Location: MAITLAND, FL, United States
Zip Code: 32751
Job ID: 846
Description
Job Summary:
The Regulatory Affairs Specialist I is an entry-level position focused on supporting the company’s regulatory compliance efforts. This role involves tasks such as assisting with and maintaining regulatory documentation, assisting with submissions to applicable state and federal licensing, permitting, registration and certification law and regulations governing the use of narcotic medications in the treatment of opioid use disorder.
Essential Functions:
-Assist in the preparation, and the completion and submission of any and all license, certificate, registration and permit applications with federal regulators, state licensing agencies and pharmacy boards that are required for the lawful operation of the company’s opioid addiction treatment programs.
-Maintaining and updating regulatory documentation including, but not limited to, documentation required for compliance with the federal Controlled Substance Act, Title 42 C.F.R 8.12, Title 21 C.F.R. 1301. Advise and educate the company’s managers and clinical staff on laws and regulations applicable to the states in which their clinics are located, to include the nature and impact of any regulatory changes on the company’s operations.
-Communicate and coordinate with internal departments and external regulatory agencies, as needed, to coordinate completion of requisite regulatory tasks required for the lawful operation of the company’s clinics.
-Assist with providing guidance on unique federal or state regulatory issues that arise during government agency regulatory audits and inspections.
-Assist with maintaining an electronic or hard copy filing system for organizational records pertaining to clinic licensing, registration, certification and permitting, including any adverse actions pertaining thereto.
-Assist as subject matter expert by gathering information and data to support regulatory compliance for company managers and clinical staff on technical requirements of federal Controlled Substances Act including, but not limited to, medication ordering requirements, proper accounting and storage of medications, and recordkeeping requirements for medication destruction and quarantine.
-Assist with advising the company’s General Counsel during the preparation of, responses submitted on the Company’s behalf pursuant to any state government-initiated request for proposals, certificate of need or determination of need processes to award or create opioid addiction treatment facilities within a particular jurisdiction.
-In response to adverse regulatory actions initiated by federal and state regulatory agencies, assist with research being conducted to assess cited violations, and participate in drafting, or advising the company’s General Counsel during the drafting of, comprehensive written responses to be submitted on company’s behalf which substantially address the alleged violations.
-Participate in providing substantive technical guidance on routine regulatory issues incorporated in the Company’s compliance strategies to improve regulatory processes and efficiency.
-Participate in the training of Company employees on general substantive topics applicable to lawful clinical operations including, but not limited to, the federal Controlled Substances Act, individual laws pertaining to clinic licensure, and applicable local ordinances.
-Participate in the periodical review the Company’s Policies and Procedures for the purpose of identifying, drafting and implementing necessary revisions as mandated by changes to federal or state law and regulations.
-For Company’s managers and clinical staff, prepare charts and guides summarizing common state law regulatory requirements and related matters relevant to clinic operations.
-Serve as a resource to the Company’s Business Development team to resolve routine regulatory issues pertaining to the opening, relocation, or closure of opioid addiction treatment facilities.
-Other duties as assigned by the company’s General Counsel.
Supervisory Responsibilities: (Scope of the person's authority, including a list of jobs that report to this job)
None
Essential Qualifications:
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the competencies (minimum knowledge, skill, and ability) required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
Education/Licensure/Certification:
High School diploma/GED or related field or equivalent experience required; bachelor’s degree preferred
Required Knowledge:
Knowledge of computer and internet applications, data management, and reporting requirements. Proficiency in Google software applications.
Experience Required
At least 3+ years of healthcare regulatory and/or licensing experience preferred.
Demonstrated experience utilizing Excel/Sheets and other Google products. Well-developed team skills, unquestioned integrity, and the experience, confidence and presence to effectively handle interpersonal relationships and sensitive confidential issues.
Experience in handling sensitive, confidential information.
Skill and Ability:
Strong administrative and data management skills. Meticulous attention to detail is crucial for accuracy in documentation and reporting
Ability to work with both technical and administrative personnel and to raise issues proactively in a timely manner.
Strong organizational skills with a keen ability to prioritize and multitask with an ability to adhere to and meet deadlines.
Physical Demands/Work Environment:
(The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Finger Dexterity:
Use primarily for writing, operating calculator, telephone, keyboard, and other office equipment.
Talking:
To convey detailed or important instructions to employees, patients, and applicants.
Hearing:
Ability to hear normal conversations and receive ordinary information.
Vision:
Average, ordinary, visual acuity necessary to observe patients and work on computer. Clear vision at 20 inches or less and distant vision at 20 feet or more.
Physical Strength:
Sedentary work; sitting most of the time. Exerts up to 10 pounds of force occasionally.
Working Conditions:
(The working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
-Ability to work in an open environment with moderate everyday noise.
Core Competencies
-Approachability
-Customer Service
-Excellent Communication (Oral and Written)
-Influencing/Persuading
-Ethics/Values/Integrity
-Information Gathering
-Problem Solving
-Strategic Planning/Thinking
Mental Activities:
(The mental activities described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Reasoning Ability:
Ability to resolve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to maintain confidentiality.
Mathematics Ability:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumferences, and volume.
Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals,technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from fellow employees, and managers..
The Regulatory Affairs Specialist I is an entry-level position focused on supporting the company’s regulatory compliance efforts. This role involves tasks such as assisting with and maintaining regulatory documentation, assisting with submissions to applicable state and federal licensing, permitting, registration and certification law and regulations governing the use of narcotic medications in the treatment of opioid use disorder.
Essential Functions:
? Assist in the preparation, and the completion and submission of any and all license, certificate, registration and permit applications with federal regulators, state licensing agencies and pharmacy boards that are required for the lawful operation of the company’s opioid addiction treatment programs.
? Maintaining and updating regulatory documentation including, but not limited to, documentation required for compliance with the federal Controlled Substance Act, Title 42 C.F.R 8.12, Title 21 C.F.R. 1301. Advise and educate the company’s managers and clinical staff on laws and regulations applicable to the states in which their clinics are located, to include the nature and impact of any regulatory changes on the company’s operations.
? Communicate and coordinate with internal departments and external regulatory agencies, as needed, to coordinate completion of requisite regulatory tasks required for the lawful operation of the company’s clinics.
? Assist with providing guidance on unique federal or state regulatory issues that arise during government agency regulatory audits and inspections.
? Assist with maintaining an electronic or hard copy filing system for organizational records pertaining to clinic licensing, registration, certification and permitting, including any adverse actions pertaining thereto.
? Assist as subject matter expert by gathering information and data to support regulatory compliance for company managers and clinical staff on technical requirements of federal Controlled Substances Act including, but not limited to, medication ordering requirements, proper accounting and storage of medications, and recordkeeping requirements for medication destruction and quarantine.
? Assist with advising the company’s General Counsel during the preparation of, responses submitted on the Company’s behalf pursuant to any state government-initiated request for proposals, certificate of need or determination of need processes to award or create opioid addiction treatment facilities within a particular jurisdiction.
? In response to adverse regulatory actions initiated by federal and state regulatory agencies, assist with research being conducted to assess cited violations, and participate in drafting, or advising the company’s General Counsel during the drafting of, comprehensive written responses to be submitted on company’s behalf which substantially address the alleged violations.
? Participate in providing substantive technical guidance on routine regulatory issues incorporated in the Company’s compliance strategies to improve regulatory processes and efficiency.
? Participate in the training of Company employees on general substantive topics applicable to lawful clinical operations including, but not limited to, the federal Controlled Substances Act, individual laws pertaining to clinic licensure, and applicable local ordinances.
? Participate in the periodical review the Company’s Policies and Procedures for the purpose of identifying, drafting and implementing necessary revisions as mandated by changes to federal or state law and regulations.
? For Company’s managers and clinical staff, prepare charts and guides summarizing common state law regulatory requirements and related matters relevant to clinic operations.
? Serve as a resource to the Company’s Business Development team to resolve routine regulatory issues pertaining to the opening, relocation, or closure of opioid addiction treatment facilities.
? Other duties as assigned by the company’s General Counsel.
Supervisory Responsibilities: (Scope of the person's authority, including a list of jobs that report to this job)
None
Essential Qualifications:
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the competencies (minimum knowledge, skill, and ability) required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).
Education/Licensure/Certification:
High School diploma/GED or related field or equivalent experience required; bachelor’s degree preferred
Required Knowledge:
Knowledge of computer and internet applications, data management, and reporting requirements. Proficiency in Google software applications.
Experience Required
At least 3+ years of healthcare regulatory and/or licensing experience preferred.
Demonstrated experience utilizing Excel/Sheets and other Google products. Well-developed team skills, unquestioned integrity, and the experience, confidence and presence to effectively handle interpersonal relationships and sensitive confidential issues.
Experience in handling sensitive, confidential information.
Skill and Ability:
Strong administrative and data management skills. Meticulous attention to detail is crucial for accuracy in documentation and reporting
Ability to work with both technical and administrative personnel and to raise issues proactively in a timely manner.
Strong organizational skills with a keen ability to prioritize and multitask with an ability to adhere to and meet deadlines.
Physical Demands/Work Environment:
(The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Finger Dexterity:
Use primarily for writing, operating calculator, telephone, keyboard, and other office equipment.
Talking:
To convey detailed or important instructions to employees, patients, and applicants.
Hearing:
Ability to hear normal conversations and receive ordinary information.
Vision:
Average, ordinary, visual acuity necessary to observe patients and work on computer. Clear vision at 20 inches or less and distant vision at 20 feet or more.
Physical Strength:
Sedentary work; sitting most of the time. Exerts up to 10 pounds of force occasionally.
Working Conditions:
(The working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
? Ability to work in an open environment with moderate everyday noise.
Core Competencies
? Approachability
? Customer Service
? Excellent Communication (Oral and Written)
? Influencing/Persuading
? Ethics/Values/Integrity
? Information Gathering
? Problem Solving
? Strategic Planning/Thinking
Mental Activities:
(The mental activities described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Reasoning Ability:
Ability to resolve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to maintain confidentiality.
Mathematics Ability:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumferences, and volume.
Language Ability:
Ability to read, analyze, and interpret general business
periodicals, professional journals,technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from fellow employees, and managers..
For over 30 years, New Season Treatment Centers have been a leading national health care service provider of outpatient treatment centers that specialize in providing safe, quality and best in class care for individuals living with Opioid Use Disorder ("OUD").
Operating in over 70 treatment centers in multiple states, our team members are engaged in medication-assisted treatment, counseling, support, and care management of individuals living with OUD. We treat the whole person and, in so doing, address the underlying causes of OUD in an effort to provide a continuum of care that not only addresses treatment needs but supports the patient on their journey to recovery.
Job Summary:
The Regulatory Affairs Specialist I position's primary function is to provide guidance and direction to company managers and clinical staff on laws and regulations impacting company and clinic operations, and to ensure that the company and the company's clinics remain compliant with all applicable state and federal licensing, permitting, registration and certification law and regulations including, but not limited to, laws and regulations governing the use of narcotics in the treatment of opioid addicted patients.
_____________________________________________________________________________________
Essential Functions:
_ Prepare and submit, as assigned, any and all license, certificate, registration, and permit applications with federal regulators, state licensing agencies, and pharmacy boards that are required for the lawful operation of the company's opioid addiction treatment programs.
_ For assigned jurisdictions, maintain current knowledge on all licensing laws and regulations applicable to those jurisdictions.
_ Facilitate communications with state and federal regulatory agencies on issues critical to the company's clinical operations including, but not limited to, mandatory clinical inspections, system audits, and related regulatory inquiries.
_ Assist with the completion of regulatory audits.
_ Assist with maintaining an electronic or hard copy filing system for organizational records pertaining to clinic licensing, registration, and certification, and permitting, including any adverse actions pertaining thereto.
_ Attain and maintain proficiency on technical requirements of federal Controlled Substances Act including, but not limited to, medication ordering requirements, proper accounting and storage of medications, and recordkeeping requirements for medication destruction and quarantine.
_ Assist in the preparation of responses submitted on the company's behalf pursuant to any state government-initiated request for proposals, certificate of need or determination of need processes to award or create opioid addiction treatment facilities within a particular jurisdiction.
_ In response to adverse regulatory actions initiated by federal and state regulatory agencies, conduct research to assess cited violations, assist in the preparation of, comprehensive written responses to be submitted on company's behalf which substantially address the alleged violations.
_ Assist in the preparation of substantive technical guidance utilized in the creation of compliance strategies.
_ Assist in training company employees on substantive topics relevant to lawful clinical operations including, but not limited to, the federal Controlled Substances Act, individual laws pertaining to clinic licensure, and applicable local ordinances.
_ Assist in the preparation of changes to the company's Policies and Procedures as mandated by changes to federal or state law and regulations.
_ For company's managers and clinical staff, assist in the preparation of job aids and process guides on common state law regulatory requirements and related matters relevant to clinic operations.
_ Other duties as assigned by the company's General Counsel.
Essential Qualifications:
Education/Certification: High School diploma/GED ; Bachelor's degree preferred
Required Knowledge: Knowledge of computer and internet applications, data management, and reporting requirements. Proficiency in Google software applications.
Experience Required: At least 1+ year of healthcare regulatory and/or licensing experience.