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KGS - Life Sciences - C - BLR - US

3.00 to 5.00 Years   Chennai   04 Oct, 2021
KPMG
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryNBFC ( Non Banking Financial Services )
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

  • Support KPMGs Life Sciences Practice by leading teams to deliver Quality, and Pharmacovigilance related projects
  • Provide regulatory compliance, medical/clinical guidance, Quality/QMS implementation and support to KPMG clients
  • Develop pharmacovigilance case processing strategies, drive assessment & associated activities in compliance with regulatory requirements
  • Assist in developing quality related templates and standard operating procedures
  • Ensure quality program management adhering to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards, requirements, and policies
  • Support Regulatory Affairs transformation projects for Life Sciences clients
  • Drive progress against project milestones to help ensure timely delivery of project deliverables, review the work product of associates, and provide direction and training as necessary
  • Provide input into engagement decisions, including work plan and timeline, project management, resource allocation, and career development of staff members
  • Perform analysis on regulatory-related data, processes, business requirements, operating models, etc.
  • Execute process transformation, measurable improved operational performance, and organizational restructuring
  • Identify and communicate performance improvement opportunities for clients
,
  • In depth knowledge of Quality/QMS, Pharmacovigilance and Medical Device Reporting related to biopharmaceuticals/devices within Life Sciences Industry
  • Experience and good understanding of the regulations and industry standards such as ICH, ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
  • Background in management consulting with a track record of successful engagement management and experience in delivering client presentations
  • Experience with operational process improvement initiatives in a pharmaceutical and/or medical device industry; prior professional services or consulting experience preferred
  • Strong understanding of Regulatory Affairs related data and documents
  • Excellent foundational skills including strong analytical, written and verbal communication skills, MS Office expertise, impactful client presence, compelling facilitation and presentation skills
  • Experience and good understanding of the regulations and industry standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
  • Background in management consulting with a track record of successful engagement management and experience in delivering client presentations

Keyskills :
standard operating proceduresprocess improvement initiativesms officelife sciencescase processingoperating modelsproject managementregulatory affairsprogram managementstatements of work sow

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