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.
Job Role:
• 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:
Labeling
• 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
Qualifications:
- 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
SUPERVISES: 1-2
JOB SUMMARY
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 ...
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