POSITION SUMMARY

To perform experiments, ensuring that projects are completed to plan, while complying with all quality and safety regulations. Assist with study plan writing, data analysis and interpretation, and report writing.

• Assist or act as the lead scientist on assigned studies.
• Draft study plans and contribute to the preparation of reports for sponsors.
• Review literature and appropriate guidances (FDA and/or EMA) in preparation for studies and to regularly update knowledge by reviewing appropriate literature.
• Perform experiments (with supervision as needed) in line with in vitro testing such as in vitro permeation and penetration studies, in vitro release testing studies, extractions, stability studies, etc.
• Assist with data analysis for studies related to in vitro testing.
• Confer with scientists, study managers, and management to conduct analyses of research projects, interpret test results, or develop nonstandard tests.
• Crosstrain and assist with research biology activities (e.g. PCR, PK/PD, etc.) as needed.
• Report any amendments or deviations from Study Plans/SOPs to Lead Scientist and/or Study Manager/Director, as appropriate.
• Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions with scientists when needed.
• Adhere to MedPharm Standard Operating Procedures (SOPs) and guidance documents, where applicable.
• Contribute to the preparation and review of SOPs and Forms where applicable.
• Where applicable, promptly record all data according to Good Documentation Practices.
• Adhere to MedPharm Health & Safety Policy and OSHA regulations at all times and to ensure the safety of others in any procedures or tasks performed.
• Ensure that all documentation, computer data, and records are stored appropriately.
• Any other duties and/or tasks that may be assigned
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