Supports the Medical team by managing standard and complex in vitro and in vivo studies required for filing new and on-going multi-source ANDA products, and for working closely with the Product Development Team (PDT) on all issues surrounding the medical requirements and studies used to demonstrate bioequivalence.
Manages standard and complex in vitro and in vivo studies to support new and ongoing multi-source products independently.
The scope of the studies includes various in vitro studies including developmental work, dissolution studies for Extended Release products, and additional in vitro studies required for nasal and inhalation studies. The scope of the in vivo studies includes single dose and multiple dose studies in healthy subjects and patients. These studies may be conducted both in the U.S. and internationally.
The CRM works with the PDT to schedule, implement, and complete all required in vitro and in vivo studies needed to support 14 to 18 ANDA filings.
Responsible for determining regulatory requirements for international studies and relaying required information to relevant departments to meet submission requirements.
Ensures studies comply with all requirements, such as WIs, SOPs, and GCP’s. Leads critical review of all study related documents.
Ensures the appropriateness of the study design based on pharmacokinetic and/or clinical knowledge of the drug product, and all regulatory requirements.
Demonstrates leadership skills in the management of studies to independently direct all study related activities to ensure it is conducted to meet time-line requirements.
Serves as the medical member and works closely with the Product Development Team (PDT) on all issues surrounding the medical requirements and studies required to demonstrate bioequivalence. Become the medical expert in all pharmacokinetic parameters of the drug substance and knowledgeable about studies to help design future studies.
Responsible for keeping up-to-date on and relaying to the PDT the most recent regulatory requirements regarding the project. The project scope covers immediate release oral dosage forms; controlled, extended, and modified release oral dosage forms; nasal sprays, inhalation products, and additional dosage forms in development.
Participate as the medical PDT member for up to 5 new project starts every year. Ensures medical review for project is completed prior to PDT 1 meeting and communicates to PDT changing medical requirements throughout the life of the project.
Reviews relevant information regarding the formulation with Product Development (PD) during the development of the product. Provide input on the formulation and strategy based on the information reviewed.
Provide medical review and input as needed on additional issues pertaining to product development and post-approval activities for drug products (such as API and drug product impurities, excipients, leachables and extractables, and product labeling information).
Responsible for reviewing and ensuring completeness of study data and final reports. Ensures appropriate completion of relevant medical sections of (A)NDAs.
Responds to FDA deficiencies and questions as required.
Responsible for compiling information and completing all relevant medical sections of INDs for development of products when needed.
Responsible for developing and submitting briefing packets with proposed clinical development plans, clinical study protocols, informed consent documents, etc. during development of products for FDA review/discussion.