Strategy and delivery of PCS deliverables for products under development and in-market.
Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products.
Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts.
Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives.
Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines.
Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books.
Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables.
Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement.
Act as a nonclinical scientific liaison to Submissions & Documentation (S&D) vendor supporting nonclinical submission document management.
Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines.
Essential Requirements:
PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing
In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment
Understanding of GLP principles in nonclinical studies and submission writing.
Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred.
Registration and certification with one of the International Toxicology registers.
Desirable Requirement:
Animal Models ,Communication Skills, Data Analysis.
