Business Process Management Consulting & Projects, Clinical Studies/Medical Operations, Medical Governance, Grant Management, and Quality & Compliance
Aktualisiert am 13.11.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 02.12.2024
Verfügbar zu: 100%
davon vor Ort: 50%
Prozessmanagement
Good Clinical Practice
Qualitymanagement
Prozessentwicklung
Prozessoptimierung
BPMN
Projektmanagement
Klinische Studien
ICH-GCP
Pharma Compliance
Analysefähigkeit
Medical Governance
Audit
Audit Practise
CAPA
Quality Documentation
Medical Affairs
Prozessberatung
Clinical Research
Grant Management
Early Access
Medizinprodukte
ISO 13485
Deutsch
Muttersprache
Englisch
Verhandlungssicher
Französisch
Grundkenntnisse

Einsatzorte

Einsatzorte

Deutschland, Schweiz
möglich

Projekte

Projekte

10 Monate
2024-02 - heute

Business Process Management Consulting

Owner & General Manager
Owner & General Manager
  • Business Process Management Consulting & Projects
  • Clinical Studies/Medical Governance
  • and Quality & Compliance Services
progressence Consulting GmbH
Rastatt, Germany
5 Jahre 5 Monate
2018-07 - 2023-11

Oversee, implement and improve business processes

Director | Head Medical Governance Mature Products
Director | Head Medical Governance Mature Products
  • Oversee, implement and improve business processes and the respective controlled documentation landscape of the Chief Medical Officer (CMO) and Global Medical Affairs (GMA) function, i.e., Policies, Standards, SOPs. Represent CMO/GMA at global Business Process Management Excellence Committees
  • Own, author, contribute to and review CMO/GMA and other R&D cross-functional processes and related quality documents, also including several Corporate Compliance Policies
  • Establish robust and integrated medical governance oversight by managing and co-chairing Global Medical governance bodies for review and approval of Global and Local Medical Affairs clinical studies, Investigator-Sponsored Studies, and Patient Support Programs across all Therapeutic Areas
  • Enhance the organization?s overall capability for cross-functional audits/inspections by coordinating and training the Chief Medical Officer (CMO) and Global Medical Affairs (GMA) function
Merck KGaA
Darmstadt, Germany
7 Jahre 4 Monate
2010-09 - 2017-12

Global Medical Affairs Study Coordination & Compliance

Associate Director
Associate Director
  • Similar to above, yet covering less Therapeutic Areas
  • Additional responsibility for Medical Governance of Patient Support Programs taken in 2016
Merck KGaA
Darmstadt, Germany
1 Jahr 9 Monate
2009-01 - 2010-09

Diverse Projekte

Performance Manager Medical Science & Innovation
Performance Manager Medical Science & Innovation
Merck KGaA
Darmstadt, Germany
1 Jahr
2008-01 - 2008-12

Diverse Projekte

Operations & Liaison Manager, Global Clinical Development Unit Oncology
Operations & Liaison Manager, Global Clinical Development Unit Oncology
Merck KGaA
Darmstadt, Germany
1 Jahr 11 Monate
2006-02 - 2007-12

Resourcing Management

Resourcing Manager
Resourcing Manager
Ingenix Pharmaceutical Services Deutschland GmbH, Previously SKM Oncology Research GmbH
Hannover, Germany
4 Jahre 1 Monat
2002-01 - 2006-01

Clinical Operations positions of increasing responsibility

Ingenix Pharmaceutical Services Deutschland GmbH, Previously SKM Oncology Research GmbH
Hannover, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

3 Monate
2024-09 - heute

Fachkraft für Qualitätsmanagement in der Medizinprodukteindustrie nach ISO 13485:2016 - TÜV

TÜV SÜD Akademie
TÜV SÜD Akademie

Position

Position

  • Business Process Management

  • Medical Affairs Operations

  • Audit Coordination

  • Medical Governance / Grant Management

Kompetenzen

Kompetenzen

Top-Skills

Prozessmanagement Good Clinical Practice Qualitymanagement Prozessentwicklung Prozessoptimierung BPMN Projektmanagement Klinische Studien ICH-GCP Pharma Compliance Analysefähigkeit Medical Governance Audit Audit Practise CAPA Quality Documentation Medical Affairs Prozessberatung Clinical Research Grant Management Early Access Medizinprodukte ISO 13485

Produkte / Standards / Erfahrungen / Methoden

Profil:

  • I am combining 20+ years of experience in Clinical Development/Medical Affairs with modern-day business process management to build and strengthen effective quality- and risk management systems and procedures, to organize and improve efficient internal review and medical governance mechanisms, and by that help to maintain and improve the quality of patient care
  • I am a results-oriented, self-organized, and problem-solving team player with a keen eye for detail, leveraging strategic and analytical thinking to deliver complex information clearly to wide range of audiences and business units

Klinische Forschung

Klinische Studien phase II-IV Prozesse, Planung, Governance
Experte
Early Access, Compassionate Use
Fortgeschritten

Medical Affairs

Klinische Studien phase II-IV Prozesse, Planung, Governance
Experte
Investigator-Initiated Research/Studies
Experte
Patient Support Programs
Experte
HCP Interaktion, Compliance Regelungen
Fortgeschritten

Qualitätssicherung

Geschäftsprozessmanagement
Experte
Kontinuierliche Verbesserung
Experte
Prozessdokumentation
Experte
BPMN 2.0
Fortgeschritten
Audit Koordination
Experte
ISO 13485
Basics

Branchen

Branchen

Arzneimittelindustrie

Pharmazeutische Industrie

Medizinprodukteindustrie

Healthcare

Einsatzorte

Einsatzorte

Deutschland, Schweiz
möglich

Projekte

Projekte

10 Monate
2024-02 - heute

Business Process Management Consulting

Owner & General Manager
Owner & General Manager
  • Business Process Management Consulting & Projects
  • Clinical Studies/Medical Governance
  • and Quality & Compliance Services
progressence Consulting GmbH
Rastatt, Germany
5 Jahre 5 Monate
2018-07 - 2023-11

Oversee, implement and improve business processes

Director | Head Medical Governance Mature Products
Director | Head Medical Governance Mature Products
  • Oversee, implement and improve business processes and the respective controlled documentation landscape of the Chief Medical Officer (CMO) and Global Medical Affairs (GMA) function, i.e., Policies, Standards, SOPs. Represent CMO/GMA at global Business Process Management Excellence Committees
  • Own, author, contribute to and review CMO/GMA and other R&D cross-functional processes and related quality documents, also including several Corporate Compliance Policies
  • Establish robust and integrated medical governance oversight by managing and co-chairing Global Medical governance bodies for review and approval of Global and Local Medical Affairs clinical studies, Investigator-Sponsored Studies, and Patient Support Programs across all Therapeutic Areas
  • Enhance the organization?s overall capability for cross-functional audits/inspections by coordinating and training the Chief Medical Officer (CMO) and Global Medical Affairs (GMA) function
Merck KGaA
Darmstadt, Germany
7 Jahre 4 Monate
2010-09 - 2017-12

Global Medical Affairs Study Coordination & Compliance

Associate Director
Associate Director
  • Similar to above, yet covering less Therapeutic Areas
  • Additional responsibility for Medical Governance of Patient Support Programs taken in 2016
Merck KGaA
Darmstadt, Germany
1 Jahr 9 Monate
2009-01 - 2010-09

Diverse Projekte

Performance Manager Medical Science & Innovation
Performance Manager Medical Science & Innovation
Merck KGaA
Darmstadt, Germany
1 Jahr
2008-01 - 2008-12

Diverse Projekte

Operations & Liaison Manager, Global Clinical Development Unit Oncology
Operations & Liaison Manager, Global Clinical Development Unit Oncology
Merck KGaA
Darmstadt, Germany
1 Jahr 11 Monate
2006-02 - 2007-12

Resourcing Management

Resourcing Manager
Resourcing Manager
Ingenix Pharmaceutical Services Deutschland GmbH, Previously SKM Oncology Research GmbH
Hannover, Germany
4 Jahre 1 Monat
2002-01 - 2006-01

Clinical Operations positions of increasing responsibility

Ingenix Pharmaceutical Services Deutschland GmbH, Previously SKM Oncology Research GmbH
Hannover, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

3 Monate
2024-09 - heute

Fachkraft für Qualitätsmanagement in der Medizinprodukteindustrie nach ISO 13485:2016 - TÜV

TÜV SÜD Akademie
TÜV SÜD Akademie

Position

Position

  • Business Process Management

  • Medical Affairs Operations

  • Audit Coordination

  • Medical Governance / Grant Management

Kompetenzen

Kompetenzen

Top-Skills

Prozessmanagement Good Clinical Practice Qualitymanagement Prozessentwicklung Prozessoptimierung BPMN Projektmanagement Klinische Studien ICH-GCP Pharma Compliance Analysefähigkeit Medical Governance Audit Audit Practise CAPA Quality Documentation Medical Affairs Prozessberatung Clinical Research Grant Management Early Access Medizinprodukte ISO 13485

Produkte / Standards / Erfahrungen / Methoden

Profil:

  • I am combining 20+ years of experience in Clinical Development/Medical Affairs with modern-day business process management to build and strengthen effective quality- and risk management systems and procedures, to organize and improve efficient internal review and medical governance mechanisms, and by that help to maintain and improve the quality of patient care
  • I am a results-oriented, self-organized, and problem-solving team player with a keen eye for detail, leveraging strategic and analytical thinking to deliver complex information clearly to wide range of audiences and business units

Klinische Forschung

Klinische Studien phase II-IV Prozesse, Planung, Governance
Experte
Early Access, Compassionate Use
Fortgeschritten

Medical Affairs

Klinische Studien phase II-IV Prozesse, Planung, Governance
Experte
Investigator-Initiated Research/Studies
Experte
Patient Support Programs
Experte
HCP Interaktion, Compliance Regelungen
Fortgeschritten

Qualitätssicherung

Geschäftsprozessmanagement
Experte
Kontinuierliche Verbesserung
Experte
Prozessdokumentation
Experte
BPMN 2.0
Fortgeschritten
Audit Koordination
Experte
ISO 13485
Basics

Branchen

Branchen

Arzneimittelindustrie

Pharmazeutische Industrie

Medizinprodukteindustrie

Healthcare

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