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- Irvine, CA

The candidate will work on a biologics pre-filled syringe product and guide the team with the design controls deliverables by reviewing the plans, protocols, reports, etc., and providing input. The candidate will perform engineering duties associated with the design, research, and development of combination products. RESPONSIBILITIES: Review all development documentation generated in projects. Provides technical assessments for business development decisions as needed. Provides technical....

- Irvine, CA

The Quality Control Associate is responsible for performing hands-on quality related tasks to fulfill QA/QC support for implementing and maintaining QMS compliance as directed by management. This position is responsible for supporting and maintaining quality systems and functions within the company. RESPONSIBILITIES: - Participate in developing, reviewing and maintaining documents to include corporate level Standard Operating Procedures to ensure quality objectives are met. - Inspect finished....


Job Title: Specialty Pharmacy Director Location: Baltimore, MD PRINCIPAL ACCOUNTABILITIES: The position reports directly to the Senior Director of the Pharmacy Evaluation & Oversight and is a critical leadership position within the unit responsible for understanding the specialty marketplace, opportunities for utilization management, and cost containment. The Director of Specialty Pharmacy will interact frequently with the EVP of Medical Affairs, the CEO, and other senior leaders across....

- San Fernando Valley, CA

Seeking a candidate to organize and coordinate new site recruitment as well as create and implement unique Pharma studies. The candidate will work closely with the Medical Director to select new sites to join our growing USA and International network as well as develop and implement original studies and help seek Pharma sponsorship. The candidate will maintain high levels of organizational effectiveness and communication. Our ideal candidate will be able to manage multiple sites for....


The Clinical Trial Data Analyst is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other sources. In addition, the position coordinates in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Responsibilities: Prepare data reports, tables and graphs for regulatory submissions, IRB submissions,....


This position is responsible for leading internal and outsourced Clinical Data Management activities in support of Clinical Research studies, managing the definition of Case Report Form (CRF) requirements, creation of the Data Management Plan, coordination of Centralized Data Review activities (a key component of Risk-Based Monitoring), and is accountable for data integrity, quality, and consistency at Database Lock. The employee must be able to lead data review activities and engage different

- Irvine, CA

The candidate is responsible for expeditiously developing and processing raw material and product documentation to meet quality requirements within timelines established for product launch and/or timely project completion.The Master Specifications and Documentation department interacts with various Pharmaceutical groups within the organization and departments such as Quality, Global Pharmaceutical Technology, Regulatory Affairs, Operations, Manufacturing (all sites), Procurement (Sourcing),....


The specialist will work with a team of medical information professionals to capture unsolicited medical inquiries from health care professionals, consumers, and corporate business partners. Also, research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database (product label, published and unpublished studies) to develop a medical/scientific response that is accurate, fair balanced, complete and delivered in a....

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