Clinical Program Lead
Biberach an der Riß
Vollzeit
BI International GmbH
… of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product … Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and … and approve publications within your project in collaboration associate Head of Medicine. As a Senior Clinical Program Leader, you: You author …Affairs StellenangeboteSenior Clinical Study Administrator, Country Operations
München
Vollzeit
Alexion Pharmaceuticals,Inc. (gehört zu AstraZeneca)
… translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions, as required within the country/region. Providing … Practices (GCP), Alexion Standard Operating Procedures (SOPs) and evolving regulatory requirements. The CSA collaborates closely with the Project Manager … posted: 12/05/2023 Location: Office-based (Munich, Germany) Reports To: Head of Country Operations This is what you will do: The Clinical Study …Regulatory Affairs StellenangeboteAssociate Clinical Operations Manager (Regulatory) (m/f/d)
München
Vollzeit
MSD
… partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas … language Informed Consents and translations. Interact with IRB/IEC and Regulatory Authority for assigned protocols. Manages country deliverables, timelines … internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for Supporting budget/finance …Head Affairs
SSO Study Start-Up Manager (m/d/w)
Nürnberg
Vollzeit
Novartis
… Überprüfung von Einverständniserklärungen, Zusammenarbeit mit Regulatory Affairs/CTA-Hub Koordiniert die rechtzeitige Reaktion auf Mängelschreiben in … etc.), Überprüfung von Einverständniserklärungen, Zusammenarbeit mit Regulatory Affairs/CTA-Hub Koordiniert die rechtzeitige Reaktion auf Mängelschreiben … in enger Zusammenarbeit mit dem SSO Study Start-Up Team Lead und dem SSO Head Portfolio. Arbeitet mit dem SSO Country / Cluster Head Portfolio, den SSO …Head StellenangeboteMedical Science Liaison
Deutschland
Vollzeit
Sobi
… medical environment (i.e. MSL, Medical Advisor) Experience from medical affairs, medical/clinical science, clinical development, access and health … of biologics and/or small molecule pharmaceuticals and industry regulatory standards. Nice to have experience in Hemophilia or rare diseases. … HQ when performing Business Development Due Diligence. Deliver inputs to head office led medical programs ahead of launch. Coordinate Investigator …Head Regulatory Affairs StellenangeboteHead QPPV & PRRC Office (f/m/d)
Wehr
Vollzeit
Novartis
… Management experience regarding managing a Patient Safety or Regulatory Affairs team (line or functional management) Excellent stakeholder management … combined medical devices and (2) heading the QPPV & Person Responsible for Regulatory Compliance (PRRC) Office. The role reports to the Head Patient Safety & … 384853BR Head QPPV & PRRC Office (f/m/d) Germany About the role The Head QPPV & PRRC …Head Regulatory AffairsFinance Manager (m/w/d)
Bad Homburg vor der Höhe
Vollzeit
Celltrion Healthcare Deutschland GmbH
… critical. Position Summary: The position of the Sr. Associate Regulatory Affairs is newly created to ensure regulatory requirements in accordance with … is critical. Position Summary: The position of the Sr. Associate Regulatory Affairs is newly created to ensure Regulatory requirements in accordance … QM/SCM Location: Office-based (Bad-Homburg, Germany) Reports To: Head of QM/SCM FTE 100% (40 hours/week) We are Celltrion Healthcare. Celltrion …Head Regulatory AffairsPR & Communications Manager EU Policy
Deutschland
Vollzeit
REDSOFA BERLIN GMBH
… communications, support global ones and help manage / external public affairs and PR agencies. WHAT DO I NEED TO BE GOOD AT? 5+ years relevant … to advance and enhance positions and conversations taking place with key regulatory and legislative bodies globally. You will also assist in building a more … corporate events. You will work closely with Policy and Legal teams, Head of Communications, Europe and Director of Policy and Corporate …Head Regulatory Affairs