Medical Writer II – CSR Narrative

Syneos Health

. Mentor less experienced medical writers on projects, as necessary .

Posted 10/28/2026full-timeHyderabad • IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical writing, including clinical study protocols, reports, and narrative writing, while adhering to regulatory guidelines such as ICH and FDA standards. Possesses strong communication and leadership skills to mentor peers and collaborate effectively with cross-functional teams.

Highest-signal resume keywords

Medical Writing ExperienceCSR Narrative WritingKnowledge of FDA RegulationsProficiency in Microsoft WordClinical Research Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical WritingClinical Study ProtocolsClinical Study ReportsNarrative WritingStatistical Analysis ReviewEditingLiterature SearchesBudget MonitoringRegulatory GuidelinesDrug Development Process

Soft Skills

MentoringInterpersonal SkillsLeadership SkillsPresentation SkillsTeam-Oriented Approach

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPointEmailInternet

Industry Keywords

ICH-E3 GuidelinesAMA Style GuideClinical Data InterpretationAdministrative TasksClient Standards

About the role

Key responsibilities & impact

Mentor less experienced medical writers on projects, as necessary
Compile, write, and edit medical writing deliverables with minimal supervision
Develop or support clinical study protocols and amendments
Develop or support clinical study reports
Draft and author patient narratives
Develop or support annual reports and investigator brochures
Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
Interact with department heads and data management, biostatistics, regulatory affairs, and medical affairs teams
Serve as peer reviewer and address team comments
Follow ICH-E3 guidelines, company SOPs, client standards, and approved templates
Perform online clinical literature searches
Continue professional development on regulatory guidance and client expectations
Monitor budget specifications and communicate changes to medical writing leadership
Complete required administrative tasks within specified timeframes
Perform other assigned work-related duties

Requirements

What you’ll need

Min 2-4yrs of medical writing experience
Min 1 yr of narrative writing experience
Should be well versed with CSR Narrative writing (Drafting and authoring)
Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines
Familiarity with AMA style guide
Demonstrated high degree of independence
Effective presentation, proofreading, interpersonal, and leadership skills
Team-oriented approach
Strong proficiency in Word, Excel, PowerPoint, email, and Internet
Familiarity with principles of clinical research
Ability to interpret and present clinical data and other complex information
Working knowledge of drug development process and regulatory guidelines

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Minimal travel (less than 25%)