Associate Director, Compliance

1 day ago

Parsippany NJ United States Pacira BioSciences, Inc. Full time

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.

Summary:

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

Responsibilities:

  1. Design, develop, and implement healthcare compliance policies, standard operating procedures, and guidance documents in collaboration with cross-functional teams.
  2. Oversee authoring of new or amended policies, standard operating procedures and guidance documents and circulation for internal partner and stakeholder input.
  3. Develop communications, live training materials, e-learning modules and other training or educational materials to aid in implementing new policies and procedures.
  4. Conduct internal presentations and reviews to inform and educate others on new or amended policies and related implications.
  5. Identify policy gaps and develop and execute an annual plan for development of additional policies and guidance documents, as well as a plan for making updates to existing policies and procedures, as required, based on prioritized needs in coordination with the Vice President, Compliance, and key stakeholders.
  6. Willingness to collaborate cross functionally within and beyond the Legal and Compliance department to support a One Pacira mindset.
  7. Manage projects and resources ensuring vendors meet timelines and develop appropriate, effective, and compliant materials and resources.
  8. Stay abreast of industry best practices and current trends in the pharmaceutical, medical device, and biotech industries.
  9. 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.
  10. 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.

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:

  1. Bachelor’s degree required; law degree or masters preferred.
  2. 5+ years of experience working as a compliance professional for a pharmaceutical and/or medical device manufacturer or within the life sciences industry; or 3+ years of experience as legal counsel in a life sciences or healthcare related practice.
  3. Compliance and Legal background with a strong business focus.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  1. 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.
  2. Demonstrated knowledge of enforcement landscape, including relevant industry investigations, litigation, and settlements.
  3. Experience developing corporate policies and standard operating procedures is preferred.
  4. Experience in building and implementing key components of an effective compliance program, including written standards, training, auditing, and monitoring and investigations, is preferred.
  5. Strong grasp of relevant laws and FDA guidance regarding promotional labeling and advertising for drugs and devices is preferred.

Knowledge, Skills, and Abilities:

  1. Ability to work well under pressure, to meet short deadlines, and to collaborate with cross-functional teams and key stakeholders.
  2. Excellent interpersonal skills and the ability to collaborate and communicate seamlessly with all levels.
  3. Excellent written and verbal English communication skills.
  4. Demonstrated excellent organizational skills.
  5. Excellent skill level in MS Office including Word, Excel, and Outlook.

Physical Demands:

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.

Ability to safely navigate and work in office environment consistent with Pharmaceutical and Medical Device industry. Moderate noise level, work in cubicles. 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:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation. Employee is located in cubicle setting.

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