GRA CMC Specialist (m/f/d)

GRA CMC Specialist

m / f / d)

Freelance / temporary employment for a project Bern Start date : asap Reference number : 747520 / 1

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Your responsibilities

• Annual Product Quality Report (APQR) based on RIMS (Regulatory Information Management System)
• Annual Reports support for US, Canada, Brazil, China, EU Submissions document updates, Dossier content creation and Optimization for CH, AU, EU and including all Bern products
• Coordination of implementation plans with implementation experts
• Management of documents in Document Management Systems (upload, compliance check, QC)
• Compliance checks of RIMS and TW Change Controls Regulatory Assessments including follow up with Affiliates and Quality

Your profile

• Degree in Life Sciences or Engineering (Master or PhD)
• Experience in Regulatory CMC and very good MS Office Excel
• Fluent English and intermediate German
• Any experience with Tracking Systems ( Veeva, TrackWise) and documents data bases Data analytical skills
• Project Management skills and ability to accommodate and learn very fast large amount of new data
• Motivated, communicative, proactive
• Preference to quality of work and attention to the details

Your benefits

• Pleasant working atmosphere
• Interesting and varied activities
• Future-proof industry
• Support from Hays throughout the entire recruitment process
Vor 30+ Tagen