Kristen Harmon

Kristen Harmon Email and Phone Number

Consultant @ Jasper Therapeutics
Kristen Harmon's Location
Wilmington, North Carolina, United States, United States
Kristen Harmon's Contact Details

Kristen Harmon personal email

n/a

Kristen Harmon phone numbers

About Kristen Harmon

Global Reg Ops; Regulatory Intelligence, Project Mgmt; Global Submission Planning & Strategy, PublishingeCTD/NeeS submissions (IND/NDA/BLA/MAA/NDS) and Major Efficacy Supplements (NDA/BLA/MAA/NDS) in US, EU and Canada. ROW Core submissions.Proficient in MS Teams, Veeva Vault, SmartSheet, SharePoint, Insight Publisher, Adobe, ISI Toolbox

Kristen Harmon's Current Company Details
Jasper Therapeutics

Jasper Therapeutics

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Consultant
Website:
jaspertherapeutics.com
Employees:
67
Kristen Harmon Work Experience Details
  • Jasper Therapeutics
    Jasper Therapeutics
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  • Arcus Biosciences
    Regulatory Operations & Intelligence
    Arcus Biosciences Jul 2020 - Present
    Hayward, California, Us
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  • Beigene
    Regulatory Operations & Intelligence
    Beigene Feb 2018 - May 2020
    Cambridge, Ma, Us
    View
  • Gilead Sciences
    Global Regulatory Operations / Consultant, Sr. Publisher
    Gilead Sciences Feb 2013 - Mar 2018
    Foster City, Ca, Us
    Regulatory Operations - Prepare and support electronic regulatory submissions around the world.
    View
  • Allergan
    Global Regulatory Operations / Sr. Regulatory Publisher
    Allergan Aug 2001 - Aug 2012
    Dublin, Coolock, Ie
    Manage submission teams through global submissions and lifecycle management. Provide strategic direction in regards to the global publishing process and dossier re-use strategies. Provide oversight and preparation of regulatory dossiers for global registrations. Accountable for company milestone achievements. Identify and recommend best course of action to resolve technical or operational problems to enhance process efficiencies. Articulate regulatory technology requirements in real-time both inside and outside the Company. Maintain professional relationships with Health Authorities to ensure best practices are current and utilized. Liaise with outside publishing vendors/contractors to provide guidance on submission projects.
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Kristen Harmon Skills

Ectd Customer Service Regulatory Operations Project Management Regulatory Submissions Fda Regulatory Affairs Training 21 Cfr Part 11 Pharmaceutical Industry Regulatory Requirements Computer System Validation Clinical Development Drug Development Sop

Kristen Harmon Education Details

  • University Of Phoenix
    University Of Phoenix
    Business

Frequently Asked Questions about Kristen Harmon

What company does Kristen Harmon work for?

Kristen Harmon works for Jasper Therapeutics

What is Kristen Harmon's role at the current company?

Kristen Harmon's current role is Consultant.

What is Kristen Harmon's email address?

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What is Kristen Harmon's direct phone number?

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What schools did Kristen Harmon attend?

Kristen Harmon attended University Of Phoenix.

What skills is Kristen Harmon known for?

Kristen Harmon has skills like Ectd, Customer Service, Regulatory Operations, Project Management, Regulatory Submissions, Fda, Regulatory Affairs, Training, 21 Cfr Part 11, Pharmaceutical Industry, Regulatory Requirements, Computer System Validation.

Who are Kristen Harmon's colleagues?

Kristen Harmon's colleagues are Wendy Pang, David Lowe, Mark Yaukey, Kimberly Baxter, Britex Flooring, Sophia R. Majeed, Jade Cenina.

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