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Karen Driver Email
Director Clinical Writing . Synchrogenix a Certara company
Wilmington, DE
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How to contact Karen Driver
Join and see Karen's contact info for free!Current Roles
Employees:
246Revenue:
$49.4MAbout
PROVIDING REGULATORY STRATEGY, SCIENCE, and SERVICES to PHARMACEUTICAL, DEVICE/DIAGNOSTICS, and TOBACCO COMPANIES WORLDWIDE REGULATORY STRATEGY - Strategic cross-functional guidance and comprehensive implementation - Submission and Program Leadership - Strategic messaging alignment, overall Vendor strategy and management, agency communications - Modules 1-5 of the Common Technical Document (CTD) / PMA, 510k / PMTA, TPMF, MRTP - Regulatory Operations REGULATORY and MEDICAL WRITING By merging our cross-functional expertise with our writing and operations experience, we deliver documents that not only support clients strategic messaging, but also enhance their marketability. We provide many of the benefits of an in-house teamincluding the experience and perspective of industry insiderswithout increased overhead or struggles with fluctuating workloads. Synchrogenix provides clients with objective, professional document review services. Our rigorous quality-control process includes checks of data, formatting, spelling, grammar, and clarity. Our team includes industry experts, medical doctors, and clinicians who provide our clients with objective content review. TECHNOLOGY-ENABLED SERVICES - GlobalSubmit Regulatory operations technology - ClinGenuity Artificial intelligence technology platform TRANSPARENCY and DISCLOSURE Our disclosure team consults with our clients to educate cross-functional teams as to the requirements for and compliance to FDAAA, FDAMA, and EMA's policies 43 and 70. We develop a roadmap for compliance for our domain experts to fulfill in tandem with client stakeholders. - Global Trial and Results Registries - Redaction and Dataset De-Identification - Plain Language Summaries, in partnership with CISCRPSynchrogenix a Certara company Address
2951 Centerville RoadWilmington, DE
United States