Jobs In California City, California

Regulatory Affairs Manager

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Regulatory Affairs Manager at a prestigious Fortune 500® company working in Foster City. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Regulatory Affairs Manager Pay: $73 per hour depending on experience Responsibilities • Responsible for preparing and submitting moderately complex regulatory documents which require extensive interactions with departments outside of Regulatory Affairs for maintenance of products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include safety reports, protocol and information amendments, new investigator amendments, responses to health authority requests for information, labeling supplements and NDA annual reports • Contributes to the development and Regulatory review of documents required for maintenance of products in assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include aggregate safety reports (e.g. PSUR, DSUR, etc), clinical protocols, clinical study reports, investigator brochures, Module 2 documents, US labeling documents and other product-related documents • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements • May serve as primary contact with local Regulatory Authority responsible for ensuring IND and NDA applications are updated and maintained in accordance with FDA requirements • May serve as Regulatory representative on Regulatory Project Team, Regulatory Submission Teams, study management teams, clinical teams and other subteams • Participates in group meetings and local and global product submission team meetings and presents project status updates and strategy approaches to moderately complex programs/projects • May provide regulatory expertise to submission teams on specified projects and topics • Initiates or contributes to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments Knowledge and Skills • Knowledge and understanding of US regulations and guidelines. • Previous experience in the preparation and submission of clinical/non-clinical regulatory documents in support of US IND and NDA • Experience with marketed products is a plus • Excellent organizational, computer and documentation skills and an ability to prioritize effectively with tight timelines • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment • Ability to work in a cross-functional team environment and project teams • Strong attention to detail and the ability to handle multiple tasks • Demonstrates capability to act as primary Company contact with Regulatory Authorities • Work is performed under minimal direction of a senior Regulatory Affairs professional Education and Experience • 5+ years of experience in Regulatory Affairs or other relevant industry experience • Degree in a scientific field is preferred A. Will consider remote candidate B. One year contract C. There will be an initial phone screen, then a face to face or Skype 1. Candidate MUST have ability to work as Global and Regional Regulatory Leak 2. US Regulatory knowledge – major market request to be processed EXPERIENCE 1. Small molecules and biologic ACTUAL experience 2. Medical device experience will be considered if they have at some point had small molecules and biologic experience 3. 4 YEAR BACHELOR SCIENTIFIC DEGREE We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Associate Director

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an Associate Director at a prestigious Fortune 500® company working in Foster City. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Associate Director Pay: $133 per hour Specific Responsibilities and Skills for Position – Demonstrated ability to manage Phase 1 clinical trials within designated program budgets and timelines is required – Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required – Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers – Contributes to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents – May contribute to project team governance documents – Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams – Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of complex problems – Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines – Excellent verbal, written, interpersonal skills and ability to lead multifunctional teams manage staff and mentor junior staff is required – Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required Knowledge: – Excellent verbal, written, interpersonal skills, and ability to lead multifunctional teams, ability to manage staff and mentor junior staff is required – Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials is required – Thorough knowledge and understanding of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCPs governing the conduct of clinical trials and noninterventional studies – Proven ability for successful study implementation and completion – Ability to motivate teams and drive performance Experience and Skills: – At least 8+ years of experience and a BS or BA in a relevant scientific discipline – At least 8+ years of relevant experience and a MS degree – At least 8+ years of experience and an RN (2 or 3 year certificate) We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Clinical Project Manager – Data Management

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Clinical Project Manager at a prestigious Fortune 500® company working in Redwood City, CA. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Clinical Project Manager – Data Management Pay: $97 per hour Description This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities •Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team •For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level •Interacts with and influences cross-functional team members to achieve program objectives •Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions •Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits •Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance •Responsible for coaching and mentoring team members •Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives •Conducts study execution “lessons learned” across functions •May include indirect supervision of employee as well as supervision of work of contract resources Qualifications •Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired. •Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience). •In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred •Demonstrated performance as a functional leader •Demonstrated ability to influence others without direct authority •Demonstrated ability to successfully coach / mentor in a matrix environment •Demonstrated effective communication skills •Demonstrated effective analytical skills Monday to Friday WFH-One day a week Desired experience EDC Data Management Clinical Project Management We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Data Engineer – Media Analytics Platform

Data Engineer – Media Analytics Platform If you are a Backend or Data Engineer looking to join an innovative media analytics company & optimize data flow & infrastructure, READ ON! Founded by top talent in entertainment and data science, we are a media analytics company building a robust & disruptive product. We’ve raised a significant Series A round and are growing our team. We are looking for a motivated & well rounded engineer to scale our data systems, improve data processing, and optimize the data pipelines & infrastructure to enable massive amounts of data to be analyzed within our web application. If you’re looking to work with massive amounts of unique data and change the way major companies & entire industries approach advertising, APPLY NOW! Top Reasons to Work with Us – Series A Funded & offering early-stage equity – Competitive salary, strong benefits, flexibility in scheduling & work remote – Work with big-name clients across numerous industries What You Will Be Doing – Optimizing data pipelines & data processing jobs – Scaling and improving our data collection – Powering our analytics/reporting web application – Writing robust & scalable software (stack is Ruby on Rails, React, MySQL, AWS) What You Need for this Position A Bachelor’s Degree is preferred but not required. We’re looking for candidates with 2 to 5 years of professional experience and understanding of – Data Architecture – Data Pipelines – Data Processing – MySql or Postgres – ETL – AWS – Kafka – Ruby On Rails – Airflow – Resque or Redis So, if you are a Backend or Data Engineer looking for an opportunity for growth while owning data infrastructure optimization, APPLY NOW! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.

Front End (React) Engineer – Entertainment Analytics

Front End (React) Engineer – Entertainment Analytics If you are a Front End Engineer with experience working in React.JS, read on! Founded by top talent in entertainment and data science, we are a media analytics company building a robust & disruptive product. We’ve raised a significant Series A round and are growing our team. We are looking for well-rounded & savvy Front End Engineers to work on the new iteration of our successful analytics web application. You’ll be developing a robust analytics tool, dashboard & self-service reporting application to be used by big-named companies across various industries. Your work will impact the way major companies & entire industries approach advertising. If you’re a Front End Engineer experienced with React and looking to grow within a collaborative, no-ego and growth-oriented team, APPLY NOW! Top Reasons to Work with Us – Series A Funded & offering early-stage equity – Competitive salary, strong benefits, flexibility in scheduling & work remote – Work with big-name clients across numerous industries What You Will Be Doing – Web Application Development in React – Application design & architecture – Data visualization feature development – Working with Product, Design, and Backend engineers on platform expansion and API integration What You Need for this Position A Bachelor’s is nice to have but not necessary. We’re looking for mid-level (2-4 years of experience) AND Senior-level (5+ years) engineers with knowledge of: – React.JS – TypeScript – MySQL or Postgres – Ruby On Rails or other backend frameworks (Python, Node) – Front End Engineering – Data Visualization – Web Application Development – Design, Architecture, API integration – Agile environments – The full software development lifecycle So, if you are a Front End Engineer experienced with React and looking to impact advertising, APPLY NOW! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. CyberCoders will consider for Employment in the City of Los Angeles qualified Applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance Initiative for Hiring (Ban the Box) Ordinance.

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