What are the responsibilities and job description for the Compliance Analyst position at Biofrontera Inc.?
Job Purpose/Summary
The Compliance Analyst is responsible for reviewing and analyzing data necessary for internal operations and external reporting and executing the processes to detect and identify activities which may be non-compliant with the applicable laws, industry requirements and company policies governing pharmaceutical and medical device companies. The position will remain current with changing regulations, recommend changes, and contribute to the continuous improvement of compliance education.
Duties/Responsibilities
The Compliance Analyst is responsible for reviewing and analyzing data necessary for internal operations and external reporting and executing the processes to detect and identify activities which may be non-compliant with the applicable laws, industry requirements and company policies governing pharmaceutical and medical device companies. The position will remain current with changing regulations, recommend changes, and contribute to the continuous improvement of compliance education.
Duties/Responsibilities
- Audit documentation required to ensure compliance with applicable laws, regulations company policies and industry codes. Maintain detailed records of audit activities and results; prepare monthly report for review
- Prepare supporting documentation for all federal and state Sunshine reports and related healthcare compliance requirements. Review and approval all expense reports
- Identify and promptly report potential non-complaint activity. Prepare a summary of any issues identified with supporting documentation for review
- Contribute to the periodic review of policies and procedures governing business operations and compliance training programs for new and existing employees; recommend changes as required
- Participate in and contribute to compliance training for new and existing employees
- Monitor the business integrity hotline for the anonymous reporting of compliance concerns and conduct and/or facilitate investigations
- Keep abreast of compliance trends and collaborate with members of management to provide practical business solutions to maintain Biofrontera's compliance within an evolving regulatory landscape
- Other duties as assigned.
- Bachelor's degree required
- Minimum of 5 years of experience in a healthcare or corporate compliance role in the biotech/pharma/device industry
- Demonstrated knowledge of federal/state laws and industry requirements affecting the biotech/pharma/device industry, specifically as they pertain to the areas of Sales and Promotion.
- Prior auditing experience
- Demonstrated skills with O365 and web-based data reporting
- Ability to work autonomously and with detailed information
- Strong interpersonal, collaboration, and communication skills.
- Strong orientation to deadline and detail.
- None
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