Labeling Specialist
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Jersey City, NJ · On-site
Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines. Candidate will be required to work ...
Review and develop product labels to ensure compliance with FDA, USDA, and customer-specific requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations ...
Review and develop product labels to ensure compliance with FDA, USDA, and customer-specific requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations ...
Pine Brook, NJ · On-site +1
Labeling and advertising reviews * FDA registration and annual filings * FDA inspections, 483 responses and warning letters * Drug withdrawals and recalls * FDA importation and exportation rules
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Pine Brook, NJ · On-site +1
Labeling and advertising reviews * FDA registration and annual filings * FDA inspections, 483 responses and warning letters * Drug withdrawals and recalls * FDA importation and exportation rules
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... The associate will also develop knowledge and skills to interpret FDA regulations and guidances to ...
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... The associate will also develop knowledge and skills to interpret FDA regulations and guidances to ...
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... The associate will also develop knowledge and skills to interpret FDA regulations and guidances to ...
Regulatory Labeling & Advertising/Promotion * Safety Sciences Associates will also have ... The associate will also develop knowledge and skills to interpret FDA regulations and guidances to ...
Pine Brook, NJ · On-site +1
$250K - $400K/yr
Labeling, Advertising and Promotion Review product labels, packaging, promotional materials, websites, social media, and advertising for FDA compliance. Advise on disease claims, structure-function ...
Pine Brook, NJ · On-site +1
$250K - $400K/yr
Labeling, Advertising and Promotion Review product labels, packaging, promotional materials, websites, social media, and advertising for FDA compliance. Advise on disease claims, structure-function ...
$100K - $120K/yr
Able to independently validate packaging and labeling against retailer and certifying body requirements (e.g., WERCSmart, NSF Certified for Content, Prop 65, FDA labeling), and partner with R&D, ...
$100K - $120K/yr
Able to independently validate packaging and labeling against retailer and certifying body requirements (e.g., WERCSmart, NSF Certified for Content, Prop 65, FDA labeling), and partner with R&D, ...
Manhattan, NY · On-site
$100K - $120K/yr
Able to independently validate packaging and labeling against retailer and certifying body requirements (e.g., WERCSmart, NSF Certified for Content, Prop 65, FDA labeling), and partner with R&D, ...
Manhattan, NY · On-site
$100K - $120K/yr
Able to independently validate packaging and labeling against retailer and certifying body requirements (e.g., WERCSmart, NSF Certified for Content, Prop 65, FDA labeling), and partner with R&D, ...
Review and develop food product labels for compliance with FDA, USDA, and customer requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations for candy ...
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Review and develop food product labels for compliance with FDA, USDA, and customer requirements * Create and verify ingredient statements, Nutrition Facts Panels, and allergen declarations for candy ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Paramus, NJ · On-site
$151K - $200K/yr
Lead all interactions with the US FDA Office of Prescription Drug Promotion (OPDP) and, where applicable, the Advertising and Promotional Labeling Branch (APLB), including pre-submission requests for ...
Monmouth Junction, NJ · On-site
Prepare DHF, risk management, clinical studies, labeling, and technical files. * Serve as primary contact with FDA. Quality Management System (QMS): * Lead remediation of U.S. QMS. * Ensure ...
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Monmouth Junction, NJ · On-site
Prepare DHF, risk management, clinical studies, labeling, and technical files. * Serve as primary contact with FDA. Quality Management System (QMS): * Lead remediation of U.S. QMS. * Ensure ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Raritan, NJ · On-site
$38/hr
Manufacturing Process Engineer - Labeling Duration: 2 Years Location: Raritan NJ Job Summary ... FDA, TUV, EPA and OSHA. Responsible for audit preparation and participation Occasionally, the ...
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Raritan, NJ · On-site
$38/hr
Manufacturing Process Engineer - Labeling Duration: 2 Years Location: Raritan NJ Job Summary ... FDA, TUV, EPA and OSHA. Responsible for audit preparation and participation Occasionally, the ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Summit, NJ · On-site
$159K - $210K/yr
Ensure that all labeling content and artwork comply with international and local Health Authority regulations (e.g., FDA, EMA, MHRA etc.) and Good Manufacturing Practices (GMP); This includes ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
Manhattan, NY · On-site
$225K/yr
Familiarity with FDA labeling, food compliance, and marketing law is a nice to have. * Experience supporting legal work for a growth-stage company (either at a top-tier firm or in-house). * Strong ...
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Jersey City, NJ • On-site
Full-time
Re-posted 20 days ago
Description:
Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA submissions, Annual Reports and PSURs in compliance with regulatory requirements and within company timelines.
Candidate will be required to work with limited oversight and have a basic understanding of FDA labeling regulations and FDA guidance to the level of applying them effectively to all work output.
Specific responsibilities include:
Assisting labeling managers with overall labeling process of brand prescription products
Proofreading of package insert as well as packaging components.
Preparing red-line documents and comparison charts
Understanding of working in a digital workflow system and using online proofreading tools
NDC number assignment
Completion of electronic drug listing and conversion of label to structured product labeling (SPL)
Maintenance and posting of correct labels to company websites and Dailymed
Maintain, catalog, and retain all labeling materials in accordance with company policies, procedures, and technologies
Additional labeling / organizational responsibilities as needed
Job-specific Competencies:
Excellent written communication and organizational skills
Works cooperatively with others; can also manage tasks and priorities independently as needed.
Takes responsibility for his/her own performance; promptly notifies his/her manager about any problems that affect his/her ability to accomplish planned goals
Demonstrates flexibility in managing changing priorities and demands
Knowledge of:
Food and Drug Administration (FDA) regulations and guidelines.
Current FDA/Regulatory Affairs submission requirements.
Logistics and work of the pharmaceutical industry.
Current Company policies, practices and procedures, including safety rules and regulations.
Education Required: BA/BS
Education Preferred: BA/BS with a Scientific or Regulatory background
Experience Preferred: 2+ years of pharmaceutical labeling experience; scientific background or familiarity with medical terminology.
Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint
All your information will be kept confidential according to EEO guidelines.
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Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Recruiting and staffing services
1,001 - 5,000 Employees
Herndon, VA, US
2000