Pharmacokinetic/Pharmacodynamic (PK/PD) Analyst Service
- Provides scientific expertise in designing studies and pharmacokinetic/pharmacodynamic (PK/PD) analysis and performs, evaluates PK/PD analyses and support the writing of protocols and NDA clinical/pharmacokinetic integrated reports for clients' clinical studies.
- Conducts data interpretation of clinical pharmacology and pharmacokinetic data to contribute to the design of regulatory strategies and drug development programs.
- Collaborates with a team to research, write, edit and format scientific, medical, and regulatory research documentation and other necessary documents for client product development projects.
- Works with a team to write, edit and format submission documentation to ensure high quality INDs, ANDAs, NDAs and other applications to regulatory agencies related to clients' projects.
- Participates in relevant meetings/teleconferences with team and with clients.