Associate Director, Compliance

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 will have a significant role in the implementation of the corporate compliance program for our growing business.  The Associate Director 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 Executive Director, Compliance, the Senior Vice President, Legal and Compliance, and the Chief Compliance Officer with ensuring obligations set forth under U.S. laws and regulations are met.

Responsibilities:

  • Provide timely and practical advice and support to the business related to compliance requirements, 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 support to the company in accordance with Pacira’s healthcare compliance policies and related laws, codes and regulations.
  • Design, develop, and implement 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 Executive Director, 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 guidance and support.

Qualifications:

  • Bachelor’s degree required;
  • 8+ years of experience working as a compliance professional for a pharmaceutical and/or medical device manufacturer or within the life sciences industry;
  • Compliance and Legal background with a strong business focus; law degree or masters preferred.
  • Demonstrated strong understanding of relevant federal, state and local laws, rules, and regulations as well as industry standards impacting U.S.-based pharmaceutical and medical device manufacturers, including: the Anti-Kickback Statute, the False Claims Act, the Food, Drug, and Cosmetic Act (FDCA), the Prescription Drug Marketing Act (PDMA), the Sunshine Act, the OIG Compliance Program Guidance, the PhRMA Code, and the AdvaMed Code.
  • Demonstrated knowledge of enforcement landscape, including relevant industry investigations, litigation and settlements.
  • Experience providing corporate training is preferred.
  • Experience in building and implementing key components of an effective compliance program, including written standards, training, auditing and monitoring and investigations, is preferred.
  • Experience with international third-party auditing and monitoring programs is preferred.
  • Strong grasp of relevant laws and FDA guidance regarding promotional labeling and advertising for drugs and devices is preferred.
  • Knowledge of current laws, regulations and industry standards governing clinical trials, such as FDA regulations, ICH Guidelines, and GCPs is preferred.
  • Knowledge of compliance laws, rules, regulations and industry standards in Canada, Europe and/or Latin America is preferred.
  • Ability to work well under pressure, to meet short deadlines, and to collaborate with cross-functional teams and key stakeholders;
  • Excellent interpersonal skills and the ability to collaborate and communicate seamlessly with all levels;
  • Excellent written and verbal English communication skills.
  • Demonstrated excellent organizational skills.
  • Excellent skill level in MS Office including Word, Excel and Outlook.

 

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.