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Medical Writer Ii

1-3 years
Not Disclosed
10 Sept. 17, 2025
Job Description
Job Type: Hybrid Remote 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 II

Location: IND-Remote
Updated: August 29, 2025
Job ID: 25101318


Company Overview

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

  • Patient- and customer-centric Clinical Development model

  • Agile, collaborative, and innovative teams

  • 29,000 employees across 110 countries

Global Impact:

  • 94% of novel FDA-approved drugs and 95% of EMA-authorized products in the last 5 years

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

Learn more: www.syneoshealth.com


Why Syneos Health

  • Career Development: Training, mentorship, and progression opportunities

  • Inclusive Culture: Total Self culture fostering authenticity and belonging

  • Collaboration: Cross-functional teamwork to achieve customer goals


Role Summary

The Medical Writer II leads medical writing activities for clinical and regulatory documents, ensuring scientific information is accurate and clearly presented.

  • Focus on clinical trial disclosure, registries, and regulatory submissions

  • 1–3 years of relevant experience in clinical trial disclosure required

  • May involve combination of redaction and disclosure activities


Core Responsibilities

Medical Writing & Document Support

  • Complete documents including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Annual reports, investigator brochures, informed consents

    • Plain language summaries, periodic safety update reports

    • Clinical development plans, IND submissions, integrated summary reports, NDA/eCTD submissions

    • Journal manuscripts, abstracts, posters, and scientific presentations

  • Ensure deliverables comply with regulatory standards (ICH E3, company SOPs, client standards, approved templates)

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

  • Perform online clinical literature searches and maintain copyright compliance

Collaboration & Leadership

  • Coordinate medical writing activities across departments with minimal supervision

  • Interact with clients, department heads, and peers in:

    • Data Management, Biostatistics, Regulatory Affairs, Medical Affairs

  • Act as a peer reviewer for internal team members

  • Mentor and guide less experienced medical writers on complex projects

Compliance & Process

  • Adhere to established regulatory standards and internal SOPs

  • Ensure source documentation is managed appropriately

  • Maintain awareness of project budgets and complete work within allocated hours

  • Identify and propose solutions to resolve issues, provide technical support and training


Qualifications & Experience

  • 1–3 years of experience in clinical trial disclosure

  • Knowledge of clinical research, clinical trials, and clinical registries (CT.gov, CTIS, EUDRACT)

  • Bachelor’s degree in a relevant discipline (graduate degree preferred)

  • Client interaction experience preferred


Key Skills

  • Strong presentation, proofreading, collaborative, and interpersonal skills

  • Strong project and time management skills

  • Proficiency in MS Office

  • Strong understanding of medical terminology, clinical research principles, and data interpretation


Additional Information

  • Tasks and responsibilities may be adjusted at company discretion

  • Equivalent skills and experience will be considered

  • Compliance with employment legislation and ADA requirements


How to Apply

  • Apply via Syneos Health careers portal

  • Join the Talent Network to stay connected with future opportunities