Ute Heidenreich

Angestellt, Associate Director (Start-up) - Clinical Operations, PPD

München, Deutschland

Fähigkeiten und Kenntnisse

Clinical Research
Clinical Trials
CTA
Drug Regulatory Affairs
Project Management
Scientific Advice
CMC
IMPD
IND
ASMF
US-DMF
CEP
CTD
ICH/EU-Guidelines
GMP
Quality Control
Validation
Stability Studies
Reference Substances
Impurities
Pharmacovigilance
Start-Up
Medical Devices

Werdegang

Berufserfahrung von Ute Heidenreich

  • Bis heute 3 Jahre und 2 Monate, seit März 2021

    Associate Director (Start-up) - Clinical Operations

    PPD

    Global Clinical Development - Start-up - Germany/Austria/Switzerland Oversight of department management activities Responsible for successful execution of start-up deliverables and for effective alignment of teams within global management team Responsible for providing direction and creating a high-performance culture through leadership, management, coaching and development Lead of and participation in local and international process improvement initiatives, implementation of technology solutions

  • 11 Monate, Apr. 2020 - Feb. 2021

    Associate Director (start-up) - Country Management

    PPD

    Global Clinical Development - Start-up - Germany/Austria/Switzerland Oversight of department management activities Responsible for successful execution of start-up deliverables and for effective alignment of teams within global management team Responsible for providing direction and creating a high-performance culture through leadership, management, coaching and development Lead of and participation in local and international process improvement initiatives, implementation of technology solutions

  • 8 Jahre und 6 Monate, Okt. 2011 - März 2020

    Senior Manager (Start-up) - Country Management

    PPD

    Global Clinical Development - Start-up - Germany/Austria/Switzerland Accountability for oversight of start-up deliverables. Functional responsibility across projects in start-up. Development of start-up department for effective operations in a global company. Main contact for Senior Management and for internal stakeholders. Supervision of Regulatory Intelligence and applicable systems for Clinical Trials. Supervision and people management of start-up team.

  • 2 Jahre und 9 Monate, Jan. 2009 - Sep. 2011

    Senior Manager Regulatory Affairs

    PPD

    Provision of project specific regulatory strategy, technical expertise and co-ordination oversight for all clinical trials being conducted in Germany, Austria and Switzerland Oversight of Regulatory Intelligence and related systems for Germany, Austria and Switzerland Line Management for regulatory professionals in Germany, Austria and Switzerland Interaction of regulatory bodies in Germany, Austria and Switzerland

  • 2 Jahre und 1 Monat, Dez. 2006 - Dez. 2008

    Scientific Project Management

    i.DRAS GmbH

    Regulatory Affairs Manager

  • 5 Jahre und 5 Monate, Juli 2001 - Nov. 2006

    Scientific Project Management

    LAT GmbH

    Regulatory Affairs Manager

Ausbildung von Ute Heidenreich

  • 1996 - 2001

    Pharmacy

    LMU München

  • 1992 - 1997

    MSc Biology

    LMU München

    Humangenetik/Tumorgenetik, Immunologie, Mikrobiologie, Pharmakologie/Toxikologie

Sprachen

  • Deutsch

    -

  • Englisch

    -

Interessen

Skifahren
Badminton
Inlinern
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