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Affinity Executive Search
Palo Alto, CA, United States
Job description: This is an exciting opportunity to work in our Client's Life Sciences patent group. Opportunities are available in our Boston, New York, Palo Alto, San Diego, San Francisco, Washington D.C., and Los Angeles offices. You will draft and prosecute patent applications, prepare patent opinion letters, provide IP counseling to clients
Job Source: Affinity Executive SearchCACI International
Sunnyvale
Credentialed Background Investigator Job Category: Service Contract Act Time Type: Full time Minimum Clearance Required to Start: Top Secret Employee Type: Regular Percentage of Travel Required: Up to 25% Type of Travel: Local Anticipated Posting End: There is not an anticipated end date for this posting since applications are needed on an ongoing
Job Source: CACI InternationalCACI International
Alameda
Credentialed Background Investigator Job Category: Service Contract Act Time Type: Full time Minimum Clearance Required to Start: Top Secret Employee Type: Regular Percentage of Travel Required: Up to 25% Type of Travel: Local Anticipated Posting End: There is not an anticipated end date for this posting since applications are needed on an ongoing
Job Source: CACI InternationalBCG Attorney Search
Palo Alto, CA, United States
A law firm in Palo Alto is seeking an experienced FDA Regulation Associate Attorney to join their team. The ideal candidate will have 5-10 years of broad experience counseling companies with FDA-regulated products, reviewing contracts, and supporting corporate deals involving regulated companies. Duties: Provide legal counsel and guidance to client
Job Source: BCG Attorney SearchAffinity Executive Search
Palo Alto, CA, United States
Job description: Our Client's FDA regulatory group works with broad range of companies, including medical devices, drugs, biologics, diagnostics, digital health, research tools, cosmetics, dietary supplements, wellness products, and other consumer products. Given the firms nexus to companies with next-generation products and innovative biotechnol
Job Source: Affinity Executive SearchBCG Attorney Search
Palo Alto, CA, United States
Senior FDA Drug/Biologics Regulation Counsel Company name BCG Attorney Search Experience 9-15 yrs required Posted on Mar 27, 2024 Valid Through Apr 26, 2024 Profile A law firm based in Palo Alto is seeking a highly experienced Senior FDA Drug/Biologics Regulation Counsel to provide comprehensive legal support in FDA regulatory matters pertaining t
Job Source: BCG Attorney SearchSRI International
Menlo Park, CA, United States
Quality Assurance Unit Manager I (FDA, GMP, GLP) Job Locations US-CA-Menlo Park ID 2024-5910 Category Biosciences Position Type Full-Time Worker Type Hybrid Overview SRI's Biosciences Division develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the bre
Job Source: SRI InternationalSRI International
Menlo Park, CA, United States
Overview: SRI's Biosciences Division develops transformative approaches and platforms for challenging therapeutic problems. We conduct basic and translational research, have the breadth - and depth - to deliver the latest in biomedical research through technology development. Our researchers have a rich legacy of collaboration with government agenc
Job Source: SRI InternationalHayward
Our client, a leading Biotechnology company is seeking an FDA Investigator to support audit/inspection readiness programs and drive
**Job Title: Ex FDA Investigator**
**Pay Range: $95-$125/hr**
**What’s the Job?**
+ Preparing for, conducting, and reporting on mock FDA inspections and compliance evaluations in support of ANDA, NDAs, and BLA submissions
+ Evaluation of inspection readiness programs including providing recommendations for improvement
+ Drafting or reviewing responses to FDA 483 observations, warning letters or similar documents as needed
+ Participate in complex root cause investigations including manufacturing deviations and OOS investigations
+ Conduct gap assessment of quality management systems and provide prioritized remediation recommendations
**What’s Needed?**
+ B.S. life sciences and 10 years’ relevant experience
+ MUST BE a Former FDA Employee and experience as an investigator
+ Demonstrated regulatory compliance expertise in one or more dosage forms as well as both drug products and active pharmaceutical ingredients
+ Expert knowledge of current FDA, ICH, and USP laws, regulations, guidances and expectations.
+ Expertise in reviewing regulatory filings and the drug, biologic or device review and approval process (DMFs, ANDAs, NDAs, BLAs, PMAs, etc.)
+ Experience with planning and conducting FDA inspections/mock audits to include GMP/GLP audits
+ Experience with data integrity and electronic data reviews
If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
**About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells**
_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
Email Alert for Ex FDA Investigator_ jobs in Hayward
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