Head of Clinical Trial Disclosure (m/f)

UCB

Thu, 17 Nov 2016 09:11:42 GMT


Description

Our challenge. Your impact.

We aspire to be the patient-preferred global biopharmaceutical leader transforming the lives of people with severe diseases and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, who want to make a difference and deliver results.

Based in Monheim (Germany) or at the Brussels Headquarter / Belgium- we are currently recruiting an

Head of Clinical Trial Disclosure (m/f)

Your key responsibilities in this role include
  • Lead, track and coordinate activities of the Clinical Trial Disclosure Team
  • Provides expertise on existing and new legal requirements for registration and submitting summary results information of clinical trials across the disclosure ecosystem
  • Identify, implement and standardize best industry practices throughout clinical trial registry end-to-end processes, including management of third parties and the generation and review of relevant policies and SOPs
  • Act as primary contact on processes and procedural issues related to clinical trial registry
  • Build and sustains strong collaboration for input to the master disclosure plan
  • Develop training plans, and prepare and conduct presentations on clinical trial registry processes and guidelines to train and inform all interfacing departments involved in clinical trial activities
  • Participate in the implementation and maintenance of software systems, procedures, and follow-up tools in Global Medical Affairs and Integrity Practice
  • Support Global Medical Affairs and Integrity Practice with audits and inspections as required

Your qualifications and experience level for this role :
  • PharmD, PhD, at least four years’ relevant experience in clinical development (trial management, and/or data management, and/or biostatistics, publications management)
  • Expert understanding of the pharmaceutical regulatory environment and hands on experience to identify, analyse and apply relevant guidelines, laws or regulations within clinical research
  • Analytical thinker, data driven
  • Experience managing global and cross-functional teams and proven ability to create suitable and effective work environments
  • Extensive project management experience
  • Experience creating new processes and standards of practice
  • Excellent communication skills and strong interpersonal skills
  • Negotiation, influencing, and conflict resolution skills
  • Strong networking skills and ability to utilize the networks she/he has created for the benefit of UCB and role
  • Ability to operate effectively within an international and rapidly changing environment

Have we made you curious?

Then we look forward to receiving your online application (please only use our online application tool) for this position stating your earliest availability or actual notice period as well as salary expectations. We thank you for your interest in UCB and look forward to get in touch with you! UCB is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7500 people in approximately 40 countries, we generated revenue of EUR 3.9 billion in 2015.

Do you want to find out more about us then

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