Associate Director, Compliance

• Design, develop, and implement healthcare compliance policies, standard operating procedures, and guidance documents in collaboration with cross-functional teams.
• Oversee authoring of new or amended policies, standard operating procedures and guidance documents and circulation for internal partner and stakeholder input.
• Develop communications, live training materials, e-learning modules and other training or educational materials to aid in implementing new policies and procedures.
• Conduct internal presentations and reviews to inform and educate others on new or amended policies and related implications.
• 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.
• Willingness to collaborate cross functionally within and beyond the Legal and Compliance department to support a One Pacira mindset.
• Manage projects and resources ensuring vendors meet timelines and develop appropriate, effective, and compliant materials and resources.
• Stay abreast of industry best practices and current trends in the pharmaceutical, medical device, and biotech industries.
• 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.

• Bachelor's degree required; law degree or masters preferred
• 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
• Compliance and Legal background with a strong business focus

• 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 developing corporate policies and standard operating procedures 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.
• Strong grasp of relevant laws and FDA guidance regarding promotional labeling and advertising for drugs and devices 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.

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.