Sr. Regulatory Counsel (Pharmacy)
Des Moines, Iowa, United States, Hybrid, Remote
About the Role
OpenLoop is looking for a Senior Regulatory Counsel (Pharmacy) to join our team remotely or at HQ in Des Moines, IA. In this role, you will have the opportunity to provide teams from across the company with actionable legal advice on various healthcare and pharmacy laws, rules, and regulations impacting the products and services offered through OpenLoop Health. You will get to work on interesting and novel issues that arise from the intersection of healthcare, technology, and e-commerce.
What You'll Do
- Support multiple teams throughout the organization, including but not limited to the innovations and compounding operations team, and the pharmacy quality and compliance team
- Advise cross-functional teams across the business on a broad variety of healthcare regulatory issues and considerations related to legal risks
- Identify issues that may touch upon privacy and product issues
- Work with the public policy team to inform and shape the company’s legislative efforts by providing subject matter expertise to support the review of proposed laws, rules, and regulations impacting the business, specifically as related to certain aspects of pharmacy operations
- Stay up-to-date on relevant state and federal laws, regulations, and guidance around compounding and other areas related to pharmacy operations
Who You Are
- Juris Doctor from an ABA-accredited law school and current active license to practice law in at least one US jurisdiction
- 7+ years of healthcare regulatory experience with focus on compounding pharmacy representation
- Extensive experience with healthcare laws and regulations, particularly experience with Food and Drug Administration (FDA) regulatory matters, including familiarity with laws, rules, regulations, and guidance documents in the area of compounding
- Familiarity and experience interpreting and advising on state and federal laws, rules, and regulations applicable to compounding pharmacies and outsourcing facilities
- Strong record of providing creative, solution-focused advice
- Team-oriented mindset and positive attitude
- Ability to adapt quickly in a dynamic, fast-paced environment
- Strong time management, project prioritization, and management skills
- Experience interacting with licensing/regulatory authorities such as the FDA or state Boards of Pharmacy is a plus
About OpenLoop
OpenLoop was co-founded by CEO, Dr. Jon Lensing, and COO, Christian Williams, with the vision to bring healing anywhere. Our tele-health support solutions are thoughtfully designed to streamline and simplify go-to-market care delivery for companies offering meaningful virtual support to patients across an expansive array of specialties, in all 50 states.
Our Company Culture
We have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work.
Our Benefits
In addition to the salary for this role, you would also be eligible for:
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Medical, Dental, and Vision plans
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Flexible Spending/Health Savings Accounts
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Unlimited PTO
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401(k) + Company Match
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Life Insurance, Pet insurance, and more
Sound like a good fit? We’d love to meet you.
Apply
Job Profile
Hybrid Remote
Benefits/Perks401(k) match Dental Flat organizational structure Flexible Spending Hybrid work Life Insurance Medical More Pet Insurance Unlimited PTO Vision Vision plans
Tasks- Advise on healthcare laws
- Identify legal risks
- Inform legislative efforts
- Provide legal advice
- Support regulatory compliance
Compliance Cross-functional Collaboration E-commerce FDA regulations Healthcare Healthcare law Legal advice Organizational Pharmacy law Pharmacy operations Privacy Law Project Management Regulatory Compliance Time Management
Experience7 years
EducationBusiness DO Juris Doctor Management
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9