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Medical Writer I (Ctd/Ctt)

6 months to 1 year years
Not Disclosed
10 Sept. 1, 2025
Job Description
Job Type: Hybrid Education: Clinical Trial Disclosure (CTD) or Clinical Trial Transparency (CTT). 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

Job Title: Medical Writer I (CTD/CTT)

Location: Gurugram, India (Hybrid)
Job ID: 25101317
Updated: August 29, 2025
Company: Syneos Health®


About Syneos Health®

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into real-world outcomes. With over 29,000 employees across 110 countries, we are united in our commitment to making a meaningful difference in patients' lives.


Why Work With Us

  • People-Centric Culture: Career development, progression support, peer recognition, and total rewards.

  • Total Self Culture: Be your authentic self in a diverse and inclusive workplace.

  • Global Impact: We've supported 94% of all novel FDA-approved drugs in the last 5 years and managed over 200 studies across 675,000+ patients.

Work here matters everywhere.


Position Summary

As a Medical Writer I (CTD/CTT), you will support clinical study and regulatory project teams by writing, editing, and coordinating clinical and regulatory documents. This role involves collaboration across departments with moderate supervision.


Key Responsibilities

Primary Duties

  • Serve as a medical writer on clinical trial disclosure (CTD) or clinical trial transparency (CTT) projects.

  • Compile, write, and edit various medical writing deliverables such as:

    • Clinical Study Protocols & Amendments

    • Clinical Study Reports

    • Patient Narratives

    • Investigator Brochures

  • Ensure adherence to:

    • ICH-E3 guidelines

    • Company SOPs

    • Client-specific standards and templates

Disclosure Responsibilities

  • Experience in protocol registration and results posting on disclosure platforms (e.g., ClinicalTrials.gov).

  • Perform online literature reviews as applicable.

Cross-functional Collaboration

  • Interact with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.

  • Review Statistical Analysis Plans and TFL specifications for clarity, grammar, format, and consistency.

Project Management

  • Manage time and deliverables within budgeted hours.

  • Communicate any scope or time changes to medical writing leadership.

  • Complete all required administrative tasks on time.

Other Responsibilities

  • Participate in ongoing professional development.

  • Perform additional tasks as assigned.

  • Travel may be required (up to 25%).


Required Experience & Skills

  • Experience: Minimum 6 months to 1 year in Clinical Trial Disclosure (CTD) or Clinical Trial Transparency (CTT).

  • Technical Expertise:

    • Protocol and results registration experience

    • Familiarity with regulatory documents and guidelines

  • Soft Skills:

    • Excellent communication and client management

    • Strong attention to detail and organizational skills


Additional Information

  • This job description is not exhaustive. Tasks and responsibilities may change at the company's discretion.

  • Equivalent experience, education, and transferable skills will be considered.

  • Syneos Health is an Equal Opportunity Employer and complies with ADA requirements.


How to Apply

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