Medical Writer II (Narrative Writing)
Updated: Yesterday
Location: Pune, Maharashtra, India
Job ID: 25100333
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a leading global biopharmaceutical solutions organization focused on accelerating customer success. By integrating clinical development, medical affairs, and commercial capabilities, Syneos Health delivers meaningful outcomes that address today’s evolving healthcare and regulatory landscape.
With a patient-centric Clinical Development model, the organization is committed to simplifying processes, fostering collaboration, and enabling innovation across global clinical programs. With more than 29,000 professionals operating in over 110 countries, Syneos Health offers an environment where impactful work truly matters.
Role Overview
The Medical Writer II (Narrative Writing) position is responsible for the authoring, review, and coordination of high-quality clinical safety narratives and related regulatory documents. This role requires strong expertise in clinical study report (CSR) narrative writing, a solid understanding of regulatory standards, and the ability to collaborate effectively with cross-functional teams under minimal to moderate supervision.
Key Responsibilities
Author, edit, and finalize clinical study report (CSR) safety narratives, including incorporation of reviewer comments and coordination with internal stakeholders
Compile, write, and manage medical writing deliverables that present scientific and clinical data clearly, accurately, and in compliance with regulatory standards
Prepare a range of clinical and regulatory documents, including:
Clinical Study Reports (CSR)
Patient narratives
Clinical study protocols and amendments
Investigator’s Brochures
Informed Consent Forms (ICF)
Plain Language Summaries (PLS)
Periodic Safety Update Reports (PSUR/DSUR)
Annual reports
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure adherence to ICH E3 guidelines, FDA and EMA regulations, company SOPs, client standards, and approved templates
Coordinate and support quality control and editorial review processes, ensuring appropriate source documentation management
Act as a peer reviewer to ensure scientific accuracy, consistency, clarity, and formatting compliance
Review statistical analysis plans (SAPs) and tables, figures, and listings (TFLs) for content accuracy and data consistency
Collaborate with biostatistics, data management, regulatory affairs, medical affairs, and clinical teams to support document development
Conduct clinical literature searches while ensuring copyright compliance
Identify documentation issues and propose effective solutions, escalating when necessary
Mentor junior medical writers as required on assigned projects
Maintain current knowledge of drug development processes, regulatory guidance, and industry best practices
Work within assigned project budgets and timelines, communicating progress to medical writing leadership
Complete administrative tasks and other assigned duties within defined timelines
Required Experience
Minimum 2 years of hands-on experience in medical, scientific, or technical writing
Demonstrated experience in CSR safety narrative writing
Experience within the biopharmaceutical, medical device, or contract research organization (CRO) environment preferred
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Master’s degree or other graduate qualification preferred
Required Skills and Competencies
Strong understanding of FDA, EMA, ICH guidelines, and global regulatory requirements
Excellent written English skills with strong grammar and clarity
Familiarity with the AMA Manual of Style
Solid understanding of clinical research principles and drug development processes
Ability to interpret and present complex clinical and statistical data
Strong organizational, time management, and multitasking abilities
Effective communication and stakeholder collaboration skills
Proficiency in Microsoft Office applications
Why Join Syneos Health
Work on global clinical programs supporting regulatory submissions worldwide
Access structured career development, technical training, and mentorship opportunities
Be part of a diverse, inclusive, and collaborative global work culture
Contribute to studies supporting the majority of FDA- and EMA-approved therapies
Over the past five years, Syneos Health has supported:
94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ studies across 73,000+ sites and 675,000+ trial participants
Additional Information
This job description is not intended to be all-inclusive. Syneos Health reserves the right to assign additional responsibilities as needed. Equivalent combinations of education, skills, and experience may be considered. Employment terms comply with applicable local and international employment legislation, including equal opportunity and disability accommodation requirements.
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