Governance Documentation Author

Employer

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 Governance Documentation Authorto 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.

You hold an BSc degree in Life sciences or IT with experience in the life sciences industry. You have an interest in and an understanding of IT, and you manage to bridge your professional experience from the life sciences industry with IT. It is an advantage if you have experience with pharmacovigilance business processes, patient safety systems, and cloud-based systems.

This Includes

The role will support the Business Process and Governance Document team with the implementation of a new cloud-based patient safety system.
  • Working closely with the client and vendors to review the current process documents and author new documents for Veeva Safety Vault.
  • Authoring of GxP documentation for global case processing procedures and IT system maintenance.
  • Facilitating review and approval of GxP documentation.
  • Developing and maintaining close collaboration between business and IT.
The Main Responsibilities For This Person Include
  • Author Standard Operating Procedures and associated Job Aids for the business process and system maintenance for Veeva Safety Vault. Processes include Global Case Handling, Quality and Compliance, Aggregate Reporting, Metadata Maintenance, etc.
  • Supporting the first implementation of Veeva’s Safety Vault for a large pharmaceutical company.
  • Opportunity for growth in multiple areas and workstreams.
The Main Skills Of The Person Include
  • BSc in Life Sciences
  • Experience in the life science industry.
  • Experience working with cloud-based software applications.
  • Strong skills with all Microsoft Office apps, Microsoft Word document formatting
  • GxP documentation
  • IT systems
  • Ability to work as a team player in a consulting environment
  • Consulting Mindset
  • Excellent written and spoken communication skills
  • The ability to work without close supervision to tight deadlines meeting all quality and schedule requirements
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