Associate Director, Compliance Officer

Par Pharmaceuticals

Par Pharmaceuticals

Legal
Malvern, PA, USA
Posted on Thursday, July 11, 2024

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Responsible for supporting the Executive Director, Global Commercial and R&D Compliance Officer with creating risk-based compliance strategies and ensuring comprehensive compliance of assigned functions within our organization. This includes assisting with key compliance initiatives in the Branded Specialty, Injectable Solutions, Generics, & Paladin Pharma business units and the R&D Department to ensure alignment with business goals and objectives. Serves as a Compliance partner and primary contact for regular Compliance-related activities, training, monitoring, and investigations. Collaborates with colleagues in the Corporate Compliance Department to identify risk areas and assist in developing Compliance plans and program enhancements to address existing and emerging areas of risk. Incumbent must have a strong understanding of and be able to apply external regulations and requirements to key activities, processes, and policies & procedures. Provides support to the Executive Director, Global Commercial and R&D Compliance Officer in carrying out roles and responsibilities for fostering a culture of compliance and ethics throughout the organization.

Job Description

Key Accountabilities

Support Compliance Activities for the Global Commercial Business Unit

  • Independently provide compliance guidance on promotional and non-promotional materials, scientific exchange, disease state, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance that is in alignment with applicable regulations.
  • Identifies Compliance risk areas and assists with developing strategies to address risk areas.
  • Foster a company culture that focuses on compliance and ensures on-going commitment to the Endo Values and Behaviors
  • Assists with the evaluation and implementation of SOPs, policies, and training as well as contributes to guidelines for concept and activity reviews for field implementation.
  • Assists with monitoring commercial and non-commercial programs and business processes to ensure adherence to company’s policies and procedures in a manner that is consistent with best practices and applicable laws and guidance.
  • As appropriate, review and approve annual engagement plans and business need reviews for HCP engagements and other interactions incoming from the Commercial business units as well as the Global R&D department.
  • Acts as a representative on select cross functional teams or Committees as assigned for matters relating to Commercial Compliance including task forces.

Collaboration and Leadership

  • Collaborates with business and Compliance colleagues and may serve as the lead for key Compliance initiatives in support of the Global Commercial business unit and Global R&D.

Planning, Program and Policy Development, and Reporting

  • Supports and provides input to the Executive Director, Global Commercial & R&D Compliance Officer for the development of the annual Compliance monitoring plans for the Global Commercial business unit and R&D;
  • Provide relevant guidance and insight into business unit policy development; and identifies program enhancements to address Compliance risk areas.
  • Assists the Executive Director, Global Commercial and R&D Compliance Officer with reporting business unit metrics and key performance indicators that reflect the effectiveness of the Global Commercial Business Compliance program to the Chief Compliance Officer and Senior/Executive management.

Investigations, Auditing and Monitoring

  • Reviews and supports, when applicable, Compliance investigations as required and assists with appropriate resolution and, corrective action, as needed; conducts live monitoring of Promotional and Non-Promotional activities including: Speaker Programs, sales representatives (ride-alongs), advisory boards, conferences; Promotional and Non-Promotional monitoring of Global Commercial activities and Global R&D activities, to assess compliance with applicable policies and procedures.

Qualifications

Education & Experience

  • Bachelor’s Degree required; advanced degree preferred.
  • Minimum 8 years of pharmaceutical, Compliance, Legal, or Regulatory experience required
  • Minimum of 5 years providing Compliance guidance to Global Commercial and/or R&D processes, including:
    • Knowledge, understanding and insight of Global Commercial and R&D processes, including the regulatory environment and trends impacting Branded and Generic Pharmaceuticals.
    • Broad understanding of the compliance risks facing Branded Pharmaceuticals, Generic Pharmaceuticals, and R&D including practical approaches to influencing the business to implement risk mitigation strategies.
    • Broad understanding of interfaces between Compliance and Commercial Business Units, and R&D departments.

Knowledge

  • Knowledge of state and federal laws and regulations, industry guidelines and other requirements relevant to the Company’s Compliance Program, including government price reporting laws, fraud and abuse and anti-kickback laws, PDMA, OIG, DOJ and AdvaMed and PhRMA guidelines, state and federal aggregate spend reporting requirements, and corporate integrity agreements.

Skills & Abilities

  • Strong interpersonal skills including ability to communicate effectively with people individually and groups; ability to communicate with technical and non-technical colleagues; ability to develop important relationships with key stakeholders and work with all levels of management and employees, as well as with external partners and vendors
  • Outstanding verbal and written communication skills, with the ability to communicate complex issues in a simple way and influence for greater outcomes
  • Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace
  • Able to prioritize and align the organization against goals and objectives; ensures rigor in operational excellence; and focuses on outcomes with clear measures and metrics
  • Ability to build and manage relationships with business partners and Compliance colleagues
  • Exceptional communication and presentation skills required, with demonstrated success inspiring confidence and support for Compliance initiatives within the organization
  • Ability to thrive in a fast-paced, innovative environment with the ability to handle multiple, conflicting priorities while managing a substantial workload
  • Able to effectively execute both strategically and tactically
  • Highly self-motivated, with the ability to quickly gain trust and credibility from team members and stakeholders
  • Strong team player that is customer and solution-oriented, with the ability to understand and differentiate approach to complex compliance matters
  • Must be well-organized and possess strong planning skills, with extremely high attention to detail and ability to manage numerous projects simultaneously

Physical Requirements

  • Business travel up to 20% of time

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.