Senior Manager Ethics & Compliance

139680
  • Competitive
  • Fort Lee, United States
  • Permanent

We are working with a small/mid-size Biotechnology client seeking a highly skilled and detail-oriented professional to join our team as the Senior Manager of Ethics & Compliance. In this crucial role, you will be responsible for ensuring that their organization adheres to all relevant laws, regulations, and industry standards while also championing transparency in our operations. The ideal candidate will possess a deep understanding of compliance frameworks, a strong grasp of transparency reporting requirements, and excellent communication skills to collaborate across various departments.


 

Key Responsibilities:

  1. Develop, implement, and continuously improve ethics and compliance policies, procedures, and training programs in alignment with applicable laws, regulations, and industry standards.
  2. Provide guidance and support to leadership and employees on ethical decision-making, conflicts of interest, and compliance matters.
  3. Conduct regular risk assessments and audits to identify potential areas of compliance vulnerability and develop strategies to mitigate risks.
  4. Collaborate with cross-functional teams, including Legal, Human Resources, Regulatory Affairs, and Quality Assurance, to address compliance issues and drive remediation efforts.
  5. Lead investigations into allegations of misconduct, ethical breaches, or violations of company policies, ensuring thoroughness, fairness, and confidentiality throughout the process.
  6. Monitor changes in laws, regulations, and industry standards to proactively identify emerging compliance issues and recommend appropriate actions.
  7. Foster a culture of ethics, integrity, and transparency through effective communication, training initiatives, and recognition programs.
  8. Prepare and present regular reports to senior management and the Board of Directors on the status of the ethics and compliance program, including key metrics, trends, and areas for improvement.

Qualifications:

  1. Bachelor's degree in Business, Law, Compliance, or related field; advanced degree (e.g., JD, MBA) preferred.
  2. Minimum of [X] years of experience in ethics, compliance, regulatory affairs, or related fields, preferably within the biotech or pharmaceutical industry.
  3. In-depth knowledge of relevant laws, regulations, and industry guidelines (e.g., FDA regulations, FCPA, HIPAA) governing biotech companies.
  4. Strong understanding of ethical principles, corporate governance, and risk management frameworks.
  5. Proven experience developing and implementing compliance programs, policies, and training initiatives.
  6. Excellent communication and interpersonal skills, with the ability to effectively engage and influence stakeholders at all levels of the organization.
  7. Analytical mindset with the ability to assess complex situations, identify root causes, and develop pragmatic solutions.
  8. Professional certifications in compliance (e.g., CCEP, CCEP-I) or related fields are a plus.
Paige Pecora Senior Dvision Manager

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