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Medical Writer Ii (Clinical Trial Transparency)

2+ years
Not Disclosed
10 April 30, 2025
Job Description
Job Type: Full Time Education: BA/BS 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 II (Clinical Trial Transparency)
Updated: April 3, 2025
Location: India-Asia Pacific – IND-Home-Based
Job ID: 25002559

Job Description:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into impactful outcomes. With over 29,000 employees in 110 countries, we are dedicated to streamlining work, centering on patients and customers, and ultimately delivering therapies faster.

Why Join Syneos Health:

  • Career development and progression opportunities

  • Supportive line management

  • Technical and therapeutic area training

  • Recognition and rewards programs

  • Inclusive “Total Self” culture for authenticity and belonging

Key Responsibilities:

  • Mentor less experienced medical writers when needed

  • Independently compile, write, and edit medical writing deliverables

  • Create/support development of documents including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Annual reports

    • Investigator brochures

  • Review statistical analysis plans and data presentation formats

  • Collaborate with cross-functional departments such as biostatistics, regulatory affairs, and medical affairs

  • Act as a peer reviewer to ensure clarity, scientific accuracy, consistency, and formatting

  • Adhere to ICH-E3, FDA, company SOPs, client standards, and approved templates

  • Conduct clinical literature searches

  • Maintain professional development in regulatory guidance and medical writing standards

  • Track project hours and maintain budget alignment

  • Complete administrative responsibilities timely

  • Other duties as assigned

  • Travel requirement: <25%

Qualifications:

  • B.Sc. with relevant writing experience or B.A. in English, Communications, or Social Sciences with scientific/medical knowledge

  • Strong command of English grammar, FDA/ICH guidelines, and AMA style

  • High independence with excellent presentation, proofreading, and interpersonal skills

  • Team-oriented with leadership capabilities

  • Proficiency in MS Word, Excel, PowerPoint, email, and internet usage

  • Solid understanding of clinical research principles and ability to interpret clinical data

About Syneos Health:

  • Partnered with 94% of all Novel FDA Approved Drugs over the last 5 years

  • Supported 95% of EMA Authorized Products

  • Participated in 200+ studies across 73,000 sites and 675,000+ trial patients

Note:
Responsibilities and qualifications outlined may evolve. The company reserves the right to make changes without notice and remains compliant with local employment legislation and equal opportunity guidelines.