Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
The Sr. Specialist/Manager of Healthcare Compliance provides support for all elements of the comprehensive compliance program at Puma Biotechnology, including conducting training and providing compliance guidance to various teams, monitoring activities with significant compliance risk, conducting investigations, reviewing needs assessments, and partnering with the business to ensure that all HCP transparency requirements are met. This role will support efforts to enhance compliance culture across the company.
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.
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
Monitor interactions with and payments to healthcare professionals. Work with various business partners and third party vendors to ensure HCP spend transparency reporting obligations are met on time.
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.
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
Bachelor’s Degree in a related discipline.Experience in lieu of a Bachelor’s Degree may be considered.
Four to six years of direct experience in healthcare compliance and implementation of a compliance program in the pharmaceutical 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
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.
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.
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.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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