Description
Regulatory Information Management training and support ManagerLocation: You can commute from London, Essex, Hertfordshire, Cambridge
Salary: Up to £60,000 circa + excellent package including flexible working hours
Role:
As the RIM Training and Support manager you are responsible for supporting the Global Regulatory Affairs systems and processes. He/she will be responsible for overseeing and coordinating business training for end users in all RIM systems. Will be responsible for managing, creating, reviewing and maintaining training programs and materials ensuring they reflect best industry practice and company agreed standards.
He/she will also be responsible for coordinating the super/key user community and providing resources and support for end user business process support in context of RIM systems and documentation.
- The candidate will be expected to contribute to the overall vision and success by focusing on GRA/GRO business results. They will ensure all training and support demands are met within the business agreed time frames and continually drive to improve the standards of training, education and support processes through innovative and resourceful ideas.
- The candidate will be able to forge and maintain relationships at all levels within the organization in order to facilitate cross functional collaboration and influence other areas of the organization to ensure best in class service for systems and processes under RIM responsibility.
Skill require:
The ideal candidates will be looking for a career move from a Regulatory Affairs Manager into a different area of Support and Training within Regulatory Affairs OR already have experience working in Regulatory Information Management itself.
YOU MUST HAVE: Direct line management experience
- Your must demonstrate in depth knowledge of global / regional Pharma industry initiatives and direction
- Working knowledge and understanding of global (FDA, EMA, Health Canada, Japan, International) requirements and standards
- Strong knowledge of regulations/guidelines governing electronic submissions and 21 Part 11 requirements
- Strong Knowledge, exposure and experience of best industry practices for submission management processes and documentation processes including but not limited to eCTD publishing/validation, documentation workflows, regulatory data management processes including exposure to xEVPRM/ISO IDMP standards
Required:
Bachelor's Degree in Life Sciences or Information Technology
For more information please contact our Senior Regulatory consultant Natalie Hopkins on or email your application direct to
n.hopkins (a) realstaffing.com
Real Pharma have a team of 7 consultants in the regulatory Affairs team and work on a range of roles from Regulatory Officers up to VP's of Regulatory Affairs. If you are keen to find out about live roles contact one of our team members.