Instagram
youtube
Facebook

Medical Writer Ii (Clinical Trial Transparency)

0-2 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Job Title:

Medical Writer II (Clinical Trial Transparency)

Updated:

Yesterday

Location:

India-Asia Pacific – IND-Gurugram-Hybrid, India

Job ID:

25002559-IND002

Company:

Syneos Health®


About Syneos Health:

Syneos Health® is a fully integrated biopharmaceutical solutions company committed to accelerating customer success. Operating in 110 countries with over 29,000 employees, it brings clinical, medical, and commercial insights to drive patient-centered outcomes.


Why Work at Syneos Health:

  • Career growth and progression opportunities

  • Inclusive Total Self culture for authenticity and belonging

  • Strong focus on training, peer recognition, and rewards

  • Passionate, global team driving real-world health impacts


Job Responsibilities:

Writing & Documentation

  • Independently compile, write, and edit clinical and regulatory documents, including:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Patient narratives

    • Annual reports

    • Investigator brochures

  • Review statistical analysis plans and related outputs for accuracy and clarity

  • Ensure scientific accuracy, consistency, and adherence to templates and regulatory standards

  • Conduct literature searches as needed

  • Maintain awareness of timelines and budget

Collaboration & Mentorship

  • Collaborate with cross-functional departments (e.g., biostatistics, data management, regulatory)

  • Mentor junior medical writers

  • Participate in internal peer reviews and address reviewer comments appropriately

Compliance & Standards

  • Follow ICH-E3 guidelines, FDA/EMA regulations, and company/client SOPs

  • Adhere to AMA style and maintain documentation quality and compliance

  • Stay updated with evolving regulatory guidelines and industry practices


Qualifications:

Education & Experience

  • Required:

    • Bachelor of Science (life sciences) with relevant writing experience

    • OR Bachelor of Arts (English, Communications, or Social Sciences) with scientific/medical knowledge

Skills & Competencies

  • Proficient in English grammar, with strong understanding of FDA/ICH guidelines

  • Familiarity with AMA style guide

  • Strong presentation, editing, interpersonal, and leadership abilities

  • Skilled in Microsoft Office tools (Word, Excel, PowerPoint), email, and internet research

  • Ability to interpret and present clinical data accurately


Additional Information:

  • Minimal travel required (less than 25%)

  • Responsibilities are subject to change at company’s discretion

  • The company complies with global employment equality and accessibility standards