Compliance Counsel

Do you want to contribute to a larger purpose to save the lives of infants in the NICU? This is Prolacta Bioscience's mission! Take a look at this opportunity with our Legal team, which is seeking a passionate individual, to fill the role of our Compliance Counsel. This role developing, operating, and monitoring the Corporate Compliance Program and serving as the compliance business partner for all aspects of Prolacta's organization as well as assisting the General Counsel with making periodic reports to the Board of Directors and other senior management concerning the Corporate Compliance Program.

The Compliance Counsel is responsible for implementing and maintaining the Corporate Compliance Program, which serves to prevent, detect, and deter noncompliance, to promote compliance with Corporate policies, and to uphold an ethical culture. The scope includes ensuring compliance with all laws, regulations, and/or Corporate policies in the following general areas:

• Interactions with health care professionals (including consulting arrangements).
• Advertising and promotion of medical devices and Prolacta's other products.
• Gifts and charitable contributions, grants for medical education.
• Investigator-initiated research.
• Pricing and reimbursement for products in general.
• Social media and FTC regulations
• Government enforcement issues, such as compliance with the following (as applicable):




• Food, Drug & Cosmetic Act.
• False Claims Act.
• Anti-Kickback Statute.
• Foreign Corrupt Practices Act.
• Physician Payments Sunshine Act and similar state laws.
• Health Insurance Portability and Accountability (HIPAA).
• Prescription Drug Marketing Act.
• AdvaMed Code of Interactions with Healthcare Professionals.
• PhRMA Code of Interactions with Interactions with Healthcare Professionals.

Who Is Prolacta Bioscience?

We give babies a brighter future by unlocking the biological power of human milk. Established in 1999, Prolacta Bioscience is a privately held life sciences company that has touched the lives of more than 100,000 premature infants globally. Prolacta is the world's leading hospital provider of 100% human milk- based nutritional products. Based in Southern California, we employ more than 300 people globally, many of whom have dedicated their lives to neonatal care.

For more information, please visit www.prolacta.com

How you will contribute

This role will provide you with the opportunity to contribute to the growth of our organization and develop your professional skills by performing the following...

• Oversight- Report to the General Counsel with direct access to the Management Team, as necessary, to address areas of concern relating to Prolacta's Corporate Compliance Program. Continue to maintain and grow the Corporate Compliance Program subject to the direction of the General Counsel and the Compliance Committee (composed of members of senior management) who collectively maintain accountability for compliance with laws and regulations.

• On an ongoing basis, assess the current state of the Corporate Compliance Program and identify gaps and opportunities for improvement while providing recommendations of how to address the same. Report material concerns to the General Counsel and Compliance Committee through appropriate reporting tools.
• Periodically update the General Counsel and Compliance Committee on the status of Corporate Compliance Program initiatives including policy and procedure development, compliance education, communication, monitoring, auditing, and response to identified compliance violations.
• Identify resources needed to effectively operate the Corporate Compliance Program.




• Policies and Documentation -Develop and/or update policies and procedures within the scope of the Corporate Compliance Program to help personnel comply with applicable laws, regulations, and company policies, and to assist in preventing violations of compliance standards. Collaborate with other functions to ensure compliance requirements are included in their processes, as needed.
• Education and Training- Develop and implement effective compliance trainings both annually, and as needed, to address new or updated policies, relevant industry highlights, etc. Ensure completion of regular compliance training is mandatory for all applicable personnel.
• Communication-Design and implement a compliance communication strategy to keep senior management and other employees informed of changes to the regulatory environment within the scope of the Corporate Compliance Program, as well as communicating about specific initiatives throughout the year.
• Monitoring and Auditing- Design and execute an auditing and monitoring plan to assess compliance, detect violations and, as needed, develop an action plan to address and prevent future violations.
• Response to Compliance Issues- Maintain the Compliance Hotline to respond to compliance concerns raised by employees or others who suspect a violation of law, policy, or Prolacta's ethical standards. Ensure all concerns raised through the Hotline, or through any other means, are tracked, documented, handled in a confidential manner, and resolved promptly.
• Knowledge- Have a solid understanding of the laws and regulations impacting an international medical device and infant nutritional product company and will maintain and update that knowledge through continuous education. Stay abreast of compliance requirements and continuously monitor new and proposed legislation that may impact the company's operations.
• Business Support- Collaborate cross-functionally with business partners in Medical Affairs, Sales, Marketing, Market Access and other functions to provide relevant and actionable support and guidance. Advise and guide business partners on compliance questions/issues and provide feedback and input on various commercial projects.
• Third Party Risk Management - Lead the cross-functional TPRM process including owning the TPRM system, coordinating cross-functional diligence review, conducting debarment screenings.

• Federal and State Transparency: Implement a transparency reporting program and ensure accurate transparency reporting at the federal and state levels.
• Other Duties -




• Collaborate with Prolacta Legal Counsel and General Counsel, as appropriate, to ensure Prolacta's Compliance Program is well designed and effective.
• Update the General Counsel and Compliance Committee on the status of identified areas of concern.
• Ensure, where appropriate, the Counsel-Client Privilege and Work Product Doctrine are appropriately utilized and preserved.

What you bring to the role

Education: Licensed Counsel skilled in Health Care Compliance laws, regulations, guidance, and applicable authorities. California bar admission preferred.

Experience: Five (5) years of experience practicing health care compliance regulatory law. Either pharmaceutical or medical device experience is required; medical device is preferred.

Specific demonstrated experience in the following areas:

• Demonstrating sound judgment and integrity
• Strong business acumen
• Influencing / effecting change without direct reporting authority
• Conducting internal investigations.
• Reporting to a Board of Directors or senior management.
• Educating, training, or presenting to groups.
• Managing projects.
• Working with a team to accomplish a common goal.
• Resolving conflicts.
• Drafting policies and procedures.
• Conducting audits.
• Prioritizing and handling multiple assignments at once.
• Understanding how a commercial enterprise functions; and
• Handling confidential information.

Other Skills: Superior analytical, written, oral communication skills, investigational, and interpersonal skills required.

How Prolacta benefits you

To drive the personal growth and business impact of our employees, we're committed to developing a supportive and enriching culture for everyone. From up to 100% healthcare coverage starting on your first day and 401(k) match, we value our employees' health and financial wellbeing. We offer four weeks PTO during your first year of employment and support our new parents with a generous time-off program. We encourage employees to participate in our employee affinity groups, take volunteer time off, and provide access to different educational opportunities.

What else do you need to know

Location: Remote United States

Schedule: Monday - Friday

FLSA: Exempt

Depending on your residential location certain laws might regulate the way Prolacta manages applicant data. California Residents, please review our Privacy Notice for California Employees and Job Applicants for further information, this can be found on Prolacta.com on www.prolacta.com . By submitting your application, you are agreeing and acknowledging that you have read and understand the above notice.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to effectively communicate (e.g., talking/ hearing), walk, sit, use hands and fingers to handle, feel and reach things. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.

Sedentary to light work; repetitive motions; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.

EEO Statement

"Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer." Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.

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