Serve as a compliance monitor, work independently with ICPT team members worldwide and outside advisers to set up policies and processes for transparency, and other general compliance matters, attend events, and complete appropriate documentation.
In this role, you will identify, report, and implement monitoring controls and make recommendations for policies and procedures, training and/or other mechanisms to mitigate risks, or improve the effectiveness of business operations and the compliance program.
Support the day to day operations of the Corporate Compliance function including participating in Compliance and Privacy training, develop and draft revisions to policies, maintaining compliance database, conduct investigations and participate in special projects which impact enhancing the patient experience.
Manage the expectations and obtain buy-in for ideas across senior individuals in the Business, Technology and Compliance; develop and communicate business case and delivery plans required to gain support and deliver the change.
Work with the Operations and Quality groups to interpret and evaluate risk associated with internal audit and health authority inspection findings and provides compliance subject matter expertise to ensure the development of robust corrective action plans that address the root cause of issues.
The experiencedPharmacovigilance/Drug Safety Senior Manager would be responsible for leadingand conducting complex process/system audits, affiliate/local operating companyaudits, and Contract/Licence Service Providers in areas such as drug safety,risk management, REMS.
Conduct compliance audits as coordinated with the Compliance group, likely to include Anti-Bribery/Anti-Corruption audits, distributor/vendor compliance audits, Transparency reporting reviews, Pharma code compliance audits, etc.
Manage the SOX compliance calendar, controls execution schedule and technology audit checklists, programs and/or guidelines; work with local IT Directors to ensure all Sarbanes-Oxley control documentation is up-to-date and accurate for all IT areas.
The Senior Manager of Compliance Monitoring and Auditing will manage and support the overall compliance monitoring and auditing program at Mallinckrodt which are essential elements of an effective compliance program.
In this role, the Regulatory and Compliance Project Manager will be responsible for managing all aspects of regulatory reporting and data submission for various lines of business, including MLTC, FIDA, SNP and MAP.