Job Title: Operations Leader
Location: Gaithersburg, MD
Duration: 12 months
Lead the delivery of a portfolio of Company and Non-Company sponsored studies and manage the cross functional activities required for granting Early Access to Investigational Medicinal Products up to 6 months post marketing authorization approval within any defined market, region, institution and/or therapeutic area(s).
Ensures compliant and appropriate adherence with all relevant Company policies/procedures, local and international regulatory and legislative guidance for the different procedural frameworks as well as when operating with external organizations.
Requirements Education and Experience
Bachelors degree required preferably in medical or biological science or equivalent by experience.
Pharmaceutical industry/CRO experience within clinical study/research project delivery
Drug development process and relevant guidelines, for example GCP/ICH, for a specific therapeutic and geographical area
Project Management qualification /demonstration of project management skills including scope,
use of associated tools
Scientific awareness and extensive knowledge of observational study guidelines and SOPs.
Extensive knowledge of early and late stage Pharmaceutical Development
Ability to effectively work with Clinical Research Organizations/External Providers.
Proven ability to interact widely and effectively within the company across regions, functions and cultures.
Experience and knowledge within compliant management of Externally Sponsored Scientific Research
Open to periods of travel
Artech Information Systems