Senior Regulatory and Licensing Analyst

7,000 Diseases - 500 Treatments - 1 Rare Pharmacy

PANTHERx is the nation’s largest rare disease pharmacy, and we put the patient experience at the top of everything that we do.

If you are looking for a career in the healthcare field that embraces authentic dedication to patient care, you don’t need to look beyond PANTHERx. In every line of service, in every position and area of expertise, PANTHERx associates are driven to provide the highest quality outcomes for our patients.

We are seeking team members who:

Are inspired and compassionate problem solvers;

Produce high quality work;

Thrive in the excitement of the ever-challenging environment of modern medicine; and

Are committed to achieving superior health outcomes for people living with rare and devastating diseases.

At PANTHERx, we know our employees are the driving force in what we do. We cultivate talent and encourage growth within PANTHERx so that our associates can continue to explore their interests and expand their careers. Guided by our mission to provide uncompromising quality every day, we continue our strategic growth to further reach those affected by rare diseases.

Join the PANTHERx team, and define your own RxARE future in healthcare!

Location: Pittsburgh, PA

Classification: Exempt

Job Type: Full-time (Hybrid)

Reports to: Director of Quality and Compliance

Purpose:

The Senior Regulatory and Licensing Analyst is an integral part of the compliance team within PANTHERx Rare Pharmacy. Under the direction of the Director, Quality and Compliance and working collaboratively with individuals across the company, this position is responsible for all required licensure to support PANTHERx operations. The Senior Regulatory and Licensing Analyst initiates new license applications, completes license renewals, responds to regulatory inquiries, conducts regulatory research, and communicates effectively with individuals throughout the organization. This position also supports PANTHERx’s growth initiatives by identifying relevant statutes and/or regulations, reviewing and interpreting legal/regulatory guidance and translating regulatory requirements into actionable information for internal customers.

Responsibilities:

• Works collaboratively with individuals across the organization to determine all licensure required for PANTHERx operations.
• Reviews regulatory requirements for licensure in applicable jurisdiction(s); ensures that regulatory requirements are satisfied; and collects all required information supporting application submissions.
• Tracks the status of submitted applications; responds to requests for additional information; and communicates the application status to internal stakeholders as appropriate.
• Tracks renewal dates for licenses and submits renewal applications to ensure that PANTHERx does not experience a lapse in licensure.
• Identifies organizational changes that require notification to regulatory agencies and/or new license applications; provides notifications and completes new applications as needed.
• Identifies relevant statutes and regulations for PANTHERx’s growth initiatives; reviews and interprets the legal/regulatory guidance; and translates regulatory requirements into actionable information for internal stakeholders.
• Completes annual and ad hoc reporting to federal and state agencies as required based on new licenses obtained.
• Escalates regulatory, compliance and/or licensure issues as needed and appropriate.
• Maintains licensure information for pharmacists who are designated as a pharmacist-in-charge in any jurisdiction and ensures that pharmacists-in-charge satisfy regulatory requirements in the applicable jurisdiction(s) including active licensure.
• Researches and maintains state-based exemption criteria for Prescription Drug Monitoring Programs (PDMPs); submits state-based waiver applications; and renews waivers as needed and appropriate.
• Organizes licensure documents and maintains internal files so that documentation is easily accessible for reference.
• Other duties as assigned to support PANTHERx’s compliance department.

Required Qualifications:

• Bachelor’s Degree.
• At least five (5) years’ experience reviewing and interpreting regulatory guidance.
• Demonstrated ability to apply regulatory guidance to fact-based scenarios in order to form well-reasoned conclusions.
• High degree of self-direction and ability to work independently with little or no supervision.
• Ability to communicate effectively in a manner that is clear, logical and consistent.
• Ability to work effectively in a collaborative, cross-functional manner.
• High degree of organization and follow through.
• Ability to manage multiple projects simultaneously, adjusting priorities as needed to meet project deadlines.
• Proficient in Microsoft Office suite of products (Word, Excel, Power Point).

Preferred Qualifications:

• At least three (3) years’ experience with obtaining and renewing healthcare licensure.
• Previous experience in healthcare, preferably with a healthcare provider.
• Previous experience in a similar role interacting with regulatory agencies.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee frequently is required to stand; walk; use hands and fingers, handle or feel; and reach with hands and arms. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of the job.

Benefits:

Hybrid, remote and flexible on-site work schedules are available, based on the position. PANTHERx Rare Pharmacy also affords an excellent benefit package, including but not limited to medical, dental, vision, health savings and flexible spending accounts, 401K with employer matching, employer-paid life insurance and short/long term disability coverage, and an Employee Assistance Program! Generous paid time off is also available to all full-time employees, as well as limited paid time off for part-time employees. Of course we offer paid holidays too!

Equal Opportunity:

PANTHERx Rare Pharmacy is an equal opportunity employer, and does not discriminate in recruiting, hiring, promotions or any term or condition of employment based on race, age, religion, gender, ethnicity, sexual orientation, gender identity, disability, protected veteran's status, or any other characteristic protected by federal, state, or local laws.