- Locations: Maryland, California, Illinois, New Jersey, Pennsylvania
- Related Keywords: Insert, Package, Patient Package Insert
- Director of Loyalty & Direct Marketing
- Leading Flowers and Gifts Delivery Service (Chicago, IL)
- ...through program benefits and customer communications and acquire new customers via direct marketing programs such as direct mail and package insert programs. As the Director, you will: o Lead the loyalty program strategy and development, including overseeing financial modeling and...
- QPM Processor - Swing Shift
- Burlington Coat Factory (San Bernardino, CA)
- ...style, color, and quantity of merchandise in cartons against all paperwork. Insert or attach tags or shipping label. Place cartons on rollers....that values trust and respect, offer a competitive wage and benefits package that includes a generous paid time off plan, plus an...
- Senior Associate Regulatory Affairs - NB
- Amgen (Thousand Oaks, CA)
- ...(GLL) for assigned products, which include but are not limited to: - Preparing and maintaining quality labeling documents [e.g. US Package Insert (PI), Patient Product Information (PPI) or Medication Guide (MG), Core Data Sheet (CDS)], electronic draft revisions and version control...
- Clinical Science Specialist
- Kforce Professional Staffing (NJ)
- ...Prepare clinical progress reports for regulatory agencies before they are reviewed by line-managers and assure the consistency of labeling and package insert (clinical section) with the database The preparation and contents of annual reports and safety updates and ensures corrects data...
- Senior Associate Regulatory Affairs - NB
- Amgen (Thousand Oaks, CA)
- ...(GLL) for assigned products, which include but are not limited to: - Preparing and maintaining quality labeling documents [e.g. US Package Insert (PI), Patient Product Information (PPI) or Medication Guide (MG), Core Data Sheet (CDS)], electronic draft revisions and version control...
- Clinical Science Specialist
- Kforce Inc. (Nutley, NJ)
- ...Prepare clinical progress reports for regulatory agencies before they are reviewed by line-managers and assure the consistency of labeling and package insert (clinical section) with the database * The preparation and contents of annual reports and safety updates and ensures corrects...
- Clinical R&D - Other
- Innovative Alternatives (Waukegan, IL)
- ...by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at...
- Clinical R&D - Safety Reviewer
- Innovative Alternatives (Abbott Park, IL)
- ...by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at...
- Clinical Medical Services Specialist - B
- Artech Information Systems, LLC (Abbott Park, IL)
- ...department answer Health Care Professionals' questions reagrding adverse events in the Postmarketing database. Consumer questions are addressed regarding package insert related product information. Postmarketing Safety is also involved in the ongoing review of reported events as they...
- Medical Director (MD)
- Genentech (South San Francisco, CA)
- ...Supports GNE Regulatory Affairs on clinical development aspects of filings; plays a central role in developing language in a drug's Package Insert . Acts as the clinical lead on Filing Teams. Monitors IND filings for all assigned molecules and programs Provides clinical oversight...
- Associate Medical Director, Postmarketing Safety Evaluation
- Abbott (Deerfield, IL)
- ...issues for allocated products. Working with the Lead PSE physician, assess and participate in the development of US (US Package Insert ), European (Summary Product Character), and Core Safety (Company Core Data Sheet) reference labeling documents for assigned products. Working with...
- Global Safety Medical Director - NB
- Amgen (Thousand Oaks, CA)
- ...regarding pregnancy and lactation issues - Review and propose language for Study Concept Documents, Statistical Analysis Plans, and Proposals; Package Insert ; Informed Consent Form; Investigatora?Ts Brochure; Data monitoring plan; Data collection forms; Risk Evaluation and Mitigation...
- Medical Reviewer/Safety Reviewer
- Artech Information Systems, LLC (Morris County, NJ)
- ...and custom responses to communication requests, in-depth assistance to the medical and Client community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
- Medical Writer
- Talon (Bridgewater, NJ)
- ...Clinical Trial Reports (CTRs), Application Summaries, Integrated Summaries of Efficacy and Safety, Statistical Section (Item 10), Product Labeling ( Package Insert ), Writing Investigator Brochures and Briefing Documents. -Pre-analysis definition of CTR formats, including data analysis...