We have a current opportunity for a Regulatory Affairs Manager on a 4- month contract basis (likely to extend). The position will be based in Philadelphia. For further information about this position please apply. We are only able to place candidates on a W/2.
The Manager, Regulatory Information Management (RIM), will work closely Global Regulatory Affairs, as well as other functions within R&D, and with IT, to manage training, documentation, user experience, and maintenance of the RIM system.
Essential Functions
* Triaging support requests from users across GRA, R&D, Manufacturing and Legal
o Including support with report level content plans, submission content plans, document authoring and workflows
* Meeting with the business to understand their process, regulatory and reporting requirements and converting these into system configuration ideas/proposals
* Completing activities related to system maintenance and configurations
* Supporting IT in validation testing as needed (including the writing and completion of UAT test scripts)
* Develop training material regarding RIM including SOPs, Manuals, or other training materials
* Creation of end user reports
* Supporting migrations requests and database entry
Required Knowledge, Skills, and Abilities
* Education with a minimum of 3-5 years of pharmaceutical/Regulatory Affairs experience
* Veeva White Belt certified
* Knowledge of US/EU/International Regulatory Requirements
* Ability to manage timely delivery of projects and / or programs
* Exceptional written and verbal communication skills
Required/Preferred Education and Licenses
* Bachelor's Degree in Business or Life sciences is required
