Clinical Affairs Associate Stellenangebote

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22 Stellenangebote

Stellenangebote Clinical Affairs Associate Jobs bei Jobleads

Job vor 7 Tagen gefunden

Associate Director- (Senior) Patient Safety Physician (gn) : Oncology Baden- Württemberg, German. . .

Führungs-/ Leitungspositionen

MEHR

Associate Director- (Senior) Patient Safety Physician (gn) : Oncology Baden- Württemberg, Germany, or relocation to Germany (relocation assistance available) . [...] (Bio) Pharmaceutical Companies Your primary focus will revolve around orchestrating the global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development. In this role, you will work closely with the clinical development department and will be involved in a very strategic and global function. TASKS RESPONSIBILITIES: Crafting proactive, patient- centric RM [...] database setup, continual safety monitoring, and addressing safety concerns. Engaging in cross- functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient- centric benefit- risk evaluations for developmental compounds. Collaborating with Global Epidemiology and Medical Affairs to design safety- oriented post- authorization studies. Analyzing clinical trial safety data for incorporation into clinical trial reports and regulatory [...]
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Job vor 13 Tagen gefunden Associate Director Engineering- Device Technology (m/f/d) • Schaftenau, Tirol Führungs-/ Leitungspositionen

MEHR

Associate Director Engineering- Device Technology (m/f/d) Job ID: REQ- 10026381 Summary LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you [...] design input requirements, global component specifications, and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs to prepare medical device/ combination product pre- registration documents and provide input to answer health authority questions. Support internal external [...]

Job vom 05.11.2024

Associate Director Engineering- Device Technology (m/f/d)

• Schaftenau, Tirol Führungs-/ Leitungspositionen

MEHR

[...] and scientists who are responsible for the development of parenteral combination products to ensure that our delivery systems fulfill the highest customer expectations? If yes, then this is the opportunity for you The Device Technology Solution Center is seeking an Associate Director Engineering within the Global Device and Packaging Development (GDPD) department in Schaftenau, Austria. Job Description Key Responsibilities: Lead technical [...] design input requirements, global component specifications and design verification documents. Ensure device design development is delivered to a high quality following the design control process and applicable regulatory framework. Ensure components are delivered and controlled to the required quality for clinical trials and commercial production. Support Regulatory Affairs to prepare medical device/ combination product pre- registration documents and provides input to answer health authority questions. Support internal external [...]

Stellenangebote Clinical Affairs Associate Jobs bei StepStone

Job vor 5 Tagen gefunden QIAGEN GmbH Senior Specialist (m/f/d) Clinical Quality Assurance • Hilden bei Düsseldorf

MEHR

QIAGEN GmbH sucht in Hilden bei Düsseldorf eine/n Senior Specialist (m/f/d) Clinical Quality Assurance (ID- Nummer: 11722002) . At the heart of QIAGENs business is a vision to make improvements in life [...] you make a difference every day. Position Description An exciting new role has arisen within the QIAGEN Manchester Quality Assurance team. The successful candidate will take on responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team at QIAGEN, in support of the testing and registration of diagnostic tests covering a diverse portfolio of indications. The [...] QA audits of clinical study sites - Participate in the QIAGEN internal audit program - Review Clinical Affairs SOPs Position Requirements - Degree qualification in a relevant subject, or equivalent employment experience - Proven working experience as a Clinical Research Associate or similar with knowledge of relevant regulations, standards, guidelines and best practice - Desirable: working knowledge of In Vitro Diagnostic [...]
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Job vom 29.10.2024 DKMS Group gGmbH

Naturwissenschaftler:in/ Gesundheitswissenschaftler:in/ Dokumentationsassistent:in als Study Manager:in (m/w/d)

• Dresden Teilzeit Homeoffice möglich Abgeschlossenes Studium Abgeschlossene Ausbildung Betriebliche Altersvorsorge Sabbaticals 30+ Urlaubstage Vermögenswirksame Leistungen

MEHR

[...] helfen, brauchen wir regelmäßig Verstärkung von engagierten und hochqualifizierten Mitarbeitenden mit Persönlichkeit. In einem weltweiten Netzwerk von rund 1. 300 DKMS- Kolleg:innen möchten wir gemeinsam mit Ihnen und über 12, 5 Mio. registrierten Spender:innen weiter an diesem Ziel arbeiten. Die Clinical Trials Unit ist eine Forschungsabteilung innerhalb der DKMS, welche in direkter Zusammenarbeit mit Kliniken klinische Prüfungen und andere Forschungsprojekte im [...] GCP, nationalen sowie internationalen Regularien und internen SOPs Betreuung von Prüfzentren und Kommunikation mit weiteren beteiligten Akteuren Anleitung klinischer Monitore sowie Review von Monitoringberichten Verwaltung und Pflege des Trial Master File (TMF) sowie studienrelevanter Management Tools Unterstützung im Bereich Regulatory Affairs, insbesondere Nutzung von CTIS Unterstützung der Arzneimittelsicherheit in der Verarbeitung von eingehenden Meldungen Unterstützung des Qualitäts- und Risikomanagements Abgeschlossene Ausbildung als Study Nurse, Medizinische:r Dokumentationsassistent:in (MDA) , Clinical Research Associate (CRA) (m/w/d) bzw. vergleichbarer Qualifikation, oder erfolgreich abgeschlossenes Studium der Naturwissenschaften/ im Bereich Gesundheitswissenschaften Berufserfahrung in der Betreuung und Koordination [...]
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Jobs aus Regio-Jobanzeiger

Stellenangebote Clinical Affairs Associate Jobs bei Regio-Jobanzeiger

Job vom 02.11.2024 DKMS Group gemeinnützige GmbH Naturwissenschaftler:in/ Gesundheitswissenschaftler:in/ Dokumentationsassistent:in als Study Manager:in (m/w/d) • 01307, Dresden Teilzeit Abgeschlossenes Studium Abgeschlossene Ausbildung Betriebliche Altersvorsorge Sabbaticals 30+ Urlaubstage Vermögenswirksame Leistungen

MEHR

[...] helfen, brauchen wir regelmäßig Verstärkung von engagierten und hochqualifizierten Mitarbeitenden mit Persönlichkeit. In einem weltweiten Netzwerk von rund 1. 300 DKMS- Kolleg:innen möchten wir gemeinsam mit Ihnen und über 12, 5 Mio. registrierten Spender:innen weiter an diesem Ziel arbeiten. Die Clinical Trials Unit ist eine Forschungsabteilung innerhalb der DKMS, welche in direkter Zusammenarbeit mit Kliniken klinische Prüfungen und andere Forschungsprojekte im [...] GCP, nationalen sowie internationalen Regularien und internen SOPs Betreuung von Prüfzentren und Kommunikation mit weiteren beteiligten Akteuren Anleitung klinischer Monitore sowie Review von Monitoringberichten Verwaltung und Pflege des Trial Master File (TMF) sowie studienrelevanter Management Tools Unterstützung im Bereich Regulatory Affairs, insbesondere Nutzung von CTIS Unterstützung der Arzneimittelsicherheit in der Verarbeitung von eingehenden Meldungen Unterstützung des Qualitäts- und Risikomanagements UNSERE ANFORDERUNGEN: Abgeschlossene Ausbildung als Study Nurse, Medizinische:r Dokumentationsassistent:in (MDA) , Clinical Research Associate (CRA) (m/w/d) bzw. vergleichbarer Qualifikation, oder erfolgreich abgeschlossenes Studium der Naturwissenschaften/ im Bereich Gesundheitswissenschaften Berufserfahrung in der Betreuung und Koordination [...]

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Weitere Stellenangebote Clinical Affairs Associate bei Jobleads

Neu Job vor 6 Std. gefunden

Associate Director, Oncology Therapeutic Group

Führungs-/ Leitungspositionen

MEHR

[...] patients, aiming to positively impact the health of 2. 5 billion people by the end of the decade. R D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/ or regional regulatory strategies for assigned assets. These strategies will [...] have them, please still apply: Advanced Scientific Degree (PhD, MD, PharmD) . Knowledge of all phases of the drug development process in regulatory affairs. Capability to lead regional development, submission, and approval activities in local region (s) . Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. [...]
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Job gestern gefunden Associate Director, Clinical Operations Führungs-/ Leitungspositionen

MEHR

Job Description- Associate Director, Clinical Operations (240041) Associate Director, Clinical Operations Job Number: 240041 Summary of Key Responsibilities Lead and manage integration of all project [...] and execution of sound development strategies. Provide support to clinical trial managers within and/ or across programs. Budgets, timelines, and forecasts preparation for clinical studies. Interface with Finance, Program Management, Accounting, Supply Operations, Quality Assurance, Clinical Research, Commercial, Regulatory, Medical Affairs; which may include leading sub- teams and/ or acting as a liaison between groups. Provide a variance analysis of budget [...]
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Job gestern gefunden Associate Director, Oncology Therapeutic Group • Baar, Zug Führungs-/ Leitungspositionen

MEHR

[...] patients, aiming to positively impact the health of 2. 5 billion people by the end of the decade. R D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/ or regional regulatory strategies for assigned assets. These strategies will [...] disease area. Preferred Qualifications Skills: Advanced Scientific Degree (PhD, MD, PharmD) . Knowledge of all phases of the drug development process in regulatory affairs. Capability to lead regional development, submission, and approval activities in local region (s) . Knowledge of clinical trial and licensing requirements in all major countries in the region and, ideally, knowledge of other key Agency processes globally. [...]

Job gestern gefunden Associate Director, Quality Operations Global API • Boudry, Neuenburg Führungs-/ Leitungspositionen

MEHR

[...] pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency. Extensive experience and technical knowledge in chemical, biological and/ or pharmaceutical operations which enables first- hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/ sciences and interface with research development. In depth knowledge of cGMP regulations pertinent to the USA, EU and other international [...] as Transforming patients lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each [...]

Job gestern gefunden

Associate Director, Quality Operations Global API

• Boudry, Neuenburg Führungs-/ Leitungspositionen

MEHR

Associate Director, Quality Operations Global API Working with Us Challenging. Meaningful. Life- changing. Those aren t words that are usually associated [...] pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency. Extensive experience and technical knowledge in chemical, biological and/ or pharmaceutical operations which enables first- hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/ sciences and interface with research development. In depth knowledge of cGMP regulations pertinent to the USA, EU and other international [...] as Transforming patients lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each [...]

Job vor 6 Tagen gefunden VP Clinical Development

MEHR

Job Description Job Title: VP Clinical Development- Oncology Tasks Responsibilities In this role, you represent Medicine at the International Multidisciplinary Evidence Teams and take clinical development [...] Data Monitoring boards. In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need for studies that need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within your project in collaboration with the associate Head of Medicine. As a VP Clinical Development, you: Author Investigator s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols [...]

Job vor 6 Tagen gefunden

Associate Director Quality Assurance and Compliance

Führungs-/ Leitungspositionen

MEHR

Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance with Good Clinical [...]
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Job vor 6 Tagen gefunden Executive Director Clinical Development Führungs-/ Leitungspositionen

MEHR

Job Description Job Title: Executive Director Clinical Development- Oncology Tasks Responsibilities In this role, you represent Medicine at the International Multidisciplinary Evidence Teams and take clinical development [...] committees, and Safety Data Monitoring boards. You provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues. You proactively identify the need for studies that need to be conducted and provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance, and Optimization Summary. You review and approve publications within your project in collaboration with the associate Head of Medicine. As an Executive Director Clinical Development, you: Author Investigators Brochures, Asset Evidence Plans, Core Clinical Trial Protocols, [...]

Job vor 8 Tagen gefunden

Associate Director, WW Medical Affairs Cell Therapy, Franchise Strategy and Operations

• Boudry, Neuenburg Führungs-/ Leitungspositionen

MEHR

[...] benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Position Summary Independently and proactively leads matrixed cross- functional medical project management teams within the Worldwide Medical Affairs (WWMA) Cell Therapy (CT) Organization. Details This role reports directly into the Senior Director of Strategy and Operations and will [...] motivated individual with the ability to work independently. Strong technical skills, including advanced Excel, Sharepoint, TEAMS and other analytics business intelligence and finance. Comfort with ambiguity, driving change and innovation across a matrix. Experience with drug development, commercialization, and healthcare, clinical trial management a plus. #LI- Hybrid If you come across a role that intrigues you but doesnt perfectly line [...]
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Job vor 9 Tagen gefunden Associate Director Quality Assurance and compliance • Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

Job Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands- on administration and management of Quality Systems and ensures compliance with Good Clinical [...]

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Stellenangebote Clinical Affairs Associate Jobs bei NewScientist Jobs

Neu Job vor 6 Std. gefunden Lane Clark Peacock LLP

HEOR Statistician (Associate Consultant)

• Winchester, United Kingdom, Hampshire Beratungs-/ Consultingtätigkeiten

MEHR

HEOR Statistician (Associate Consultant) Location- London or Winchester Hybrid working available with a minimum 40 (2 days a week) in office and Tuesday [...] systems from importers of illness to exporters of health and to support our clients to deliver value to patients. We have already developed a track record for leading approaches to real world evidence generation, health economic modelling, evidence strategy, medical affairs and genetics. We have been growing the team quickly in response to the demand we are seeing for the service [...] We are looking for someone who can bring scientific rigor to statistical analyses and who is motivated to work at the cutting edge of methods. This opportunity will require someone who can apply their statistical expertise to the analysis of clinical trial data and real- world data alike. Who are the team? LCP s Health Analytics team works across the healthcare [...]
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Job vor 6 Tagen gefunden Bio Marin Pharmaceutical Inc. Associate Medical Director, Clinical Science • London, Greater London, United Kingdom, London (Greater) Führungs-/ Leitungspositionen

MEHR

[...] the right technical expertise and a relentless drive to solve real problems- and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well- understood biology and provide an opportunity to be first- to- market or offer a [...] of concept to Phase 3 and BLA/ NDA/ MAA filing. The Clinical Science team provides leadership for clinical strategy and oversight to ensure excellence in clinical trial conduct, data analysis and interpretation, publication preparation, and safety monitoring. SUMMARY DESCRIPTION The Associate Director/ Associate Medical Director is an emerging leadership position within Clinical Science. S/ he leads tasks related to Clinical Science [...] Statistical Analysis Plans (SAPs) Help define study quality metrics and perform study data reviews during study execution to ensure integrity of accruing study data Clinical Science Communication and Collaboration Serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed Clinical Study Monitoring Act as [...]

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