Chief Toxicity Investigator

17 hours ago

Hyderabad Secunderabad Telangana, India beBeeToxicologist Full time ₹ 15,00,000 - ₹ 20,00,000
Senior Scientific Researcher

This role involves the development and review of nonclinical scientific submission components. You will join a team to discuss strategies and deliver non-clinical safety deliverables for products globally responsible for.

Key Responsibilities:
  • Strategy and delivery of PCS deliverables for products under development and in-market.
  • Independently provide PCS inputs in regulatory documents, address queries on delegated products, conduct literature searches and analyze relevant non-clinical safety data.
  • Contribute to the objectives and deliverables of cross-functional teams in collaboration with other representatives.
  • Evaluate toxicological profiles of impurities, degradants, and assess specification limits based on ICH guidelines.
  • Provide nonclinical scientific writing support for regulatory submission documents.
  • Organize nonclinical scientific activities and timelines in collaboration with authors for planned submissions.
  • Develop expertise in document management systems to facilitate timely completion of projects and meet compliance requirements.
Requirements:
  • PhD in life sciences with 6+ years' experience in drug discovery, drug development, and/or life cycle management studies.
  • In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics/pharmacodynamics, and experience working in project teams.
  • Understanding of GLP principles in nonclinical studies and submission writing.
  • Proficient with full range of techniques used in job and core areas.
  • Extensive library research skills and knowledge of problem-solving techniques; publication and presentation experience preferred.
  • Excellent communicators, strong team players, and have a high level of logistical/planning ability.

The ideal candidate will have a strong background in toxicology and preclinical safety assessment, excellent communication and teamwork skills, and experience working in project teams.

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