Bioresearch Monitoring (BIMO) Expert

  • Anywhere

Lachman Consultants

Experience. Excellence.

Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking Bioresearch Monitoring (BIMO) experts:

  • Sponsors/Monitors/Clinical Research Organizations (CRO)
  • Data audits and for-cause inspections of clinical investigator (CI) sites, institutional review boards (IRBs), analytical laboratories, and CROs to ensure the quality and integrity of bioresearch data submissions
  • Simulated BIMO inspections in accordance with US FDA and EMA regulations
  • Expertise in SAE and AE management, adherence to Study Protocols, clinical supply management, study director oversight, records management and data governance
  • FDA 483 and Warning Letter response preparation and remediation
  • Training in BIMO regulations and industry best practice
  • Capable of assessing BIMO activities across all regulated commodities including, pharmaceuticals, medical devices and biologics Regulatory compliance
  • Bioavailability / bioequivalence requirements
  • Good Laboratory Practice (GLP)
  • Risk evaluation and mitigation strategies

Qualifications:

  • B.S. / M.S. / Ph.D. in Biology, Chemistry, or related clinical area
  • Minimum of 10 years’ experience in pharmaceuticals, biologics, and/or medical device environment
  • Detailed knowledge of current FDA, ICH, ISO and EMA regulations / guidance and expectations
  • Strong communication / presentation skills, verbal and written, are required for interaction with clients and coworkers
  • Ability to recognize and differentiate importance of issues and prioritize accordingly
  • Verifiable and recent “hands-on” experience, including demonstrated remediation skills
  • Domestic and international travel required

Apply below, or send resume to: recruitment@lachmanconsultants.com

For four decades, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available.  Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.

Upload your CV/resume or any other relevant file. Max. file size: 50 MB.