Organon - Sr. Scientist, Regulatory Affairs - Chemistry Manufacturing Controls ( MERCUSR114310ENUS)
Regulatory CMC – Regulatory Material Compliance Specialist (R3)
Position Overview (Basic responsibilities and overview)
Under the direction of the Director, the Regulatory Material compliance specialist is responsible for direct verbal and/or written communication to the FDA Local Ports; representing Regulatory; and Organon Trade Compliance and Logistic Operations. This includes responding to FDA Notice of Actions, authoring, tracking, and closing out the FDA Import for Export Requests, initiating CAPA’s in cross divisional database, validating source regulatory data for Organon Shipments for Broker Clearance Instructions (BCI), and entering source regulatory data in Organon (Global Trade System – GTS). Overall, ensuring compliance with FDA FD&C and CFR’s relating to the importation of approved and investigational drug. In addition, processing Global Clinical Supplies Regulatory Comparator Searches for investigational studies.
1) Reports to the Director, Regulatory Material Compliance
2) Supports specified activities surrounding compliance to the US Food and Drug Administration regulation for Importation of Approved and Unapproved drug for all Merck divisions as detailed below:
- Under direction of Director, respond to and resolve FDA detentions & holds for Organon shipments. Actively facilitate resolution to unforeseen operational impediments to minimize supply chain interruption and impact on revenue, such as stock out or shortages, patient dosing & key R&D activity.
- Support Organon’s FDA compliance standing and PREDICT score are positive by building and expanding solid relationships with FDA Import and Export Office, including FDA Compliance Officers at all ports of entry through following departmental procedures
- Support Organon Launch Teams, as needed.
- Regulatory contact on the GTS Broker Interface System owning regulatory fields and prospectively reviewing and entering SAP master data for all Commercial product fields and codes for Organon Import database.
- Oversee Regulatory fields for Organon import database (GTAS) Database
- Under oversight of Director Participate in Organon Import Planning Strategies by devising innovative strategic import solutions across U.S. supply chains regarding FDA import clearance requirements based on previous departmental experiences for all drugs, biologics, devices, intermediates, etc.
- Directly support Organon Trade Compliance import specialist and import planners by reviewing regulatory information, document review, labeling review, providing end use letters and verifying FDA ACE data elements
- Initiate CAPA’s for Organon Trade Compliance groups and collaborate to determine discrepancy and problem solve, and assist with correcting the problem for future shipment for U.S. Supply Chain to improve FDA compliance.
- Under direction of Director provide regulatory support for "Import for Export" shipments, including Interfacing with FDA to “close-out” “Import for Export” (IFE) shipments on detentions which includes tracking, providing inventory records & export documentation to FDA.
- Initiate, track, and collate results for global sourcing inquires for comparator drugs for Organon investigational teams
- Support Export Certification Mailbox, confirming need for submission of Export Certification Letter, and assure Department Export Certification Tracking Sheet is maintained
- Maintain RMC Departmental SOP List tracking required review times for updating, and initiating communication for the SOP’s to be updated.
Education Minimum Requirement:
- BA/BS preferably in a science, health-related field or business.
- Experience:(1)Minimum of 2 years experience in clinical research, regulatory, or trade compliance
(2) Good written and oral skills required
(3) General knowledge of MS Word, Excel and Power Point
Required Experience and Skills:
- Strong organizational skills
- Strong written and verbal communication skills
Preferred Education, Experience and Skills:
- Knowledge of FD&C and CFR’s relating to the importation of drug
- Understanding of Supply Chain Management
- Ability to effectively interact with various levels of management
- Ability to contribute to departmental initiatives assuring compliance with new regulations
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Number of Openings:2