We are seeking an experienced Clinical Research Domain Analyst with expertise in IVRT (In Vitro Release Testing) and IVPT (In Vitro Permeation Testing) to join our team. The ideal candidate will have a strong background in clinical research, specifically within the formulation and development sectors, with a focus on IVRT/IVPT methodologies. You will be responsible for supporting research projects, analyzing data, and ensuring compliance with regulatory standards.
Key Responsibilities:
- IVRT/IVPT Method Development and Execution:
- Design, develop, and validate IVRT/IVPT protocols in accordance with regulatory guidelines.
- Perform data analysis and interpretation of IVRT/IVPT results to support formulation and product development.
- Ensure compliance with FDA and other regulatory bodies’ requirements for topical and transdermal formulations.
- Data Analysis and Reporting:
- Analyze and summarize data from IVRT/IVPT studies.
- Prepare technical reports, scientific publications, and regulatory submission documents.
- Project Management:
- Collaborate with cross-functional teams, including formulation scientists, regulatory affairs, and clinical operations.
- Manage timelines and deliverables for clinical research studies focused on IVRT/IVPT.
- Ensure proper documentation and data handling for all research activities.
- Regulatory Compliance:
- Ensure that all IVRT/IVPT studies are conducted in compliance with regulatory standards such as FDA, EMA, and ICH guidelines.
- Assist in the preparation of regulatory submission documents related to product development.
- Collaboration and Communication:
- Liaise with internal and external stakeholders, including contract research organizations (CROs) and regulatory authorities.
- Present study results and recommendations to senior management and external partners.
