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Medical Writer I (Ctd/Ctt)

1 years
Not Disclosed
10 Sept. 10, 2025
Job Description
Job Type: Hybrid Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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

Job Title:

Medical Writer I (CTD/CTT)

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. By combining clinical, medical affairs, and commercial insights, we deliver outcomes that address modern market needs.

With 29,000 employees across 110 countries, our mission is to keep both the customer and the patient at the center of everything we do. We continuously strive to simplify processes, drive innovation, and accelerate the delivery of therapies that change lives.

Work Here Matters Everywhere.


Why Syneos Health?

  • Career development and progression opportunities

  • Supportive and engaged line management

  • Technical and therapeutic area training

  • Peer recognition and total rewards program

  • A Total Self culture that fosters authenticity and belonging

  • A diverse, inclusive, and collaborative workplace where everyone feels valued


Position Summary

The Medical Writer I serves as a key member of clinical study and regulatory project teams. This role involves writing, editing, and coordinating content for a wide range of clinical and regulatory documents, ensuring quality, compliance, and timely delivery.


Key Responsibilities

  • Act as a medical writer for clinical trial disclosure (CTD/CTT) deliverables with 6 months–1 year of experience in the field.

  • Support and prepare documentation for:

    • Clinical study protocols and amendments

    • Clinical study reports (CSRs)

    • Investigator brochures (IBs)

    • Patient narratives

  • Perform protocol registration and results registration for clinical trials.

  • Review statistical analysis plans, tables, figures, and listings for accuracy, clarity, format, and consistency.

  • Collaborate with cross-functional teams (Data Management, Biostatistics, Regulatory Affairs, Medical Affairs).

  • Adhere to regulatory standards (ICH-E3, SOPs, client guidelines, templates).

  • Conduct online clinical literature searches as needed.

  • Maintain awareness of project budgets, timelines, and communicate risks or changes.

  • Ensure professional development to keep current with evolving regulatory guidance.

  • Complete administrative tasks within defined timelines.

  • Perform other assigned duties; minimal travel (<25%) may be required.


Qualifications

  • Minimum 6 months–1 year experience in clinical trial disclosure/CTT.

  • Strong experience in protocol and results registration.

  • Excellent communication and client management skills.

  • Working knowledge of regulatory guidelines (ICH-E3) and medical writing best practices.

  • Ability to collaborate effectively across departments.

  • Detail-oriented, organized, and able to meet deadlines within budget.


Additional Information

  • Responsibilities listed are not exhaustive; additional tasks may be assigned.

  • Equivalent experience, education, or transferable skills will be considered.

  • Syneos Health complies with global employment legislation, including ADA accommodations and EU Equality Directive requirements.

  • No employment contract is created by this description.


About Syneos Health’s Impact

  • Partnered with 94% of all novel FDA-approved drugs in the last 5 years

  • Supported 95% of EMA-authorized products

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


Application Process

Interested candidates are encouraged to apply. If your experience does not align perfectly, we still welcome your application and invite you to join our Talent Network to stay connected to future opportunities.

[Apply Now] | [Join Talent Network]