Global Regulatory Systems & Information Specialist (GRA)
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POST DATE 9/13/2016
END DATE 12/15/2016
Holly Springs, NC
JOB DESCRIPTIONJob Purpose:
* The position is responsible for maintaining and continuously improving existing systems and databases used in or owned by GRA (excluding the publishing system)
* Implementing new systems and databases to be used in or owned by GRA
* Training the users of these systems and databases
* Providing reports related to GRA metrics and performance
* Development and Implementation of the globally used GRA regulatory systems
* Maintains and continuously improves the assigned system(s). This includes:
* Troubleshooting (i.e. 1st level support for users)
* Identification of new user requirements and definition of well-suited solutions
* In collaboration with the Global Regulatory Compliance Manager, ensures that SOPs/Work Instructions and training materials for all systems are created and updated and that all users are appropriately trained
* Monitors regulatory information requirements and interfaces with regulatory bodies if needed, to ensure the implementation of new systems or the evolution of
* existing system to comply with these requirements
* Interfaces with GRA stakeholders and IT department on system related matter, including the implementation of new systems, vendor selection, system maintenance, issue resolving etc.
* Supports other Global Regulatory Operations, Compliance and Business
* Excellence activities as needed
* Provides reports related to GRA metrics and performance.
* A degree in life science, computer information systems or equivalent
* Previous experience in a regulatory operations role or related required, biotechnology/vaccines experience preferred.
* Previous experience with regulatory information management systems and processes preferred.
* Familiarity with International regulatory information requirements.
* Must have a good understanding of regulatory information management, both from a technical and regulatory process perspective
* Good project management skills including simultaneous management of multiple projects
* Good planning, time management & coordination skills
* Good analytical skills and competence in documentation practices
* Excellent problem solving, attention to detail and customer service skills
* Ability to use clear judgment and flexible approach to managing situations
* Ability to work in a matrix organization and multicultural organization
Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.