Description The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex development program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team developing a new molecular entity currently being studied for central nervous system applications. Team matrix interactions include project planning, regulatory affairs, ...
Our client, a global pharmaceutical client, is seeking a Director/Manager, Health Outcomes Research for about 1 year. The compensation is up to $84 an hour plus amazing benefits - medical, 401K with match, vacation and holiday.
• Supports the development of research projects with key opinion leaders and communication of data & research outcomes
• Supports development of HEOR strategies and assist in creating tactics for economic value & quality of life arguments during product ...
**BA/BS or advanced degree required! 3 years of experience required!**
-The Clinical Research Scientist (CRS) will support US efforts in the planning, execution and reporting of US CD&MA clinical trials in Oncology/Hematology/Rare Disease/Early Therapeutics.
-Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement ...
As Head of Global Quality Management in the Quality Assurance group, you will report to the Regulatory Affairs Director and coordinate the implementation of the Global Quality Management and Assurance strategy for the Scientific Division and Phase IV studies. You will supervise more than 20 employees worldwide (Europe, North America, and Asia).
Implement the quality systems to fulfil regulatory requirements applicable to Company (GLP, GCP, GMP, GDP)
Prior experience with Implementation of clinical trials in the United States safety, data consistency, trial timelines, budget, resources, eligibility and enrollment.
Education: Bachelor Degree required
Support US efforts in the planning, execution and reporting of USCDMA clinical trials in Oncology.
Implementation of clinical trials in the United States (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), ...
Seeking a Hands-On Director of Regulatory Affairs. Apply today!
My client is a biopharmaceutical company that is focused on developing breakthrough treatments for human disease. Lexicon has advanced multiple drug candidates into clinical development. They are presently devoting most of their resources to the development of their two most advanced drug candidates. LX4211 is an orally-delivered small molecule drug candidate developed as a treatment for type 1 and type 2 diabetes. They have completed ...
GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. This is a highly visible and strategic role within RA that will help shape the global development strategy and life cycle management strategies. This role reports to the Global Head of RA and will be part of the RA Leadership Team. The Regulatory Affairs Segment Lead will be responsible for leading, setting, and driving a robust ...
We are currently seeking a Regulatory Affairs Specialist for a 9+ month contract in Florham Park:
**This is a speciality role-need someone with the following skill sets**
This position will be responsible for FDA Site Registrations, Pharma Wholesaler State License/Permit Registrations/Renewals, Customer Audit Scheduling, Animal Nutrition permits and tonnage reports and license database, issuing LOAs, annual DEA registrations.
In addition, the role coordinates the systems part of ...
*Experience in sterile injectables is required
Roles and Responsibilities:
Compile ANDA/NDA dossiers, including: requesting necessary documents from CMO/CRO, performing pdf CRO conversion and size reduction, bookmarking, and compiling Modules. Ensure quality submission.
Manage regulatory document submissions, including: uploading all modules to eCTD software, performing hyperlinking, submitting through ESG, and sending notice to management and partners.
Create draft labeling and SPL for ANDA ...
Come find out why Fortune 100 pharmaceutical & biotechnology clients consistently rank SciStaff Services, LLC as their business partner of choice when identifying contract and consultant talent in the areas of clinical development, medical affairs, regulatory affairs, pharmacovigilance, medical writing, data management, quality assurance and scientific roles. While many of our competitors have faced insolvency under a tough economy, we have actually hit record sales. Come find out why.
Feb 26 -
eBay Classifieds provides a large number listings for biotech, R&D & science jobs in Newark, such as clinical research assistant jobs, laboratory director jobs, clinical technician jobs, senior device engineer jobs and mechanical design engineer jobs. Once you find a biotechnology, research development or science job that you are interested in, you should consider sending in your application. Include a full resume as well as a cover letter. You can do this by clicking on the reply put on the ad's page. Perhaps you are looking to move to the local region and you need to find a job as soon as possible.