- Ascendis Pharma (Palo Alto, CA)
- …of 8 years recent experience in Pharmacovigilance + Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; ... working knowledge of global safety regulations. + Ability to travel up to 20% of the time domestically and internationally The estimated salary range for this position is $185-205K/year. Actual salary determination is dependent on a variety of factors some of… more
- Abbott (Alameda, CA)
- …best practices for clinical trials familiarity with regulatory frameworks (eg, FDA , EMA, ICH-GCP). + Knowledge of global clinical research operations. **Preferred ... Qualifications:** + Certification in risk management (eg, RMP, or clinical research certifications). + Risk based or quality management experience + Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to… more
- Moonlight Companies (Reedley, CA)
- …years of food safety experience, knowledge and experience with HACCP, USDA, or FDA preferred. + Previous experience with SQF, GFSI, Primus, BRC, GMP's, GAP'S and/or ... USDA audits desirable + Bilingual a plus (Spanish/English) + Must be flexible with work hours and days + Proficiency with basic computer skills, including e-mail, Microsoft Office, Famous Software + Experience with Facility Sanitation Benefits + Medical +… more
- Abbott (Pleasanton, CA)
- …property. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Serves as lead systems engineer on 1 or more projects. + Mentors and develops junior engineers. +… more
- Cordis (Irvine, CA)
- …all scientific/marketing materials adhere to relevant regulations and standards (eg, FDA , CA, PMDA,Sunshine Act) + Responsible for identifying clinical insights and ... knowledge gaps and be able to articulate the impact and magnitude of the findings. + Develops and maintains strong scientific knowledge of the current competitive landscape and competitive messaging. + Be a strategic partner to the overarching data… more
- Abbott (Sylmar, CA)
- …QA, and regulatory teams to ensure our systems are fast, reliable, and compliant with FDA and ISO standards. **What You'll Work On** As a DevOps Engineer 2 working ... under general supervision, you will apply engineering principles and practices to a variety of development and deployment activities, including but not limited to: Core Responsibilities + Build and maintain CI/CD pipelines that support traceability, automated… more
- US Tech Solutions (South San Francisco, CA)
- …experience as a Clinical Research Coordinator. + Working knowledge of GCP and FDA Regulations. + Proficiency in MS Word, Excel PowerPoint, or Suite. + Experience ... utilizing Electronic Data Capture (EDC) systems for clinical studies. **Desired:** + Desired Experience with digital medical device research studies. + Experience maintaining an Electronic Trial Master File (eTMF). **Education:** + BS/BA degree in life… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with process validation principles and CPV. ... + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work effectively in a fast-paced, virtual environment. **Travel… more
- University of Southern California (San Diego, CA)
- …procedures, with some familiarity with ICH-GCP guidelines and working knowledge of FDA guidance documents. Skilled at technical documentation and writing, and at ... assembling, organizing and conceptualizing numerical data in spreadsheets, databases, reports and presentations. Lead/guidance skills, with the ability to manage and prioritize different tasks and projects. Deft interpersonal skills for communicating with all… more
- Ascendis Pharma (Palo Alto, CA)
- …including a thorough understanding of PV processes + Expert knowledge of FDA , EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; ... working knowledge of global safety regulations. + Ability to travel up to 20% of the time domestically and internationally Benefits + 401(k) plan with company match + Medical, dental, and vision plans + Company-offered Life and Accidental Death & Dismemberment… more