The Legal Compliance Analyst is responsible for supporting the legal compliance team at Penumbra, specifically focusing on Penumbra’s compliance with internal policies and laws and regulations concerning interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). In addition to support of the Healthcare Compliance Committee (HCC) process and Penumbra’s Compliance Program generally, the Compliance Analyst reviews and analyzes data that is submitted for compliance with all corporate, international, federal and state requirements for tracking and reporting HCP and HCO expenditures, as well as with Penumbra’s compliance policies, including the Code of Business Ethics and Conduct, and applicable laws and regulations. As a member of the compliance team within the Legal Department, the Legal Compliance Analyst position is responsible for managing the compliance operations and provides support regarding various aspects of the Company’s compliance function.

• Draft, execute and facilitate organization of various contracts, particularly those that include physician services or other compliance-related issues. *

• Duties may include filing compliance-related contracts, in a timely and accurate manner; and responding to requests for contract-related information. *

• Review and process expense reports through Certify or other T&E platforms on a timely basis and consistent with Company’s compliance policies and related laws and regulations and assist with identification of potential compliance issues. *

• Serve as field team resource for Certify expense report questions.

• Review and process invoices from healthcare professionals, and all related data entry and documentation, on a timely and accurate basis. *

• Manage compliance-related workflow for the team to ensure that all email requests are tracked and completed. *

• Support of the Healthcare Compliance Committee (HCC) function, including managing HCC-related data in Legal Compliance Platforms. *

• Work closely with marketing, events, and medical evaluation teams to ensure that all required submissions are made to HCC in a timely, complete, and accurate manner via Legal Compliance platforms, such as MediSpend.

• Understand and assist in training and implementation related to Penumbra’s Compliance Program and policies, as well as AdvaMed Code and other relevant compliance guidance related to interactions with health care professionals and related entities.*

• Support initiatives of process updates and training documentation

• Achieve mastery of compliance systems and requirements. *

• Monitor legal compliance shared inboxes including, but not limited to, Compliance, Sunshine Act & HCC. Own the review of emails and research that may be required to respond to inquiries. Ensure all inquiries receive responses in a timely manner. *

• Lead other Legal Compliance team projects on an as-needed basis*

• Gather master data information on healthcare professionals (HCPs) and healthcare organizations (HCOs) expenditures for analytics and transparency reporting. Perform data validation and reconciliation activities to validate accuracy and completeness of aggregate spend reporting information. *

• Respond to ad-hoc requests for information on Penumbra’s interactions HCPs and HCOs.

• Maintain confidentiality of information. *

• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *

• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *

• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *

• Perform other work-related duties as assigned.

*Indicates an essential function of the role.

• Bachelor's degree with 2+ years of experience in an administrative assistant role or similar, or equivalent combination of education and experience. Additional qualifications:

• Experience with contract drafting and contract management preferred but not required

• Medical device, pharmaceutical, biotech, or other regulated industry experience desired

• Strong proficiency with Microsoft Excel, and in the use of business systems applications such as Certify, Salesforce, Agiloft, and MediSpend.

• Proficiency with other MS office tools, (Outlook, Word, Teams,etc.)

• Familiarity with medical device industry guidelines (AdvaMed Code, MedTech Europe Code) and aggregate spend reporting obligations and requirements, including applicable U.S. Federal (Sunshine Act) and state transparency laws, regulations, and guidance preferred.

• High degree of accuracy and strong attention to detail

• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

• Strong oral, written, and interpersonal communication skills

• General office environment

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds

• Must be able to move between buildings and floors.

• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.

• Must be able to read, prepare emails, and produce documents and spreadsheets.

• Must be able to move within the office and access file cabinets or supplies, as needed.

• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

 

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

We offer a competitive compensation package plus a benefits and equity program, when applicable.

Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. 

•A collaborative teamwork environment where learning is constant, and performance is rewarded.

•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

 

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

 

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

 

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

 

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.