About Us:
Global Impact Group is a leading provider of high-quality interpreting and translation services nationwide. We are ISO 9001 and ISO 17100 certified, a certified Service-Disabled Veteran-Owned Small Business (SDVOSB). Our mission is to bridge communication gaps and deliver accurate, culturally competent language services across healthcare, government, legal, education, and community sectors.
Position Overview
We are seeking a skilled Japanese Interpreter with proven experience supporting pharmaceutical audits and regulatory inspections. The ideal candidate will have a strong command of both Japanese and English, and a deep understanding of pharmaceutical regulatory environments, including U.S. and international agency standards such as FDA, PMDA, MHRA, ANVISA, and others.
Key Responsibilities
- Provide real-time consecutive or simultaneous interpretation during pharmaceutical site audits and regulatory inspections.
- Accurately interpret complex technical, scientific, and regulatory terminology.
- Ensure clarity and cultural accuracy between Japanese-speaking stakeholders and international regulatory inspectors.
- Assist with pre-audit preparations, documentation reviews, and follow-up communications.
- Maintain strict confidentiality and compliance with professional ethics and client protocols.
Qualifications
- Fluency in Japanese and English (spoken and written).
- Minimum 3 years of interpretation experience, preferably in a GMP-regulated pharmaceutical environment.
- Proven experience interpreting for FDA, PMDA, or other international regulatory agency inspections (e.g., ANVISA, MHRA, EMA).
- Familiarity with pharmaceutical manufacturing processes, Good Manufacturing Practices (GMP), and regulatory terminology.
- Certification in interpretation (e.g., court, medical, or professional interpreter certification) is preferred.
- Strong interpersonal, organizational, and communication skills.
- Availability for potential onsite or virtual assignments, depending on audit schedule.
Preferred Experience
- Background in life sciences, biotechnology, or pharmaceutical sectors.
- Experience supporting multinational inspections or third-party audits.
- Knowledge of ICH guidelines, regulatory submission documents, or CAPA responses is a plus.
What We Offer:
- Competitive hourly compensation.
- Flexible scheduling based on your availability.
- Opportunities to work with a diverse client base and gain experience in different sectors.
- Ongoing professional development and training opportunities.
Global Impact Group LLC is an equal opportunity employer.
We value diversity and are committed to creating an inclusive environment for all employees and contractors.
Employment Type: Contract / As-Needed
We are an equal opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color, religion, sex,
national origin, disability status, protected veteran status, or any other
characteristic protected by law.
Global Impact Group LLC is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) and Minority-Owned enterprise based in Raleigh, North Carolina, providing innovative and quality-driven solutions in Staffing, Language Services, Consulting, Janitorial, and Employment Placement. As an ISO 9001 and ISO 17100 certified firm, we serve government, healthcare, education, and corporate clients with excellence, efficiency, and cultural competence. Our mission is to deliver tailored services that empower individuals, strengthen organizations, and create lasting impact in the communities we serve.