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Clinical Registry Specialist (Yacht Life Sciences)

Medical
Diemen
A global biotechnological company that develops, acquires, and commercializes pharmaceutical products and biopharmaceutical therapies.  Yacht Life Sciences has a vacancy for a Clinical Registry Specialist at our client, a global biotechnological company.  As a Clinical Registry Specialist you will be responsible for developing processes and tools to support streamlined International disclosure for assigned countries. You act as a Subject Matter Expert for supporting all of the operational asp...

Requirements:

  • A Bachelor or Master degree in (Bio)medical Science, Bio-pharmaceutical Science, Life Science & Technology or equivalent is required
  • A minimum of 4 years of experience in a medium to large scale matrix quality organization (operational quality and/or quality assurance) or equivalent time and experience in a related R&D area (clinical trials, regulatory affairs, data management, data operations and/or statistics) is preferred
  • Demonstrated competency in accurate work with clinical trial or regulatory data, data management, programming, scripting or data operations
  • Successful global collaborations and partnerships in a globally diverse environment
  • Knowledge of procedural and records management requirements in a regulated industry is beneficial.
  • Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required
  • Prior pharmaceutical and quality/compliance related experience is preferred
  • Knowledge of the pre-clinical and clinical drug development process is beneficial
  • Excellent knowledge of English is required
Non Technical Skills and Additional Details:           

You must be strong multitasker, used to a complex, non-standard work environment whilst maintaining highest admin record standards for 'reproducibility' of trials. We are open to candidates with the right background (CTA-GTM/Regulatory Submission experience) and skill-set.

Required skills:
  •  Strong personal leadership with demonstrated competency interfacing with other team members 
  •  Strong networking and relationship building skills 
  •  Ability to support an open, inviting and creative environment 
  •  Ability to embrace generational differences 
  • Experience working with multidisciplinary and cross functional leaders from IT, R&D, Medical Safety, Regulatory and Quality functions 
  •  Strong interpersonal skills with demonstrated history of collaboration across multiple functional areas 
  •  Proactive strategic thinker with strong problem solving skills 
  •  Strong conflict management/negotiation skills
​Technology experience and skills: 
  •  Experience with Quality and Compliance systems is preferred  
  •  Proficient in Microsoft Office applications 
Address:

Leiden