Compliance Manager

Compliance Manager

Requirements

• BS/BA degree or equivalent and 8+ years of experience in a biotech/pharmaceutical or medical device industry
• Compliance and Ethics Professional Certification preferred
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Thorough working knowledge of Microsoft office, including use of Outlook and Excel
• Excellent attention to detail and organizational skills
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Adaptable and flexible, able to prioritize duties and manage multiple matters from start with finish with minimal supervision
• Strong critical thinking using creativity and sound judgment
• Demonstrated ability to research, identify and recommend relevant/applicable laws and regulations
• Strong ability to use word processing and presentation software to prepare documents, and to use spreadsheet and statistical analysis software to store, manipulate, analyze and present data
• Thorough understanding of healthcare compliance laws and regulations applicable to a pharmaceutical company with a commercial product
• Travel up to 40%

Responsibilities

• Provides expert level compliance guidance consistent with applicable laws, regulations and Neurocrine policies
• Leads effort to conduct monitoring and auditing, training, and assists with transparency data collection and reporting
• Proactively monitors, interprets laws or regulations impacting the business, and recommends and gains approval for new/changes to company guidelines for compliance issues
• Manages reviews of alleged compliance violations and escalates to executive leadership as needed
• Leads general case management: Case intake and assignment, check-ins with other investigators, manage case files, and ensures case closure in case management system
• Conflicts of Interest Reviews: Analyze requests for review and flag potential conflicts of interest for discussion and disposition with the Ethics & Compliance leadership; Work with employees and managers to analyze and resolve potential conflicts of interest
• General case management of requests Reporting to CEO Staff and Audit Committee of the Board: Prepares data analysis from Ethics Point hotline; Prepare presentations for a variety of audiences to share metrics, Ethics report information, and program updates; E&C Communications: drafts communications and outreach to employees
• May lead and coach lower level team members
• Performs other duties as assigned

Preferred Qualifications

• Compliance and Ethics Professional Certification preferred