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Medical Writer - Vimta Labs Ltd

Vimta Labs Limited
Vimta Labs Limited
2-6 years
₹ 3L - ₹ 7L (Per Year)
10 Feb. 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

Medical Writer – Vimta Labs Ltd (Hyderabad)

About the Role

Vimta Labs Ltd is seeking a Medical Writer with 2 to 6 years of experience to join our team in Cherlapally, Hyderabad. This role involves crafting regulatory documents, clinical trial protocols, study reports, and submissions, ensuring compliance with global regulatory standards.

Compensation

  • CTC: ₹3L - ₹7L per annum (as per market standards)

Key Responsibilities

  • Design clinical trial protocols and PK/PD study designs for biosimilars.
  • Prepare Informed Consent Forms (ICF) and review Case Report Forms (CRF/eCRF).
  • Draft study reports and ensure compliance with eCTD regulatory submission requirements.
  • Collaborate with statisticians for data analysis and study result reviews.
  • Address sponsor, regulatory, and ethics committee queries.
  • Additional regulatory writing experience is a plus.

Required Skills

  • Clinical trials and regulatory writing.
  • Protocol design and study report writing.
  • eCTD submissions and regulatory documentation.
  • ICF preparation and CRF review.

How to Apply

Interested candidates can send their resumes to keerthana.rojanala@vimta.com.