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Senior Medical Writer

5 years
Not Disclosed
10 Sept. 11, 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:

Senior Medical Writer (with Project Management Experience)

Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization built to accelerate customer success. With more than 29,000 employees across 110 countries, we bring clinical, medical affairs, and commercial expertise together to deliver outcomes that change lives.

Work Here Matters Everywhere – Join a team where collaboration, innovation, and passion drive meaningful impact in patient care and industry advancement.

Why Join Us

  • Career development and progression opportunities

  • Supportive line management and peer recognition

  • Technical and therapeutic area training

  • Total Rewards Program

  • A strong Total Self Culture – encouraging authenticity, inclusivity, and belonging

Key Responsibilities

  • Lead and manage medical writing activities for assigned projects with minimal supervision

  • Mentor and support less experienced medical writers on complex projects

  • Serve as lead writer for medical writing deliverables, including:

    • Clinical study reports, protocols, amendments, narratives, annual reports, investigator brochures, and informed consents

    • Regulatory submissions (NDA, IND, eCTD, integrated summary reports)

    • Safety documents (DSUR, PSUR, safety updates)

    • Plain language summaries, clinical development plans, and scientific publications (manuscripts, abstracts, posters, presentations)

  • Prepare and edit internal guidance documents, SOPs, and training materials

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

  • Create process maps using MS Visio or similar tools

  • Conduct online clinical literature searches and comply with copyright requirements

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

  • Act as peer reviewer to ensure clarity, consistency, and compliance with standards

  • Adhere to FDA, ICH, AMA style guide, company SOPs, client templates, and authorship guidelines

  • Propose solutions for issues arising during the writing process, escalating when necessary

  • Ensure deliverables are on-time, within budget, and aligned to project specifications

  • Stay updated on industry practices, regulatory requirements, and therapeutic knowledge

  • Complete administrative and compliance tasks as assigned

  • Minimal travel required (≤25%)

Qualifications & Experience

  • Bachelor’s degree in Life Sciences, English, Communications, or related field

  • Minimum 5 years of project management experience in a relevant setting

  • Strong experience in team handling and leadership

  • Excellent command of English grammar, with expertise in medical/scientific writing

  • Knowledge of FDA, ICH regulations, AMA style guide

  • Strong proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook); MS Visio preferred

  • Proven ability to interpret and present complex clinical data

  • Strong communication, proofreading, presentation, and interpersonal skills

  • Ability to work independently and collaboratively across departments

Impact & Contribution

  • Deliver accurate, high-quality scientific documents for regulatory submissions and publications

  • Enhance team efficiency by mentoring and leading junior writers

  • Strengthen client and cross-functional relationships by ensuring clear, compliant, and timely documentation

  • Contribute to Syneos Health’s mission of accelerating the delivery of therapies that change lives

Additional Information

  • Tasks and responsibilities listed are not exhaustive; other duties may be assigned

  • Equivalent experience, education, or skills will be considered

  • Syneos Health is committed to diversity, inclusion, and compliance with global employment regulations (including ADA and EU Equality Directive)

Apply Now

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