...Notes: Firm is seeking an associate with 5-10 years of experience in FDA regulation. Preferred experience includes counseling companies with FDA-regulated products, reviewing contracts, and supporting corporate deals involving such regulated companies, including risk assessment...
Suggested
Worldwide
...glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor’s Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical,...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Traineeship
Local area
Remote job
Relocation
Shift work
Afternoon shift
...treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2...
Suggested
Contract work
Remote job
...devices, and food products. Regulatory experience with the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) is a significant advantage. This position is vital to our succession planning, as some of our senior attorneys are nearing...
Suggested
...Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment....
Suggested
Hourly pay
Permanent employment
Temporary work
Work experience placement
For subcontractor
Shift work
...Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment....
Suggested
Hourly pay
Permanent employment
Work experience placement
For subcontractor
Shift work
...with Medical Physics Department staff, monitor all Quality Assurance programs daily, prepare all documentation, and presents data for FDA/MQSA/NYCBRH inspections.
Perform all venipunctures and access VADs per nursing policy using accepted principles of infection...
Suggested
...Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment....
Suggested
Hourly pay
Permanent employment
For contractors
For subcontractor
...milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; 10 consecutive positive phase 3 trials; 6 FDA approvals; 10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic...
Suggested
Local area
Remote job
Free visa
Flexible hours
Shift work
...junior/mid-level account team members, focused on answering strategic and creative expectations.
The CS has a robust understanding of FDA regulations and pharmaceutical promotion requirements across all communication channels.
Additionally, the CS has an intimate...
Suggested
...globally, with studies conducted in more than 140 countries. More than 70% of novel drugs approved by the Food and Drug Administration (FDA) in 2022 were developed with Medidata software. Medidata is headquartered in New York City and has offices around the world to meet...
Suggested
Hourly pay
Full time
Work experience placement
Internship
Summer internship
Local area
Relocation bonus
...selected for employment cannot begin working until they provide verification that they are fully vaccinated against COVID-19 (with an FDA-authorized vaccine).
Schedule: 11:00AM-7:00PM, flexible weekdays, weekends as needed.
JOB SUMMARY:
The Clinics at ICL are a...
Suggested
Flexible hours
Weekend work
Weekday work
...of a custom-developed Clinical Safety Monitoring software solution.
pplying your deep understanding of regulatory requirements (FDA, EU, ICH, etc.) to the validation process, ensuring that the software meets all necessary guidelines.
Developing and executing comprehensive...
Suggested
...operations; oversee industry-sponsored site visits, audits and monitoring from various agencies (EPA, OSHA, and NYS Board of Health, IRB, FDA).
Qualifications
Required Education:Bachelor's Degree in Public Administration or related fieldRequired Experience:3+ years...
Suggested
Work experience placement
Remote job
...Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment....
Suggested
Permanent employment
For subcontractor
...QC) tests of gene therapy products in compliance with the quality system established in the Belfer Gene Therapy Core Facility and the FDA and/or EU Good Manufacturing Practice Standards for early drug development phase.
Job Responsibilities
Manufactures AAV and...
Monday to Friday
...glove wear
PREFERRED QUALIFICATIONS:
Associates or Bachelor’s Degree
Experience working with SOPs, GDP, GMP, CLIA, and the FDA
Experience working in a highly regulated or high-volume retail environment
Excellent interpersonal, organizational, technical,...
Minimum wage
Holiday work
Full time
Temporary work
Traineeship
Local area
Remote job
Relocation
Shift work
Afternoon shift
...Safety Requirement Mandate, Breaking Ground strongly recommends all employees, interns, volunteers, and subcontractors to receive an FDA authorized and/or approved COVID-19 vaccination and provide a one-time verification of immunization as a condition of employment....
Hourly pay
Permanent employment
For subcontractor
...agreements.
Provide medication management according to standard practice; monitor adherence and response to medications.
Prescribe FDA-approved buprenorphine products approved for the treatment of opioid dependence.
Administer psychotropic injections.
Order...
Holiday work
Temporary work
Monday to Friday
...single-minded result - creating behavior. FCB NY works across a portfolio of iconic brands, including Anheuser-Busch InBev, Burger King, FDA's The Real Cost, GSK, LG, Morningstar Farms, New York Mets, Unibet and Verizon.
FCB is looking for a Finance Manager to...
Local area
Work from home
Flexible hours
Monday to Friday
...manipulation, pushing and pulling.
Work requires the following motions: bending, twisting, squatting and reaching.
Exposure to FDA approved cleaning chemicals.
Exposure to temperatures: 90 degrees Fahrenheit.
Ability to work in a wet and cold environment....
Hourly pay
Holiday work
Full time
Traineeship
Immediate start
Flexible hours
Shift work
Night shift
All shifts
...responses to study questions or issues from Health Authorities
* Oversee inspection readiness activities, ensure adherence to ICH/GCP/FDA regulations and Lexeo policies and SOPs
* Oversee implementation and documenting of quality events in QMS and finalization of any...
...selected for employment cannot begin working until they provide verification that they are fully vaccinated against COVID-19 (with an FDA-authorized vaccine).
JOB SUMMARY:
The Unit Counselor performs a wide variety of tasks related to the care, nurturing, treatment...
Hourly pay
Immediate start
...knowledge in Microsoft Office, particularly PowerPoint
Agency experience in a client-facing role preferred
Understanding of the FDA regulations guiding social media efforts for biotech and pharma clients preferred
Pay Range: $65,000-$80,000
This is the pay...
Work experience placement
Local area
Remote job
Flexible hours
2 days per week
...for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical...
Permanent employment
Temporary work
Freelance
Local area
Visa sponsorship
Flexible hours
3 days per week
...milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; 10 consecutive positive phase 3 trials; 6 FDA approvals; 10$B in global pharma partnerships and proceeds; expanding pipeline of assets across various modalities and therapeutic...
Local area
Flexible hours
...selected for employment cannot begin working until they provide verification that they are fully vaccinated against COVID-19 (with an FDA-authorized vaccine).
JOB SUMMARY:
The program Case Manager will have the prime responsibility for organizing comprehensive...
Local area
Immediate start
...Knowledge of principles of ethical conduct of research with human subjects.
+ Knowledge of applicable federal regulations (OHRP, NIH, FDA, USDA, and other government agencies) related to human subjects research and compliance.
+ Advanced skills in MS Word and...
Full time
Temporary work
Part time
...biostatistics regulatory requirements and guidelines. Significant prior experience interacting with health authority agencies such as FDA and EMA. Prior experience contributing to an NDA/BLA is required.
Associate Director: Solid understanding of biostatistics...
...treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying...
Permanent employment
Temporary work
Local area
Visa sponsorship
Flexible hours
3 days per week