Search Results: 584 vacancies
...years of demonstrated experience developing GUI and conducting user research, preferably in the medical arena.
• Experience in software architecting and software implementation.
• Experience with Balsamiq and Adobe XD.
• Experience working with FDA guidelines....
Suggested
2 days per week
3 days per week
$145k - $223.2k
...oversight activities for analysis of clinical trial data, ensuring quality and timeliness; prepare deliverables for regulatory submission to FDA/EMA/PMDA or other agencies (e.g. eCRTs, ISS, ISE, BIMO, P21 checks) and provide support for regulatory questions; perform statistical...
Suggested
Full time
Remote job
$46.88 - $67.71 per hour
...revalidation.
Write protocols and reports, and interpret validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1).
Plan, and...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
For contractors
Local area
Shift work
$78.12 - $130.21 per hour
...understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, PMDA, NMPA, WHO).
Actively engaged in major industry associations (e.g. CPC, EFPIA, BIO, PhRMA, CASSS, PDA, ISPE, DIA) and...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
$67.71 - $83.33 per hour
...: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions). Up to 20% travel required. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
...fellows training at Tufts and Boston Childrens Hospital. Our academic program is nationally recognized with major awards funded by NIH and FDA for genome sequencing, real world data, and novel device development. Our Clinical and Translational Science Award program was just...
Suggested
Local area
...support life cycle management.
The Sr. Engineer will support regulatory medical device reporting requirements for agencies such as FDA and European Competent Authorities, including representing CPO-RE in corresponding audits. The Sr. Engineer will assist with the...
Suggested
Remote job
Worldwide
Flexible hours
...dispensing protocols, maintaining drug records and inventory control, formulating dosages, monitoring patients and ensuring compliance with FDA and DEA regulations.Prepares drug monographs and review of drugs requested for admission to formulary.Assists in reviewing the cost...
Suggested
Full time
Immediate start
Day shift
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...
Suggested
...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
...use and a valid driver's license.
~ Due to the requirements of this position, completion of all routine vaccinations including an FDA approved COVID-19 vaccination and annual flu shot, is mandatory prior to starting in this position, due to the constraints of the environments...
Suggested
Permanent employment
Contract work
Temporary work
...and multi-task to thrive in a small company
~ Experience in early-stage development programs
~ Demonstrated command working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
~ Self-starter who works with a sense of urgency...
Suggested
...Manufacturing, or equivalent role
Strong computer, verbal and written communication skills
Knowledgeable in CGMP, ICH, EMA and FDA rules, guidance and expectations
Experience in on the job training and authoring SOPs
Strong technical writing skills
What Do...
Suggested
...transfer activities suitable for progressive stages of small molecule pharmaceutical development that are in compliance with ICH and FDA guidance
Work closely with colleagues across Pharmaceutical Development and Research organizations to best leverage internal and...
Suggested
...and procedures when issues are identified.
Assist investigators and study teams in preparing and submitting IND applications to the FDA.
Preparation and submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety...
Suggested
Work experience placement
Local area
Immediate start
Remote job
Shift work
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...
...optimization, and capital expenditures while creating/maintaining site forecast and AOP. This individual should have a strong understanding of FDA and will be providing financial support for the Ward Hill Manufacturing site by becoming a true business partner to the operations...
Full time
...Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
**Preferred Qualifications:**
1. Basic knowledge of FDA, cooperative group, NCI and or OHRP regulatory guidelines
**Competencies:**
1. **Decision Making:** Ability to make decisions that...
Full time
Work experience placement
Immediate start
Shift work
...out to prove that effective medicine for serious illnesses can also be fun and engaging.
Our flagship product, , is the first ever FDA-cleared prescription treatment delivered through a video game to treat children living with ADHD. This is only the beginning, as we...
Contract work
For contractors
For subcontractor
...closed their Series C round
They seek an initiative-taking and talented Chief Operation Officer (COO) who has been through the full FDA approval process, including Testing, Design Control Documentation, Clinical trials, and understand Regulatory compliance....
Afternoon shift
