PROMOTION REVIEW COMMITTEE SPECIALIST

Promotion Review Committee Specialist

IRI believes in commitment, integrity, and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled, and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow. We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity. Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description

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
Qualifications

• 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.