Hannah Miesner

Hannah Miesner Email and Phone Number

Director, Global Regulatory Operations at ICON PLC @ ICON Strategic Solutions
Hannah Miesner's Location
Chesterfield, Missouri, United States, United States
Hannah Miesner's Contact Details
About Hannah Miesner

With over 14 years of experience in regulatory operations and information management, I am a passionate and skilled leader who strives to deliver high-quality and reliable regulatory data to clients across the life sciences industry. As the Director of Regulatory Information Management (RIM) at ICON plc, I lead a team of 25-30 RIM professionals who use industry-leading RIM technology to support small, mid, and large clients in managing their regulatory data. My mission is to influence and guide key RIM stakeholders as they build best-in-class RIM organizations that comply with global regulatory requirements and standards. I bring diverse perspectives and experiences to the team, as I have worked with different types of products, applications, and markets in my previous roles at Mallinckrodt Pharmaceuticals. I value collaboration, innovation, and continuous improvement, and I aim to align my goals with the organization's vision and culture.

Hannah Miesner's Current Company Details
ICON Strategic Solutions

Icon Strategic Solutions

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Director, Global Regulatory Operations at ICON PLC
Hannah Miesner Work Experience Details
  • Icon Strategic Solutions
    Director, Global Regulatory Operations
    Icon Strategic Solutions Nov 2020 - Present
    Dublin , Gb
    Develop and execute ICON’s overall RIM strategy and roadmap, ensuring alignment with company goalsFoster strong, effective communication with leadership teams and key stakeholders to design and implement tailored, best-in-class RIM environments that meet client needsLead large team of Regulatory Operations professionals in delivering regulatory data management, regulatory project management, and publishing services to a diverse portfolio of clients, from small to large pharma, utilizing leading regulatory technologyManage project teams focused on data enrichment and remediation to align deliverables with client standards and regulatory requirementsProvide end-to-end Regulatory Technology support to clients, offering expertise across all areas from technical assistance to comprehensive business system ownership
  • Icon Strategic Solutions
    Associate Director, Regulatory Information Management, Global Regulatory Operations
    Icon Strategic Solutions Apr 2018 - Nov 2020
    Dublin , Gb
  • Icon Strategic Solutions
    Senior Information Manager
    Icon Strategic Solutions Mar 2017 - Apr 2018
    Dublin , Gb
  • Mallinckrodt Pharmaceuticals
    Manager, Regulatory Operations
    Mallinckrodt Pharmaceuticals Jul 2016 - Mar 2017
    Dublin, Ireland, Ie
    Held positions with an increasing level of responsibility during my seven-year tenure at Mallinckrodt. Most recently as Manager with the following responsibilities:Supervised a team of eight in day-to-day activities across three functional areas within regulatory operations - RIM, EDMS, Labeling OperationsCreated and executed RIM integration strategies for internal clientsProvided regulatory operations expertise to cross functional teams within the companyServed as subject matter expert for the business during RIM system upgrades and patchesOversaw global submission tracking for 120+ products in over 100 countriesManaged and coordinated development and implementation of data standards across global regulatory affairs
  • Mallinckrodt Pharmaceuticals
    Project Manager, Regulatory Operations
    Mallinckrodt Pharmaceuticals Aug 2015 - Jul 2016
    Dublin, Ireland, Ie
  • Mallinckrodt Pharmaceuticals
    Senior Regulatory Operations Specialist
    Mallinckrodt Pharmaceuticals May 2013 - Aug 2015
    Dublin, Ireland, Ie
  • Mallinckrodt Pharmaceuticals
    Regulatory Operations Specialist
    Mallinckrodt Pharmaceuticals Jun 2011 - May 2013
    Dublin, Ireland, Ie
  • Mallinckrodt Pharmaceuticals
    Regulatory Operations Associate
    Mallinckrodt Pharmaceuticals Jun 2010 - Jun 2011
    Dublin, Ireland, Ie
  • Mccarthy Building Companies, Inc.
    Vision Data Coordinator
    Mccarthy Building Companies, Inc. 2008 - 2009
    St Louis, Missouri, Us
  • Spectrum Healthcare Resources
    Contract Administrator
    Spectrum Healthcare Resources Jun 2007 - Apr 2008
    Saint Louis, Missouri, Us

Hannah Miesner Skills

Contract Negotiation Pharmaceutical Industry Regulatory Affairs Software Documentation Regulatory Operations Fda Cross Functional Team Leadership Customer Service Document Management Gmp Management Microsoft Excel Microsoft Office Quality System Regulatory Submissions Sop Healthcare Regulatory Requirements Validation Medical Devices Standard Operating Procedure U.s. Food And Drug Administration

Hannah Miesner Education Details

  • University Of Central Missouri
    University Of Central Missouri
    Business Administration

Frequently Asked Questions about Hannah Miesner

What company does Hannah Miesner work for?

Hannah Miesner works for Icon Strategic Solutions

What is Hannah Miesner's role at the current company?

Hannah Miesner's current role is Director, Global Regulatory Operations at ICON PLC.

What is Hannah Miesner's email address?

Hannah Miesner's email address is ha****@****ahs.com

What is Hannah Miesner's direct phone number?

Hannah Miesner's direct phone number is +4412462*****

What schools did Hannah Miesner attend?

Hannah Miesner attended University Of Central Missouri.

What skills is Hannah Miesner known for?

Hannah Miesner has skills like Contract Negotiation, Pharmaceutical Industry, Regulatory Affairs, Software Documentation, Regulatory Operations, Fda, Cross Functional Team Leadership, Customer Service, Document Management, Gmp, Management, Microsoft Excel.

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