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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