Key Responsibilities Medical science expertise: Act as trusted scientific expert, delivering accurate and compliant scientific and clinical education to external stakeholders. Present complex data in a clear and compelling manner, in oral and written form.
We are looking for an exceptional Board-Certified physician to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio, with an emphasis on Gene Therapy/Gene Editing platforms, and advance this dynamic and rapidly expanding area of clinical development.The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials in CAGT and especially in the areas of Gene Therapy/Gene Editing, who will be a champion for CAGT across IQVIA.The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in Cardiovascular development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CNS clinical development. As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations.
POSITION Reporting to the Director of Global Portfolio in the Human Health Division you will be part of the global portfolio management team and commercial development department. Your main task will be to act as expert within your category enabling profitable category sales growth through clear go-to-market strategy. Key responsibilities: Be category expert mastering key drivers for growth; consumer and customer insights coupled with understanding of the regulatory landscape and the competitive situation.
POSITION Reporting to the Director of Global Portfolio in the Human Health Division you will be part of the global portfolio management team and commercial development department. Your main task will be to act as expert within your category enabling profitable category sales growth through clear go-to-market strategy. Key responsibilities: Be category expert mastering key drivers for growth; consumer and customer insights coupled with understanding of the regulatory landscape and the competitive situation.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts on study sites and client representatives. Qualifications: University Degree in life science or other scientific discipline or apprenticeship in health care.Minimum of two years of on-site monitoring experienceKnowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment.Good command of German and English.Flexibility to business travel up to 60% of working time.Driver’s license class B.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge.
DAS BRINGEN SIE MIT Besides a solid theoretical foundation as Bachelor or Master in Food Science/Food Technology, you have several years of experience working in or with the dairy or ice cream industry. You are confident in the role as expert, and you keep yourself updated with the latest scientific and market developments within your field of expertise. Based on an outgoing personality you are comfortable approaching the customers alone or together with colleagues.
Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. Collaborating with experts at study sites and with client representatives. Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included.
Your responsibilities will include: Performing site selection, initiation, monitoring and close-out visits.Supporting the development of a subject recruitment plan.Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.Collaborating with experts at study sites and with client representatives.Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices).
Collaborating with other functional groups within the client where necessary to support milestone achievement and to manage study issues and obstacles. Consulting with pharmacogenetics experts on preclinical and medical aspects as well as side effects (including SAEs and SUSARs). Anticipating project risk and implementing mitigation strategies.
Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
Our innovative, tech-enabled solutions ensure accuracy and efficiency in translating critical documents. Our expert Linguists, supported by continuous training and cutting-edge technology, streamline processes for faster turnaround times and cost savings.
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience.
You can therefore expect to: Identify user needs, design inputs and specifications through participation in the project start-up phase where interaction with key opinion leaders, doctors and other experts worldwide is crucial to fulfil the ambitious innovation targets Be a key influencer in significant development projects within Ambu, either through a mechanical design or lead role Develop new, and further improve existing, mechanical design solutions of components and assemblies as well as optimization of existing designs for Ambu's extensive product portfolio within endoscopy, anesthesiology, and patient monitoring Have the responsibility for the mechanical design and construction of functionalities, parts and assemblies including quality aspects for robust and safe medical products Translate technology concepts into fully working prototypes ready for feasibility testing and process evaluation including documentation Ensure that the component or product is manufacturable in high volume, fulfils function and stays within defined cost framework Ensure continually updated documentation in accordance with the regulations from FDA and ISO certification including FMEA's, risk assessments and tolerance analyses Trust cooperation with internal and external partners.