This position reports to the Clinical Operations department and has overall responsibility for developing, implementing, managing and maintaining Clinical Trial Master File (CTMF) systems according to FDA GCP requirements, ICH GCP requirements and...
This individual will support pre-approval compounds in the development phase through marketing registration and post approval follow up. Responsible for implementation of practical, workable plans to support all CMC regulatory filings. Oversees and...
Adamas Pharmaceuticals, Inc.
Adamas Pharmaceuticals is dedicated to improving the lives of those affected by central nervous system (CNS) disorders by optimizing the pharmacokinetic profiles of approved drugs to create novel treatments for use alone and as components of...
Astex Pharmaceuticals, Inc.
Work for a company that is making a difference in the fight against cancer. Astex Pharmaceuticals, Inc., www.astx.com, brings together high tech and biotech to discover and develop more effective medicines for the treatment of cancer. We are looking...
Sr. Clinical Quality Assurance Associate (GCP Auditor)
This position will
• Schedule, conduct and/or coordinate Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which...
Halozyme Therapeutics, Inc.
The Senior Regulatory Affairs CMC Specialist is responsible for role that includes Chemistry Manufacturing and Quality (CMC) for developmental, initial applications and post marketing requirements for regulatory applications. The...
The Director will lead global regulatory strategy for assigned programs (development and marketed products) in Oncology and Cardiovascular Therapeutic Areas at Gilead Sciences Headquarters in Foster City, CA.
As Global Regulatory Lead the Director...
Eli Lilly and Company
Eli Lilly is the 10th largest pharmaceutical company in the world, and has been creating medicines that help improve peoples' quality of life for more than 135 years. Across the globe, we are a leader in investing in research and...
Integrated Project Management
Do you have what it takes to be a Project Management Consultant?
Our Project Management Consultants work onsite in our clients’ environments to lead critical projects. It’s not easy. Are you up for the challenge?
We are headquartered in Chicago...
Lab Support, A Division Of On Assignment
South San Francisco,
**** ONLY LOCAL CANDIDATES WILL BE CONSIDERED ****
Support the release of finished clinical and commercial combination product including batch record review, resolution of investigations and quality issues, and assessment of change...