PUMA BIO TECHNOLOGY

Position Description

Senior Manager, Healthcare Compliance
Location South San Francisco
Department Quality Assurance
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Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters. 

The Senior Manager of Healthcare Compliance will be responsible for all aspects of reporting of transfers of value to covered recipients that are required for external reporting to US Federal, State, and District agencies and other international reporting requirements. Responsible for coordinating internal and external resources to ensure all reportable spend is captured and audit the detail data for disclosure thus ensuring validity of the report. 

 

The Senior Compliance Manager will act as the Subject Matter Expert in areas such as: transparency, training, communications, healthcare professional interactions, sponsorships and grants/donations, internal investigations, high-risk third-party vendors management, auditing and monitoring.

 

The successful candidate will be a passionate pharmaceutical healthcare compliance professional who works well 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 position is located in Puma’s South San Francisco office.

 

Essential Functions

  • Monitor, capture, analyze and verify marketing and healthcare expenditures required for external reporting to the US district, state, and federal agencies and other international regulatory agencies.

  • Critical focus on improvement initiatives that increase the efficiency, accuracy, and timeliness of all external reporting deliverables

  • Support the implementation of the comprehensive compliance program under the direction of the Compliance Director.

  • 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.

  • Has an active role in the drafting, implementation and communication of Compliance-related 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 particular business need.

  • Assist in conducting compliance risk assessments as well as developing and supporting implementation of mitigation plans.

  • Support compliance monitoring and audit efforts, conducts field monitoring, review data, draft reports, collaborate with team members to identify corrective actions, and verify effectiveness of corrective actions post-implementation.

  • Assist in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports

 

Competencies

  • Demonstrated ability to function independently

  • Demonstrated proficiency in compliance or auditing

  • Strong knowledge of regulatory requirements for the Physician 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 or 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.

 

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.

 

Education & Professional Experience

Education

  • Bachelor’s Degree in a 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, 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

 

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

This job operates in a professional office environment.  This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

 

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.

 

 

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 15 %).

 

Equal Opportunity Employer
 

Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law

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