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Medical Writer

7-10 years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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 Title: Medical Writer
Date: 24 Jan 2025
Job Location: Bangalore
Department: Medical Writing


About Syngene

Incorporated in 1993, Syngene International Ltd. is a global innovation-driven organization specializing in discovery, development, and manufacturing services. Syngene provides integrated scientific solutions across pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. Partnering with global leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife, Syngene is driven by a culture of innovation, backed by a dedicated team of 4,240 scientists.


Role Overview

The Medical Writer will independently develop clinical and scientific documents for regulatory submissions, collaborating with internal and external stakeholders to ensure high-quality deliverables aligned with operational timelines and regulatory standards.


Key Responsibilities

Document Development:

  • Prepare and finalize clinical and scientific documents, including but not limited to:
    • Bioanalytical reports
    • Clinical Study Reports (CSRs)
    • Electronic Common Technical Document (eCTD) modules
  • Work across multiple therapeutic areas and clinical research phases.

Collaboration and Communication:

  • Collaborate with internal teams and external clients to ensure effective communication and operational excellence.
  • Support cross-functional teams in the review and approval of medical writing deliverables.

Quality and Compliance:

  • Ensure adherence to regulatory guidelines, department SOPs, and client-specific style guides and conventions.
  • Perform and document quality control (QC) checks on medical writing outputs.

Additional Responsibilities:

  • Conduct literature searches and reviews to gather background information for scientific content.
  • Adhere to and promote environment, health, and safety (EHS) measures as per company guidelines.
  • Take on other duties and responsibilities as assigned by the supervisor.

Educational Qualification

  • Graduate in Life Sciences
  • Master’s degree in Life Sciences

Experience

  • 7–10 years of relevant experience in medical writing and clinical research.

Skills and Competencies

Technical/Functional Skills:

  • Strong comprehension of scientific information.
  • In-depth understanding of clinical research.
  • Proficiency in Microsoft Word, PowerPoint, and other relevant tools.

Behavioral Skills:

  • Effective communication skills.
  • Quick learner with the ability to adapt to change.
  • Strong time management and professionalism.

Syngene Values

All employees are expected to demonstrate alignment with Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunities (EEO) to all individuals regardless of age, gender, nationality, disability, or any other characteristic protected by law. Reasonable accommodations are available for qualified individuals with disabilities.


For more information, visit Syngene’s official website.