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Fda Labeling Jobs in New York (NOW HIRING)

LanceSoft Inc

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 ...

The Rockridge Group

FDA Attorney

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

The Rockridge Group

Be Seen First

Senior FDA Regulatory Attorney

New York, NY · Remote

$250K - $350K/yr

FDA registrations and annual filings ... Labeling, marketing, and advertising reviews * Product recalls and withdrawals * Import/export ...

Jobot

Senior FDA Attorney

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 ...

Sanofi EU

Pharmaceutical Graphic Designer

Morristown, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Paterson, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Pharmaceutical Graphic Designer

Elizabeth, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Pharmaceutical Graphic Designer

Jersey City, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Newark, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Morristown, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Jersey City, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Manhattan, NY · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Pharmaceutical Graphic Designer

Newark, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Pharmaceutical Graphic Designer

Paterson, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Senior Graphic Designer

Elizabeth, NJ · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

Sanofi EU

Pharmaceutical Graphic Designer

Manhattan, NY · On-site +1

$81K - $117K/yr

Candidates must demonstrate strong technical knowledge of FDA labeling regulations, GMP standards, and MAC-based production systems. Technical Skills: * Experience & knowledge of production ...

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Labeling Specialist

LanceSoft Inc

Jersey City, NJ • On-site

Full-time

Re-posted 26 days ago

Job description

Job Description

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.

Qualifications


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 

Additional Information

All your information will be kept confidential according to EEO guidelines.

LanceSoft logo

About LanceSoft

Sourced by ZipRecruiter

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.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

Social media

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