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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Rs 7 - 12 Lakh/Yr |
| Industry | Retail |
| Functional Area | Pharmacist / Medical Representative |
| EmploymentType | Full-time |
JOB TITLE: Associate Director, Global Preclinical Development EPDDIVISION: Abbott Established Pharmaceuticals DivisionREPORTS TO: Director, EPD IndiaTHE POSITION:Assist Senior Management in leading the EPD Preclinical Development function by providing preclinical input to Toxicologists in the Global Preclinical Development (GPD) Team, manage and direct as needed toxicology Project and EPD Development.Expected non-clinical development support through the design, management and regulatory requirements of specific non-clinical safety projects for the companys drug development programs, as well as provide expertise and guidance in Scientific, Regulatory & Innovation Toxicology to project teams as needed.Highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. Adhere to established processes, policies, and quality systems for outsourcing, managing and reporting regulatory toxicology programs, studies, and other activities.CORE JOB RESPONSIBILITIES:Responsible for the performance and quality of preclinical work and deliverables, e.g. nonclinical safety and risk assessments related to EPD products as well as preclinical contributions to regulatory submissions (dossiers, variations).Contributes via global project teams to oversight and guidance in the design, conduct, and supervision of pre-clinical toxicology studies in accordance with rules and regulations.Responsible for chairing the Abbott Drug Handling Committee (ADHC), review GPD team member preparation and maintenance of Employee Exposure Limits and Residual Dose Limits for EPD products and its intermediates, to ensure occupational and product safety.Establish effective working relationships with cross functional team members to ensure all toxicology studies are completed with high quality in a timely, and scientific manner.Contribution to the preparation of regulatory documents interactions with regulatory authorities as needed. Lead operational activities as appropriate. Interface with Senior Management to provide and obtain information and to build consensus regarding project direction. Active participant on global project/program teams and work closely with other functional area.POSITION ACCOUNTABILITY / SCOPE:Accountable for planning and developing nonclinical activities (toxicology) and will provide guidance in nonclinical development to project/program team members.Conversant with tools for insilico analysis, organizing & monitoring of in vivo toxicology studies, able to review and approve final study reports, and communicate with Senior Management and external stakeholders.Essentially, the candidate needs to offer support by managing the team, attend day-to-day tasks, peer review the risk assessment reports and take the responsibility of developing the excellent centers of DMPK & in-silico analysis.Potential to manage direct reports in toxicology.MINIMUM EXPERIENCE / REQUIREMENTS
Keyskills :
medicaldevices riskassessment qualitysystems drugdevelopment toxicology iprojectteams nonclinicalsafety DrugHandling