Job Description

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. NNIT has grown by more than 1,000 people globally over the last four years, and we are rapidly expanding our US Operations.

We are currently seeking a IDMP Data Governance Lead to join our team. This is a mid level to senior level role with experience providing consulting services in life sciences. Remote work for the next few months due to COVID.

Data Analytics role for an existing IDMP project in which the client is preparing to comply with upcoming IDMP regulations. Subject Matter Expert and well versed in IDMP requirements for SPOR and upcoming expectations in other Health Authorities.

At NNIT, you can design your professional profile, and we will support you on that journey, through high focus on assignments, where you will be offered a number of certifications that will match your profile and continued development.

The Main Responsibilities For This Person Include

• Data readiness, business process across functional areas, and communication skills with leadership teams.
• Immediate replacement for existing engagement. You need to be able to pick up where the other team left off as well as add value via their own experience
  

The Main Skills Of The Person Include

• Strong scientific background with research experience and Scientific Education to Masters and PhD level.
• Several years experience within the Life Sciences industry.
• Main expertise is in ISO IDMP and related international initiatives (both EMA and FDA).
• Worked in IDMP data analysis, data readiness and business processes improvement projects in the pharmaceutical industry. These projects included stakeholder engagement and training.
• Good knowledge of the Pharmaceutical Product Lifecycle
• Experience in data analysis and data mapping.
• Working knowledge of EMA SPOR Initiative and implementation guidance.
• Working knowledge of (ISO) IDMP standards for human medicines (ISO 11615).
• Experience presenting information and updates to different stakeholders.
  

It's Beneficial If The Person Has

• Detailed knowledge of the Pharmaceutical Development Process.
• Working knowledge of Pharmaceutical IT systems and landscape.
• Understanding of IT system development lifecycle.
• Experience with IDMP readiness assessments.
• Experience with Data Quality assessments.
• Experience with Data Governance
• Knowledge of (ISO) IDMP standards for Substances (ISO 11238)
  

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.

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 jqhk@nnit.com