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Caroline Hattersley

Regulatory Operations Contractor @ Amicus Therapeutics | Certified Veeva Vault Administrator

Professional Background

Caroline Hattersley is a highly accomplished Veeva Vault Certified RIM System Administrator with extensive experience in the pharmaceutical and biotechnology sectors. Over the course of her career, she has exhibited a profound understanding of regulatory information management systems, particularly Veeva RIMS, which has enabled companies to streamline their regulatory submission processes. Caroline has demonstrated exceptional capabilities in validating, deploying, and operationalizing modules within the Veeva platform, notably the Veeva RIMS Submissions, Submissions Archive, and Publishing modules. Her hands-on experience encompasses the migration of global dossiers into Veeva RIMS, establishing her as an invaluable asset in any organization leveraging this advanced technology.

In her role as a system administrator, Caroline has effectively overseen all facets of Veeva RIM system administration. She is dedicated to assessing, managing, and documenting the impact of Veeva's three annual releases, skillfully recertifying at each release to ensure compliance and system integrity. Caroline proactively identifies operational improvements within Veeva RIMS, implementing necessary configuration changes to maximize efficiency. Additionally, she manages the daily operational aspects of the Veeva system, providing essential technical and process support across the organization to ensure that all stakeholders can utilize the software efficiently. Caroline frequently conducts introductory training sessions for new users, which not only enhances their knowledge but also ensures that the organization reaps the maximum benefits from Veeva RIMS.

Moreover, Caroline's role extends to document management services, where she meticulously handles all documentation intended for Veeva RIMS. Her attention to detail is crucial in formatting, building, and publishing global regulatory submissions, thereby supporting the compliance framework of her organization. Caroline has adeptly managed timelines with external publishers and has been instrumental in researching and purchasing reference documents via RightFind, further solidifying her expertise in regulatory submissions.

Education and Achievements

Caroline's educational background laid a solid foundation for her impressive career in information systems and regulatory operations. She holds a Bachelor of Arts in Information Systems & Modern Languages from the University of the West of England, where she combined her technical acumen with linguistic skills, preparing her for various roles in multi-disciplinary environments. Furthering her professional development, Caroline attained her Certified Project Manager (CPM) accreditation from the Project Management Leadership Group, which has honed her project management abilities and strategic oversight in high-stakes projects.

Throughout her career, Caroline has held pivotal roles in several prominent organizations. Her professional journey began with her tenure as a Business Analyst at Biogen Idec, where she gained crucial insights into the biotech industry. She continued to enhance her career as she progressed through various positions such as Business Analyst at Alexion Pharmaceuticals and Consultant at StratAcuity. Caroline notably served as a Senior Manager of Regulatory Information Systems at ARIAD Pharmaceuticals, where she spearheaded important initiatives in regulatory operations.

Caroline's leadership skills came to the forefront during her tenure as Associate Director at AlloVir, where she was pivotal in driving the vision for regulatory operations and systems. Following this, she took on the role of Regulatory Operations Contractor at Amicus Therapeutics, further establishing her reputation as a leader in the regulatory space.

Skills and Expertise

Caroline Hattersley is a well-rounded professional equipped with an array of skills that enhance her contributions within regulatory operations. Her proficiency in Veeva RIM Submissions, Submissions Archive, and Publisher modules is complemented by her adeptness with essential software tools, including MS Word, Excel, PowerPoint, Visio, Project, Outlook, and SharePoint. Caroline's business process analysis skills enable her to evaluate and refine the regulatory operations process meticulously, streamlining workflows for improved productivity.

Her expertise in Computer System Validation documentation is noteworthy; Caroline excels in authoring critical risk assessments, specifications, protocols, User Acceptance Test (UAT) test scripts, and validation summary reports. This thorough understanding is particularly vital in highly regulated environments where compliance and documentation accuracy are paramount. Additionally, Caroline possesses substantial knowledge of Change Control procedures, ensuring that any modifications or upgrades to systems are handled seamlessly, minimizing disruption to operations.

In summary, Caroline Hattersley has established herself as an expert in regulatory information management systems, specifically within the realm of Veeva RIMS. Her educational background, extensive professional experience, diverse skill set, and numerous achievements speak volumes about her capabilities and accomplishments in the industry. Whether managing regulatory submissions, training users, or overseeing system enhancements, Caroline continues to make significant contributions that benefit her employers and the broader field of regulatory operations.

Related Questions

How did Caroline Hattersley become a Veeva Vault Certified RIM System Administrator?
What strategies has Caroline implemented to improve operational aspects of Veeva RIMS?
In what ways has Caroline's education in Information Systems & Modern Languages influenced her career path?
How does Caroline Hattersley manage timelines with external publishers effectively?
What are some key operational improvements Caroline has made within Veeva RIMS?
How has Caroline's role evolved throughout her various positions in regulatory operations?
What techniques does Caroline use to conduct training for new users of Veeva RIMS?
How does Caroline ensure compliance with regulatory operations?
Caroline Hattersley
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Location

Harvard, Massachusetts, United States