Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
The Senior Manager/Associate Director of Ethics & Compliance Operations and Monitoring is a critical role in supporting the Ethics and Compliance Officer in the development, execution, and continuous improvement of the company’s compliance program. This individual will serve to shape compliance infrastructure in areas including, but not limited to, auditing and monitoring, training, transparency, policy/SOP development, and compliance project management. The candidate will be of the mindset that business functions as well as Ethics and Compliance function are equally accountable for both company success and ethical behavior.
The Senior Manager/Associate Director of Ethics & Compliance Operations and Monitoring will oversee and execute day-to-day activities including monitoring, training, and data analytics initiatives to identify and address potential compliance issues and ensure adherence to policies company’s policies and standard operating procedures. This role will be responsible for transparency reporting and operations of the internally developed compliance program tools.
The successful candidate will be a passionate pharmaceutical healthcare compliance professional who is a self-starter and works well independently with a variety of personnel at all levels and can play a critical role in development and building of a comprehensive and effective compliance program. This role requires compliance expertise and knowledge of applicable laws, regulations, and industry standards.
Essential Functions
• 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.
Competencies
• 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.
Education & Professional Experience
Education
• Bachelor’s Degree in related discipline.Experience in lieu of a Bachelor’s Degree may be considered.
Experience
• Six to eight years o