4 jobs found in deerfield, illinois

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    • deerfield, illinois
    • contract
    • US$31.59 - US$37.17, per hour, $31.59 - 37.17 per hour
    • 8 to 4
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $31.59 - 37.17 per hourwork hours: 8 to 4education: Bachelors responsibilities:This role is responsible for providing regulatory support for products on the market or intended to be launched into markets. Activities include data management, change assessment, variation plan delivery, creation of data submission documentation, process and product support, and participation in project sub-teams.Job ResponsibilitiesResponsible for coordinating the collection and maintenance of all required xUDID (e.g., Master Product Content) data from identified sources within the core and extended design team, routing data source and xUDID Data to SME for approval, ensuring required compliance and timelines are met.Acts as the Business Analyst for the xUDID Information & Data workflow tool (PIM & BaxSolid) under the direction of the xUDID ManagerEUDAMED and UDID SME role to revise or add modifications to data and data systems to manage data compliance to global regulations.Responsible for working with other parts of the regulatory organization to achieve desired resultsDevelop and execute global plans and regulatory submission deliverables for sustaining variationsSupport special projects as neededUtilize regulatory knowledge to prepare submission deliverables that will achieve desired resultsInterpret and apply emerging regulatory requirements to ongoing workEnsure identified standards and content requirements are met for regulatory submissionsTimely, actively support query responsesEngage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirementsInterface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).Maintain regulatory files in a format consistent with requirementsTrack status, quality/compliance and progress of regulatory documentation and xUDID SharePoint management.Review and proofread regulatory documentation qualifications:Minimum Bachelors degree in related scientific, IT, or business systems discipline, requiredMinimum of 1-year regulatory experience in RA (medical device) or related healthcare environmentProject management experience (nice to have)Software: Database (nice to have); Microsoft Word, Excel, Outlook, PowerPoint, SharePoint, and Access (nice to have)Familiarity with EUDAMED, UDID or similar regulated data management systems, processes and requirements.Experience operating in a regulated environmentAbility to operate in a matrixed-environment and manage multiple activities, priorities and deadlinesProject management (preferred)Exercise independent judgementScientific knowledge and ability to discuss technical matters with cross-functional team membersKnowledge of regulations and ability to communicate and applyAbility to identify compliance risks and escalate when necessaryDemonstrated leadership, coaching or mentoring skillsExcellent verbal and written English communication skills, suitable for multi-location working relationshipsDemonstrated teamwork and collaboration skillsAptitude for Attention to Detail skills: Project Management, Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $31.59 - 37.17 per hourwork hours: 8 to 4education: Bachelors responsibilities:This role is responsible for providing regulatory support for products on the market or intended to be launched into markets. Activities include data management, change assessment, variation plan delivery, creation of data submission documentation, process and product support, and participation in project sub-teams.Job ResponsibilitiesResponsible for coordinating the collection and maintenance of all required xUDID (e.g., Master Product Content) data from identified sources within the core and extended design team, routing data source and xUDID Data to SME for approval, ensuring required compliance and timelines are met.Acts as the Business Analyst for the xUDID Information & Data workflow tool (PIM & BaxSolid) under the direction of the xUDID ManagerEUDAMED and UDID SME role to revise or add modifications to data and data systems to manage data compliance to global regulations.Responsible for working with other parts of the regulatory organization to achieve desired resultsDevelop and execute global plans and regulatory submission deliverables for sustaining variationsSupport special projects as neededUtilize regulatory knowledge to prepare submission deliverables that will achieve desired resultsInterpret and apply emerging regulatory requirements to ongoing workEnsure identified standards and content requirements are met for regulatory submissionsTimely, actively support query responsesEngage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirementsInterface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).Maintain regulatory files in a format consistent with requirementsTrack status, quality/compliance and progress of regulatory documentation and xUDID SharePoint management.Review and proofread regulatory documentation qualifications:Minimum Bachelors degree in related scientific, IT, or business systems discipline, requiredMinimum of 1-year regulatory experience in RA (medical device) or related healthcare environmentProject management experience (nice to have)Software: Database (nice to have); Microsoft Word, Excel, Outlook, PowerPoint, SharePoint, and Access (nice to have)Familiarity with EUDAMED, UDID or similar regulated data management systems, processes and requirements.Experience operating in a regulated environmentAbility to operate in a matrixed-environment and manage multiple activities, priorities and deadlinesProject management (preferred)Exercise independent judgementScientific knowledge and ability to discuss technical matters with cross-functional team membersKnowledge of regulations and ability to communicate and applyAbility to identify compliance risks and escalate when necessaryDemonstrated leadership, coaching or mentoring skillsExcellent verbal and written English communication skills, suitable for multi-location working relationshipsDemonstrated teamwork and collaboration skillsAptitude for Attention to Detail skills: Project Management, Regulatory Affairs OperationsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • deerfield, illinois
    • contract
    • US$65.00 - US$74.34, per hour, $65.00 - 74.34 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $65.00 - 74.34 per hourwork hours: 9 to 5education: Bachelors responsibilities:May represent Global Clinical Development on Project Development Core Teams for device programs, supporting studies through for regulatory approval. Reports directly to the Director of Global Clinical Operations.Able to work independently to manage all aspects of a clinical trial from site selection/vendor selection process to database lock and review of the final clinical study report.Activities including management of product inventory, forms development, enrollment, budget, and timeline projections.Manage the interfaces with Legal, Global Project Management, Data Management, Medical Writing, Clinical Supply, Clinical Compliance and Training, Pharmacovigilance, and Biostatistics.Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors.Interact effectively with Sr. Management to provide updates and communicate issues.Review other study documents such as protocols, Investigators brochures, DMPs, CRFs, SAPs, and CSR.Clinical Plan - Partner with the Medical Monitor and Regulatory Affairs to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program.Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements.Research Agreements and Study Budgets - negotiate study budgets with sites.Identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders.Plan and conduct investigators meetings.Order clinical supplies and ensure logistics plans are in place prior to study start.Train study staff on product usage, data collection and specific procedures.Comprehensive knowledge and understanding of European/FDA regulations and ICH Guidelines for Good Clinical Practices required.Ability to maintain effectiveness under changing circumstances and priorities. Tact and diplomacy is a strength.Excellent verbal and written communication and organizational skills required.Knowledge of computer software and meticulous attention to detail expected for this position.Confident decision-making and ability to work effectively as a team leader, team member, or individually.Proficiency in data collection design, scientific evaluation and clinical planning.Demonstrated ability to represent Clinical Operations in global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment.Has a track record of delivering on commitments. Capable of handling (assimilating) in-depth technical information from a variety of disciplines in order to be scientifically credible within the global team. qualifications:Bachelor of Science in Scientific or Engineering discipline5+ years medical device (class II & III) clinical development experience3+ years Project Management experience,PMP certification, nice to haveSoftware: MS Word, Excel (pivot tables, v-lookups), Outlook, PowerPoint, SharePoint, MS ProjectPosition allows for flexibility in work week with ability to work from home up to 2 days/week at supervisors discretion. skills: Project Management, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-ProjectEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $65.00 - 74.34 per hourwork hours: 9 to 5education: Bachelors responsibilities:May represent Global Clinical Development on Project Development Core Teams for device programs, supporting studies through for regulatory approval. Reports directly to the Director of Global Clinical Operations.Able to work independently to manage all aspects of a clinical trial from site selection/vendor selection process to database lock and review of the final clinical study report.Activities including management of product inventory, forms development, enrollment, budget, and timeline projections.Manage the interfaces with Legal, Global Project Management, Data Management, Medical Writing, Clinical Supply, Clinical Compliance and Training, Pharmacovigilance, and Biostatistics.Effectively manage external team/vendors activities including CRO, central lab, IRB and other external contractors.Interact effectively with Sr. Management to provide updates and communicate issues.Review other study documents such as protocols, Investigators brochures, DMPs, CRFs, SAPs, and CSR.Clinical Plan - Partner with the Medical Monitor and Regulatory Affairs to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program.Clinical Trial Protocols - Prepare directly or facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements.Research Agreements and Study Budgets - negotiate study budgets with sites.Identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders.Plan and conduct investigators meetings.Order clinical supplies and ensure logistics plans are in place prior to study start.Train study staff on product usage, data collection and specific procedures.Comprehensive knowledge and understanding of European/FDA regulations and ICH Guidelines for Good Clinical Practices required.Ability to maintain effectiveness under changing circumstances and priorities. Tact and diplomacy is a strength.Excellent verbal and written communication and organizational skills required.Knowledge of computer software and meticulous attention to detail expected for this position.Confident decision-making and ability to work effectively as a team leader, team member, or individually.Proficiency in data collection design, scientific evaluation and clinical planning.Demonstrated ability to represent Clinical Operations in global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment.Has a track record of delivering on commitments. Capable of handling (assimilating) in-depth technical information from a variety of disciplines in order to be scientifically credible within the global team. qualifications:Bachelor of Science in Scientific or Engineering discipline5+ years medical device (class II & III) clinical development experience3+ years Project Management experience,PMP certification, nice to haveSoftware: MS Word, Excel (pivot tables, v-lookups), Outlook, PowerPoint, SharePoint, MS ProjectPosition allows for flexibility in work week with ability to work from home up to 2 days/week at supervisors discretion. skills: Project Management, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-ProjectEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • deerfield, illinois
    • contract
    • US$50.00 - US$55.76, per hour, $50.00 - 55.76 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $50.00 - 55.76 per hourwork hours: 9 to 5education: Masters responsibilities:Responsible for taking an active role in defining the strategy for projects including recommendation of appropriate research design, definition of patient population, measurement of outcome variables, and hypothesis development.Author and provide input on relevant sections of research protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).Manage Contract Research Organization (CRO) statistics activities as needed.Participate and assist in the development and approval of global statistics strategies in collaboration with colleagues.Attend investigator and coordinator meetings, representing the statistics group.Manage data release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for projects.Provide support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority advisory panels. qualifications:Masters or PhD in Statistics or related area is requiredA minimum of at least 5-7 years of related medical device industry experience (pharma is okay, but device preferred).Experience with SAS required, PASS (sample size software) would be a plus, they should know at least one sample size software if not PASS skills: MS-WORD, MS-EXCEL, SAS Macro, SAS/GRAPH, SAS/PH, SAS/STAT, SAS-BaseEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $50.00 - 55.76 per hourwork hours: 9 to 5education: Masters responsibilities:Responsible for taking an active role in defining the strategy for projects including recommendation of appropriate research design, definition of patient population, measurement of outcome variables, and hypothesis development.Author and provide input on relevant sections of research protocols including endpoint specification, study logistics, sample size determination/justification, randomization plans, statistical analysis plans, interim analysis, and stopping rules (if applicable).Manage Contract Research Organization (CRO) statistics activities as needed.Participate and assist in the development and approval of global statistics strategies in collaboration with colleagues.Attend investigator and coordinator meetings, representing the statistics group.Manage data release and review meetings for clinical projects; reviews and participates in finalizing and obtaining approval of final manuscript or final reports for projects.Provide support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority advisory panels. qualifications:Masters or PhD in Statistics or related area is requiredA minimum of at least 5-7 years of related medical device industry experience (pharma is okay, but device preferred).Experience with SAS required, PASS (sample size software) would be a plus, they should know at least one sample size software if not PASS skills: MS-WORD, MS-EXCEL, SAS Macro, SAS/GRAPH, SAS/PH, SAS/STAT, SAS-BaseEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    • deerfield, illinois
    • contract
    • US$65.00 - US$77.72, per hour, $65.00 - 77.72 per hour
    • 9 to 5
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $65.00 - 77.72 per hourwork hours: 9 to 5education: Bachelors responsibilities:Review promotional material and provide Regulatory guidance to cross-functional teamsInterface with cross-functional teams to help execute commercial campaigns and launchesParticipate in and support functional projects or business initiatives of low to medium complexityAssess impact of new regulations and provide feedback and provide recommendation upon requestCommunication with regulatory agencies with oversightMaintain appropriate communication within the RA function, GBU Marketing and other functions primarily at the project team levelInitiate, manage and maintain operational activities in support of new and existing marketing authorizationsMonitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Company and external standardsEvaluate technical and scientific information, identify deficiencies, and make recommendations to remediate risksProvide technical and strategic input for regulatory decisionsInfluence commercial acceptance of regulatory assessments, with manager input and oversight.Attend conferences and industry events for development purposesCraft IRI (important risk information) as appropriate with label changes, with guidance from manager. Specifically for Promotional Labeling experience, and not just labeling experience. qualifications:Minimum of Bachelors degree or country equivalent in related scientific disciplineMinimum of 8+ years regulatory specifically in advertising or promotions.Minimum of 3+ years of leadership experience.Experience reviewing U.S. FDA Submissions for accuracyExpert Regulatory knowledge as it pertains to advertising and promotion regulations in the US or GloballyExpert in Global or US Regulatory Affairs Advertising and Promotion for either drug or devices.Scientific KnowledgeAbility to participate in cross-functional projects while prioritizing day to day responsibilitiesExcellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting prioritiesExcellent oral and written communication and presentation skillsAbility to accomplish results through others skills: FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, SubmissionsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
    job summary:As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed! location: Deerfield, Illinoisjob type: Contractsalary: $65.00 - 77.72 per hourwork hours: 9 to 5education: Bachelors responsibilities:Review promotional material and provide Regulatory guidance to cross-functional teamsInterface with cross-functional teams to help execute commercial campaigns and launchesParticipate in and support functional projects or business initiatives of low to medium complexityAssess impact of new regulations and provide feedback and provide recommendation upon requestCommunication with regulatory agencies with oversightMaintain appropriate communication within the RA function, GBU Marketing and other functions primarily at the project team levelInitiate, manage and maintain operational activities in support of new and existing marketing authorizationsMonitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Company and external standardsEvaluate technical and scientific information, identify deficiencies, and make recommendations to remediate risksProvide technical and strategic input for regulatory decisionsInfluence commercial acceptance of regulatory assessments, with manager input and oversight.Attend conferences and industry events for development purposesCraft IRI (important risk information) as appropriate with label changes, with guidance from manager. Specifically for Promotional Labeling experience, and not just labeling experience. qualifications:Minimum of Bachelors degree or country equivalent in related scientific disciplineMinimum of 8+ years regulatory specifically in advertising or promotions.Minimum of 3+ years of leadership experience.Experience reviewing U.S. FDA Submissions for accuracyExpert Regulatory knowledge as it pertains to advertising and promotion regulations in the US or GloballyExpert in Global or US Regulatory Affairs Advertising and Promotion for either drug or devices.Scientific KnowledgeAbility to participate in cross-functional projects while prioritizing day to day responsibilitiesExcellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting prioritiesExcellent oral and written communication and presentation skillsAbility to accomplish results through others skills: FDA, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Briefing Documents, SubmissionsEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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