Adhere to regulatory guidelines, including ICH E3, company SOPs, client standards, and approved templates

  • Ensure deliverables are completed on time and within budget

  • Maintain professional development to keep pace with evolving regulations and client expectations

Administrative & Miscellaneous

  • Complete administrative tasks within required timeframes

  • Minimal travel may be required (<25%)

  • Perform other work-related duties as assigned


Qualifications & Experience

  • 6 months – 1 year of experience in Clinical Trial Disclosure (CTD/CTT)

  • Experience with protocol registration and result registration

  • Strong communication and client management skills


Key Skills

  • Competence in medical writing for clinical and regulatory documents

  • Understanding of statistical outputs and clinical trial data

  • Familiarity with ICH E3 and regulatory standards

  • Strong attention to detail and organizational skills

  • Ability to work collaboratively under moderate supervision


Additional Information

  • Tasks and responsibilities may be adjusted at company discretion

  • Equivalent skills and experience will be considered

  • Compliance with employment legislation and ADA requirements


How to Apply

  • Apply via Syneos Health careers portal

  • Join the Talent Network to stay connected with future opportunities