Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader. Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval).
Develops and is responsible for key internal safety documents from the formation of the GPT/GBT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent ...
Our client, a pharmaceutical company, is seeking a Contract Medical Affairs System Specialist for about a year. The compensation is up to $45 an hour plus benefits.
The Medical Affairs System Specialist:
• Act as a Liaison between Medical Affairs (Field & In house), Field Force Automation, and other areas of IT, to support alignment and continuous process improvement for Medical Affairs Operations
• Coordinates and compiles regular monthly reports ad hoc data as needed for metrics tracking
• Assist ...
Our client, a fast paced, growing pharmaceutical company in Central NJ is seeking a Safety Data Specialist for about 6 months. This position pays up to $47/hour, depending upon experience.
• Responsible for collection and processing of spontaneous and clinical trial adverse event and pregnancy reports, which includes data entry and verification of information into the safety database.
• Responsible for medical evaluation of relevant reports, which includes narrative generation, ...
Our client is seeking a long term Regulatory Associate for about 2 years with full benefits. This is an excellent opportunity paying up to $40 an hour.
The Regulatory Associate's responsibilities:
• Provide labeling assistance to Regulatory Affairs (RA) Department and assists RA with the preparation and approval of product labeling
• Prepare labels using Structured Product Labeling (SPL) authoring tool, Text Verification Tool (TVT), LOLA Workflow
• Perform manual proofing of labels in a ...
Contact Kristine at 815-756-1221 for more information
- MS/PhD in Toxicology, Science, Nutrition
- 7-10 years food ingredient regulatory experience
- Food, beverage, dietary supplement or personal care experience required
- Familiar with U.S. FDA and other international regulatory agencies
- Extensive toxicity knowledge
- Knowledge of corporate resources to support objectives
- Ability to interface with people at all levels
- Demonstrated written and oral communication skills
Lead the development, implementation, and management of the GCP Quality program compliant with federal regulations (IRB and IEC) and company standards.
Candidate must possess at least 5 years experience in the following:
*** Developing and executing comprehensive annual audit plans for Clinical Trials.
*** Planning, coordinating, and conducting internal and external audits.
*** Overseeing Clinical Document Audits
*** Writing, reviewing, and updating Standard Operating Procedures
JOB TITLE: Snr. Manager /Associate Director - Regulatory Affairs
DEPT: Regulatory Affairs
We are currently seeking for a Sr. manager or Associate Director for Regulatory Affairs department. This person would: ensure marketing approval of drug products in the US; be a regulatory liaison for new product development and changes to existing products; perform job tasks independently and supervise regulatory staff; and provide strategic input and guidance to ...
Mar 25 -
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