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Senior Medical Writer (Ctt)

0-2 years
₹18,00,000 – ₹24,00,000 per annum
10 Aug. 13, 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

Senior Medical Writer (CTT)
Location: Remote – India

Company Overview:
Syneos Health® is a global leader in integrated biopharmaceutical solutions, combining clinical, medical affairs, and commercial expertise to accelerate customer success. With more than 29,000 employees across 110 countries, Syneos fosters an agile, collaborative environment aimed at delivering therapies faster and improving patient outcomes.

Why Join Syneos Health:

  • Career growth through structured development and progression pathways.

  • Supportive leadership and a culture of authenticity and belonging.

  • Access to technical and therapeutic training.

  • Peer recognition programs and competitive rewards.

  • Diverse, inclusive “Total Self” workplace culture.

Key Responsibilities:

  • Lead the creation of high-quality medical writing deliverables, ensuring scientific accuracy, clarity, and regulatory compliance.

  • Manage medical writing tasks for individual studies with minimal supervision, coordinating activities across teams and departments.

  • Draft, review, and manage documents including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, regulatory submissions (IND, NDA, eCTD), integrated summaries, manuscripts, abstracts, and scientific presentations.

  • Conduct and review statistical analysis plan inputs and specifications to ensure consistency, accuracy, and alignment with document needs.

  • Lead disclosure-related activities in platforms like Disclose or PRIME, including drafting, reviewing, workflow management, and user acceptance testing.

  • Coordinate quality control and editorial review processes, maintaining adherence to company SOPs, client guidelines, and ICH E3 standards.

  • Perform clinical literature searches, ensuring compliance with copyright regulations.

  • Mentor junior writers, provide technical guidance, and support professional development.

  • Collaborate with cross-functional teams, including biostatistics, regulatory affairs, and medical affairs, to meet project timelines and budgets.

Qualifications:

  • Bachelor’s degree in a relevant field; advanced degree preferred.

  • Minimum 4 years of relevant experience, including expertise in disclosure platforms.

  • Strong understanding of FDA, ICH, and other regulatory guidelines, plus good publication practices.

  • Proficiency in MS Office and familiarity with AMA Manual of Style.

  • Strong knowledge of medical terminology, clinical research principles, and interpretation of complex data.

Skills:

  • Excellent presentation, proofreading, and communication skills.

  • Strong project and time management capabilities.

  • Ability to lead complex projects and mentor team members.

Salary Range: ₹18,00,000 – ₹24,00,000 per annum (estimated industry standard for senior-level medical writing roles in India).