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Helps. Cares. Protects.

Join our team as a

Senior Advisor for Clinical Evidence Generation (f/m/d) 

DEU-Heidenheim

 

Your area of responsibility:    

  • Assist with clinical development plans including study design and implementation strategies
  • Develop and lead the execution of strategic plans and objectives for Medical Competence Center; liaise with cross-functional departments and business partners to ensure that all related activities are in alignment with company business processes
  • Contributes to building and maintating a network of external service providers
  • Aligning internal and external partners and contributors to clinical investigations
  • Drive strong cross-functional relationships at senior leadership level through frequent interactions and solid strategic thinking and communication skills; interact effectively with senior leadership when required
  • Advising business partners on defining smart claims and medical evidence generation strategy with input from the head of the Medical Competence Center (including risk and success chances of different approaches)
  • Provide senior level input to the the implementation of clinical investigations (including establishing timelines, budgets, mitigation strategies). This includes steering of CROs, investigators, other external service providers as well as internal functions
  • Internal communication to stakeholders on progress, issues and mitigation strategies of the clinical investigations Contribute to the training and professional development of staff
  • Safeguarding compliance with applicable regulations on clinical evidence generation (including continuous updating of SOPs and Work Instructions) 
  • Constant optimization of our processes to improve efficiency and reduce cost in clinical evidence generation

 

What we look for:

  • Solid experience in different aspects of clinical evidence generation including experience in clinical project management for the pharmaceutical/biotechnology/medical device industry
  • Ideally past experience in working in wound care/tissue repair indications, alternatively experience in medical devices or OTC
  • In-depth understanding of the regulatory aspects of clinical investigations
  • Working knowledge of ICH/GCP/FDA requirements
  • Excellent communication, writing and organizational skills Track record of creation mitigation stategies and work around solutions
  • Strong track record on the excecution of clinical investigation
  • Strong time and project management skills with the ability to prioritize and handle multiple tasks simultaneously
  • Fluent in English

 

Benefits:

  • Well-developed infrastructure e.g. parking bays, canteen, well-equipped workspaces
  • Furnished apartment for the first six months, if distance to place of residence > 60 km
  • Flexible working conditions, e.g. flexitime or mobile working on a daily basis
  • Diverse development opportunities - national and international
  • Feedback conversations and resulting training opportunities

 

Please send in your application documents via our online platform to Sophia Zoller.

 

#talent.com/prio1

Helps. Cares. Protects.

Join our team as a

Senior Advisor for Clinical Evidence Generation (f/m/d) 

DEU-Heidenheim

 

Your area of responsibility:    

  • Assist with clinical development plans including study design and implementation strategies
  • Develop and lead the execution of strategic plans and objectives for Medical Competence Center; liaise with cross-functional departments and business partners to ensure that all related activities are in alignment with company business processes
  • Contributes to building and maintating a network of external service providers
  • Aligning internal and external partners and contributors to clinical investigations
  • Drive strong cross-functional relationships at senior leadership level through frequent interactions and solid strategic thinking and communication skills; interact effectively with senior leadership when required
  • Advising business partners on defining smart claims and medical evidence generation strategy with input from the head of the Medical Competence Center (including risk and success chances of different approaches)
  • Provide senior level input to the the implementation of clinical investigations (including establishing timelines, budgets, mitigation strategies). This includes steering of CROs, investigators, other external service providers as well as internal functions
  • Internal communication to stakeholders on progress, issues and mitigation strategies of the clinical investigations Contribute to the training and professional development of staff
  • Safeguarding compliance with applicable regulations on clinical evidence generation (including continuous updating of SOPs and Work Instructions) 
  • Constant optimization of our processes to improve efficiency and reduce cost in clinical evidence generation

 

What we look for:

  • Solid experience in different aspects of clinical evidence generation including experience in clinical project management for the pharmaceutical/biotechnology/medical device industry
  • Ideally past experience in working in wound care/tissue repair indications, alternatively experience in medical devices or OTC
  • In-depth understanding of the regulatory aspects of clinical investigations
  • Working knowledge of ICH/GCP/FDA requirements
  • Excellent communication, writing and organizational skills Track record of creation mitigation stategies and work around solutions
  • Strong track record on the excecution of clinical investigation
  • Strong time and project management skills with the ability to prioritize and handle multiple tasks simultaneously
  • Fluent in English

 

Benefits:

  • Well-developed infrastructure e.g. parking bays, canteen, well-equipped workspaces
  • Furnished apartment for the first six months, if distance to place of residence > 60 km
  • Flexible working conditions, e.g. flexitime or mobile working on a daily basis
  • Diverse development opportunities - national and international
  • Feedback conversations and resulting training opportunities

 

Please send in your application documents via our online platform to Sophia Zoller.

 

#talent.com/prio1