Vaf 175 Medical Writing Specialist

2+ years

Not Disclosed

Remote

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.

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Vaf 175 Medical Writing Specialist

Job Description

Responsibilities:

Background Required:

Required Education:

Required Experience:

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