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Vaf 175 Medical Writing Specialist

2+ years
Not Disclosed
10 March 6, 2025
Job Description
Job Type: Full Time Education: B.E./B.tech/BCS/B.Sc 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 Writing Specialist – Toxicology Risk Assessment

Job ID: VAF 175
Location: India (Remote Possible)
Department: Life Cycle – Regulatory Affairs & Operations
Employment Type: Permanent Contract

Responsibilities:

  • Conduct comprehensive toxicology risk assessments across diverse scenarios, ensuring robust safety evaluations.
  • Perform and review toxicology risk assessments for excipients, impurities, solvents, extractables, and leachables, ensuring adherence to regulatory standards.
  • Execute Environmental Risk Assessments (ERA) in compliance with the latest EMA guidelines.
  • Prepare, maintain, and update toxicology summaries for globally marketed products in alignment with company policies.
  • Develop and compile PDE and OEL monographs to support safety evaluations.
  • Prepare clinical and non-clinical dossier modules (Modules 2.4, 2.5, 2.6, 2.7, 4, and 5) for regulatory submissions.
  • Manage preclinical studies and associated documentation to ensure compliance and accuracy.
  • Perform QSAR genotoxicity assessments in accordance with ICH M7 guidelines.
  • Utilize advanced in-silico predictions (DEREK, SARAH, NEXUS, TOXTREE, OECD Toolbox) for data analysis and risk assessment.
  • Provide expert guidance in addressing client and regulatory inquiries effectively.

Background Required:

  • Qualified Toxicologist with expertise in non-clinical/toxicological report signing.
  • Experience in drafting Environmental Risk Assessment reports.
  • Due diligence of pre-clinical data and drafting strategies for non-clinical studies for complex generics, NCEs, Biologics, etc.
  • Proficiency in drafting and reviewing non-clinical CTD modules.
  • Expertise in drafting PDE reports.
  • Experience in toxicological risk assessment of impurities, leachables, and extractables.

Required Education:

  • Qualified and experienced Toxicologist.

Required Experience:

  • At least 2 years of experience in the mentioned activities.