Associate Director, Regulatory Affairs Advertising & Promotion

Overview

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.

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 primary purpose of this position is to provide strategic guidance and leadership relating to promotional activities. The role will be responsible for reviewing and approving all promotional and proactive medical materials for assigned marketed products, disease education materials, and products in development. The individual will also serve as the primary liaison for leading interactions with the OPDP for assigned products. The key aspect of this role is to enable the achievement of business objectives while ensuring compliance with applicable FDA regulations, guidance documents, and company policies. Additionally, the incumbent will help build the advertising and promotion team and capabilities.

Responsibilities

• Serve as internal subject matter expert on promotional and medical review committees for assigned products to ensure compliance with regulatory requirements while meeting corporate strategic promotional objectives.
• Collaborate with cross-functional teams, including commercial, medical, legal, and other expertise areas, for review and approval of promotional materials and materials used in scientific exchange for assigned products.
• Provide guidance and strategic support on proposed claims for products in development and develop Important Safety Information and Brief Summary documents as needed.
• Serve as primary liaison with OPDP for assigned products and manage interactions, including responses to regulatory inquiries or actions, preparing high-quality submissions for advisory comments, and, as needed, discussions.
• Educate colleagues on the regulatory environment and provide a risk assessment for proposed communication tactics and strategies.
• Continually develop, revise, and assess best practices, working instructions, and SOPs for promotional activities to establish standards and consistency across company brands. Monitor for OPDP enforcement actions, new or revised legislation, guidance documents, and industry standards related to prescription drug promotion, and communicate to the organization, providing training as needed.
• Work closely with Regulatory Operations in making timely 2253 submissions to OPDP.
• Work closely with regulatory strategy development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials.
• Provide advice regarding clinical trial design elements and labeling needed to support target product profiles and desired commercial claims.
• Other duties as assigned.

Supervisory Responsibilities : This position may have supervisory responsibilities.

Interaction : The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.

Qualifications

Education and Experience :

Knowledge, Skills, and Abilities :

Competencies :

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 accommodation 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 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.

The work setting is consistent of a typical pharmaceutical office environment with offices and cubicles.

Benefits

Pay Transparency

The base pay range for this role is $140,000 per year to $190,000 per year. The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to : geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications

EEO Statement

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.

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