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Medical Writer I

0-2 years
Not Disclosed
10 Sept. 26, 2025
Job Description
Job Type: Full Time 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

Location: IND-Gurugram
Job ID: 25101794


Company Overview

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

The Clinical Development model focuses on the patient and customer, ensuring streamlined processes, innovation, and collaboration across teams.


Why Syneos Health

  • Career development and progression opportunities.

  • Supportive and engaged line management.

  • Technical and therapeutic area training.

  • Peer recognition and total rewards program.

  • Inclusive Total Self culture, promoting authenticity and belonging.

  • Values diversity of thought, backgrounds, and perspectives.


Job Summary

Serves as a medical writer within clinical study or regulatory project teams. Supports the creation, editing, and coordination of clinical/regulatory documents under moderate supervision to ensure on-time and high-quality deliverables.


Key Responsibilities

Writing & Editing:

  • Compile, write, and edit clinical and regulatory documents including:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Patient narratives

    • Investigator brochures

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

Collaboration & Coordination:

  • Interact with data management, biostatistics, regulatory affairs, and medical affairs teams to produce writing deliverables.

  • Adhere to company SOPs, client standards, and approved templates.

Regulatory & Quality Compliance:

  • Follow regulatory standards, including ICH-E3 guidelines.

  • Perform online clinical literature searches as applicable.

  • Maintain awareness of budget specifications and manage assigned projects within allocated hours.

Professional Development:

  • Continuously update skills in line with regulatory guidance and client expectations.

  • Perform administrative tasks and other work-related duties as assigned.

  • Minimal travel (<25%) may be required.


Qualifications & Experience

Education:

  • Bachelor of Science (B.Sc.) with relevant writing experience, or

  • Bachelor of Arts (B.A.) in Social Sciences, English, or Communications with scientific/medical knowledge.

Skills & Competencies:

  • Extensive knowledge of English grammar and AMA style guide.

  • Understanding of FDA and ICH regulations/guidelines preferred.

  • Strong presentation, proofreading, and interpersonal skills.

  • Team-oriented approach with ability to work independently.

  • Proficiency in Word, Excel, PowerPoint, email, and internet.

  • Familiarity with principles of clinical research and interpretation of clinical data.


Additional Information

  • Posting is for a possible upcoming opportunity, not a live role. Expressing interest adds you to the talent pipeline.

  • Tasks and responsibilities may vary at the company’s discretion.

  • Syneos Health is committed to diversity, inclusion, and compliance with applicable employment laws.


Impact & Contribution

  • Ensures high-quality and regulatory-compliant clinical and regulatory documents.

  • Supports project teams by coordinating and producing critical writing deliverables.

  • Helps maintain timelines, budgets, and client expectations for assigned writing projects.