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- Campbell, CA

The candidate will act much like an office manager ensuring the day to day administrative operations runs smoothly. Responsibilities Administrative Support Manage calendars and schedules Arrange Travel and itineraries Use the Microsoft Office Suite tools for communications; reports, spreadsheets Arrangements in charge for all programs, events, conferences etc. Requirements Minimum five (5) years of progressively responsible administrative support experience, preferably in pharmaceutical....


The position is responsible for planning and preparing complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provides support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulation leads anticipates in goal regulatory teams, interprets regulations, and provides regulatory guidance. Support management with regulatory programs planning and implementations of departmental strategies and policies.


Our client seeks a Clinical Research Operations professional to plan their Phase I Clinical Trials Requirements Bachelor’s Degree in life sciences or healthcare field. Additional coursework in clinical trial design.Ability to travel as required (up to 25%).12+ years of proven experience in clinical research and/or clinical trial operations, including a minimum of 7 years in a supervisory role managing (internal/external) clinical operations staff.Industry experience within pharmaceutical....


The Clinical Research Associate is responsible for coordinating and managing clinical research studies as direct by the study Principal Investigator and Researcher Nurse. Participates in data collection related to clinical trials, enters research data into case report forms and/or electronic database systems. Maintain records and documents accordance with FDA guidelines. Act as liaison between research study sponsor and department staff, ensuring that reporting deadlines are met. Maintain....


The Systems, Analytics and Reporting Associate oversees and ensures the successful execution of tasks related to the reporting and visualization of metrics and analytics for clinical, functional, and business operations areas. The Associate is also responsible for metrics, reporting, collection of requirements, leading of meetings, and generation of dashboards or reports. Requirements BS/BA degree in Computer Science, Life Science or Engineering (2-3 years experience) Spotfire experience....


This position entails development of submissions in conjunction with other BDI Surgery departments, requiring working knowledge of products under review and of relevant regulations and guidance documents. Also, this position is responsible for writing, supporting, and assisting in gaining approval of product registrations and other submissions to International Business Centers. Qualifications: Bachelors's degree required (healthcare industry) 5-7 years of international regulatory experience....


Looking for candidates with regulatory affairs experience supporting R&D IVD, leading RA projects for new product developments Regulatory Affairs Specialist is responsible and accountable for developing and executing sound strategies for regulatory submissions and registrations for complex new product development projects. This position interfaces with multiple projects and functional teams with limited oversight, provides instruction, guidance, and regulatory interpretations to functional

- Pasadena, CA

Clinical Data Coordinator A newer Biotech company with a growing, innovative, science driven team. As process owner, the Clinical Data Coordinator, manages in-house data management activities (including vendor management) to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. In addition, the position is responsible for building programs to create datasets, listings, tables and figures from clinical databases, external data sources, and other....


The associate works cross-functionally to project manage the review process for advertising and promotional materials for approved drug products. The associate is responsible for ensuring the efficiency of the Promotional Review Committee (PRC) process, involving Legal, Regulatory and Medical teams, and for conformance with company policies and procedures. Key Duties: Ensure that all SOP requirements are met Manage all aspects of the review process for multiple brands Lead and manage....


Plan and prepare complex medical device regulatory submission documents for US, Canada, and EU regulatory filings. Provide support for other global regulatory filings. Utilizing detailed, in-depth understanding of medical device regulations, leads and participates in global regulatory teams, interprets regulations, and provides regulatory guidance. Supports management with regulatory programs planning and implementation of departmental strategies and policies.

- Northern, CA

Responsibilities Manage, develop, and train the GCP Compliance personnel. Ensure the integrity and quality of clinical data by overseeing all routine and directed; internal and external; domestic and international GCP audits and quality reviews. Promote continuous improvements in quality systems and department infrastructure. Act as a subject matter expert and provide GCP guidance to internal departments for all phases of clinical development. Report significant and/or serious ongoing quality....


Education/RequirementsAssociate degree or higher preferred 1-2 year relevant experience in pharmaceutical industry or CRO Experience supporting clinical trials preferred Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus Experience using electronic data capture (EDC) systems is a plus Financial management experience is a plus.Responsibilities: Support study feasibility activities and perform database/web searches for sites as neededWork closely with the Site....


Education/ExperienceBS in life sciences or related field At least 2 years experience in clinical researchKnowledge of FDA regulations Prior Study Start-Up experience preferredAdvanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook Experience with Adobe Acrobat Professional and Microsoft Access a plusPresentation Delivery ResponsibilitiesExecute study start-up for assigned protocols within company timelines by identifying clinical team needs, Oversee Site....


CMC and Bioanalytical Document Control Contract (Short Term) La Jolla, CA Responsibilities:Assess CMC and bioanalytical documents generated to date and implement archival and retrieval structure for electronic and/or paper documentsEnsure that all CMC and bioanalytical documentation required by regulatory authorities for Phase 2 initiation is availableCompile and organize executed Batch Records from CMOs into binders and in electronic format to ensure document completeness and securityOrganize

- Irvine, CA

Client is seeking a Head of Quality to ensure best practices are implemented and followed at this high-volume contract manufacturer. RequirementsDirector-level or higher position in Quality a high-volume manufacturingExperience managing large teams and indirect reportsManufacturing experience should include FDA-regulated products such as pharmaceuticals, over the counter drugs, or dietary supplements.Certification in QualityBachelor DegreeDutiesCreate and manage systems for high-volume....

- San Diego, CA

Our client seeks someone to manage all clinical QA efforts, including the continuous improvement of compliant GCP Quality Systems to ensure that the company and outsourced third parties are inspection ready at all times. QualificationsBachelor’s Degree in Chemistry, Biology, or Life sciences/related10 years’ experience with Clinical Quality Systems in the drug, biopharmaceutical or medical device fields.2+ years prior auditing experience required.Experience in implementation and....


EDUCATION/EXPERIENCE: - 1+ years of relevant experience in pharmaceutical industry - Science degree in medical or health-related field - Clinical Trial Support/Clinical Study experience - Work effectively in a team/matrix environment - Handle conflict management and resolution RESPONSIBILITIES: - Ensuring that clinical studies are run on time and budget - Ensure compliance with regulatory guidelines - Management of clinical trial documentaiton - Tracking of various clinical trail resources


JOB SUMMARY: Reporting to the Director, Quality, this position will plan and ensure the implementation of the ISO 14971, IEC 62366 and 21 CFR 820 standards to ensure safe products exceed customer and market requirements. This individual will need to work closely with manufacturing sites, support audits, work with new product development, as well as on-market teams in regard to change management and product life-cycle management. The Senior Manager, Risk Management will ensure product....


The Study Management Associate (also known as Clinical Trial Management Associate) assists the Sr. Clinical Trial Management Associate, Clinical Trial Manager (CTM) or Operations Study Lead (OSL) in the operational execution of assigned clinical studies. In this role the associate will perform tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and....

- Seattle, WA

Position is located in Seattle, relocation expenses covered. Client is seeking a Clinical Program Manager to plan and manage the overall execution of the assigned clinical program to meet necessary quality standards (including ICH GCP, local regulations), budget and timelines, including recommending operational strategies and/or decisions. This person reports to the Director of Clinical Operations and manages the studies through their assigned Clinical Trial Managers. Requirements:University....

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