ZEISS sucht in eine/n Senior Expert Regulatory Affairs (m/f/x) (ID-Nummer: 13400051)
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.
INCI-Listen und Auslobungen Bearbeitung unerwünschter Wirkungen (Kosmetovigilanz) in Zusammenarbeit mit medizinisch-wissenschaftlichen Funktionen Vervollständigung und Pflege von Rohstoff- und Verpackungsdokumentationen Schnittstellenarbeit mit internen Abteilungen, externen Experten und Behörden Bewertung von Rohstoffen anhand bereitgestellter Dokumente Bearbeitung von Kundenanfragen, z.B. zu Allergenen Abgeschlossenes Studium der Pharmazie, Lebensmittelwissenschaften, Biologie oder vergleichbare Qualifikation Fundierte Kenntnisse der kosmetischen Regularien (EU sowie internationale Anforderungen) Sehr gute Vertrautheit mit Rohstoffen, INCI-Deklarationen und Sicherheitsbewertungen Erfahrung im Qualitätsmanagement und in der Dokumentation (z.B.
LBBW Landesbank Baden-Württemberg sucht in eine/n Senior Lead Expert Regulatory (m/w/d) (ID-Nummer: 13703684)
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
Das sind wir: Unter unserem Dach versammeln wir mehr als 2.200 Mitgliedsunternehmen. 17.000 Expertinnen und Experten engagieren sich ehrenamtlich bei uns. Sie machen den Bitkom zu Europas größtem Thinktank der Digitalisierung. 150 Kolleginnen und Kollegen organisieren und bündeln dieses einzigartige Knowhow von Berlin aus.
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.
deine aufgaben: Networking ist alles! Du baust belastbare Beziehungen zu Experten, Entscheidern und Verbänden im medizinisch-wissenschaftlichen Bereich aus. Sei ganz vorne mit dabei! Zu deinen Kernaufgaben gehören die Entwicklung und Umsetzung regionaler Kundenstrategien in Zusammenarbeit mit dem Vertrieb, Marketing und Market Acces.
deine aufgaben: Networking ist alles! Du baust belastbare Beziehungen zu Experten, Entscheidern und Verbänden im medizinisch-wissenschaftlichen Bereich aus. Sei ganz vorne mit dabei! Zu deinen Kernaufgaben gehören die Entwicklung und Umsetzung regionaler Kundenstrategien in Zusammenarbeit mit dem Vertrieb, Marketing und Market Acces.
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.
DyStar Colours Distribution GmbH sucht in eine/n Product Safety Experte Textilchemikalien (m/w/d) (ID-Nummer: 13660604)
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 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.
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).
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.
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.
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.
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.
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 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.
Your responsibilities might include: Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Collaborate with clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files and completeness.Collaborate with CRAs and RSU on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Act as a mentor for less experienced Clinical Trial Coordinators and assist with training and onboarding of new colleagues.May serve as subject matter expert for business processes or lead Clinical Trial Coordinators study teams.May participate in departmental quality or process improvement initiatives.
Your Contribution Act as the primary technical point of contact for customers and Sales regarding OEM products, applications, and development needs.Serve as technical expert for assigned product groups; ensure specifications, requirements, and use conditions are fully understood and documented.Lead technical negotiations with customers, engaging as a peer and ensuring both technical and commercial alignment.Own product specifications for assigned OEM and standardized components.Evaluate feasibility of OEM inquiries; clarify technical questions with Technical Centers, Supply Chain Management, Product Management, Engineering, and Purchasing.Propose technical solutions and provide cost estimations in support of quotations and commercial opportunities.Lead or participate in customer-driven or strategic internal projects; coordinate prototype production, engineering samples, and technical evaluations.Drive internal and external approvals for changes in specifications, materials, supplier processes, or production methods.Perform competitive analysis and technology benchmarking to support product positioning and improvement.Provide technical documentation, application notes, and training materials; ensure all materials are accurate and up-to-date.Train Sales teams and, as needed, customers on new products, applications, and technologies.Support the Quality Department in resolving internal and customer complaints, including guiding root cause analysis and corrective actions.Contribute technical insights to global/regional product strategy, roadmap planning, and annual R&D activities.Establish and maintain product files (including medical product files when applicable).Ensure compliance with all Environmental, Health & Safety requirements.Perform additional duties as assigned to support SBF Medical's goals.
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.
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.
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.
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.
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.
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.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
Supplier Quality Engineer Packaging (m/w/d) Experts. Talents. Personalities. Ensure packaging quality and drive global pharmaceutical standards! For our esteemed client in the pharmaceutical industry, we are looking for a Supplier Quality Engineer Packaging (m/f/d) based in Bad Homburg.
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.
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.