Syneos Health Medical Writer I / Medical Writer II – CSR Narratives

Syneos Health Medical Writer I / Medical Writer II – CSR Narratives

Syneos Health is hiring Medical Writer I / Medical Writer II – CSR Narratives for its Clinical Solutions team in India.
The role focuses on clinical and medical writing, particularly drafting and reviewing patient narratives and Clinical Study Reports (CSRs).
Medical writers will prepare and edit clinical documents, review statistical analysis plans and data specifications, and collaborate with Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs teams.
Candidates with a Master’s/M.Pharm or Bachelor’s degree and relevant experience in narrative writing can apply for this remote or hybrid opportunity.

Medical Writer I / Medical Writer II – CSR Narratives

Job Overview

The position is part of Syneos Health’s Clinical Solutions team and involves preparing medical writing deliverables with minimal supervision.

The role particularly requires experience in drafting and reviewing narratives, along with knowledge of clinical research, regulatory guidelines, and medical writing standards.

Job Requisition ID: 25111845
Work Location: India – Remote / Gurugram – Hybrid
Employment Type: Full Time

Job Role & Responsibilities

The Medical Writer will be responsible for compiling, writing, editing, and reviewing medical writing deliverables.

Key responsibilities include:

• Mentor less experienced medical writers on projects, as necessary.
• Compile, write, and edit medical writing deliverables.
• Serve as a medical writer within and across departments with minimal supervision.
• Develop or support various clinical documents, including:

  • Clinical Study Protocols
  • Clinical Study Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Patient Narratives
  • Annual Reports
  • Investigator Brochures

• Review Statistical Analysis Plans (SAPs) and table, figure, and listing specifications for appropriate content, grammar, format, and consistency.
• Interact with department heads and staff members in:

  • Data Management
  • Biostatistics
  • Regulatory Affairs
  • Medical Affairs

• Serve as a peer reviewer on the internal review team.
• Address team comments accurately to ensure scientific content, clarity, overall consistency, and proper document format.
• Follow established regulatory standards, including ICH-E3 guidelines, Company SOPs, client standards, and approved templates.
• Complete medical writing projects on time and within budget.
• Perform online clinical literature searches, as applicable.
• Apply working knowledge of the drug development process and regulatory guidelines.
• Continue professional development to remain current with regulatory guidance and client expectations in medical writing.
• Stay aware of budget specifications for assigned projects and work within budgeted hours.
• Communicate changes to medical writing leadership.
• Complete required administrative tasks within specified timeframes.
• Perform other work-related duties as assigned.
• Minimal travel may be required, less than 25%.

Eligibility & Qualifications

Educational Qualification

The job posting states that candidates should have:

• Postgraduate qualification – Master’s / M.Pharm
• Bachelor’s degree

Experience

The source specifies:

• Minimum 1 year of experience working in narratives with a Master’s qualification
• 2 years of experience with a Graduation qualification
• Good experience in drafting and reviewing narratives

Eligible Qualification Courses

M.Pharm | Master’s Degree in Relevant Field | Bachelor’s Degree in Relevant Field

Required Skills

Candidates should have:

• Extensive knowledge of English grammar.
• Knowledge of FDA regulations and guidelines.
• Knowledge of ICH regulations and guidelines.
• Familiarity with the AMA Style Guide.
• Strong presentation skills.
• Strong proofreading skills.
• Strong interpersonal skills.
• Leadership skills.
• Ability to work effectively as part of a team.
• High degree of independence.
• Strong proficiency in:

  • MS Word
  • MS Excel
  • PowerPoint
  • Email
  • Internet

• Familiarity with principles of clinical research.
• Ability to interpret and present clinical data and other complex information.

Medical Writing & Clinical Research Areas

The role provides exposure to:

• Clinical Study Reports
• Patient Narratives
• Clinical Study Protocols
• Protocol Amendments
• Annual Reports
• Investigator Brochures
• Medical Writing
• Clinical Research
• Clinical Data Interpretation
• Statistical Analysis Plans
• Table, Figure and Listing Specifications
• Clinical Literature Searches
• ICH-E3 Guidelines
• FDA Regulations
• Regulatory Documentation

Job Location & Work Mode

Company: Syneos Health

Job Title: Medical Writer I / Medical Writer II – CSR Narratives

Location: India – Remote / Gurugram – Hybrid

Job Type: Full Time

Job Requisition ID: 25111845

Work Mode: Remote (Pre-Approved) / Gurugram Hybrid

Travel: Less than 25% may be required

How to Apply

Interested and eligible candidates can apply online through the official Syneos Health Careers portal.

Apply Now – Syneos Health Medical Writer I / II

Job Summary