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Early applicant
Remote
Employee
The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.
Responsibilities
- Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information
- Contribute to site selection
- Involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report...
Skills
Clinical trial protocols
Clinical study reports
Informed consent forms
Case report forms
Protocol deviation
Medical monitoring
Pharmacovigilance
Regulatory guidelines
GCP
SOPs
NDA submission process
PIP (pediatric investigation plan)
(Associate) Medical Director, Pediatrics (Client-Dedicated) - EMEA
ThermoFisher
Early applicant
Remote
Employee
The Medical Director will provide medical support and medical advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.
Responsibilities
- Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information
- Contribute to site selection
- Involved in review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report...
Skills
Clinical trial protocols
Clinical study reports
Informed consent forms
Case report forms
Protocol deviation
Medical monitoring
Pharmacovigilance
Regulatory guidelines
GCP
SOPs
NDA submission process
PIP (pediatric investigation plan)