A leading global CRO, PRA is transforming clinical trials through our people, innovation and transparency. We serve clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge PRA’s commitment to excellent in research begins with our people. Our workforce has grown by over 25% since 2010 and now comprises over 4,700 employees spanning more than 13 time zones and speaking more than 15 languages. It is our philosophy that the way in which we grow our business is to focus on our employees and as such, we recognize that successful careers are found within organisations that provide the support that employees need at work, as well as the benefits they require outside the office.
Post : Regulatory Affairs Associate
Job Responsibilities
• Management of activities associated with FDA applications and other US Regulatory activities per project requirements.
• Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
• Management of the country level Informed Consent, where appropriate.
• Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
• Perform role of Local Reviewer in the QC process as appropriate.
• Providing consultancy to the client on any US Regulatory specifics issues as requested.
• Supporting the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
• Attending internal and external project team meetings as needed.
• Any other duties deemed necessary to secure the success of PRA’s business.
• May work with GRA team members to provide Regulatory consulting services
• Provide mentoring and training for the RAA 1 position.
• Support RAA 1 with more complex submissions.
• May serve as Country Consultant.
Candiadte Profile
• Strong knowledge of current ICH, US FDA and Ethics Committee regulations and guidance as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
• Minimum 2 years prior experience preparing and maintaining US INDs in eCTD and experience working with Publishing team.
• Familiar with special submissions in US (i.e – orphan drug, fast track designation)
• Experience working in a multi discipline team
• Prior experience using computerized information systems required; experience with PC Windows, word processing, Sharepoint, Powerpoint, and electronic spreadsheets required.
• Strong communication skills. Experience working directly with clients.
• Read, write, and speak fluent English.
• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
• CRO experience preferred.
• Experience with submission of Clinical Trial Applications to Health Canada is an asset.
Additional Information
Job ID : 2018-44705
Location : USA
Industry Type : Clinical research
Functional Area : Regulatory Affairs
End Date : 20th May, 2018
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