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Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including clinical study protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), MedDRA coding of AEs, product package and labeling.
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In this role, a typical day might include:The Regulatory Intelligence Manager performs proactive global monitoring and surveillance of changes in the regulatory landscape focused on the drug development lifecycle, i.e., preclinical through commercialization, as well as disseminate relevant regulatory intelligence information to Regeneron stakeholders.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. Provide drug safety and pharmacovigilance leadership to the quality and compliance team, fostering a culture of collaboration, excellence, and continuous learning.
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Prime Benefits: First Day Medical, Dental, Vision and Rx benefits Housing and Meal stipends 401(k) Savings plan after 90 days Travel/Licensure Reimbursement Referral Bonus Plan Weekly Direct Deposit Qualifications: Current BLS (AHA Preferred) Active State License Supervisory Professional References Must complete Drug Screen and Background Screen Submit your resume and experience the Prime difference or call for more details.
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WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Banfield Pet Hospital strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.
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May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
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This role entails leading more complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical through commercialization.
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Statistical SAS Programmer Intern Statistical SAS Programmer in Bridgewater, NJ Office Or Waltham, MA Office : Provide statistical programming, data analysis, and data mapping to support clinical trials and FDA submission for new drug development.
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Familiarity/experience with end-to-end CMC drug development. Knowledge and Understanding of Drug Development Processes. The Technical Project Manager will be a key member of the Cell Therapy Development (CTD) Development Operations & Services (DO&S) Portfolio Management Office.
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Locally great and nationally strong, Albertsons Companies (NYSE: ACI) is one of the largest food and drug retailers in the United States. The organization includes 2,273 retail and drug stores with 1720 pharmacies, 402 associated fuel centers, 22 distribution facilities, and 19 manufacturing plants with over 300,000 employees across 34 states and the District of Columbia.
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Herr Foods also has a Random Drug Testing program for all active employees. All Herr Foods Inc. job offers are contingent upon successfully passing a drug test. Herrs is proud to offer a variety of quality benefits and wellness programs where we have been recognized as a 5-time Well Workplace Award winner in the area.
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Expertise in areas of drug development, strategic planning, business planning, cross-functional collaboration/alignment, and in-depth knowledge of Medical Affairs. This role will be accountable for overall strategic support across all oncology disease areas with a focus on operational excellence, process optimization, innovative evolution, cross-functional collaboration and partnership, budget planning and resource management, overall team talent development, and support of medical affairs IT-related system deployment and implementation.
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1011 BRAND NEW Peterbilt tractor pulling Lan-doll trailers Home Every Night Local Routes NY, PA, NJ Flatbed or equipment moving experience a plus Dependable willing to work overtime with clean driving record Must be able to pass a drug test Valid Class A CDL license in good standing Hazmat endorsement plus Competitive Pay based on experience.
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Paid Time Off (PTO) Medical and Prescription Drug Insurance Dental and Vision Insurance Retirement Plans Short & Long Term Disability Life & Accidental Death Insurance Tuition Reimbursement Health Care/Dependent Care Flexible Spending Accounts Wellness Programs Voluntary Benefits (e.g., Pet Insurance) Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more.
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The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug.
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drug job in Bedminster, NJ
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