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Senior Medical Writer

5+ years
Not Disclosed
10 Nov. 4, 2025
Job Description
Job Type: Full Time 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

Job Title: Senior Medical Writer

Updated: October 14, 2025
Location: IND – Remote
Job ID: 25101484
Company: Syneos Health®


About Syneos Health

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine clinical development, medical affairs, and commercial expertise to deliver innovative, efficient, and patient-centered solutions.

With over 29,000 employees across 110 countries, we operate with agility and passion to bring life-changing therapies to patients worldwide.
Work Here Matters Everywhere.


Why Join Us

  • Career Growth: Structured professional development, therapeutic area training, and advancement opportunities.

  • Supportive Leadership: Engaged management, peer recognition, and total rewards programs.

  • Inclusive Culture: “Total Self” culture that values authenticity, belonging, and diversity.

  • Global Impact: Partnered in 94% of FDA-approved novel drugs and 95% of EMA-authorized products over the last five years.


Key Responsibilities

  • Lead and manage medical writing projects across clinical and regulatory domains with minimal supervision.

  • Mentor and guide less experienced medical writers on complex projects.

  • Serve as project lead for end-to-end medical writing deliverables, ensuring compliance, quality, and timeliness.

  • Author, compile, and edit a variety of regulatory and scientific documents, including:

    • Clinical Study Reports (CSRs)

    • Clinical Study Protocols and Amendments

    • Investigator Brochures (IBs)

    • Patient Narratives

    • Periodic Safety Update Reports (PSURs) / Development Safety Update Reports (DSURs)

    • Informed Consent Forms (ICFs) and Plain Language Summaries

    • Standard Operating Procedures (SOPs), Training Guides, and Process Maps

  • Create process documentation, including flowcharts and operating guidance (using MS Visio or equivalent).

  • Conduct online clinical literature searches and review current industry practices and regulatory updates.

  • Review statistical analysis plans and table/figure/listing (TFL) specifications for accuracy, consistency, and clarity.

  • Collaborate cross-functionally with data management, biostatistics, regulatory affairs, and medical affairs teams.

  • Serve as peer reviewer, ensuring scientific rigor, grammatical accuracy, and adherence to style and formatting guides.

  • Identify and resolve issues during the writing process, escalating when necessary.

  • Manage project budgets and timelines, ensuring delivery within allocated hours.

  • Maintain compliance with ICH, FDA, EMA, and internal SOPs and templates.

  • Perform administrative tasks and additional work-related duties as assigned.

  • Occasional travel may be required (<25%).


Qualifications

Education:

  • Bachelor’s degree in Science or related field, or

  • Bachelor of Arts in English, Communications, or Social Sciences with relevant medical/scientific knowledge.

Experience:

  • Minimum 5 years of experience in medical writing, preferably in clinical or regulatory documentation.

  • Proven track record of managing end-to-end writing projects independently.

Skills and Competencies:

  • Excellent command of English grammar and style; strong familiarity with FDA and ICH guidelines and AMA style guide.

  • Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and internet-based tools.

  • Experience with MS Visio or similar tools for process mapping.

  • Strong analytical, problem-solving, and data interpretation skills.

  • Effective communication, presentation, and leadership abilities.

  • Ability to coordinate across teams and manage multiple priorities efficiently.

  • Knowledge of clinical research principles and regulatory submission processes.


Role Summary (P22 Level)

Senior Medical Writers at Syneos Health are responsible for producing clear, accurate, and compliant medical and scientific communications for clinical studies, regulatory submissions, and scientific publications.

Core Responsibilities Include:

  • Leading the completion and review of medical writing deliverables.

  • Managing writing activities across studies and functional areas.

  • Coordinating quality and editorial reviews for deliverables.

  • Preparing and reviewing clinical and regulatory documents (e.g., CSRs, protocols, IBs, PSURs, eCTD submissions).

  • Conducting literature reviews and ensuring compliance with copyright and data standards.

  • Acting as a peer reviewer for internal teams to ensure clarity, consistency, and accuracy.

  • Providing technical training and mentoring to junior writers.

  • Maintaining expertise on regulatory requirements and evolving industry standards.

  • Managing project budgets and ensuring efficient resource utilization.


Additional Information

  • Tasks and duties may be modified at the company’s discretion.

  • Equivalent education or experience may be considered for qualification.

  • Syneos Health is an Equal Opportunity Employer, committed to inclusivity, diversity, and ADA compliance.


Learn More

🌐 www.syneoshealth.com
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