Associate, Compliance

Position Summary

The Compliance Associate is responsible provides GxP (GMP/GLP/GDP) compliance oversight for the organization.

Essential Functions (ES) and Responsibilities

• Act as a liaison for ethics and compliance support adhering to critical business activities within our US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others.
• Execute and help manage paper, field, and program auditing and monitoring activities.
• Organize and evaluate facts and evidence and draw sound conclusions in relation to auditing and monitoring activities and processes.
• Prepare timely, accurate, and complete reports with corrective action recommendations and follow-through with key stakeholders for implementation.
• Assist in the development, preparation, and management of periodic reporting of results to senior management.
• Assist in the maintenance of ADMA’s compliance program, including, but not limited to, the company’s commercial compliance policies and procedures.
• Ensure compliance with internal policies, standards and procedures and external laws and regulations including environmental health and safety programs for the company.
• Monitor all state and federal regulations affecting pharmaceutical personnel and report on upcoming changes in federal and/or state laws.
• Compose and disseminate standardized internal communications to personnel on important compliance developments, company policies, and procedures.
• Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures.
• Ensure adequate GAP Analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate.
• Assists with all state, federal & regulatory inspections and information requests.
• Supports all compliance responsibilities. Supports the preparation, revision, and implementation of relevant SOPs.
• Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements:

• Bachelor’s degree in science, engineering, quality or another technical field or high school diploma with a minimum of 4 years of experience is required.
Promotional Review Committee (PRC) or Legal Medical Review (LMR) designation a plus.

Experience Requirements:

• A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.
• Must have experience acting as a liaison for ethics and compliance support adhering to critical business activities within the US market, including activities planned by Commercial, Medical Affairs, and Government Affairs teams, among others.
• Must have conducted a minimum of 2 to 3 external/field commercial audits.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.