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Medical Writer

10-12 years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Title: Medical Writer
Location: Bangalore
Date: 17 Dec 2024

Job Description:

The Medical Writer is responsible for developing and finalizing clinical and scientific documents for regulatory submissions, such as Bioanalytical Reports, Clinical Study Reports (CSRs), and other modules of the Electronic Common Technical Document (eCTD), across various therapeutic areas and phases of clinical research. The role involves collaborating with internal and external stakeholders, ensuring compliance with regulatory guidelines, and delivering high-quality documents within timelines.

Key Responsibilities:

  • Develop and finalize clinical and scientific documents for regulatory submissions, including Bioanalytical reports, CSRs, and eCTD modules.
  • Collaborate with internal and external clients to ensure effective communication and operational excellence.
  • Manage medical writing processes and ensure timely delivery of quality projects.
  • Ensure compliance with regulatory guidelines, departmental SOPs, and client-specific style guides.
  • Perform quality control (QC) checks on medical writing deliverables and address any issues.
  • Conduct literature searches/reviews as needed to obtain background information for scientific content development.
  • Follow all other related duties as assigned by the supervisor.

Required Qualifications:

  • Education: Graduate or Master's in Life Sciences.
  • Experience: 10-12 years in medical writing or a related field.

Behavioral Skills:

  • Strong communication and time management skills.
  • Ability to quickly learn and adapt to new information.
  • Professional attitude and adaptability to change.

Technical Skills:

  • Ability to comprehend complex scientific information.
  • Knowledge of clinical research and regulatory submission processes.
  • Proficient in MS Word, PowerPoint, and other documentation tools.
  • Commitment to adhering to environmental, health, and safety (EHS) guidelines.

Syngene Values:

  • Excellence
  • Integrity
  • Professionalism