Clarivate is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world's most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise.
Post : Content Specialist, CMC (Biologics)
Job Description :
• Monitor the evolution of CMC Biologics landscape worldwide (Monitoring of Regulatory information on the Agency and/or Governmental website)
• Analyze the changes in the CMC and regulatory requirements and implement them in the databases.
• Work in collaboration with a pool of external consultants: undertake the research and identification of local experts, negotiating contract terms, managing invoices and copyrights when needed.
• Provide transversal support to the team and the organization on CMC aspects
• Communicate relevant information to concerned stakeholders, internal and customer facing.
• Undertake any other reasonable duties as requested by the line manager on a permanent or temporary basis
Candidate Profile
• Degree in Life Sciences, Pharmacy, Chemistry
• 2-5 years’ experience in pharmaceutical development, CMC manufacturing or CMC regulatory affairs for Biologics and/or Biopharmaceutical products.
• Strong knowledge of ICH requirements for quality aspects for Biologics and/or Biopharmaceutical products.
• Knowledge of Biological entities appreciated.
• Demonstrated ability to work collaboratively in a highly matrixed organization.
• Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
• Good communication skills and proactivity.
• Experience working with teams globally. Ability to work successfully with extended, multinational project teams on multiple tasks under pressure of time and workload.
• Analysis of large volumes of structured or unstructured data. Ability to delve deep into content and results
• Advanced level of English. Another language would be appreciated.
• Used to work in technology environment
Additional Information
Experience : 2-5 years
Qualification : Degree in Life Sciences, Pharmacy, Chemistry
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th April, 2022
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