Job Title: Medical Writer I
Location: India (Home-Based)
Job ID: 25003114
About the Company:
Syneos Health® is a fully integrated biopharmaceutical solutions organization, accelerating customer success by blending clinical, medical affairs, and commercial expertise to deliver modern, patient-focused outcomes. With 29,000 employees across 110 countries, Syneos Health fosters a culture where collaboration, innovation, and inclusion thrive.
Why Join Syneos Health:
Career growth through structured development and progression plans
Supportive and engaged line management
Recognition and total rewards programs
Commitment to diversity, inclusion, and “Total Self” culture
Job Responsibilities:
Compile, write, and edit medical writing deliverables with moderate supervision
Develop or support creation of documents such as:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Investigator brochures
Review statistical documents for grammar, format, and consistency
Collaborate with internal teams (data management, biostatistics, regulatory, medical affairs)
Adhere to regulatory standards including ICH-E3, client SOPs, and templates
Conduct online clinical literature searches
Maintain awareness of current industry regulations and medical writing trends
Manage time and budget efficiently for assigned projects
Complete administrative tasks within deadlines
Perform other assigned duties as required (minimal travel – less than 25%)
Qualifications:
Postgraduate degree in Life Sciences (preferred: M.Pharm or PharmD)
Experience in:
Clinical Trial Disclosure
Regulatory Medical Writing
Pharmacovigilance (Safety Narrative Writing)
Familiarity with drafting CTD documents and performing quality checks
Preferred exposure to regulatory results posting (US FDA, ClinicalTrials.gov, EUCTR)
Additional Notes:
Responsibilities may be subject to change without prior notice
Equivalent education, skills, or experience may be considered
Compliance with all applicable regulations and accommodations under the ADA will be ensured
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