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Regulatory Informatics Consultant - Specialist

NNIT A/S



Senior Regulatory Informatics Consultant

We are looking for Regulatory Informatics Consultant - a senior specialist experienced in pharma industry, to join our US R&D Consulting Team.

If regulatory affairs within the pharma and IT is something that you excel in, we might be looking for you!

Your responsibilities as Regulatory Informatics Consultant

Regulatory Informatics Consulting Specialist is a senior level role with experience in providing consulting services in life sciences, and a focus on data standards and governance.

The Regulatory Informatics Consulting Specialist is well versed in ICH and ISO data standards and implementation plans.

You will be a part of quickly growing consultancy company and meet many challenges within the pharmaceutical IT.

Your work assignments will include:

  • Taking part in regulatory projects within the life sciences and post-marketing;
  • Setting up and maintaining global regulatory standards;
  • Planning and overseeing of agreements, activities and timelines;
  • Leading and driveing cross-functional team in an international organization;
  • Participating in leadership activities – public speaking;
  • Being primary contact to key clients.

Your qualifications and experience

Successful candidates will demonstrate experience in IDMP, SPOR, PQ/CMC and Data Governance.

You have:

  • 10+ years of experience in Regulatory in product development and post-marketing;
  • University degree;
  • Been leading projects on time and on budget;
  • Good communication skills and ability to build and maintain trust with key stakeholders;
  • Excellent organizational skills and a hands-on approach;
  • Interest in mentorship;
  • Proficiency in English, written and spoken
  • MS Software, MS Project, RIM skills.

It is even better if you also have:

  • PMP Certification;
  • RAC Certification.

Excellent communication skills are required, since you will work with both internal IT specialists, as well as customer stakeholders, both located in different parts of the world. You must be able to communicate complex technical issues to management and other stakeholders.

Please submit your application and resume in English and attach relevant diplomas.

Application deadline:
27 Aug 2020

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Ansøgningsfrist d. 27.08.2020
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NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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