Morristown, NJ · On-site +1
$156K - $171K/yr
... FDA-approval of new drugs and biologics for serious or life-threatening illnesses. Remote work option 100% of the time. ----- LOCATION: 10 North Park Place, Suite 201, Morristown, NJ 07960SALARY ...
Morristown, NJ · On-site +1
$156K - $171K/yr
... FDA-approval of new drugs and biologics for serious or life-threatening illnesses. Remote work option 100% of the time. ----- LOCATION: 10 North Park Place, Suite 201, Morristown, NJ 07960SALARY ...
Morristown, NJ · On-site +1
$156K - $171K/yr
... FDA-approval of new drugs and biologics for serious or life-threatening illnesses. Remote work option 100% of the time. LOCATION: 10 North Park Place, Suite 201, Morristown, NJ 07960 SALARY: $156,894 ...
Morristown, NJ · On-site +1
$156K - $171K/yr
... FDA-approval of new drugs and biologics for serious or life-threatening illnesses. Remote work option 100% of the time. LOCATION: 10 North Park Place, Suite 201, Morristown, NJ 07960 SALARY: $156,894 ...
Monitor and interpret evolving regulatory guidance from FDA, EMA, and other global agencies on ... remote monitoring platforms, or related technologies, with strong scientific writing skills and ...
Monitor and interpret evolving regulatory guidance from FDA, EMA, and other global agencies on ... remote monitoring platforms, or related technologies, with strong scientific writing skills and ...
New York, NY · On-site +1
$62K - $108K/yr
Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote Based ... Job Responsibilities Maintains strong familiarity with FDA, EU, and other relevant guidelines and ...
New York, NY · On-site +1
$62K - $108K/yr
Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote Based ... Job Responsibilities Maintains strong familiarity with FDA, EU, and other relevant guidelines and ...
Jersey City, NJ · On-site +1
$145K - $197K/yr
Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP ... Remote on the East Coast, USA or Hybrid in our New Jersey office. Reports to : VP, Associate ...
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Jersey City, NJ · On-site +1
$145K - $197K/yr
Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP ... Remote on the East Coast, USA or Hybrid in our New Jersey office. Reports to : VP, Associate ...
Nutley, NJ · On-site +1
$152K - $201K/yr
Demonstrated track record of interfacing effectively with FDA with some experience with health ... We will consider remote candidates who are unable to regularly work in our Nutley, NJ office * Must ...
Nutley, NJ · On-site +1
$152K - $201K/yr
Demonstrated track record of interfacing effectively with FDA with some experience with health ... We will consider remote candidates who are unable to regularly work in our Nutley, NJ office * Must ...
New York, NY · On-site +1
$152K - $207K/yr
Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP ... Remote on the East Coast, USA or Hybrid in our New Jersey office. Reports to : VP, Associate ...
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New York, NY · On-site +1
$152K - $207K/yr
Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP ... Remote on the East Coast, USA or Hybrid in our New Jersey office. Reports to : VP, Associate ...
... FDA, EMA, etc.) * Willingness to travel as needed * Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience and ...
... FDA, EMA, etc.) * Willingness to travel as needed * Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience and ...
New York, NY · Remote
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
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New York, NY · Remote
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
Morristown, NJ · Remote
$80K - $87K/yr
Field Clinical Specialist - (Morristown) Remote/Field role InspireMD is a dynamic growing company ... Support FDA inspections and audits, ensuring that all regulatory and complaint handling ...
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Morristown, NJ · Remote
$80K - $87K/yr
Field Clinical Specialist - (Morristown) Remote/Field role InspireMD is a dynamic growing company ... Support FDA inspections and audits, ensuring that all regulatory and complaint handling ...
Piscataway, NJ · Remote
$153K - $202K/yr
Remote (Anywhere in the U.S.) We're looking for an experienced Director - CMC Regulatory Affairs to ... Strong knowledge of FDA and global regulatory requirements for biologics/gene therapy products.
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Piscataway, NJ · Remote
$153K - $202K/yr
Remote (Anywhere in the U.S.) We're looking for an experienced Director - CMC Regulatory Affairs to ... Strong knowledge of FDA and global regulatory requirements for biologics/gene therapy products.
Manhattan, NY · Remote
$150K - $170K/yr
This is a Remote position based in New York/ Northeast USA Key Responsibilities: * Develop and ... Ensure all marketing materials comply with FDA and FTC regulations related to dietary supplements
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Manhattan, NY · Remote
$150K - $170K/yr
This is a Remote position based in New York/ Northeast USA Key Responsibilities: * Develop and ... Ensure all marketing materials comply with FDA and FTC regulations related to dietary supplements
New York, NY · On-site +1
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
New York, NY · On-site +1
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
New Providence, NJ · On-site +1
$75/hr
This exempt role can be remote or based out of a Prism Vision Group location. Compensation Range ... Knowledge of clinical research processes, GCP guidelines, FDA regulations, and medical terminology.
New
New Providence, NJ · On-site +1
$75/hr
This exempt role can be remote or based out of a Prism Vision Group location. Compensation Range ... Knowledge of clinical research processes, GCP guidelines, FDA regulations, and medical terminology.
New
New York, NY · On-site +1
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
New York, NY · On-site +1
$3.0K/mo
Working knowledge of FDA/DSHEA structure-function claim rules, with ability to flag disease-claim risk in coverage before it runs * Remote work opportunity, but LA or NYC based (or strong LA/NYC ...
New York, NY · On-site +1
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
New York, NY · On-site +1
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
New York, NY · Remote
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
New
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New York, NY · Remote
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
New
New York, NY · On-site +1
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
New York, NY · On-site +1
$70 - $80/hr
This role is open to remote candidates in the United States or Canada, with a preference for ... accuracy within FDA guidelines, internal style guidelines and brand standards * Copy edit ...
Jersey City, NJ · Remote
$60 - $65/hr
Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...
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Jersey City, NJ · Remote
$60 - $65/hr
Jersey City, NJ 07302 (Remote) Schedule: 24 hours/week (Choose: 9:00AM - 5:00PM) Compensation: $60 ... FDA regulations and industry standards. This is a part-time consulting position ideal for a ...
Paterson, NJ · Remote
$50 - $80/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...
Paterson, NJ · Remote
$50 - $80/hr
Remote micro1 is engaging Regulatory Affairs Specialists to contribute to a customer's project ... FDA, EMA, MHRA, PMDA, or Health Canada). * Proven ability to critically read clinical or safety ...
A Remote FDA job typically involves working for or with the U.S. Food and Drug Administration (FDA) from a remote location. These roles can include regulatory affairs, compliance, medical writing, research, and reviewing submissions for drug and medical device approvals. Remote FDA jobs require knowledge of FDA regulations, strong analytical skills, and experience in healthcare, pharmaceuticals, or related fields. They offer flexibility while maintaining high regulatory standards and ensuring public health and safety.
A Remote FDA Compliance Specialist generally reviews and updates regulatory documents, conducts virtual audits, and monitors company practices for FDA compliance. They regularly collaborate with cross-functional teams, such as quality assurance, legal, and product development, to provide guidance on regulatory requirements and respond to compliance queries. Additionally, they prepare and submit necessary reports, maintain records for inspections, and stay current on evolving regulations. This remote structure allows flexibility but also demands excellent organization, communication, and self-discipline to ensure all deadlines and compliance standards are met.
To excel as a Remote FDA Compliance Specialist, you need in-depth knowledge of FDA regulations, quality assurance procedures, and a background in life sciences or a related field. Proficiency in using compliance management systems, electronic document management tools, and relevant certifications such as RAC (Regulatory Affairs Certification) are often required. Exceptional attention to detail, self-motivation, and strong written and verbal communication skills are vital for remote collaboration and thorough documentation. These abilities ensure regulatory adherence, minimize compliance risks, and facilitate effective remote teamwork within the pharmaceutical or medical device industry.
The most popular types of Fda jobs in Edison, NJ are:
For Remote Fda jobs in Edison, NJ, the most frequently searched job titles are:
The top searched job categories for Remote Fda jobs in Edison, NJ are:
Cities near Edison, NJ with the most Remote Fda job openings:
$156K - $171K/yr
Full-time
Re-posted 4 days ago
Lead healthcare market access client and agency product teams. Contact and meet with client to maintain/grow current relationships. Propose ideas and new business projects to clients. Work with internal teams to develop contracts, project estimates, budget proposals, and strategic initiatives for submission to client. Contribute to the development of product strategy and implementation of communication plans. Lead projects from planning to completion. Delegate projects to junior account team members and provides oversight throughout critical phases of each project. Consult with account leadership and other team members to optimize account success. Develop and maintain strong relationships with client-related stakeholders (Marketing, Sales, Legal, Medical and Compliance). Oversee and direct projects through external vendors and internal departments as necessary, i.e., IT, Editorial, Graphics, and Art. Ensure that progressive stages of projects are executed to meet deadlines, budget, and client expectations. Manage junior account team members for enhanced professional development. Acquire thorough knowledge of client's business (disease state, product, competitors) to proactively manage anticipated opportunities and challenges. Monitor the marketplace continuously; providing updates to the client and internal team. Maintain continuous learning to ensure thorough understanding of the healthcare landscape. Participate in new business development and support including research, presentation development, potential client engagement and meeting participation. Plan, organize, and participate in client pitch presentations.
QualificationsBachelor's degree (or foreign equivalent) in Marketing, Communications, Health Economics, Advertising, or related industry field. 3 years of experience conducting healthcare payer coverage data analysis using the Managed Markets Insight & Technology (MMIT) platform. 3 years of experience specializing in healthcare market access advising on strategic objectives with respect to disease and treatment landscapes specific to product, payer channels, and government policy and regulation. 3 years of experience launching healthcare market access products into the payer space by supporting a launch brand leveraging comprehensive knowledge of FDA guidelines (2253 regulations requiring submission of all promotional materials when advertising a prescription drug or biologic) for material approvals, including experience with launch timeline management, and execution processes and team mobilization. 2 years of experience with pharmaceutical regulatory review and compliance guidelines, including the process by which branded resources are approved for use with healthcare providers, market access customers, and patients. 2 years of experience across Subpart H and Subpart E launches, including regulatory pathway for accelerated FDA-approval of new drugs and biologics for serious or life-threatening illnesses. Remote work option 100% of the time.
-----------------------------------------------------------------------------LOCATION: 10 North Park Place, Suite 201, Morristown, NJ 07960SALARY: $156,894 to $171,000/year
HOURS: 40 hours/week
#LI-DNI
Employment Type: OTHER
Sourced by ZipRecruiter
Scientific research and development services
1,001 - 5,000 Employees
New York, NY, US
2022
