Medical Writer I CTD/CTT Vacancy | Syneos Health India

Syneos Health Hiring Medical Writer I (CTD/CTT) – Remote/Gurugram

Apply for Medical Writer I (CTD/CTT) at Syneos Health. Openings in India (Remote/Gurugram). Life sciences graduates with 6+ months’ experience eligible.

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If you are passionate about medical writing and want to grow in the clinical research industry, this is your chance. Syneos Health, a global leader in biopharmaceutical solutions, is hiring Medical Writer I (CTD/CTT) for its India team (Remote/Gurugram hybrid option).

This role is ideal for candidates with clinical trial disclosure (CTD) or clinical trial transparency (CTT) experience, who are eager to contribute to the advancement of clinical research documentation for global drug development.

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Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization that partners with leading global pharma and biotech companies to accelerate product development.

• Present in 110+ countries with 29,000 employees worldwide

• Partnered in 94% of all novel FDA drug approvals in the last 5 years

• Expertise across clinical development, regulatory affairs, and medical affairs

At Syneos Health, you’ll work in an environment that encourages career growth, diversity, inclusion, and professional development. Their “Total Self Culture” ensures employees thrive both professionally and personally.

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Job Role & Responsibilities

As a Medical Writer I, you will be responsible for preparing, reviewing, and managing critical clinical trial documents in compliance with international regulatory standards.

Key responsibilities include:

• Supporting clinical trial disclosure and transparency activities (protocol registration, results registration).

• Writing, reviewing, and editing key documents:

  • Clinical study protocols & amendments

  • Clinical study reports (CSR)

  • Investigator brochures

  • Patient narratives

• Reviewing statistical analysis plans and TLF specifications for accuracy.

• Collaborating with cross-functional teams (biostatistics, regulatory affairs, data management, medical affairs).

• Performing online clinical literature searches to support documentation.

• Ensuring compliance with ICH-E3 guidelines, GCP, SOPs, and regulatory requirements.

• Maintaining accuracy, consistency, and high-quality writing across deliverables.

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Eligibility / Qualifications

• Education: Master’s degree in Life Sciences, Pharmacy, Biostatistics, or a related field (M.Sc, M.Pharm, M.Tech, MPH, Ph.D. in Life Sciences).

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

• Skills Required:

  • Strong written and verbal communication skills.

  • Experience in protocol registration and results reporting.

  • Knowledge of GCP, ICH guidelines, and regulatory submissions.

  • Client communication and stakeholder management.

  • Proficiency in MS Office (Word, Excel, PowerPoint).

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Location & Salary

• Location: India (Remote or Gurugram Hybrid).

• Work Mode: Full-time, permanent role.

• Salary: Competitive compensation package with performance-based incentives.

• Benefits:

  • Global exposure to pharmaceutical regulatory documentation.

  • Structured career growth and continuous professional training.

  • Opportunity to contribute to global drug development.

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Application Process

Interested candidates can apply directly through the official Syneos Health careers portal:

👉 Apply Here

📅 Apply immediately to secure your chance – applications are reviewed on a rolling basis.

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Why Join Syneos Health?

• Work with a global biopharma leader impacting drug development worldwide.

• Be part of an innovative, collaborative, and diverse team.

• Gain exposure to FDA, EMA, and global health authority submissions.

• Develop expertise in regulatory medical writing and clinical documentation.

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FAQs

Q1. Can freshers apply for this role?
No. A minimum of 6 months–1 year of experience in CTD/CTT is required.

Q2. What is the work mode?
You can choose between Remote (India) or Hybrid (Gurugram).

Q3. Which qualifications are accepted?
M.Sc, M.Pharm, MPH, Biostatistics, Life Sciences, Pharmacy, Biotechnology, or related fields.

Q4. Does this role involve global projects?
Yes, you will work on international submissions and global drug development projects.

Q5. What are the career growth opportunities?
Progression into Senior Medical Writer, Regulatory Writer, or Medical Writing Manager roles.

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