Job Description:
Vireo Health is a physician-founded, patient-focused company dedicated to providing best-in-class cannabis-based products and unrivaled care. We integrate best-in-class medical, scientific, and engineering practices into the cannabis industry. We are committed to creating safe, all-natural cannabis-based products and a compassionate patient experience and aim to harness data to further improve the quality, safety and affordability of cannabis-based medicines for our patients.
Vireo Health supports the evidence-based approach to plant medicine and looks to advance the pharmaceutical implementation of complex plant therapies by leveraging robust real-world evidence data sets and reinforcing safety and efficacy claims of plant-based medicine through solid science.
We are currently seeking a full-time
This role will be centered around overseeing and further developing FDA initiatives within the company. The
- Work with the clinical research team toward furthering efforts in development of FDA botanical drug candidates, formulating strategies to maintain submission goals
- Facilitate new biologics, drugs, botanicals through investigational studies and approval processes
- Spearhead the design, execution, and oversight of eNPV in clinical plan optimization
- Oversee preparation of regulatory submissions in electronic format (ANDA s/NDA s/amendments) to ensure compliance with all FDA regulations and guidelines
- Draft technical documents for regulatory submissions. Provide regulatory review and ensure submissions comply with applicable regulations and guidance documents.
- Establish and maintain contacts and effectively partner with FDA, DEA and other federal agencies to direct, co-ordinate and implement preparation of all regulatory submissions and provide regulatory
Job Requirements:
support across all areas
- Liaise and orchestrate meetings with cross functional departments; strategize and plan for timely submissions
- Plan, execute and lead successful regulatory agency meetings and interactions per regulatory strategy
- Conceptualize the scope of projects and work with the team from project initiation through completion of deliverables
- Work with project teams to identify needs, sources, and structure to further support FDA path botanical candidates
- Utilize large and complex healthcare data (EMR/Seed-2-Sale, Registry Data, Research databases) for the development of RWE support
- With supervision, prepare responses to questions (Information Requests and Complete Response letters) from the FDA
- Review technical documents for submission in new ANDAs, NDAs and provides guidance to the technical development groups.
- Gather, input and compile clinical and non-clinical data, statistics and other materials as needed
- Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting internal/external team members as necessary
- Participate in activities related to data generation and validation; ensure consistent, quality data review, monitor for clinical data trend identification in collaboration with medical team
- Make recommendations for improving resources (tools, systems, vendors, etc.) needed
- Create effective written reports and communicate findings from the databases to the clinical research team; participate in the production and presentation of deliverables
- Develop creative solutions for complex problems
- Monitor resources/reports to deliver milestones on time and budget
- Maintain strictest confidentiality in compliance with HIPAA guidelines
- Minimum of a Bachelor s degree in a science related discipline, Master degree or higher in pharmaceutical sciences, pharmacology, toxicolo