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

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 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

• Preferred 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.

Additional Eligibility Qualifications

Special Training

• Certification in healthcare compliance or auditing

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m. This position may require some overtime work.

Work Environment

Puma functions as a remote working environment, with an office in the Westwood area of Los Angeles available for use as needed. While working remotely, we maintain a professional, virtual environment. This role routinely uses standard office equipment such as computers, phones, and other technology supporting remote working.

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that may be required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Travel

Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to 20%).

Compensation Range

The salary range for this role is $160,000 - $220,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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