Associate Director, Compliance Counsel

Legal & Compliance Parsippany, NJ


Description

About Pacira

Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.

Why work with us?

Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people.  At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.

The Associate Director, Compliance Counsel will have a significant role in the implementation of the corporate compliance program for our growing business. The Associate Director/Compliance Counsel will provide compliance support for both the pharmaceutical and medical device businesses.

Responsibilities will include the development and updating of written policies and procedures, training, and education, as well as related communication, monitoring, and reporting. Responsibilities will also include assisting the Vice President, Compliance and the Chief Legal and Compliance Officer with ensuring obligations set forth under U.S. laws and regulations are met.


E
ssential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.  Other duties may be assigned.

 

  • Provide timely and practical healthcare compliance counseling and support to the business with a focus on U.S. pharmaceutical and medical device compliance requirements, with an understanding of how these requirements apply to the organization's daily operations.
  • Work closely with Legal and Compliance Department colleagues to provide consistent and efficient compliance counseling to the company in accordance with Pacira’s healthcare compliance policies, healthcare fraud and abuse laws, anti-bribery laws, privacy laws, the Food, Drug, and Cosmetic Act, the Prescription Drug Marketing Act, FDA guidance, and relevant industry codes.
  • Design, develop, and implement healthcare compliance policies, SOPs and guidance documents in collaboration with cross-functional teams.
  • Develop and deliver regular and ongoing Compliance training with strong facilitation skills through various avenues including live classroom training, virtual sessions, telephonic meetings, and national and regional field team meetings, in collaboration with the Learning and Development Department.
  • Identify training gaps and develop and execute a plan for development of additional training programs, as required, based on prioritized needs in coordination with the Vice President, Compliance and key stakeholders.
  • Assist with compliance audits, monitoring and internal investigations as needed while advising on appropriate corrective action.
  • Assist with auditing and monitoring of third-party distributors and other partners in Canada, Europe, and Latin America.
  • Assist with development and implementation of compliance policies for Canada, Europe, and Latin America.
  • Assist with federal, state, and international transparency reporting obligations.

Supervisory Responsibilities:

It is expected that the Associate Director will manage one or more compliance associates/managers in the future.

 Interaction:

The Associate Director will work closely with employees in all functional areas of the company, including senior level staff, to provide Compliance counseling and support.

Education and Experience:

  • Bachelor’s degree required; law degree or masters preferred
  • 8+ years of experience working as a compliance professional for a pharmaceutical and/or medical device manufacturer or within the life sciences industry; or 5+ years of experience as legal counsel in a life sciences or healthcare related practice;
  • Compliance and Legal background with a strong business focus.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.

Work Environment:

Typical office setting, staff in cubicles, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is in cubicle setting. The work environment may vary depending COVID-19 restrictions

EEO Statement

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.

 

EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.