- Gather, sort, refine and prepare data for annual reporting of spending data as required by the Physician Payment Sunshine Act with federal authorities.
- Manage portfolio of state permits and registrations to ensure that data on file for each is up to date, accurate, and all renewals are submitted in a timely fashion to ensure continuity of compliance.
- Assist the Chief Legal and Compliance Officer with tracking and implementing any new state requirements for pharmaceutical manufacturers related to price transparency, marketing conduct, and licensure/registration.
- Support the gathering and archiving of documentation related to Catalyst's Compliance program including training records, monitoring activities, program implementation, and investigations.
- Support Catalyst's Legal Department in document and information management related to its activities in contracting, mergers and acquisitions, and litigation, as needed.
- Participate, as needed, in any internal investigations particular regarding document review and management, recordkeeping, and other investigation activities.
- Support data gathering and analysis related to the companies Environmental, Social and Governance initiatives including transparency reporting and generic of metrics.
- Associate Degree required/ Bachelor's Degree preferred
- Paralegal Certificate/Certification preferred
- 5+ years' demonstrated experience in a position focused on document management, data organization, and legal/regulatory requirements is required. These responsibilities as a part of one's duties as a paralegal are highly desirable.
- Requisite experience in law firm, corporate legal department, or pharmaceutical regulatory compliance required.
- Experience in preparing, quality control/proofreading, and filing legal/regulatory documents required.
- Verifiable proficiency using MS Office applications, to include Word, Excel, PowerPoint, Project, as well as Internet and Outlook required.
- Experience working with contract management applications is desirable.
- Background in pharmaceutical/drug compliance/regulatory requirements required.
- Familiarity with pharmaceutical industry required. Experience is commercial phase pharmaceutical environment preferred.
- Periodic travel to the Catalyst HQ in Coral Gables, FL, is required. Occasional business travel may be required.
- Ability to work extended hours, to include evenings, weekends, and potentially holidays is required. Professional, ethical, and compliant comportment is imperative at all times.
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Compliance Specialist - Doral, United States - Catalyst Pharma Group, Inc.
Description
The Compliance Specialist will assist the Chief Legal and Compliance Officer in managing day-to-day compliance for the organization on a variety of industry-specific issues such as Sunshine Act reporting, permit renewals, documentation of compliance activities, etc.
Demonstrated experience managing a calendar of due dates, collating data for filings, preparing information into filing format, and tracking the process/outcomes is essential to this position.
In addition, the role will provide some support for Legal in overall document management related to contracting, mergers and acquisitions, and litigation, as needed.
This is a remote, home-based role with periodic travel to the home office in FL.Responsibilities
Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce.
All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.
Recruitment & Staffing Agencies:
Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.
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