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.
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Queensland |Melbourne :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Manila |Croatia :
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