Job ID : 33197
Location : West Windsor NJ
Company Name : Merit Technology Services
Job Type : Full-Time
Industry : Healthcare
Salary : $35000 - $60000 per year
No. of Positions : 10+
Required Skills : PMA, Design Dossier, IND, CTA, NDA, FDA Gateway.
Benefits : Medical Insurance
Roles and Responsibilities
· Responsible for formatting and publishing, of regulatory documents (PMA, Design Dossier, Health Authority Responses, etc., IND, CTA, NDA, and others as needed) in paper and/or electronic formats.
· Ensure documents are submitted using formats and styles essential for regulatory compliance with established operating procedures, and current medical and technical writing standards.
· Maintain current knowledge of internal and external document formatting and regulatory publishing requirements and industry best practices.
· Compilation and publishing of routine submission to PMAs (new applications, notifications, supplement), INDs (safety reports, investigator information, protocol amendments, etc.), NDAs (original submissions, supplements, responses), etc., on a routine basis.
· Control submission component receipt and workflow completion to ensure a high-quality final submission.
· Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.
· Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.
· Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.
· Dispatch submissions through the FDA Gateway.
· Maintenance of electronic and hardcopies files.
· Create and maintain templates for regulatory documents and submissions.
· Provide regulatory operations support to the Regulatory Affairs team.
· Other duties as needed.
Education and Experience:
· Bachelor's degree desired or equivalent relevant professional experience in Regulatory Publishing/Operations.
· A minimum of 2 years related experience in publishing/Regulatory Operations in the biotechnology or pharmaceutical industries.
· Basic understanding of the US, EU, and ICH publishing regulations and guidelines.
· Excellent computer skills, including proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Office) and Adobe Professional.
· Proficiency in publishing regulatory documents and using regulatory e-submission software e-Submitter, FDA validation software, ISI Toolbox.
· Previous hands-on experience with compiling documents for routine IND, NDAs, Amendments, Supplements submissions in paper and eCTD format. Experience with PMA publishing is preferable.
· Proficiency in scanning and standard graphics software.
· Ability to work independently with minimal supervision.
· Strong verbal and written communication skills.
· Ability to multitask, pay close attention to detail, and follow projects through to completion. Excellent organizational, prioritization, and planning skills
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