Medical Director(Hematology/Oncology) - Remote U.S

Position Overview

• Location Type: Onsite
• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Requirements

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Responsibilities

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
• Attends and presents at investigator and sponsor meetings.
• Provides medical consultation to clients, investigators and project team members.
• Supports business development activities.
• Provides medical review and analysis for clinical trial serious adverse events.
• Supports the preparation of ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR).
• Assists in writing and/or reviewing CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc.
• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status).
• Provides therapeutic training and protocol training on assigned studies.
• Communicates clearly with associates and clients, maintaining an open line of communication.

Additional Information

• Manages and oversees all contracted services.
• Ensures tasks delegated to PVG are properly executed.
• Adheres to applicable regulations and ICH guidelines.
• Adheres to client SOPs/directives and project specific WPDs.
• Adheres to PPD’s corporate policies and SOPs/WPDs.