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Regulatory Affairs Business Analyst

NNIT A/S


NNIT​ is one of the world’s leading consultancies for the past twenty years serving the Life Science industry around the world. We apply the latest advances in technology - such as IoT, AI, Virtual Reality, Augmented Reality, Data Analytics - to make Quality Assurance, Regulatory Affairs, Clinical, Pharma Production and Laboratory processes more effective and efficient for our clients

We are currently seeking a Regulatory Affairs Business Consultant to work out in the Philadelphia, PA area.

The main responsibilities for this person include:

  • Business Process Analysis and modelling
  • Business Data Analysis and modelling
  • Develop User Requirement and design specification
  • Planning, heading up and reporting on work shops
  • Prepare Risk Assessment and Business Impact Assessment
  • Writing Client SOPs
  • Preparing and executing training – class room, online, video
  • Preparing validation and testing of IT systems
  • Managing smaller projects and complex tasks
  • Identify and follow-up on tasks, actions, risk, issues
  • Ensure that compliance requirements and quality procedures are met

The main skills needed to be successful in this role are below:

  • Bachelors (Masters preferred) Degree in Pharmacy or similar - equivalent years of experience also would be considered
  • Worked at a Pharma, /Biotech firm or a Consultancy company
  • Prior experience working as Business Analyst for IT projects (+5 years) with regards to the responsibilities mentioned above
  • Knows IDMP
  • Knows the Regulatory Affairs data model

NNIT has a unique culture and approach to business that is quickly making us an employer of choice in the US. We are open, honest and value-adding in everything we do. Whether it’s our weekly Friday meetings for all of our US employees, or our annual company-wide Kick Off meetings, NNIT encourages employees to lean in and participate in creating new ideas and developing best practices. We want to grow our people through training and certification opportunities, as well as providing them with “stretch assignment” opportunities to gain experience in new areas. We encourage employees to work at our client sites to maximize NNIT’s value and are also open to working remotely when possible. We strive to have a good work-life-balance for all of our employees.

All this can be summarized in a recent statement from an employee: “NNIT has excellent management and great communication with employees. A weekly team meeting keeps you abreast of company progress, finances, and standing in the industry. The positions they have are challenging and may require some extra hours per week depending on which position you apply for.”

Apply today and find out the types of career opportunities NNIT can offer you!

NNIT is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you require accommodations to apply for this or any of our roles due to a disability. please contact | 609-945-5650

Application deadline:
12 Jun 2020

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Ansøgningsfrist d. 12.06.2020
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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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