Pharmaceutical Development Consultant

Broad background in pharmaceutical development and management. A strong scientific and business background that enables effective teamwork & communication with cross-functional groups at a strategic and functional level. Proven ability to handle multiple projects using excellent technical guidance, time management and organizational skills resulting in quality results, on time and within budget. Ability to translate department vision into a strategic and operational plan.

GLP & cGMP experience, Project management, GLP laboratory management, Strategic planning, Operations, Facilitator, Analytical & bioanalytical assay development & validation

Specialties:

  • Prepare IND & Annual reports
  • Develop, write, review GLP & cGMP compliance system & validation programs
  • Total project management support
  • Create development plans & timelines
  • Plan for CMC, preclinical & clinical development programs
  • Write technical documents & SOPs
  • Create and implement assay development and validation plans
  • Select /manage CROs
  • Technical and data review
  • Prepare business plans & presentations for early stage companies
  • Due diligence/technology evaluation

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Kathrin Copley at KCopley Consulting


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