Job Summary:
Syneos Health is hiring a Medical Writer II (CSR Narrative) to join its Clinical Development team in Pune, India. This role demands expertise in authoring and reviewing Clinical Study Report (CSR) narratives with a strong understanding of regulatory writing standards. Ideal for candidates with a minimum of 3 years of medical writing experience, this opportunity offers professional growth within a global biopharmaceutical organization dedicated to advancing healthcare outcomes.
Key Responsibilities:
Independently author and review CSR narratives.
Mentor junior medical writers and review their work.
Develop clinical documents including protocols, study reports, patient narratives, and investigator brochures.
Review statistical analysis plans for format and consistency.
Collaborate with data management, biostatistics, regulatory affairs, and medical teams.
Perform online literature searches as needed.
Ensure adherence to ICH-E3 and company SOPs.
Track project budgets and timelines.
Participate in peer reviews and resolve document discrepancies.
Maintain familiarity with current regulatory and clinical research guidelines.
Required Skills & Qualifications:
Bachelor’s degree in Science, or BA in English, Communications with scientific knowledge.
Minimum 3 years of medical writing experience with at least 3 years in CSR Narrative writing.
Proficient in authoring and reviewing CSR narratives independently.
Strong command of English grammar and ICH/FDA regulatory guidelines.
Familiarity with AMA style guide.
Excellent presentation, proofreading, and leadership skills.
Proficient in MS Word, Excel, PowerPoint, and Internet research.
Ability to interpret and present complex clinical data.
Perks & Benefits:
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic area training.
Peer recognition and rewards programs.
Exposure to global clinical development projects.
Company Description:
Syneos Health® is a leading biopharmaceutical solutions provider that drives success for clients across clinical, medical, and commercial segments. Operating in over 110 countries with more than 29,000 employees, the company integrates deep therapeutic expertise with operational excellence to accelerate healthcare innovation.
Work Mode:
On-site – Pune, India
Call-to-Action:
Ready to shape the future of clinical development? Apply now to join Syneos Health as a Medical Writer II and contribute your expertise in CSR narrative writing.
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