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
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 Diesen Job teilen oder drucken Your responsibilities Annual Product..
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