Regulatory Information Regional Lead - The Americas Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Health Registration Management Regional Lead for the Americas is responsible for ensuring high quality data in Global Regulatory Affair’s (GRA) enterprise system to manage core regulatory information (the ORION system). The HRM Regional Lead will support all countries in North and South America and be responsible for the data quality of that region to effectively drive business operations throughout the enterprise. The Americas Regional Lead will be responsible for understanding the business processes supported by the tool and where necessary, adapting those procedures to align with country-specific needs/requirements w2ithuin the Americas region. Subsequent to change initiatives, the Regional Lead will ensure users are trained appropriately to maintain high quality data maintenance. The Regional Lead will be responsible for evaluation of regional data from the ORION data-monitoring plan and creating action plans for the region to address data quality issues. The Regional HRM Lead will be the primary contact for the regional users with regard to questions on system usage and process. The Regional HRM Lead will represent regional needs for system and process changes on the ORION Change Control Process.
- Serve as primary contact for ORION Users in the country with regard to system usage and support.
- Responsible for providing communication to the Regional Communities of Practice for process and system changes.
- Represent the needs of the Region on the ORION Change Control Board to ensure that changes are appropriate for the region.
- Work closely with Regional RAI Lead, Regional Ops Lead, and Regional Compliance Community of Practice to agree and understand rationale for changes necessary to support the region.
- For low-frequency, high-complexity system interactions the HRM Regional Lead will provide direct support together with the system users in the region to correctly enter data into the system.
- Assist in developing and facilitating regulatory training for ORION Users in the region including on boarding and refresher training.
- Participate in the evaluation of metrics from the ORION data-monitoring plan to determine where process changes, communication, and training/retraining may be needed to improve overall data quality.
- Participate or lead change initiatives to represent regional needs for system and process and to improve overall functioning of system within the region, including participating in user acceptance testing representing the country usage.
- Work closely with ORION Business Lead to adapt or revise processes to support regional needs.
Education Minimum Requirement:
- Bachelor’s degree with 7 years of industry experience, with 5 years in a Regulatory area and experience with technical systems in a regulated environment or Master’s Degree and a minimum of 5 years of industry experience, with 4 years in a Regulatory area and experience with technical systems in a regulated environment.
Required Experience and Skills:
- Broad range of knowledge of regulatory processes .
- Knowledge of Regulatory Filing procedures and/or Health Authority Registration process.
- Demonstrated experience assessing and enabling process change.
- Ability to lead and influence others outside of a direct reporting relationship.
- Broad organizational awareness and knowledge of touch points/interdependencies.
- Demonstrated collaborative skills and ability to work in cross-functional and international environments.
Preferred Experience and Skills:
- Advanced knowledge and capabilities applying technology within a business environment.
- Experience supporting and working with tools and systems used in the Regulatory Affairs environment.
- Fluent in Spanish.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Regulatory Affairs Generic
Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Regulatory Affairs, Law, Compliance, Animal Health, Legal, Bilingual, Veterinary