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Title:  Regulatory Data Quality and Documentation Manager

Job ID:  70267
Country:  Switzerland
City:  Geneve
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Geneve, GE, CH, 00 - 000

 

We’re JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you’re free to choose. In fact, we’ve spent the last 20 years innovating, creating new and better products for our consumers to choose from. It’s how we’ve grown to be present in 130 countries.

But our business isn’t just business. Our business is our people. Their talent. Their potential. We believe when they’re free to be themselves, grow, travel and develop, amazing things can happen for our business

That’s why our employees, from around the world, choose to be a part of JTI. It is why 87% of employees feel happy working at JTI. And why we’ve been awarded Global Top Employer status, eight years running

So when you’re ready to choose a career you’ll love, in a company you’ll love, feel free to #JoinTheIdea. 

Learn more: jti.com

 

 

Job Title: Regulatory Data Quality and Documentation Manager

Location: Switzerland, Geneva

Reporting to: Regulatory Science VP

 

 

Regulatory Data Quality and Documentation Manager

 

 

What this position is about - Purpose:

 

Reporting to the VP of Regulatory Science and under their direction, the incumbent will be responsible for maintaining all internal and external data records  that support or will be included in regulatory dossiers. The jobholder will prepare internal SOPs, have oversite and coordination of JTI and external vendor audits to confirm data integrity, GxP, protocol and SOP compliance. The incumbent will coordinate or directly perform ongoing quality control reviews of all data sources for potential inclusion within regulatory dossiers. The individual is responsible for creating and maintaining a data management system in compliance with regulatory standards

 

Main Responsibilities:

 

  • Management of documentation being provided from multiple disciplines (e.g., CMC, Clinical, Non-Clinical, Behavioral, Modeling) including any requests, approvals, changes and sign-offs related to provided documentation
  • Responsible for internal SOP generation and Regulatory database maintenance and compliance; has oversight of, or directly performs quality control review of, all documentation supporting regulatory submissions
  • Managing external and internal data, including its conformity with global regulatory submission requirements
  • Monitors and regularly updates Regulatory Science Team on best practices related to data management
  • Monitors and regularly updates Regulatory Science Team on changes to regulatory submission requirements and safeguards that best practices are implemented
  • Ensures JTI and third-party vendor practices and systems, adhere to relevant regulatory requirements
    • Responsible for defining and updating regulatory audit best practices
    • Responsible for performing or coordinating audits of external vendors for data integrity, GxP, Protocol and SOP compliance
    • Periodically assesses JTI Regulatory Science compliance with internal SOPs and implements action plans to resolve potential compliance issues
  • Contributes to the delivery of Regulatory Science initiatives

 

Requirements:

 

  • Bachelor's degree with a degree in analytical chemistry, natural science, chemical engineering or a related subject preferred; RQAP certification (GCP or GLP) or equivalent preferred
  • Proven experience (3-5 years) working as an auditor or documentation management specialist in a highly regulated industry (Pharma, Medical Devices or Tobacco)
  • Experience auditing or overseeing audits of GCP or GLP studies performed by third-party vendors is preferred with experience auditing both GCP and GLP studies highly desired
  • Experience authoring SOPs required
  • Excellent working knowledge of commonly used quality management software systems required
  • Excellent English communication skills (both written and oral) and multi-cultural sensitivity
  • Cross-functional team player who can also work independently with minimal supervision
  • Good organization and communication skills
  • Excellent IT skills in MS Office and an in-depth knowledge of commonly used quality management software systems

 

 


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