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Title:  Regulatory Science Clinical Manager

Job ID:  72621
Country:  Switzerland
City:  Geneve
Professional area:  Scientific Regulatory Affairs
Contract type:  Permanent
Professional level:  Experienced
Location: 

Geneve, GE, CH, 1202

 

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

 

 

Regulatory Science Clinical Manager

 

 

What this position is about - Purpose:

Reporting to the VP of Regulatory Science and under their leadership, Regulatory Science Clinical Manager will work closely with the Regulatory Science Clinical Director to support the delivery of all clinical assessments that will be conducted as part of JTI's Reduced Risk Products Regulatory Science Strategy. She / He will provide scientific and technical input whilst managing the progression and delivery of all externally-conducted clinical assessments. You will work closely with the Regulatory Science Clinical Director and other stakeholders to ensure that all external activities adhere to the scope, testing approach protocol and overarching regulatory requirements. The individual will also manage the analysis and compilation of clinical information to be included in regulatory submissions.

 

What will you do - Responsibilities:

  • Works with the Regulatory Science Clinical Director to steer clinical initiatives by: 
    • Managing all aspects of clinical trial execution
    • Supporting feasibility assessments and early country and site engagement to optimize clinical program delivery
    • Resolving study-specific issues, including the interpretation of results, writing and issuance of final reports, timeline changes, and data integrity and/or quality
    • Supporting internal and external engagement activities
    • Collating all pertinent study information to include in clinical sections of associated regulatory submission
       
  • Supports and informs the annual Regulatory Science planning process:
    • Collates information that informs the development of Regulatory Science clinical operations activities
    • Contributes to the assessment and internal reporting of clinical and regulatory industry trends
    • Contributes to the assessment of the competitive landscape and regulatory environment and future Regulatory Science research proposals
       
  • Supports the Regulatory Science Clinical Director in providing awareness to internal business functions on the requirements and approach of the Reduced Risk Products Strategy
    • Responsible for communicating Regulatory Science strategic priorities and deprioritized deliverables
    • Responsible for communicating Program and regulatory priorities to JTI's cross-functional teams

 

Who are we looking for - Requirements: 

  • Degree (Science) preferably to PhD or professional doctorate (e.g., MD, DVM, PharmD) level.
  • 3+ years of experience of clinical trials in a highly regulated industry (Tobacco, Pharma, medical devices) with experience conducting/managing clinical studies is a must
  • Proven track record of managing clinical trials from setup to clinical study report highly preferred
  • Strong collaborative spirit that works well with internal and external stakeholders
  • Excellent relationship management with a client-focused approach to projects
  • Excellent English communication skills (both written and verbal) are a must
  • Excellent interpersonal and business relationships skills, multi-cultural sensitivity
  • Cross-functional team player who can also work independently with minimal supervision
  • Good organization and communication skills

 

What are the next steps – Recruitment process:

Thank you very much for your interest in the role. You are welcome to apply.

 

 


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