RqapGcp Lawrence Yarmaloff Email & Phone Number | • Over thirty (30) years of experience in the clinical development of investigational therapeutic and diagnostic products, including drugs, biologics, vaccines, cosmetics, and medical devices. • Over twenty (20) years of experience as an independent clinical research services provider. • Quality Assurance executive with expertise in Good Clinical Practice (GCP). • Registered Quality Assurance Professional in GCP by the Society of Quality Assurance (RQAP-GCP). • Therapeutic targets include but are not included to oncology (solid tumors and hematologic malignancies), endocrinology, obesity, dermatology, skin anti-aging, cardiovascular, neurology, orthopedics, organ transplant, mental health, immunology, women's health, rare genetic disease, infectious disease, pulmonary, gastroenterology, pediatrics, and neuropsychiatry/addiction. • Summary of expertise: o GCP, International Conference on Harmonisation (ICH) and regulatory compliance o GCP Audits and Quality Investigations (domestic and international) o Regulatory Inspection Readiness and Mock FDA Inspections o Quality Management Systems (Standard Operating Procedures, Work Instructions, Corrective and Preventative Actions) o GCP Training and Subject Matter Expert (SME) o Pharmacovigilance Operations Management and Compliance o Clinical Project Management o Clinical Trial Monitoring o Regulatory Submissions o Investigational Site Management o Staff Management and Development • Worked with over 80 biopharmaceutical and medical device companies in domestic and international Phase I-IV pharmaceutical studies and pilot, pivotal and post market studies.

RqapGcp Lawrence Yarmaloff

• Over thirty (30) years of experience in the clinical development of investigational therapeutic an...
Framingham, Massachusetts, United States

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RqapGcp Lawrence Yarmaloff’s Email lyarmaloff@panaceaclinical.com

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RqapGcp Lawrence Yarmaloff’s Location Framingham, Massachusetts, United States

RqapGcp Lawrence Yarmaloff’s Current Industry Panacea Clinical Research

RqapGcp Lawrence Yarmaloff’s Prior Industry Paragon Biomedical | Immunogen | Quintiles

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Work Experience

Panacea Clinical Research

President and Principal Consultant, GCP-QA, Compliance, Clinical Operations,

1999-01-01 00:00:00 - Present

Paragon Biomedical

Clinical Project Manager

1995-01-01 00:00:00 - 1999-01-01 00:00:00

Immunogen

Clinical Project Leader

1993-01-01 00:00:00 - 1995-01-01 00:00:00

Quintiles

Clinical Research Associate

1991-01-01 00:00:00 - 1993-01-01 00:00:00

Skills

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Languages

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FAQ About RqapGcp Lawrence Yarmaloff

RqapGcp Lawrence Yarmaloff is located at
Framingham, Massachusetts, United States

RqapGcp Lawrence Yarmaloff is a • Over thirty (30) years of experience in the clinical development of investigational therapeutic and diagnostic products, including drugs, biologics, vaccines, cosmetics, and medical devices. • Over twenty (20) years of experience as an independent clinical research services provider. • Quality Assurance executive with expertise in Good Clinical Practice (GCP). • Registered Quality Assurance Professional in GCP by the Society of Quality Assurance (RQAP-GCP). • Therapeutic targets include but are not included to oncology (solid tumors and hematologic malignancies), endocrinology, obesity, dermatology, skin anti-aging, cardiovascular, neurology, orthopedics, organ transplant, mental health, immunology, women's health, rare genetic disease, infectious disease, pulmonary, gastroenterology, pediatrics, and neuropsychiatry/addiction. • Summary of expertise: o GCP, International Conference on Harmonisation (ICH) and regulatory compliance o GCP Audits and Quality Investigations (domestic and international) o Regulatory Inspection Readiness and Mock FDA Inspections o Quality Management Systems (Standard Operating Procedures, Work Instructions, Corrective and Preventative Actions) o GCP Training and Subject Matter Expert (SME) o Pharmacovigilance Operations Management and Compliance o Clinical Project Management o Clinical Trial Monitoring o Regulatory Submissions o Investigational Site Management o Staff Management and Development • Worked with over 80 biopharmaceutical and medical device companies in domestic and international Phase I-IV pharmaceutical studies and pilot, pivotal and post market studies.