Description
The Senior Manager of Compliance will report to UroGen’s Associate General Counsel and will assist in the development, implementation and management of the company’s compliance program with particular attention to the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in the U.S.
Responsibilities
Develop and deliver training and education to employees and contractors including the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in accordance with industry standards and best practices
Develop and maintain a complete digital library of the company’s compliance policies, procedures and training materials and records of training completion in accordance with industry standards and best practices
Develop and optimize a digital platform for the company’s compliance training
Demonstrate a strong working knowledge of the federal and state laws, regulations, guidelines and industry standards that serve as the foundation for the company’s compliance program, policies, procedures and training curricula
Guide and educate business partners on the company’s compliance program, policies and procedures
Assist as needed with the management and upkeep of the company’s compliance program including monitoring the compliance hotline, building internal awareness of the compliance function and whistleblower rights, building a culture of compliance, and developing compliance communications as needed
Assist with the development and execution of risk assessments and audit plans as needed
Prepare compliance reports and metrics as needed
Work on cross-functional teams as needed
Experience and Education
5+ years of compliance experience in the pharmaceutical/biotechnology industry
Substantial experience in the development and execution of compliance training and the overall management of compliance training in accordance with industry standards
Strong working knowledge of federal and state laws, regulations, guidelines and industry standards governing the pharmaceutical industry
Bachelor’s degree required; M.S. or M.S.J. (Life Sciences Law) or equivalent preferred; J.D. attorneys will also be considered for the role
Certification in Healthcare Compliance or equivalent formal/rigorous training preferred
Skills and Training
Experience with live training in individual, group and online settings
Shows interpersonal skills and the ability to communicate at all levels of fast-paced organization
Demonstrates ability to take initiative beyond direct responsibilities
Demonstrates professional and positive demeanor
Resolves conflicts in a constructive, professional manner
Works well on teams
Creative problem solver to support business goals
Well-organized, detail-oriented, and able to manage numerous projects and conflicting demands in a fast-paced environment
Shows high proficiency with computer systems and programs such as Microsoft Office, Word, Excel, PowerPoint, SharePoint, and DocuSign
Office Location
400 Alexander Road, Princeton, NJ
Other
Occasional domestic travel required
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