[Remote] Senior Manager/Associate Director, Compliance Operations and Monitoring - Remote Position

Note: The job is a remote job and is open to candidates in USA. Puma Biotechnology Inc. is a company focused on developing and improving compliance programs within the pharmaceutical sector. The Senior Manager/Associate Director of Ethics & Compliance Operations and Monitoring will be responsible for overseeing compliance activities, monitoring, training, and ensuring adherence to policies and regulations.

Responsibilities

• Responsible for all aspects of reporting transfers of value to covered recipients that are required for reporting to US Federal, State, and District agencies and other reporting requirements
• Responsible for coordinating internal and external resources to ensure all reportable spending is captured and auditing detailed data for disclosure thus ensuring validity of the report
• Support operations of internally developed compliance program tools with focus on improvement initiatives that increase compliance program effectiveness
• Independently monitor the compliance of promotional and non-promotional business activities, including live monitoring and transactional reviews, review data, draft reports, collaborate with team members to identify corrective actions, and verify effectiveness of corrective actions post-implementation
• Identify areas of risk, and areas of improvement for Compliance and/or operational activities such as enhancements to policies, procedures, processes, training or technology
• Partner closely with various teams including Commercial, Field Employees, Sales Operations, Market Access and Medical Affairs and serve as a point of contact for compliance related questions
• Participate in the drafting, implementation and communication of Compliance-related documents such as policies and procedures
• Conduct compliance training, either in-person or online, on variety of compliance topics during New Hire Orientation, sales meeting, and any other supplemental training according to training need
• Assist in conducting compliance risk assessments as well as developing and supporting implementation of mitigation plans
• Assist in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports
• Actively seeks opportunities to simplify and automate tasks and processes through the use of technology and digital tools, including AI and Agentic AI. Willing to experiment with digital innovation and to serve as a role model to colleagues on digital dexterity

Skills

• Bachelor's Degree in related discipline. Experience in lieu of a Bachelor's Degree may be considered
• Six to eight years of direct experience in healthcare compliance and implementation of a compliance program in the pharmaceutical or medical device industry. Other complementary job experience (such as roles within Internal Audit, Finance, Quality or Legal functions) will be considered
• Comprehensive working knowledge of applicable federal, state, and local laws, regulations, and industry guidance relating to healthcare and life science compliance, and familiarity with the current life science marketplace
• Familiarity with healthcare compliance laws, such as Anti-Kickback Statute, FCA/FCPA, Sunshine Act, and state transparency laws
• Strong attention to detail and business acumen
• Experience managing projects with the ability to manage multiple projects/assignments concurrently and demonstrated project management skills with strong interpersonal skills
• Demonstrated ability to function independently
• Demonstrated proficiency in compliance or auditing/monitoring
• Strong knowledge of reporting requirements for the Physician Payment Sunshine Act and other state/federal regulations mandating marketing and healthcare expenditure disclosures
• Sound judgment and strong commitment to ethical conduct and integrity
• Excellent interpersonal skills, able to work across different functions
• Attention to detail, proficiency in Excel and ability to work with data
• Good communicator, able to communicate in one-on-one and group setting
• Able to draft clear and effective reports, policies, etc
• Project management skills. Ability to follow through and complete tasks on time with minimal supervision
• Ability to work with analytics tools, databases, reporting platforms, and EDMS systems
• Certification in healthcare compliance or auditing
• Experience with AI and Collaborative Tools: Experience using AI assistants (e.g., Copilot within Microsoft Office), collaboration platforms, and other tools to seamlessly integrate technology into daily operations. This includes leveraging AI for automating routine tasks, enhancing team collaboration, and improving overall productivity

Benefits

• Annual bonus target
• Robust benefits package

Company Overview

• At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care. It was founded in 2010, and is headquartered in Los Angeles, California, USA, with a workforce of 201-500 employees. Its website is http://www.pumabiotechnology.com.

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