Ruth Fields Email & Phone Number

Hatfield, PA, US

Jersey City, NJ, US

• Served as Business System and Process Owner of the “system of truth” that houses the marketing authorization and registered products for the company.
• Spearheaded development and initiation of Health Registration Management (HRM) department as a result of spin from Fortune 100 pharmaceutical company
• Led a 20% reduction in regulatory compliance timelines by directing the digitalization of health registration management (HRM) processes for Organon's product portfolio resulting in faster product submissions and.
• Increased data quality through the implementation of a new HRM SaaS system which streamlined data capture and improved data integrity, minimizing errors and ensuring regulatory compliance.
• Managed a team of 13 people (domestic and international) that optimized HRM processes, leading to reduction in resource allocation for data management activities.
• Allowed for reallocation of valuable resources to other critical areas within Research and Development (R&D).

Rahway, New Jersey, US

Rahway, New Jersey, US

• Led a cross-functional team of 25 colleagues (domestic and international) to optimize HRM processes for labeling, achieving an increase in data accuracy. This improved regulatory compliance and reduced the risk of.
• Led a labeling process simplification initiative, resulting in a 20% reduction in average labeling turnaround time. This expedited product approvals and time-to-market for Merck.
• Identified and implemented a new labeling template, leading to a 10% decrease in labeling review cycles by internal working partners, streamlining communication and ensuring efficient labeling finalization.
• Communicated challenges and opportunities related to labeling and HRM to management resulting in allocation of additional resources for system upgrades, which ultimately improved user efficiency.

Bertrange, Bertrange, LU

• Performed duties as Senior Consultant and successfully managed 5 client engagements using the ALSS methodology., Delivered projects on time and within budget in 100% of cases for life science platforms (specifically.
• Reduced project execution time through efficient resource allocation and task prioritization. This improved team productivity and project delivery speed.
• Delivered a complex regulatory compliance project for a client 15% under budget and cost savings for the client while meeting all project goals.
• Built strong relationships and achieved superior client satisfaction rating on project evaluations.

Tel-Aviv, IL

• Achieved a 98% success rate in meeting regulatory deadlines across assigned projects for 5 consecutive years and ensured regulatory compliance and avoided potential delays or fines.
• Managed the divestment of two business units, ensuring seamless transfer of regulatory data management systems, minimizing disruption and ensuring uninterrupted regulatory compliance for divested units.
• Implemented a new Change Control process for three global regulatory submission systems, achieving a decrease in system errors which improved data accuracy and reduced rework.
• Leveraged employee engagement survey data to develop targeted training programs, leading to a 10% increase in team productivity.

Tel-Aviv, IL

• Led the divestiture of the Animal Health division, ensuring on-time and on-budget delivery of all regulatory and product data. This minimized disruption and ensured a smooth transition for the divested unit.
• Streamlined global electronic document management systems for Quality, Manufacturing, R&D, and Regulatory Affairs, achieving a reduction in document retrieval time which improved operational efficiency and saved.
• Oversaw the successful implementation of a Product Lifecycle Management (PLM) system for North American business units, resulting in an increase in product development collaboration, improving communication and.

Tel-Aviv, IL

• Led implementation of a new document management system for Regulatory Affairs, resulting in decrease in document processing time, improved efficiency and reduced regulatory submission turnaround times.
• Managed upgrade of regulatory data management system, achieving a good data migration accuracy rate that ensured data integrity and minimized disruption for Regulatory Affairs users.
• Delivered a new regulatory submission publishing system on time and within budget which led to a 10% increase in the number of submissions processed per month which improved regulatory compliance efforts and.
• Provided ongoing consultative advice to internal stakeholders on shared and global IT solutions, contributing to reduction in redundant system development efforts. This demonstrates your collaborative approach and.

Tel-Aviv, IL

• Streamlined the Regulatory Affairs document review process through business process analysis and implementation of new workflows to improve efficiency and reduce regulatory compliance review timelines.
• Identified and implemented a new electronic document management system for Regulatory Affairs, resulting in a 10% decrease in document misplacement, which increased data integrity and saved valuable time for Regulatory.

M.Ed, Adult And Organizational Development

Phr, Human Resources

B.S., Marketing And International Business

Certificate, Drug Development