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Brello is a wellness-first brand that makes access to science-backed compounded medications feel effortless — never clinical or confusing. We connect individuals to licensed providers through Telegra, with prescriptions fulfilled by trusted 503A pharmacies. Our mission is to simplify, humanize, and demystify wellness solutions for longevity and weight management, with an authentic voice that is friendly, empowering, and transparent.
Compliance Analyst
Location
United States
Posted
68 days ago
Salary
$38 - $65 / hour
Seniority
Mid Level
No structured requirement data.
Job Description
Compliance Analyst
AP MAX INC
Role Description The Compliance Analyst plays a critical role in supporting the company's marketing efforts for 503A compounded drugs by ensuring all promotional materials, advertising campaigns, website content, sales communications, and marketing practices fully comply with FDA regulations under section 503A of the Federal Food, Drug, and Cosmetic Act, FTC advertising standards, state pharmacy and marketing laws, and other applicable federal and state requirements. - Review and approve marketing content, monitoring for compliance risks. - Conduct internal audits of current materials/website content. - Collaborate closely with marketing to mitigate risks while supporting business growth. Key Responsibilities - Serve as a key subject matter expert on compliance requirements for marketing 503A compounded drugs. - Review and approve all marketing materials for regulatory compliance before publication or distribution. - Monitor marketing campaigns and external communications for potential violations of FDA, FTC, or state regulations. - Conduct regular internal compliance audits and monitoring of marketing activities. - Track and analyze changes in relevant regulations and assess their impact on marketing strategies. - Assist in developing, updating, and implementing compliance policies, procedures, and training programs. - Document all reviews and approvals appropriately and ensure records are accurate and readily retrievable. - Support investigations into potential compliance issues, complaints, or regulatory inquiries. - Collaborate with Compliance Director, marketing leadership, and external partners to ensure promotional practices align with 503A exemptions. - Promote a culture of compliance and ethical marketing practices across remote teams. - Immediately notify the Compliance Director of any significant compliance issues. Qualifications - Experience in regulatory compliance within pharmaceuticals, compounding pharmacy, healthcare marketing, or FDA-regulated advertising/promotion environments is preferred. - Familiarity with FDA guidance on human drug compounding (section 503A), FTC advertising rules, and related enforcement trends. - Bachelor’s degree in a relevant field or an equivalent combination of education, training, and relevant experience. Advanced degree is preferred. Requirements - Familiarity with 503A compounding regulations and marketing compliance is a plus. Benefits - Full benefits package including medical, vision, dental, 401(k) with company match, PTO, Flex days, holidays, and more! Equal Opportunity Employer Statement Brello is proud to be an Equal Opportunity Employer where we are committed to fostering a diverse and inclusive workplace. We are committed to cultivating a culture where all team members feel valued & respected. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetic information, disability, age, veteran status, or any other characteristics protected by applicable law. If you have any questions or require immediate assistance or accommodations during the application or interview process, please contact us at recruiting@brellohealth.co .
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Lead Compliance & Quality Audit
Omega Healthcare SolutionsFounded in 2003, Omega Healthcare Management Services® (Omega Healthcare) empowers healthcare to thrive via intelligent solutions that optimize revenue cycle operations, administrative workflows, care coordination, and clinical research on a global scale. Works with providers, payers, life science companies, medical device manufacturers, health technology firms, researchers, and industry partners. Serves more than 350 healthcare organizations with 35,000 skilled workers in the United States, India, Colombia, and the Philippines. For more information, visit www.omegahms.com .
Summary/Objective Under limited supervision, Omega’s Lead Compliance and Quality Audit Manager performs audits of inpatient and outpatient medical records for coding accuracy and medical record documentation as it impacts the accuracy of ICD-10-CM, ICD-10-PCS codes driving the MS-DRG assignment and ICD - 10 CM and CPT-4/HCPCS codes driving the APC assignment. Lead Compliance and Quality Audit Manager must be able to identify Physician query opportunities, assess the accuracy of POA, discharge disposition and modifier assignments. Lead Compliance and Quality Audit Manager performs data collection for quality and statistical purposes and reports the finding the Client. The Lead Compliance and Quality Audit Manager is the first line of support for the HIM QA Managers, assists in coaching and developing staff members as necessary and completes special projects as assigned. Essential Job Functions - Review inpatient and outpatient medical records for accuracy of coding and data quality. Elements to be included in reviews can include: Inpatient/Observation Cases - All diagnosis and procedure assigned ICD-10-CM and ICD- 10 PCS codes - Discharge disposition assigned - Assigned Present on Admission (POA) indicators - APR, SOI, and ROM assignment for inpatient cases - All diagnosis and procedure assigned ICD-10-CM and ICD-10 PCS codes - All CPT assigned codes - Modifier use and assignment - APC assignment Outpatient Cases (ER, SDS, Ancillary) Professional Services - All diagnosis codes - All CPT assigned codes - All E&M leveling codes - Maintain auditing productivity based on Client and Omega agreed upon requirements. - Complete Quality Review reports timely and submits Omega (subsequently to Client) for review. - Work with the Omega Compliance Team to develop and provide coder/coding training and education sessions, group, or one-on-one sessions, as needed, based on results of the Coding Quality Reviews. - Provide support in the absence of the Manager, CQA Services, demonstrating aptitude to temporarily perform all duties of the Manager, CQA Services. - Provide support for special assignments which may include but are not limited to phone assessments, CodeONe, strategic initiatives and cross functional teams. - Utilize all available official references to perform reviews: to include but not limited to International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM), the Current Procedural Terminology (CPT-4) Official Coding Guidelines, Coding Clinic, CPT Assistant, CMS guidelines, etc. - Communicate effectively with supporting staff and Omega point-of-contact(s). Provides information regarding work progress, actions, and issues in a timely and effective manner. - Must be skilled in Microsoft Excel. - Perform duties in compliance with Company’s policies and procedures, including but not limited to those related to HIPAA and compliance. Key Success Indicators/Attributes - Extensive knowledge of ICD-10-CM, ICD -10 PCS and CPT-4 coding and MS-DRG and APR-DRG assignment. - Extensive knowledge of federal, state, and payer-specific regulations and policies pertaining to documentation, coding, and billing in addition to those that are state-specific. - Knowledge of documentation requirements to support coding and POA assignment is required. - Extensive knowledge of medical terminology, anatomy, and physiology - Demonstrate ability to self-motivate, set goals, and meet deadlines. - Demonstrate professional demeanor and strong interpersonal skills. - Demonstrate excellent presentation, verbal, and written communication skills. - Demonstrate excellent analytical, critical thinking and problem-solving skills. - Skill in operating a personal computer and utilizing a variety of software applications. - Knowledge of coding convention and rules established by the American Medical Association (AMA), the American Hospital Association (AHA) and the Center for Medicare and Medicaid (CMS), for assignment of diagnostic and surgical procedural codes. - Knowledge of JCAHO, coding compliance and HIPAA-HITECH standards affecting medical records and the impact on reimbursement and accreditation. Supervisory Responsibility Yes, supervises a team of Auditors (usually 15 to 20 Auditors). Work Environment This job operates in a remote home office environment. This role routinely uses standard office equipment such as computers and phones. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. Position Type/Expected Hours of Work This is a full-time position. Days and hours of work are generally Monday through Friday, 8:00 a.m. to 5 p.m. This position occasionally requires long hours and weekend work. Travel Minimal travel required; up to 5% Required Education and Experience - AHIMA Approved ICD-10 CM/PCS Trainer - Minimum of successful completion of an AHIMA-approved Coding Certificate Program; - Associate’s degree or equivalent training acquired through five years of progressive on-the-job experience. - Must have at least five years of HIM experience, preferably as an Auditor. Preferred Education and Experience None Additional Eligibility Qualifications Must have CCS, CPC, CPC-P, CPC-H, RHIA or RHIT Security Access Requirements In addition to the specific security access required by the employee’s client engagement, the employee will have access to the Omega systems set forth in the “Standard Field Employee”” profile. Equal Employment Opportunity Omega Healthcare is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, gender, age, sexual orientation, gender identity or expression, marital status, mental or physical disability, protected veteran status, and genetic information, or any other basis protected by applicable law. Omega Healthcare also prohibits harassment of applicants or employees based on any of these protected categories. Omega Healthcare makes reasonable accommodations when needed for applicants and candidates with disabilities or religious observances. If reasonable accommodation is needed to participate in the job application, interview, or any other part of the hiring process, please contact Human Resources at employeerelationsus@omegahms.com. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Employee may perform other duties as assigned.
Senior Director, Quality & Compliance
Precision Medicine GroupPrecision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of successful business in
• Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements. • Provide ICH/GCP compliance guidance throughout the clinical development life cycle. • Plan, oversee, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits. • Manage Quality and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs. • Work closely with the Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance. • Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non-compliance. • Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards. • Oversee quality events, deviations, and CAPA processes related to GCP activities. • Lead and support global health authority inspections. • Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance. • Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems. • Supervisory responsibility of Quality & Compliance employees (where applicable).
Senior Director, Quality & Compliance
Precision for MedicinePrecision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Position Summary: The Senior Director, Quality & Compliance provides strategic and operational leadership for clinical quality assurance to ensure studies are planned, conducted, documented, and reported in compliance with applicable global regulations (e.g., ICH E6 GCP), sponsor requirements, and Precision procedures. This role leads the design, implementation, and continuous improvement of GCP-focused quality systems and oversight activities, including risk-based audit programs (sites, vendors, internal process, and TMF), issue management (deviations, quality events, and CAPA), inspection readiness, and support of health authority and Sponsor audits/inspections. Partnering cross-functionally with Operations and other stakeholders, the Senior Director proactively identifies and mitigates quality and compliance risks, drives a culture of quality and data integrity, and develops and mentors QA professionals while serving as a trusted advisor to internal teams and external clients. Key Responsibilities: - Lead and maintain GCP quality assurance programs to ensure compliance with FDA, EMA, and ICH regulatory requirements. - Provide ICH/GCP compliance guidance throughout the clinical development life cycle. - Plan, oversee, and conduct GCP audits including but not limited to qualification and re-qualification of vendors, internal process, site, TMF and other document audits. - Manage Quality and Compliance functional activities, including implementation and management of the QMS, inclusive of SOPs, Training and CAPAs. - Work closely with the Quality and Compliance staff and Operational Functions to provide strategic compliance advice and guidance. - Initiate the process of follow-up when suspicion of suspected scientific misconduct/serious non-compliance. - Review clinical and nonclinical documentation to ensure regulatory compliance, data integrity, and adherence to GCP standards. - Oversee quality events, deviations, and CAPA processes related to GCP activities. - Lead and support global health authority inspections. - Provide GCP guidance and training to cross-functional teams to promote a culture of quality and regulatory compliance. - Lead and develop Clinical QA staff while supporting continuous improvement of GCP and quality systems. - Supervisory responsibility of Quality & Compliance employees (where applicable). - Provide quality support to Sponsors in line with established or new Quality Agreements (where applicable). - Audit regulatory documents for submission to the Food and Drug Administration (FDA) and global regulatory authorities (e.g., PMDA, MHRA, etc.). - Provide ICH/GCP guidance, auditing advice and training to internal and external clients. - As part of the Management Team, help counsel on and direct quality initiatives to provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally. - Support and enhance Precision’s Corporate Compliance functions and facilitate business development and proposals for these areas as the need arises, including bid defense meetings and project kick-off meetings. - Review/audit documents intended for submission to the FDA or other regulatory agency or body to assure compliance with regulatory standards. - Build upon the current QMS in establishing additional company standards and metrics to ensure the highest quality of services provided to clients. - Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine. - Maintains current knowledge of regulations and guidance documents, providing expert analysis to project - Other duties as assigned. Qualifications: Minimum Required: - Requires 10+ years of experience in GCP Quality Assurance within a CRO, biotechnology or pharmaceutical industry. - Bachelor’s degree in life sciences or a related scientific field (advanced degree preferred). - Demonstrated experience conducting and leading GCP audits across clinical sites, Internal Process audits, TMF audits and Vendor qualification audits. - Strong knowledge of FDA, EMA, and ICH regulations, including global GCP guidelines. - Experience supporting regulatory inspections and inspection readiness activities. - Strong leadership and communication skills with the ability to work cross-functionally across clinical and nonclinical teams. - Ability to interpret regulatory requirements and translate them into effective quality systems, procedures, and risk-based approaches. Other Required: - Availability to travel up to 25% domestically and/or internationally - Supervisory/management experience leading quality personnel Preferred: - Graduate, postgraduate degree, ideally in a scientific or healthcare discipline - CRO, Pharmaceutical and/or Medical Device experience - Experience hosting client/Health Authority inspections Skills: - Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills Competencies: - Demonstrates mastery knowledge of GCP/ICH guidelines, FDA regulations and Precision SOPs. - Resolves project related problems and prioritize workload to meet deadlines with little support from management. - Exhibits high self-motivation and can work and plan independently as well as in a team environment. - Motivates other members of the project team to meet timelines and project goals. - Focuses on continuous improvement, including the ability to make proactive. assessments on how to make processes more efficient and people more effective. - Ability to review and evaluate clinical data. - Proven ability to communicate with senior management, external thought leaders and operational staff. - Advanced proficiency in Microsoft Word, Excel, and PowerPoint, Teams. - Understands financial management to review proposals and budgets. - Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and keen attention to detail. - Ability to work with cross functional groups and management under challenging situations. - Ability to prioritize work and handle multiple and/or competing assignments. - Excellent verbal and written communications skills. #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $181,400—$272,200 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Import Specialist
Livingston InternationalWe provide clarity in a world of trade complexity so that businesses can grow further, faster, smarter.
Import Specialist Join Livingston, the largest customs broker in Canada and the third largest entry filer in the U.S. We’re a market leader offering customs brokerage, consulting and compliance, and freight forwarding services at more than 90 key locations in North America, Europe and Asia. Customs brokerage is our core business and helping our customers navigate the complex and changing world of international trade is what we do best. Consider joining our team for the opportunity to grow your career. From entry level to expert advisors, our supportive culture of learning will help you get the career you want. 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KEY DUTIES & RESPONSIBILITIES - Ensure accurate and timely processing of complex shipments. - Create customs entries through proper selection of client and client records, interpretation of documentation for all clients' shipments, in a one-step process in National Service Center (NSC). - Data entry of shipment information for release, rating and billing and ensuring that all mandatory fields are completed and accurate in NSCs. - Ensure correct value for duty is reported based on invoice details and terms of sale. Establish correct value for duty and tariff treatment by selecting the correct keyword/HS code. - In a professional manner, work with team members as required for missing documentation, information or instructions necessary to release a shipment in - Verify documentation for release conditions, compliance and rating compliance (e.g., free trade certificates). - Escalate two-step release requirements, authorization or release issue resolution to required team members. - Participate fully with other team members in the day-to-day operation of Release Operations in NSCs. - Endeavor to utilize and take advantage of system automation tools that are available to support release processing. - Open file/data input for new shipments in relevant systems. - Coordinate and prepare entry summary as needed. - At time of release, monitor status of Customs and PGA releases. - Ensure that all SOP's and business rules are adhered to following special client instructions, notes and alerts. Identify those that are missing or those that have become outdated or ineffective, making recommendations for change. - Research and respond to requests for information from team or traffic in a professional manner via phone or email. - Prioritize and complete work according to production supervisor direction, Customs requirements and Livingston standards. - Maintain effective relationship with clients, carriers, forwarders, Customs, etc. - Perform other related duties as assigned by management. - Adhere to established policies and procedures. KNOWLEDGE & SKILLS - Familiar with all applicable Customs laws, regulations, procedures and industry practices. - Client service oriented. - Organizational skills with the ability to meet tight deadlines. - Assertiveness in problem solving. - Excellent communication skills. - Ability to multitask. - Detailed oriented. - Excellent time management skills. - Ability to present a professional image. - Knowledge of Word and Excel software. - Office equipment/machinery used: Personal computer and common business machines/software WORK EXPERIENCE – MINIMUM REQUIRED 2 years of related experience EDUCATION Required: High School/GED or equivalent CERTIFICATIONS DESCRIPTION Working towards/or successful completion of the Certified Customs Specialists (CCS) designation with the Canadian Society of Customs Brokers (CSCB) or the National Customs Brokers & Forwarders Association of America (NCBFAA) is a requirement, if not already obtained. Successful completion of the CCS examination is a mandatory requirement for further advancement. COMPETENCIES Inclusion and Collaboration Business Acumen and Straight Talk Accountability Customer First Focus Leading and Developing Agility All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. For Canada: Livingston is an equal opportunity employer and committed to creating and sustaining an inclusive environment in which all individuals are treated with dignity, respect and one which reflects the diversity of the community in which we operate. Accommodations are available for applicants and employees with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application.

