5 jobs found in Basel, Basel-Stadt

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    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in medical device development? You should then read the following lines! Our client, based in Basel, is looking for a Senior Process Engineer for a 1 year contract. Your Responsibilities: • Support the technical development and life cycle management of safe and user-friendly (connected) autoinjector and on body pump systems as Senior Expert Engineering.• Translate user and business needs into system/sub-system requirements using the systems engineering tool for requirement and test management.• Define interface specification definition with drug, packaging, label & eco system.• Manage project specific 3rd party activities and support the delivery technology lead.• Work within and contribute to broader cross?functional drug product development teams. Your Profile: • MSc/MA in mechanical/electronics or micro systems engineering or relevant fieldExcellent understanding of the current drug delivery technologies.• Autonomous and independent working style with at least 3 years of experience in Medical Device development and LCM.• Ability to interact with cross functional team in matrix organization.• Strong communication skills, emotional intelligence as well as ability to navigate into complex organization and create networks.• Design change management experience and enthusiasm to support the maintenance of existing and building of new platforms.• Proficient spoken communication and excellent technical writing skills in English.Should be able to work on technical documents with experience in Design History filing. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Do you have experience in medical device development? You should then read the following lines! Our client, based in Basel, is looking for a Senior Process Engineer for a 1 year contract. Your Responsibilities: • Support the technical development and life cycle management of safe and user-friendly (connected) autoinjector and on body pump systems as Senior Expert Engineering.• Translate user and business needs into system/sub-system requirements using the systems engineering tool for requirement and test management.• Define interface specification definition with drug, packaging, label & eco system.• Manage project specific 3rd party activities and support the delivery technology lead.• Work within and contribute to broader cross?functional drug product development teams. Your Profile: • MSc/MA in mechanical/electronics or micro systems engineering or relevant fieldExcellent understanding of the current drug delivery technologies.• Autonomous and independent working style with at least 3 years of experience in Medical Device development and LCM.• Ability to interact with cross functional team in matrix organization.• Strong communication skills, emotional intelligence as well as ability to navigate into complex organization and create networks.• Design change management experience and enthusiasm to support the maintenance of existing and building of new platforms.• Proficient spoken communication and excellent technical writing skills in English.Should be able to work on technical documents with experience in Design History filing. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Are you a M.D.? Do you have experience in Neuroscience? You should then read the following lines!Our client, based in Basel, is looking for a Medical Director for a 1 year contract.General Information:• Start date: 01.12.2021• Workload: 80-100%• Home Office: possible from time to time Your Tasks:Cross-Functional Team Membership:• Participates in the relevant Clinical Science Team (CST)• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution Global Clinical Development Planning:• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.• Participates in CD strategy development• As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)• Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of the company and patients Clinical Development Plan Implementation, Provides clinical support across all relevant studies and programs:• Designs and develops clinical studies for review and discussion with other CST members• May collaborate with others in the development of the product safety profile• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials• May participate in the identification and selection of appropriate external investigators and sites• Collaborates with others in development of study analytics and data management plans• Participates in investigator and other external presentations, meetings and other communications• May act as a medical monitor for assigned studies• Conducts ongoing reviews of medical/safety data• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials• Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment• Consistently complies with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines Your Profile:• M.D. with relevant medical experience in psychiatry (PTSD, anxiety disorders, schizophrenia) • Working knowledge of the US healthcare System is an asset • At least 2 years professional experience and understanding of Phase II – III drug development • At least 2 years professional experience in working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g. ISS, ISE, competitor data, etc.) • At least 3 years professional experience developing product and safety profiles • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within budget accomplishment of such• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally• Excellent English skills, both written and spoken Do not waste any minutes, apply now!  We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Are you a M.D.? Do you have experience in Neuroscience? You should then read the following lines!Our client, based in Basel, is looking for a Medical Director for a 1 year contract.General Information:• Start date: 01.12.2021• Workload: 80-100%• Home Office: possible from time to time Your Tasks:Cross-Functional Team Membership:• Participates in the relevant Clinical Science Team (CST)• Participates as a standing or ad hoc member in sub-teams (e.g., Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports the CST lead and overall team with cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution Global Clinical Development Planning:• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, regulatory, business development, commercial operations, legal, etc.• Participates in CD strategy development• As assigned, may also consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)• Participates in development of the CD plan for assigned molecule(s)/indication(s) and/or other programs• Supports other CST members in preparing for HA meetings. As appropriate, participates in HA meetings. Ethically, effectively and professionally represents the interests of the company and patients Clinical Development Plan Implementation, Provides clinical support across all relevant studies and programs:• Designs and develops clinical studies for review and discussion with other CST members• May collaborate with others in the development of the product safety profile• Collaborates with others in development of clinical sections of investigator brochures, presentations and other materials• May participate in the identification and selection of appropriate external investigators and sites• Collaborates with others in development of study analytics and data management plans• Participates in investigator and other external presentations, meetings and other communications• May act as a medical monitor for assigned studies• Conducts ongoing reviews of medical/safety data• Participates in the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials• Works with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies or other programs in the relevant therapeutic area of assignment• Consistently complies with all governing laws, regulations, Standard Operating Procedures (SOPs) and other guidelines Your Profile:• M.D. with relevant medical experience in psychiatry (PTSD, anxiety disorders, schizophrenia) • Working knowledge of the US healthcare System is an asset • At least 2 years professional experience and understanding of Phase II – III drug development • At least 2 years professional experience in working with the principles and techniques of data analysis, interpretation and clinical relevance (e.g. ISS, ISE, competitor data, etc.) • At least 3 years professional experience developing product and safety profiles • Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within budget accomplishment of such• Good business presentation skills; is comfortable and effective when presenting to others, internally or externally• Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally• Excellent English skills, both written and spoken Do not waste any minutes, apply now!  We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in clinical trial data analysis? You should then read the following lines!Our client, based in Basel, is looking for a Principal Biostatistician for a 9 months contract. Your Tasks:1. Study level:a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.b. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.c. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required.f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.g. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. 2. Project level:a. Contribute to project level activities as needed.b. Contributes to project team preparation for HA Advisory Committees and meetings.3. Enterprise level:a. Participate in non-clinical project activities as neededb. Contribute to the review and implementation of health authority guidancesc. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings4. External level:a. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.b. Represent the company in statistical discussions at external congresses, conferences, scientific meetings. 5. People Management: Mentor new hires and/or junior Statisticians Your Profile:MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.Experience in Franchise/Therapeutic Area and/or regulatory activities desirable. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Do you have experience in clinical trial data analysis? You should then read the following lines!Our client, based in Basel, is looking for a Principal Biostatistician for a 9 months contract. Your Tasks:1. Study level:a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.b. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.c. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings.d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials.e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required.f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.g. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. 2. Project level:a. Contribute to project level activities as needed.b. Contributes to project team preparation for HA Advisory Committees and meetings.3. Enterprise level:a. Participate in non-clinical project activities as neededb. Contribute to the review and implementation of health authority guidancesc. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings4. External level:a. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.b. Represent the company in statistical discussions at external congresses, conferences, scientific meetings. 5. People Management: Mentor new hires and/or junior Statisticians Your Profile:MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.Experience in Franchise/Therapeutic Area and/or regulatory activities desirable. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    • basel, basel-stadt
    • contract
    Do you want to work in a pharmaceutical company? Do you have experience in digital software implementation for Life Sciences? You should then read the following lines! Our client, based in the Basel area, is looking for a Digital Biomarker Scientific Collaboration and Project Manager for a 1 year contract. Your Tasks:• Drive the adoption of developed digital biomarker solutions by establishing and managing clinical digital measurement collaborations with academic institutions and pharmaceutical companiesestablish frameworks for engaging collaborators, incl. the solution offering and contractual termsengage collaborators to shape scientific objectives and collaboration scopemanage the relationship with the collaborator• Lead the delivery of complex, interdisciplinary projects in the clinical digital measurement space to meet the needs of the collaborationsthese projects have a major informatics component, including user experience, workflows, mobile application sensor data capture, data transfer and storage, data processing, data sharinglead the solution definition, including user story definition and prioritizationsuccessfully complete audits by third party organizations on the implemented solutions• Administrate the program, including facilitating resource planning, budget tracking, contract management, preparation of status updates across different work streams streams• Ensure that our collaboration partners as well as patients, clinicians, clinical operation specialists, data managers and scientists are excited by and use the provided solutions• Engage and influence stakeholders inside and outside to ensure the success of the collaborations Your Profile:• Proven project- and product management experience in digital health implementation projects (incl. custom software development), within scope, budget and time • Minimum 10 year of relevant professional experience, including consulting or similar • Proven experience establishing collaborations with clinical researchers, including with consortia • Real passion for transforming healthcare using digital technology, especially for modernizing clinical endpoints in drug development and improving disease management and patient care• Excellent analytical, communication and presentation skills• Ability to build strong partnerships with stakeholders and influence without authority• Advanced scientific/medical degree, especially in digital health, cognitive neuroscience, clinical neuroscience, outcomes research, psychometrics • Experience with eCOA (electronic clinical outcome assessment) or sensor- data collection solutions in a clinical study setting • Experience with software development projects, and especially with functional requirement models like use case and user story development, and requirement gathering • Experience with software quality (GXP)• Previous experience with analyzing data and/or implementation of information workflowsDo not waste any minutes, apply now!  We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a pharmaceutical company? Do you have experience in digital software implementation for Life Sciences? You should then read the following lines! Our client, based in the Basel area, is looking for a Digital Biomarker Scientific Collaboration and Project Manager for a 1 year contract. Your Tasks:• Drive the adoption of developed digital biomarker solutions by establishing and managing clinical digital measurement collaborations with academic institutions and pharmaceutical companiesestablish frameworks for engaging collaborators, incl. the solution offering and contractual termsengage collaborators to shape scientific objectives and collaboration scopemanage the relationship with the collaborator• Lead the delivery of complex, interdisciplinary projects in the clinical digital measurement space to meet the needs of the collaborationsthese projects have a major informatics component, including user experience, workflows, mobile application sensor data capture, data transfer and storage, data processing, data sharinglead the solution definition, including user story definition and prioritizationsuccessfully complete audits by third party organizations on the implemented solutions• Administrate the program, including facilitating resource planning, budget tracking, contract management, preparation of status updates across different work streams streams• Ensure that our collaboration partners as well as patients, clinicians, clinical operation specialists, data managers and scientists are excited by and use the provided solutions• Engage and influence stakeholders inside and outside to ensure the success of the collaborations Your Profile:• Proven project- and product management experience in digital health implementation projects (incl. custom software development), within scope, budget and time • Minimum 10 year of relevant professional experience, including consulting or similar • Proven experience establishing collaborations with clinical researchers, including with consortia • Real passion for transforming healthcare using digital technology, especially for modernizing clinical endpoints in drug development and improving disease management and patient care• Excellent analytical, communication and presentation skills• Ability to build strong partnerships with stakeholders and influence without authority• Advanced scientific/medical degree, especially in digital health, cognitive neuroscience, clinical neuroscience, outcomes research, psychometrics • Experience with eCOA (electronic clinical outcome assessment) or sensor- data collection solutions in a clinical study setting • Experience with software development projects, and especially with functional requirement models like use case and user story development, and requirement gathering • Experience with software quality (GXP)• Previous experience with analyzing data and/or implementation of information workflowsDo not waste any minutes, apply now!  We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.

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