GxP Compliance Associate
GxP Compliance Associate
Ft Lauderdale area, Onsite
Company Profile: Pharmaceutical company with (3) Commercial Products in Infectious Disease
What You Can Expect To Be Doing
#IND1
Ft Lauderdale area, Onsite
Company Profile: Pharmaceutical company with (3) Commercial Products in Infectious Disease
What You Can Expect To Be Doing
- 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 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.
- 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.
- 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.
- A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.
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