Alfasigma USA is seeking an Internal Controls & Compliance Manager to strengthen the internal controls environment by supporting management to ensure the adequacy, efficiency and effectiveness of controls in the areas of healthcare compliance, financial operations, and other assigned compliance areas. The job includes performing monitoring activities, conducting audits, determining the cause of deficiencies, advising and recommending improvements, assisting management with the development and implementation of remediation plans or documents for instances of deficiencies, and assisting the Compliance Officer in the day to day management of the Company’s compliance program.
The ideal candidates would be located near either of our offices in Bedminster, NJ. or Covington, LA.
- Conduct internal control process reviews/audits in pharmaceutical/healthcare compliance (healthcare provider payments, speaker programs, advisory boards, grants, sample compliance, market access, pharmacy laws, privacy and security requirements pursuant to HIPAA/HITECH, state privacy laws, etc.), corporate compliance program, financial operations compliance and other specified areas; create and execute an audit plan.
- Align with internal and external parties in the development, implementation and creation of corrective action plans/remediation for internal control violations or deficiencies; monitor action plans to ensure remediation of gaps and closure.
- Monitor the Company’s Integrity Hotline and compliance investigation process; when requested investigate potential compliance violations and report the investigation findings.
- Oversee the Company's pharmaceutical/healthcare related state and federal reporting (PDMA Sample Losses/Thefts, Physician Payments Sunshine Act (aka Open Payments)/similar state laws, State Drug Price Transparency, Government Contracting, etc.).
- Create and update training for pharmaceutical/healthcare compliance, the corporate compliance program, and financial operations compliance for new hires, annual refreshers and remedial needs.
- Support the Compliance Officer with the development of strategies, policies and procedures for pharmaceutical/healthcare compliance and the management of the corporate compliance program.
- Document all collected information in an organized, accurate and concise manner, showing the process taken or the conclusions reached for IC reviews, audits or monitoring activities performed; this includes maintaining all records associated with compliance.
- Monitor changes in laws and regulations regarding pharmaceutical/healthcare compliance and changes to Alfasigma’s IC framework.
- Support Legal with various special projects from time to time, including records management.
- Interface with executive leadership, directors, managers, and their administrative assistants.
- Assist the Attorneys in Legal as needed.
- Copy, scan, fax, mail, and file documents as needed.
- Perform other duties and assignments as required.
WHO WE ARE:
- Bachelor’s Degree
- 5-7 years of experience in pharma or healthcare industry working with compliance of healthcare regulations and related guidance (Anti-Kickback Statute, False Claims Act, Sunshine Act (federal and states), State Drug Price Transparency, Food, Drug & Cosmetic Act, PDMA, HIPAA/HITECH, State Privacy Laws, OIG guidance, and the PhRMA Code) is preferred
- Government contracting compliance experience is desired
- Certification in healthcare compliance or auditing is preferred
- Auditing or legal experience is preferred
- Computer skills with familiarity in Excel, Word, PowerPoint, and Outlook
- Excellent communication (written and oral) and presentation skills
- Capable of recognizing and retaining confidential information
- Ability to work in a cross functional and team environment
- Excellent organizational and time management skills
- Cooperative and pleasant attitude
Alfasigma USA is the local affiliate of the Italian based pharmaceutical company, Alfasigma. The company was formed, in 2015, as a result of the merger between two historic Italian pharmaceutical companies, Alfa Wassermann and Sigma-Tau. Alfasigma is a leading Italian pharmaceutical company focused on prescription drugs, over-the counter (OTC) and nutraceutical products and has a presence in 90 countries.
Alfasigma USA’s main goals are to improve the health and quality of life of patients by finding solutions to treat specific patient populations, expand our existing portfolio and bring new products into the US market. We strive to be a strong healthy company in a strong healthy world.
Alfasigma USA is headquartered in Covington, LA., has a manufacturing plant in Shreveport, LA., a mail order pharmacy call center in the Covington location and an established national salesforce. In addition, a commercial operations hub opened in 2018 in Bedminster, NJ. Alfasigma USA, Inc. offers:
- Competitive compensation
- Annual bonus potential
- Comprehensive benefits package (Medical, Dental, 401K and Paid Time Off are some examples)
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