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Legal Compliance Analyst

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.


What You’ll Work On:

• 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.


What You’ll Bring:

• 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


Working Conditions:

• General office environment

• Willingness and ability to work on site

• 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.


Alameda, CA


Starting Base Pay is $29.57/hour - $38.39/hour.   

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. 


What We Offer

•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.

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What You Should Know About Legal Compliance Analyst, Penumbra

Are you passionate about legal compliance in the healthcare industry? Penumbra is on the lookout for a dedicated Legal Compliance Analyst who will play a vital role in our success. Based in Alameda, CA, this position involves supporting our legal compliance team as we navigate the complexities of compliance with internal policies, as well as federal and state regulations pertaining to interactions with healthcare professionals (HCPs) and organizations (HCOs). You will become an integral part of our Healthcare Compliance Committee, assisting with various analytical tasks, contract management, and data reviews. Your attention to accuracy and detail will ensure that HCP and HCO expenditures are reported correctly and in line with Penumbra's Code of Business Ethics. With responsibilities ranging from reviewing expense reports to managing compliance workflows, you'll help facilitate seamless communication across our teams, including marketing and medical evaluations. If you have a knack for contract drafting and a background in regulated industries like medical devices or pharmaceuticals, we want to hear from you! Join Penumbra and be part of a collaborative environment that prioritizes learning and innovation in healthcare solutions.

Frequently Asked Questions (FAQs) for Legal Compliance Analyst Role at Penumbra
What are the main responsibilities of a Legal Compliance Analyst at Penumbra?

The Legal Compliance Analyst at Penumbra is focused on supporting compliance with internal policies and external regulations. Key responsibilities include managing compliance operations, reviewing expense reports, assisting with contract drafting, and ensuring timely submissions to the Healthcare Compliance Committee. You'll also act as a resource for field teams regarding expense report queries and gather essential data for transparency reporting.

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What qualifications do you need to become a Legal Compliance Analyst at Penumbra?

To qualify for the Legal Compliance Analyst position at Penumbra, candidates should have a Bachelor's degree and at least 2+ years of experience in an administrative or contract management role. Familiarity with medical device guidelines, aggregate spend reporting, and business applications such as Certify and Salesforce is preferred. Strong attention to detail and communication skills are essential to thrive in this role.

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How does the Legal Compliance Analyst support the Healthcare Compliance Committee at Penumbra?

The Legal Compliance Analyst supports the Healthcare Compliance Committee by managing compliance-related data, processing and organizing relevant contracts, and ensuring all submissions are accurate and timely. This role is crucial in upholding Penumbra's compliance initiatives and helps maintain the integrity of the organization’s interactions with healthcare professionals and organizations.

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What is the work environment like for a Legal Compliance Analyst at Penumbra?

The work environment for a Legal Compliance Analyst at Penumbra is collaborative and dynamic, primarily set in a general office environment in Alameda, CA. The role requires effective communication with employees at various levels, the ability to multitask with different projects, and a commitment to maintaining adherence to compliance regulations and corporate policies.

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What benefits can Legal Compliance Analysts expect at Penumbra?

Legal Compliance Analysts at Penumbra can expect a competitive compensation package, including a generous benefits array such as medical, dental, and vision coverage, a 401(k) plan with employer matching, paid parental leave, and substantial vacation time. Working at Penumbra means being part of a team that values innovation and performance, ensuring employees have the support they need to thrive.

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Common Interview Questions for Legal Compliance Analyst
What experience do you have with compliance programs?

When answering this question, focus on specific instances where you contributed to compliance initiatives, detailing how you ensured adherence to regulations and internal policies. Highlight any familiarity with healthcare compliance principles, such as the Sunshine Act or AdvaMed Code, and how your actions positively impacted your previous workplace.

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How do you prioritize multiple compliance-related tasks effectively?

Describe your method for prioritizing tasks based on urgency and importance, utilizing tools like to-do lists or project management software. Provide an example of how you successfully managed competing deadlines and delivered high-quality work under pressure.

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Can you explain your experience with contract drafting and management?

Discuss any relevant experience you have in drafting, reviewing, or managing contracts, particularly in a legal or compliance context. Mention the specific types of contracts you've worked with and any systems or software you have used to streamline the contract management process.

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What strategies do you employ to maintain accuracy in compliance reporting?

Share strategies such as double-checking your work, conducting regular audits, or using automated tools that assist in data validation. Give examples of how meticulous attention to detail helped you avoid discrepancies in previous roles.

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Describe a time when you identified a compliance issue. How did you handle it?

Provide a specific example that illustrates your analytical skills and proactive approach to compliance issues. Discuss how you identified the problem, the steps you took to address it, and the outcomes of your actions.

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How do you stay updated on compliance regulations in the healthcare sector?

Explain your methods for staying informed, such as attending webinars, following relevant industry news, participating in professional associations, or engaging with online communities. Highlight any formal training or certifications you've achieved.

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What role does communication play in your work as a Legal Compliance Analyst?

Emphasize the importance of clear communication when interacting with cross-functional teams, addressing compliance inquiries, and preparing reports for stakeholders. Cite examples of how you facilitated communication to resolve compliance challenges effectively.

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How do you approach the training and implementation of compliance policies?

Discuss your approach to training others on compliance policies, including how you distill complex regulations into understandable concepts. Describe previous training sessions you've led, the feedback received, and how you measured the effectiveness of your training initiatives.

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Have you ever had to manage conflicting priorities? How did you approach it?

Explain how you handle situations with conflicting priorities by ensuring open lines of communication, delegating tasks when possible, and keeping a flexible schedule. Provide an example where you navigated such a conflict successfully.

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What is your experience with data analysis related to compliance?

Talk about your experience with data analysis, particularly how it relates to compliance reporting. Mention specific tools you have used, the types of data you analyzed, and how your insights contributed to improved compliance strategies.

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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 ...

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December 10, 2024

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