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.
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.
Assist the Compliance Executive in maintaining and communicating regulatory changes, advising and directing business leaders to ensure that regulatory requirements are addressed in their respective procedures and controls so that their day to day activities operate in a compliant manner.
This position is responsible for managing the US international aspects of tax compliance for Corning and subsidiaries. The position will also assist with accounting for income taxes, research on international tax issues, selected tax planning projects, and audits as well as a variety of other tax and compliance related projects.
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.
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.
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.
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.
Maintain a thorough knowledge and understanding of applicable cGMP Regulations, Regulatory Agency Guidelines, Industry Association Guidelines, and Good Practices. Lead the practical interpretation and implementation of Regulations, Guidelines and Good Practices, to ensure that all site activities are compliant. Ensure that documentation and records are compliant.