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Medical Writer Ii (Csr Narrative Exp Only)

3+ years
Not Disclosed
10 June 12, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 Summary:

Syneos Health, a globally recognized biopharmaceutical solutions company, is seeking a Medical Writer II (CSR Narrative experience only) to join its Pune, Maharashtra team. This role is ideal for candidates with 3+ years of experience in Clinical Study Report (CSR) narrative authoring and reviewing, coupled with strong regulatory knowledge including FDA and ICH guidelines. Take part in shaping life-changing therapies and drive clinical research excellence.


Key Responsibilities:

  • Mentor junior medical writers as required.

  • Independently compile, write, and edit various clinical documents, including protocols, reports, narratives, and brochures.

  • Author and review CSR Narratives as a core focus.

  • Review statistical plans and specifications for consistency and clarity.

  • Collaborate across departments like Data Management, Biostatistics, Regulatory Affairs, and Medical Affairs.

  • Serve as an internal peer reviewer ensuring scientific accuracy and regulatory compliance (ICH-E3, SOPs).

  • Conduct clinical literature research to support document development.

  • Maintain awareness of budget and time constraints, updating leadership as necessary.

  • Perform additional tasks as assigned with occasional travel (less than 25%).


Required Skills & Qualifications:

  • Minimum 3 years of medical writing experience with at least 3 years in CSR Narrative authoring.

  • Strong experience in independent CSR Narrative writing and review.

  • Bachelor’s degree in Science or related fields; Arts graduates (English, Communications) with scientific knowledge may also apply.

  • Excellent command of English grammar, FDA, and ICH regulatory guidelines.

  • Familiarity with AMA style guide.

  • High level of independence, leadership, and presentation skills.

  • Proficiency in MS Word, Excel, PowerPoint, email, and internet tools.

  • Ability to interpret complex clinical data and research principles effectively.


Perks & Benefits:

  • Clear career progression and growth opportunities.

  • Specialized technical and therapeutic training.

  • Total rewards and peer recognition programs.

  • Supportive, inclusive “Total Self” company culture.

  • Global exposure within 110+ countries and a team of 29,000 professionals.


Company Description:

Syneos Health is a leading global biopharmaceutical services organization offering clinical development, medical affairs, and commercial solutions. The company partners with pharmaceutical and biotech firms to advance therapies faster and more efficiently to global markets.


Work Mode: On-site (Pune, Maharashtra, India)


Call to Action:

Qualified candidates passionate about CSR narrative writing and clinical research are invited to apply now and make a meaningful impact with Syneos Health.