Job Description

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Must be fluent in both Japanese and English. Please submit an English version of your CV.

RESPONSIBILITIES:

• Plan and conduct GCP audits in the Medical Device, Biological Drug/Agent, and/or Pharmaceutical realm.  Audits may include investigator site, sponsor, Mock Inspection, process, quality assurance/quality management system, software/computer system qualification and validation, vendor (including vendor qualification), and/or bioanalytical/bioequivalent/pharmacokinetic. 
• Report Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.
• Assist with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required by the client.
• Write confirmation letters, and audit plans, agendas, reports and other required audit documentation. 
• Provide drafts of required documents, and finalize following internal QA and sponsor reviews according to project timeline.
• Provide GCP and inspectional preparedness training to clinical sites, vendors, and sponsors as required by client.
• Provide good documentation training to auditees as required by client.
• Perform gap analysis of SOPs and procedures as required by client.
• Review, develop and revise client procedures, guidance documents, form templates, and quality documentation as required by client.
• Perform all audit-related activities in accordance with MMS procedures and using MMS document templates, or client procedures and templates as required by the client.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree or higher in biomedical, nursing or related life science discipline required.
• Minimum 5 years relevant auditing experience preferred.
• Minimum 2 years SOP development experience preferred.
• Minimum 2 years GxP training experience preferred.
• Comprehensive understanding of ICH Guidelines [i.e., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.
• Training to and understanding GDPR requirements relative to clinical research preferred.
• Excellent demonstrated verbal and written communication skills
• Ability to travel up to 50%, both domestically and internationally.

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