Primary Responsibilities • Provides advanced operational support to PRC team, and mentors less experienced employees on job duties and general client operations • Manages PRC submission process including answering questions related to the submission process • Review all PRC submissions for completeness and accuracy • Tracks electronic review cycle and adherence to PRC planning calendars and timelines • Manages logistics of meetings with PRC members including creation of the meeting agenda and recording comments during discussions • Drives adherence with SOPs to improve PRC coordination and streamline PRC work processes • Provides input on workflow planning and prioritization • Utilizing a document management system, maintains records for potential FDA audits, ensuring they are accurate and complete • Proofreads final submission and print layouts • Provides editorial review of marketing materials • Provide PRC SOP and system training to key stakeholders and agencies • Collaborates cross-functionally with Regulatory, Medical, Legal, Marketing and Agencies • Assists with FDA audits or other legal issues as needed • Works with PRC manager to develop processes and/or metrics and presenting to senior leadership • Proactively provides logical recommendations and solutions • Drives PRC consistencies across the organization
• Must have a good understanding of the pharmaceutical environment, relevant PRC process knowledge, and the ability to work proactively through the product review process. • 3 years of relevant industry experience and a BA/BS degree; or zero years’ relevant experience with Master, MBA degree.
Regards,
Monil Patel
Technical Recruiter
Integrated Resources, Inc
(732) 844-8747 Ext.338
monil @irionline.com
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.