Job Description

Key Duties:

• 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.
• Maintain audit files, evidence, and other records.
• 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 our 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.
• Prepare and conduct regular compliance inspections.
• Monitor compliance systems to ensure their effectiveness.
• 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.
• Assist in the preparation of compliance training for company employees.
• Supports all compliance responsibilities. Supports the preparation, revision, and implementation of relevant SOPs.
• Actively participates in continuous improvement programs to align with business strategies.
• Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance.

Core Competencies/Behaviors:

Knowledge of global cGMP regulations; 21 CFR Parts 210, 211, 600, 610 and 820, ICH Guidelines, and IQPP Standards.

Computer proficient with intermediate skills in office programs.

Written and oral communication skills.

Strong organizational, interpersonal and collaborative skills.

Use independent judgment to assess compliance with regulatory requirements and SOPs.

Other Duties as Assigned:

Compliance Requirements (ES):

As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all Quality policies, standards, and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.

Physical Requirements (ES):

Sitting, ability to stand, walk and carry approximately 10 – 15 pounds (laptop, documents and personal luggage).

Hazards: exposure to chemicals, human source products, muscular strain, odors and sudden temperature change under normal laboratory conditions.

Travel Requirements (ES):

Travel required up to 10% of the time.