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1-2 years
Not Disclosed
10 Jan. 8, 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

Job Position: Medical Writer
Industry Type: Clinical Research / Contract Research
Department: Research & Development
Employment Type: Full-Time, Permanent
Role Category: Pharmaceutical & Biotechnology

Role & Responsibilities:

  • Coordinate with the Project Manager (PM), Principal Investigator (PI), Clinical Investigator (CI), Bioanalytical team, and Statistician for protocol preparation.
  • Prepare Informed Consent Documents (ICD) in English and coordinate their translation into local languages and back-translation, if applicable.
  • Prepare Case Report Forms (CRFs) and other working documents, if applicable.
  • Prepare documents for submission to regulatory authorities.
  • Incorporate comments received from the Investigator, QC, QA, BR, and Sponsor before finalizing the protocol.
  • Conduct internal quality control (QC) of study documents.
  • Perform literature searches.
  • Assist the Project Manager with feasibility assessments for study proposals.
  • Conduct literature surveys for PK & Safety studies.
  • Coordinate with the Principal Investigator (PI) and/or Clinical Investigator (CI) for application submissions.
  • Prepare documents for submission to the Ethics Committee (EC).

Qualifications & Experience Required:

Education:

  • UG: B. Pharma (Any Specialization)
  • PG: M. Pharma (Any Specialization)

Key Skills:

  • CRF
  • ICD
  • Medical Writing

About Veeda Clinical Research Limited:
Veeda Clinical Research Limited, together with its subsidiary Bioneeds India Private Limited and joint venture Ingenuity Biosciences Private Limited, offers a comprehensive portfolio of clinical, preclinical, and bioanalytical services. We support global innovator, biosimilar, and generic drug development programs. As a professionally managed contract research group, we provide scientific leadership, global quality management systems, and long-term operational and financial stability. Our commitment to quality is reflected in our continuous investment in people, processes, systems, infrastructure, and technology.

We serve clients globally in the following industries:

  • Pharmaceutical and Biopharmaceutical
  • Agrochemical and Industrial Chemicals
  • Herbal/Nutraceuticals
  • Medical Devices

Company Info:

  • Address: 2nd, 3rd, 4th Floor, Shivalik Plaza-A, Nr. Atira, IIM Road, Ahmedabad, Gujarat 380015, India