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Senior Clinical Trial Manager (CTM, Phase III) – Project Team Leader
Coopers Group AG, Basel-Stadt
Leading, planning, and delivering clinical trials Phase III in Oncology & / or Infectious disease , to ensure that studies are carried out according to protocols, SOPs, regulations and principles of GCP. From start-up to close out.Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are metManage operational aspects of projects including budgeting, study initiation and risk managementSelect and manage external vendors, such as CROs, central laboratories ...Ensure the delivery of the clinical study according to ICH GCPProvide operational & scientific input into Protocol synopsis, Study protocol and all other study related documentsParticipate to due diligence activitiesYour profileMSc or PhD degree in Biotechnology, Biology, Microbiology or Life Sciences related mattersMin of 8-10+ years' experience with proven track record of international clinical trials management (Phase III) in the Pharmaceutical Industry, biotech & / or CRO. Previous monitoring experience requiredSuccessful candidate must provide sound experience in Phase III clinical trial in Oncology (& / or Haematology & / or Infectious disease): mandatorySound expertise in the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.Excellent experience in management of CROs, vendors and consultantsProven track record in project management skills & team resources allocation and coordinationFluent in English Only the profiles matching the requirements will be considered (#PHASE III ONCOLOGY). Successful candidate must provide a FULL DOSSIER IN ENGLISH
Clinical Research Study Leader (HOME OFFICE)
Coopers Group AG, Basel-Stadt
The perfect candidate is someone with solid experience in global study management (on a leading level), ideally with experience of early phases, someone with effective leadership skills still able and happy to do operational work. The CRSL is accountable for the strategic and tactical study activities, ensuring high quality execution standards within the agreed budget and timelines Tasks & Responsibilities:Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality.Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking.Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders.Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines.For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle.Assures consistency and standards across a study or studies for all investigational sites and in line with project standards.  Must haves:Minimum 5 years in study management with extensive experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, sample management, conduct and monitoring of clinical studiesMinimum Bachelor (preference on Master) in Life Sciences Experience with global study managementExperience in pharma (preferred) or CRO Effective leadership skills, able to lead cross-functional teams across multiple time zonesExperience working in matrix environment and flat hierarchical team setting Nice to haves: Experience with early phases of clinical trialsNS & Infection & Oncology
Analytical Project Leader (Scientist / Senior Scientist)
Coopers Group AG, Basel-Stadt
The Analytical Development team is responsible for the development of resource and cost efficient analytical methods for all materials used during drug manufacturing using state of the art methodologies such as e.g. High-performance liquid chromatography (HPLC), Gas Chromatography (GC), Ion Chromatography (IC), Mass Spectrometry (MS), and others. The ultimate goal of our work is a robust control strategy to release pharmaceutical products for clinical trials, and finally for commercial supply. As Scientist in Analytical Development, you have a strong quality mind-set and excellent attention to detail. You routinely apply GMP requirements where necessary, and understand how to exert them in different clinical phases. You have solid IT/Digital skills to actively contribute to our digital transformation. You are open-minded, goal-oriented, and able to work in a fast developing environment. As a matter of course, you take challenges as opportunities and you are able to respectfully collaborate with team members, customers and stakeholders.  Tasks & Responsibilities:Cover all analytical aspects during the project development lifecycleDeliver packages that provide a solid control strategy for reliable commercial manufacturing of each product.Work in close collaboration with peers, lab technicians and cross-functional partners from e.g. process development, material sciences, manufacturing, regulatory affairs, and quality assurance.Actively contribute to regulatory submissions such as IND and NDA by authoring relevant sections and provide scientific support to address any questions from the health authorities.You will be part of larger Technical Development Teams in which you regularly report out your progress and in which you additionally collaborate with stakeholders from different disciplines, varying with the clinical phase of the project.Contribute to or drive activities to implement innovative approaches and technologies in cross- functional teams. Must haves:Master or PhD in chemistry, pharmacy, biotechnology or biochemistry Min 3 y of experience in pharma (pharma preferred, university acceptable) Experience with analytical development, synthetic molecules technical development (small molecule) Experience with Health Authorities Experience supervising technical work and lab technicians Fluent English speaker (German is an advantage) Nice to haves:Experience with vendor management (CMO/CRO) Experience in analytical development with Oligonucleotides, Peptides, biologically derived molecules and/or broad and advanced formulation principles 
Project Leader Data Science (Home Office)
Coopers Group AG, Basel-Stadt
 Tasks & Responsibilities:• Builds, maintains and innovates processes and tools for Data Science portfolio management, resource allocation and project tracking• Supports setting the goals, ways if working and daily operations for the team• Guides DS portfolio management• Support scoping of projects and efficient resourcing• Leads development of DS prototypes in close collaboration with RIS Customer Areas, RIS chapters as well as external research and commercial partners• Plans, tracks and controls execution of the portfolio and the budget to ensure best allocation of resources• Prepares communication materials for multiple stakeholders• Facilitates the effective sharing of experiences and knowledge within Data Services and other relevant Data Science teamsMust haves:• Minimum a master in business / economics / computer science / biology / chemistry / engineering / computer science / medicine or epidemiology and/or MBA • Minimum 5 years of work experience in strategy consulting • Minimum 5 years experience in healthcare or life science environment • Minimum 5 - 7 years of top management consulting Nice to haves:• PhD• Experience with data privacy respective regulatory environment• Familiarity with regulatory framework and guidelines for pharmaceutical/diagnostics productsPersonal requirements:• Solves problems in a hypothesis-driven, structured, analytical, pragmatic and end-product focused approach• Thinks broadly, strategically, and timely when preventing, solving or managing problems, thinks quickly under pressure• Possesses excellent leadership, planning, organizational and analytic abilities, manages multiple tasks• Has the ability to identify and resolve critical issues and to assess the impact of decisions• Is an excellent listener and can spot new ideas, directions and potential conflicts in DS team early on• Actively establishes and maintains effective working relationships with other functions; is co-operative, takes cultural and value differences into account in dealings with others• Communicates flawlessly and effectively in written reports, presentations and meetings• Transparent leadership style ensuring that DS goals, its roles, and responsibilities are well communicated to the team members
Bioanalytical Manager
Coopers Group AG, Basel-Stadt
The perfect candidate is someone who has done a similar position in bioanalysis previously within a pharma (preferred) or a CRO or an experienced scientist with experience with small and/or large molecules very keen to learn and with a positive attitude. Please note the preference goes to the first profile (experience in pharma/CRO). In any case, the successful candidate will have an education within biology / biochemistry. On this position, the perfect candidate has strong experience on both small AND large molecules. This is a long-term contract with a potential internal opportunity afterwards.  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 issues Must haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysis Excellent work experience on both large and small molecules bioanalysis Strong vendor management experience, looking after outsourced studies to external CROsDegree in biology/biochemistry  
Discovery Area Leader in Metabolism
F. Hoffmann-La Roche AG, Basel, Basel-City, Switzerland
Discovery Area Leader in MetabolismThe Position In Roche’s Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. The Position This position will play a key role in establishing and growing a new Metabolism discovery area focussed on obesity and type II diabetes in the Pharma Research and Early Development (pRED) organization. At Roche, we are currently expanding our efforts to deliver innovative medicines to patients with cardiovascular and metabolic diseases. By joining us, you will have the privilege of designing and building your own Metabolism focused group to meet the unmet needs for our patients. We are looking for a motivated scientific leader with an entrepreneurial mindset who is willing to contribute to this amazing opportunity. As an experienced leader in the Metabolism group, your impact in the success of our portfolio is critical: You are responsible for the strategic development and implementation of pre-clinical metabolic discovery programs as well as ensuring the long term outlook of the portfolio. Additionally, you will be responsible for the coordination of both internal and external efforts in the Metabolic disease space. Your main responsibilities You build and implement the Metabolism discovery strategy at the scientific and operational level. You’re accountable for recruiting a team of scientists and associates with expertise in metabolic disease You’re will oversee the establishment of relevant assays including in vivo and in vitro model systems You are accountable for establishment of project strategies from target idea throughout the discovery and development phases You support & mentor project leaders in questions related to project strategy, in particular on questions of strategic fit, scientific rationale, competitive fit and feasibility. You promote and develop new research areas, technologies and programs both internally and through business development opportunities You serve as key contact-person across the Discovery and Translational Area, cross-functional and cross-divisional Metabolic research activities. Catalyst for cross-departmental scientific exchange and portfolio support You represent the Metabolism team both internally and externally at conferences and international meetings. Who You Are You’re someone who can build a discovery team and a vision for the scientific future of metabolism in the R&D group. You create a motivating environment for the entire team and engender a high level of psychological safety. You create a clear vision for the entire organization. You empower teams by setting clear priorities and expectations, and make decisions in a timely manner. Essentials PhD and/or MD with a focus on Metabolism, physiology, biology or related field. At least 5 yrs work experience in leading drug discovery teams in Metabolism discovery (ideally at the hinge between discovery and clinical) Deep expertise in Metabolism research, preferably with a focus on obesity and/or type II diabetes Ability to think and lead strategically: articulate long-term objectives and strategies; maintain focus on a long term-strategy while successfully adapting to changing and uncertain environmental conditions. Ability to communicate effectively: clearly articulate complex concepts at all levels of the organization, encourage direct and open discussions; seek common ground in an effort to resolve conflicts. Desirable At least 8 yrs work experience in biotech or large pharma In-depth know-how of the early R&D phases of drug discovery and a deep understanding of the requirements for projects to progress from inception to clinical development. Experience in people leadership, team builder, ideally leading in a matrix organization: ability to achieve results in a matrix organization; align organizational resources to accomplish key objectives; build alliances with key stakeholders If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients’ lives. If you want to work in a passionate team, make your mark & improve lives, apply now. Our commitment Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career. We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.
Device Engineer (Temporary contract)
F. Hoffmann-La Roche AG, Basel, Basel-City, Switzerland
Device Engineer (Temporary contract)The Position The Device Development Department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Roche is recruiting for a (senior) Device Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors). The Device Engineering group performs combine design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities. This role will require considerable cross-functional interaction, notably including QA, Regulatory Affairs, Clinical and Commercial functions. The Device Engineer will report to the Section Head of Device Engineering and will be integrated into the Roche Device Development function. As a Device Engineer, your primary responsibilities include: Act as project leader to successfully bring combination products and medical devices to the market Evaluation of new and breakthrough technologies. Application of theoretical engineering knowledge, to establish robust technical product requirements and develop engineering design solutions to assure devices maintain the required level of performance throughout the life of the product Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation. Forecast and plan resource demands for device development projects. Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices Apply your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30) As a Device Engineer, you will bring the following qualifications and experience: University level education (engineering degree or related discipline) and minimum 5 year proven track record in mechanical engineering and drug delivery device development with experience of working in pharma or other closely-regulated environment, under current Good Practice (cGxP),Quality System Regulation (QSR) or similar working practices Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Experience with Health Authority interactions Demonstrable knowledge of the following: drug delivery devices, parenteral drug delivery, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation Excellent documentation, presentation and interpersonal communication skills with an excellent command of English language and proficiency in German preferable. Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more. Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events. We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer.
Medical Director / Rheumatology, Autoimmune Translational Medicine
Novartis AG, Basel, Switzerland
Medical Director / Rheumatology, Autoimmune Translational MedicineJob ID 385923BR Nov 01, 2023 Switzerland About the Role 30 million! That is the estimated number of patients worldwide suffering from inflammatory arthritis. Join Novartis to help find the right drugs that transform and improve patients' lives all around the world. You will join an international team of clinicians and scientists making significant impact on autoimmune diseases with high unmet medical need, taking new medicines into early-stage clinical trials: in many cases you will be the first to witness the effectiveness of a new medicine that may transform the lives of millions. Your medical and scientific leadership / expertise will significantly impacts the Novartis autoimmune drug development pipeline. Go to https://www.novartis.com/our-science and scroll to the Autoimmunity research area and Translational Medicine area for more information Your responsibilities will include:• Medical / scientific contributor and leader of complex global cross-functional teams. Our successful drug discovery and development environment has close collaboration across Research, Clinical Research and Development.• Major initiator of the Proof-of-Concept strategy and the early Clinical Development Plan. Develop and implement strategies for efficient, high value management of drug development projects leading to clinical Proof-of-Concept and competitiveness of compounds• Develop and implement disease area and biomarker strategies: contribute effectively to the preclinical and clinical Disease Area strategies, project-specific Biomarker strategy, innovative target identification and in-licensing efforts resulting in a high quality preclinical and clinical portfolio• Ensure full implementation of studies during the Proof-of-Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team, and direct or supervisory medical support for all pharmacokinetic studies• Translational Medicine representative to Health Authorities in matters and meetings that focus on early exploratory development: negotiate effectively with Health Authority representatives on all aspects of Translational Medicine and obtain results favorable to Novartis. Translational Medicine representative to Translational Medicine/medically related experts and organizations, advancing the interests of Novartis by your knowledge, style and personal skill and enhancing the position of Novartis with these individuals and groups• Contribute senior expertise to Research in support of target identification, selection, target validation and preclinical development of compounds. Review and evaluates cross-Disease Area activities at and beyond the early compound optimization stage. Provide clinical context and help design optimal preclinical studies• Evaluate clinical centers and foster communication with crucial collaborating investigators. Interact effectively with external medical and non-medical leaders and be an internal Novartis expert leader in your scientific and clinical subspecialty field. Matrix people responsibility per project: 5-8 cross-functional members from Translational Medicine plus other line functions per project team Impact of this role?• Design and implementation of early Clinical Development Plan and studies according to the Integrated Development Plan / Clinical Development Plan / Clinical Pharmacology Plan enabling efficient and rational decision-making, high probability of fast drug registration, favorable drug label and high competitiveness of compounds• This role has a key impact on the entire Novartis pipeline, transitioning programs from preclinical through early clinical and ultimately to full development via the Proof of Concept mechanism, and driving the program after Proof of Concept by delivering key Profiling data to support regulatory submissions• As a recognized expert in your field, you drive project team clinical strategies and bring global credibility across various Novartis Institutes and Divisions as well as country organizations Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements This position is written for Director - we can hire Associate Director for those with careers that include less established science / clinical study experience. We support International family relocation and integration support to Switzerland. What you’ll bring to the role:• MD and Board certified Rheumatologist (or similar relevant sub-specialty clinical training with directly relevant patient experience) with PhD-level basic science. A completed relevant postdoctoral fellowship is strongly preferred• Advanced / business-level / fluent English (oral and written)• Recognized for your medical expertise: an experienced Clinician treating relevant patient groups at an academic medical center or private medical practice group• Recognized for your scientific expertise: respected by colleagues internally and externally, you’ve made significant contributions to your field and created / established new concepts; you have a record of high quality publications in international scientific journals• Experience designing and conducting early phase clinical trials including for inflammatory arthritis: either from pharma/biotech, a senior CRO role where you were responsible for the medical relationship and studies with Sponsors, or from a relevant academic medical center with co-PI ideally also PI clinical trial experience. 5+ years trial experience particularly in inflammatory arthritis preferred• You are used to working independently and within teams including autoimmune disease research scientists and non-scientists on study planning and execution, demonstrating competence in a broad range of project and more strategic planning skills and leading complex cross-functional/matrix project teams Your behavioural characteristics• Demonstrated passion for treating patients and science• Strategic thinker: you have created major innovations, networked with and influenced external medical leaders with your clear and logical presentation of complex strategic issues• Results-driven self-starter and decision taker• Strong cooperative team player, flexible in a changing environment• Good planning, prioritisation, problem solving and organisational skills• Resilient, energetic and enthusiastic; responding constructively to challenging new ideas and input ABOUT TRANSLATIONAL MEDICINE:Translational Medicine is a global group of scientists and physicians working at the pre-clinical and early clinical stage of drug discovery. Our Physician-Scientists drive innovative and cutting-edge science through the selection, profiling and effective global development of successful medicines, integrating clinical science into the discovery and preclinical development phase. Our Translational Medicine concepts are driven by medical needs of patients and the concept of personalized medicine, tailoring the drug, dose and dosing regimen to the patient so the clinical response is optimal in efficacy and safety. We focus from identification of drug targets (molecular pathways relevant to disease) up to the completion of Proof of Concept (Phase IIa studies). Our Translational Medicine Experts are part of preclinical project teams in all drug discovery phases and help design the pathway for First in Human studies (healthy volunteer) that bridge to studies in the patient population. They have the comprehensive responsibility for designing and executing the early clinical drug development phase with a project team including research, biomarkers, biostatistics, modeling & simulation, toxicology, technical experts and clinical trial teams. Why Novartis?766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Division Biomedical Research Business Unit Translational Medicine Location Switzerland Site Basel Company / Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Shift Work No Apply to JobAccess Job Account
Mitarbeiter/in Buchhaltung mit Assistenzaufgaben 50% in Basel
Schweizerisches Tropen- und Public Health-Institut, Basel
Wir suchen ab sofort oder nach Vereinbarung im Zentrum für Tropen- und Reisemedizin des Swiss TPH eine engagierte Persönlichkeit als:Mitarbeiter/in Buchhaltung mit Assistenzaufgaben 50%Ihre verschiedenen Aufgaben beinhalten: Die sorgfältige Bearbeitung der Kreditoren- und Debitorenbuchhaltung, wobei der Fokus auf präzisen Abwicklungen liegt.Ihr Verantwortungsbereich umfasst ebenso das effiziente Durchführen des Mahnwesens, um eine reibungslose finanzielle Abwicklung zu gewährleisten.Im Rahmen Ihrer Tätigkeit übernehmen Sie die Buchung und Abstimmung der Kasse, wobei Sie Tages- und Monatsabschlüsse in Vitomed mit höchster Genauigkeit durchführen. Dies ermöglicht einen transparenten Überblick und eine zuverlässige Grundlage für weiterführende Analysen.Eine weitere Aufgabe besteht in der monatlichen Bereitstellung von umfassenden Daten.Ein wesentlicher Bestandteil dieser Rolle ist zudem die Unterstützung der Zentrumsleitung in verschiedenen Assistenzaufgaben, indem proaktiv aufkommende Anforderungen identifiziert und effektiv angegangen werden. Diese Tätigkeiten erfordern nicht nur ein fundiertes Verständnis für die betriebswirtschaftlichen Abläufe, sondern auch ein geschicktes organisatorisches Talent.Diese Erfahrungen und Fähigkeiten bringen Sie mit:Mit einem erfolgreich abgeschlossenen Kaufmännischen Bildungsgang (KV) bringen Sie eine solide Grundlage für die Anforderungen mit.Ihre ausgeprägte Teamfähigkeit, verbunden mit einem ausgezeichneten Koordinationstalent und höchster Sorgfalt, ermöglichen es Ihnen, in dynamischen Arbeitsumgebungen effektiv zu agieren.Durch Ihre Erfahrung in der Führung von Buchhaltungen haben Sie Kenntnisse im Finanzbereich erworben. Ihr Verständnis für Zahlen und Ihr rasches Auffassungsvermögen ermöglichen es Ihnen, Buchhaltungsaufgaben zu bewältigen.Ihre Arbeitsweise zeichnet sich durch höchste Exaktheit, Selbstständigkeit und Zuverlässigkeit aus. Diese Eigenschaften gewährleisten nicht nur präzise Ergebnisse, sondern auch eine effektive und zeitgerechte Abwicklung von Aufgaben.Erweiterte Kenntnisse in der Verwendung einer Arztpraxis-Software wären bei dieser Tätigkeit von Vorteil, idealerweise könnte man die Rolle eines Power Users übernehmen.Fliessende Deutschkenntnisse sowie gute Englischkenntnisse sind bei dieser Stelle erforderlich.Wir bieten Ihnen: Eine enge, vertrauensvolle und auf Loyalität basierende Zusammenarbeit in kleinem, familiären Team und einem spannenden, internationalen Umfeld mit interessanten Begegnungen mit Menschen verschiedenster HerkunftEine nutzbringende, sinnvolle Arbeit zur Unterstützung der Forschung und internationalen EntwicklungszusammenarbeitAm neuen, zentralgelegenen Standort im «Turmhaus» am Aeschenplatz erwartet Sie ein topmoderner Arbeitsplatz in Basel mit optimaler ÖV-AnbindungDas Swiss TPH bekennt sich zur Chancengleichheit und ist der Exzellenz durch Vielfalt verpflichtet.Rahmenbedingungen: Startdatum: sobald wie möglichVertragsdauer: unbefristetArbeitspensum: 50%Arbeitsort: Swiss TPH, Zentrum für Tropen- und Reisemedizin, NEU im «Turmhaus», Aeschenplatz 2, 4052 BaselReisetätigkeit: keineInterne Stellenbezeichnung: Accountant Treffen Sie unsere MitarbeitendenIn ihrer Muttersprache erzählen Swiss TPH Mitarbeitende, was sie an ihrer Arbeit besonders motiviert.Senior Scientific CollaboratorCharles Abongomera, Senior Scientific CollaboratorGroup Leader AccountingClara Waltisperger, Group Leader AccountingScientific Project LeaderSonia Borrell, Scientific Project LeaderStudy NurseMarianne Rutschi, Study NurseMain Secretary CoordinatorSaskia Strasser, Main Secretary CoordinatorPhD StudentTafadzwa Dhokotera, PhD StudentScientific CollaboratorTobias Suter, Scientific CollaboratorICT SupporterÜnal Keles, ICT SuppporterClinical ConsultantVéronique Sydow, Clinical ConsultantWie kann ich mich bewerben:LebenslaufMotivationsschreiben inkl. Name und Kontaktangaben (E-Mail und/oder Telefonnummer) von 1 – 2 ReferenzpersonenZertifikate und ArbeitszeugnisseGemeinsam können wir zu einer gesünderen Welt beitragen. Wir freuen uns auf Ihre Bewerbung.Bitte beachten Sie, dass wir ausschliesslich Bewerbungen über unsere Onlineplattform berücksichtigen können. Solange die Stelle online auf unserer Webseite ersichtlich ist, sind wir offen für neue Bewerbungen. Bewerbungen via E-Mail oder Agenturen werden nicht berücksichtigt.Kontakt:Christina Bucher, Senior Recruiting Partner, +41 (0)61 284 87 59Das Schweizerische Tropen- und Public Health-Institut (Swiss TPH) ist ein weltweit renommiertes Institut auf dem Gebiet der globalen Gesundheit mit besonderem Fokus auf Länder mit niedrigen und mittleren Einkommen. Assoziiert mit der Universität Basel, verbindet das Swiss TPH Forschung, Lehre und Dienstleistungen auf lokaler, nationaler und internationaler Ebene. Rund 950 Personen aus 80 Ländern arbeiten am Swiss TPH in Bereichen wie Infektionskrankheiten und nicht-übertragbare Krankheiten, Umwelt, Gesellschaft und Gesundheit sowie Gesundheitssysteme und -programme.Im Zentrum für Reise- und Tropenmedizin werden Reisende aus Basel und Umgebung vor der Reise beraten und nach der Reise behandelt. Als Nationales Referenzzentrum für importierte parasitäre Krankheiten des Menschen bietet es Ärzten und Spitälern in der ganzen Schweiz eine Vielzahl von Dienstleistungen an.
Principal Medical Writer
IQVIA, Basel
Responsibilities• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.• Review and edit documents for consistency, progression, structure, and grammar.• Review statistical analysis plans and incorporate into clinical study reportsor submission documents, as applicable.• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.• Participate in team and client meetings as requested• Deliverables above plus able to work independently on a range of complex clinical documents• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently• Resolves complex problems independentlyEDUCATION AND EXPERIENCE• At least 8(PhD)-10(Masters) years of regulatory medical writing experience in the pharmaceutical industry.•Extensive medical writing experience inclusive of clinical study documents and global clinical regulatory submissions.• Extensive authoring experience across multiple TAs in both early and late development programs.• Experience authoring Health Authority responses is required.• Strong project management skills required.• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.• Knowledge of current requirements and guidelines applicable to submission documents.• Excellent writing skills.• Excellent interpersonal and oral communication skills.• Strong knowledge of MS Word and Outlook, some knowledge of Excel and PowerPoint.• Project management and organizational skills required including ability to manage timelines and prioritize multiple projects.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.comIQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.EEO Minorities/Females/Protected Veterans/DisabledÜber das Unternehmen:IQVIA