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Business Analyst - Regulatory Affairs


Business Analyst - Regulatory Affairs

We are looking for Business Analyst experienced in pharma industry, to join our Regulatory Affairs department.

If process and data analysis and modeling are your bread and butter, and you do have the experience to prove it, then we are looking for you!

Your responsibilities as Business Analyst

As our new Business Analyst, you will work for large pharma customers. Your main responsibility will be providing structured analysis and corresponding documentation.

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

Your work assignments will include:

  • Business Process Analysis and modelling;
  • Business Data Analysis and modelling;
  • Development of User Requirement and designing specification;
  • Planning, heading up and reporting on workshops.

You will:

  • Prepare Risk Assessments and Business Impact Assessments;
  • Write Client SOP’s;
  • Prepare and execute training – classroom, online, video;
  • Prepare validation and testing of IT systems;
  • Manage smaller projects and complex tasks;
  • Identify and follow-up on tasks, actions, risk, issues;
  • Ensure that compliance requirements and quality procedures are met.

Your qualifications and experience

You have significant working experience within Pharmaceutical Industry, preferably from a service provider or a larger organization. Your communication skills, both verbal and written, are something that you are proud of. You have analytical mindset and enjoy investigations leading to meticulous reports.

You have:

  • Bachelor’s in pharmacy or chemistry/chemical engineering;
  • Worked for/at a pharma company;
  • Worked for/at a consultancy company;
  • Prior experience working as Business Analyst for IT projects (+5 years) with regards to the responsibilities mentioned above;
  • Knowledge of IDMP;
  • Knowledge of the Regulatory Affairs data model;
  • Excellent written and verbal communication skills;
  • Ability to work with Executives (e.g. to the point, service mindset, available when needed)
  • Consultancy mindset.

It is even better if you also have:

  • Master’s in pharmacy or chemistry/chemical engineering.

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

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.

Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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