Kategorie: Gesundheit - Medizin - Pflege

QA Manager Biopharmaceuticals - BIG PHARMA End to End Quality Stewardship with external partners - region Zurich Come on board for one of the most successful biopharmaceutical companies worldwide. Our customer has an extensive product portfolio, which includes various biotechnologically manufactured active pharmaceutical substances (drug substance) and various galenical technologies for drug product, especially Steriles. Growing volumes result in an increased complexity of the processes. We seek for a QA Manager who can provide expertise in being a reliable point of contact from Quality side on the Product Operational Team and provide end-to-end quality stewardship of assigned Products from manufacturing - to delivery - to warehouse. Your will act as Deputy of the Responsible Person (FvP), ensuring, that all external manufactured batches from drug substance- drug product - primary packaging - secondary packaging to warehouse shipping meet the set specifications. In collaboration with the Product Operations Team you provide review and input to product specific deviations, changes and quality complaints. You will also participate in local and global quality and business related meetings to ensure alignment of activities and provide support to the Quality Operations and to the wider Supplier Relationship Management, Global Procurement, Supply Chain and Manufacturing Science and Technology teams in support of projects, technical transfers programs, supplier selection programs, etc. You will establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs. Your profile: B.Sc, M.Sc, PhD in Life Sciences 3-5 years of experience in Pharma QA and/or Operations - strong preference for Biologics Sound expert knowledge of GMP documentation requirements and batch release process Smooth collaboration with Partner Companies and numerous CMOs German language skills B2 level upwards Strong interpersonal communication, collaborative and leadership skills in dealing with a broad variety of cultures. You have demonstrated the ability in technical writing are able to work in a matrix organization in virtual international environment. Act as a quality influencer throughout all steps in the multi-site supply network and show your talent in building trustful and effective relationships.

Application Developer - Healthcare We are currently working on behalf of a leading healthcare/pharmaceutical company who are looking to hire an Application Developer due to their continued growth. They are looking for someone to join them who will be responsible for the design and programming of client-side application components. If you are looking to join a company where your contributions make a real difference to people's lives, then his role is for you. Requirements: Expertise in Java Several years' experience with object-oriented programming Higher professional education in Computer Science or similar Experience programming GUI components High level of German and English Soft Skills: Careful way of working Precise & quick minded Independent and team orientated Flexible, proactive, organized, detail-oriented Benefits: Very competitive Salary Great bonus structure Casual dress code Central Location 80 + employees

Für unseren Kunden - ein Unternehmen im Bereich Medizintechnik - suchen wir für die Mitarbeit an einem Projekt einen Technical Consumables Manager mit Erfahrung im Bereich Medizintechnik und guter Kenntnisse über die Herstellung von Spritzgussteilen. Arbeitsort: Kanton Zug, Schweiz Projektdauer: 01.11.2019 - 31.10.2020 mit Möglichkeit auf Verlängerung Bereitschaft zur Reisetätigkeit: 10-20% Wir bei Spring Professional Engineering Solutions (The Adecco Group AG) verbinden die klügsten Köpfe mit den innovativsten Projekten in der ganzen Schweiz. Mit ihren Kompetenzen, bringen unsere Ingenieure die Projekte unserer Kunden in den Bereichen industrielle Automatisierung, Automobilindustrie, Elektronik und Eisenbahninfrastruktur massgeblich weiter. Als Mitglied unseres Teams, unterstützen sie mit ihrem Know-How die Top Unternehmen der Schweiz direkt vor Ort. Ihre Herausforderung Sie stellen die Produktqualität und die Versorgung in der Zusammenarbeit mit den externen Lieferanten und den internen Stellen sicherSie bearbeiten und dokumentieren ReklamationenSie leiten die Product Care Projekten und wirken bei Consumables Development Projekten mitSie pflegen und erstellen die regulatorisch korrekten ProduktdokumentationMitarbeit oder Leitung von Organisationsentwicklungsprojekten gehört auch zu Ihrem AufgabengebietSie arbeiten bei der Lieferantenentwicklung und Durchführung von Lieferantenaudits zusammenSie wirken bei der Einführung neuer Mitarbeitenden mit Ihre Kompetenz Sie haben Ihr Hochschulstudium (z.B. Maschinenbau, Automatisierungstechnik/ Werkstofftechnik) oder vergleichbare höhere Ausbildung in einem technischen und analytischen Fachgebiet erfolgreich abgeschlossenSie bringen Erfahrung im Medizinalbereich mit, insbesondere in der in-vitro Diagnostik ist von VorteilSie verfügen über gute Kenntnisse über die Herstellung von SpritzgussteilenSie kennen sich gut mit der regulierten Produktentwicklung aus, am besten in Zusammenarbeit mit internationalen StakeholdernSie haben Kenntnisse in der Beurteilung von Prozessen und des ProjektmanagementsIhre sehr gute Kommunikationsfähigkeit in Deutsch und Englisch zeichnet Sie aus Ihre Perspektiven Innovatives, internationales ArbeitsumfeldAttraktiver Arbeitsvertrag mit einem flexiblen GleitzeitkontoIndividuelle Karriere- und Entwicklungsmöglichkeiten und interne Trainings Ihr Kontakt Frau Dominika Ciarczynska, Recruiter, beantwortet Ihre Fragen gerne unter der Nummer . Bitte bewerben Sie sich direkt online. Beziehen Sie sich dabei bitte auf die Referenznummer JN -07273.

Summary: This position is for Medical Director within Early Stage Clinical Development. This position will be responsible for supporting clinical trials and the development strategy for multiple early stage programs in the Seattle Genetics portfolio, and has the potential to grow into a role with overall accountability as Global Development Lead (GDL) for at least one global early stage program. The GDL role is responsible for defining and delivering a comprehensive development strategy, and will partner with Commercial, CMC, and Program and Portfolio Management to ensure effective and efficient execution of the program. The GDL serves as a scientific and medical expert both internally and externally and represents the product strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders worldwide. The Medical Director will partner strategically with other Early Stage GDLs and provide medical monitoring coverage, SIVs, and regulatory interactions relevant for the European sites of active Phase 1 programs. The role may also assist with medical monitoring on late stage programs as needed. The successful candidate will report to Executive Director, Early Stage Clinical Development and should have demonstrated proficiency in leading clinical trials and supporting development programs. The successful candidate should also be adept at managing relationships across collaborations and with the external clinical community from a global perspective. Responsibilities: Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates Partner with early stage GDLs to provide strategic and executional support in Phase 1. Assist with European Site Initiation Visits (SIVs) and investigator calls in as needed. Provide medical monitoring cross-coverage for the European sites of active Phase 1 programs In the GDL role, is accountable for delivering on the program strategy. Represent the Development strategy at the Global Product Team to develop and execute an integrated cross-functional global product strategy working in partnership with GPT members (Research, Regulatory, Translational Sciences, CMC, Commercial, and Program Team Leadership & Management) and key contributors (Biostatistics, Safety). The GDL will design and guide strategy from proof of concept through initial approval and subsequent development Support the design, execution and medical/scientific data interpretation of global clinical studies. Provides advice and guidance on other ongoing early stage programs Provide clinical leadership for regulatory interactions including pre-CTA meetings Oversee the evaluation and interpretation of safety, pharmacology, and efficacy data from ongoing and completed studies Oversee strategy and execution of preparation of manuscripts, abstracts and presentations for scientific meetings and Development advisory boards Collaborate with a variety of internal and external partners and stakeholders, such as HAs, clinical investigators, clinicians, scientists and key opinion leaders (KOLs) May provide leadership and management to clinical personnel and medical monitors who support the clinical study teams Travel will be required Requirements: Demonstrated experience working on product development. Experience with early stage development including IND or CTA submissions is preferred Demonstrates strategic agility: has in-depth knowledge and experience in the pharma/biotech industry from a global perspective Has a strong leadership presence and ability to work effectively with clinical/scientific and cross functional leaders Demonstrated expertise in protocol generation, safety monitoring, and data analysis Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders Excellent communication, presentation, and time management skills Proven ability to work well independently and as part of remote global teams Global perspective; works effectively with colleagues from varied cultures and geographies Able to work remotely and with remote global teams when necessary Fluent in English Education: MD or MD/PhD As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit . Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

Spring Life Sciences is looking for his client a The Role: • Contributes, with appropriate oversight, to all aspects of the assigned clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. • May lead specific aspects of the assigned clinical trial(s). • Core member of the Clinical Trial Team (CTT), deputy for the Associate Clinical Development Director/Clinical Development Director. Contributes to operational excellence through process improvement and knowledge sharing. Responsibilities: 1. Contribute to all operational trial deliverables, under the oversight of the Associate Clinical Development Director/Clinical Development Director, according to timelines, budget, operational procedures, quality/compliance and performance standards. 2. Resource Management: • Support the Associate Clinical Development Director/Clinical Development Director with the development, management and tracking of the trial level life cycle budget including forecast, and annual cost targets. 3. Core member of the CTT; participate in establishment of study progress and issues/resolution plan at the CTT meeting; can deputize for the Associate Clinical Development Director/Clinical Development Director to chair and facilitate CTT meetings. Ensure completion of CTT meeting minutes. Organize and chair trial sub teams within the scope of his/her delegated responsibilities. 4. Contribute to preparation of the Data Review Plan (DRP); participate in data review as specified in the DRP. 5. Contribute to the development of clinical sections of regulatory documents e.g., Investigators' Brochures, Annual Safety Update Reports. 6. Contribute to talent development through active participation in onboarding and training activities. May participate in Development Operations and/or cross-functional initiatives. 7. Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management within assigned clinical trial(s), including sharing lessons learned. Profile: • Advanced degree or equivalent education/degree in life science/healthcare recommended. • Fluent English (oral and written). • 3-5 years of experience in a pharmaceutical company or a contract research organization with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trials demonstrated ability in supporting operational aspects of clinical trials. • Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines. • Proven ability to work either independently or in a team setting, to meet goals by managing compliance and budget. Votre contact Etes-vous intéressé(e)? Merci de postuler directement en ligne. Merci de préciser la référence JN -07215 - HAID.

Spring Life Sciences is looking for his client a The Role: • The Clinical Trial Associate (CTA) is involved in the set up and follow-up of the studies, in the management of study documentation and actively supports the Clinical Research Associate (CRA) and Clinical Trial Manager (CTM) by creating, updating, distributing study materials, tools and documents. • The CTA contributes to project team and study team goals. Responsibilities: • Generate, finalise and distribute study team agenda and meeting minutes in a timely manner. • Act as a support to the CTM for meeting preparation; • File and archive all study documents on Veeva Vault (eTMF) under the responsibility of the CTM and ensure inspection readiness of the TMF; • Verify vendor's work order and create / update purchase orders accordingly, with confirmation from CTM; • Follow up and discharge invoices according to the relevant purchase order on an ongoing basis, track payments to vendors and study sites and keep Accounts file up to date (financial agreements and payments); • Ensure review of study budget (ProConcept Extract) under responsibility of the CTM; • In case of short / unexpected absences of the CTM, systematically act as Backup and primary point of contact of the study by directing the action items to the most appropriate person; • Contribute to the quality of all activities and key steps of the clinical study deliverables, and the delivery of the clinical study according to the ICH GCP and local applicable regulations, and in accordance with International's SOPs/WPs; • Update and/or track study reporting tools (e.g. weekly follow-up chart on-line, Export of the CRO reporting tool). Profile: • University/College degree level or equivalent in a relevant discipline; • Proven track record of at least 2 years of experience as CTA or comparable operating experience in Pharma/CRO/healthcare with good knowledge of budget and invoicing requirement, as well as drug development process and medical terminology; • Experience in Management and filing of Trial Master File content (Veeva Vault Experience is a plus); • Excellent spoken and written English and French; • Customer orientation and Team spirit, with ability to foster a collaborative team environment and to • work effectively with others in a fast paced matrix organization; • Ability to communicate with cross-functional teams; • Strong organizational skills with ability to manage stress, pressure and deadlines; • Good to advanced computer skills with requirement of MS applications. Votre contact Etes-vous intéressé(e)? Merci de postuler directement en ligne.

We are Recruiting an experience clinical data manager to strenghten the team. Your Responsibilities Clinical Data Reports; Develop scripts to produce study-specific clinical data status reports as requiredReview clinical data on an ongoing basis to ensure compliance of data Integrity and quality control proceduresLiaise directly with Clinical Research Associate (CRA) to ensure data discrepancies are addressed in a timely mannerPoint of contact for project manager, statistician and/or sites, regarding clinical data, data reporting needs and data analysisContribute to Data Management (DM) documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, annotated CRF, CRF Completion Guidelines to ensure standardizationResponsible for database build activities such as; input in database selection and coordination of CRF design, edit check development and user acceptance testing, for all versions.Provides effective user support during data base implementationAbility to support design, develop, implement, maintenance and support clinical databases for clinical studies/registries TBCWork with database programmer to develop reconciliation reports and performs data reconciliationResponsible for ensuring reporting requirements are met and are standardized across the clinical programContribute during database vendor qualification and auditPerform strategic research, from various data sources and scientific literature, and synthesizes, analyzes, edits, and filters information appropriatelyPrepare presentations for colleagues and present clinical data status reports for both internal and external stakeholdersWork independently within projects and actively seeks to develop the role further to support Clinical Affairs projectsAssist in building departmental initiativesResponsible for support of multiple studies simultaneously in a dynamic environment Your Profile Bachelor's degree with minimum 8 years' experience in the clinical research field including 3+ years of relevant work experience in Data management.Experience working with medical data in a research environmentStrong knowledge and adherence to Good Clinical Practice (GCP) and other clinical affairs regulatory practices and laws and of clinical trial process, CRF design, Clinical database applications such as EDC and CTMS.Excellent understanding of data administration and management functions (collection, analysis, data review process, etc.)Proficient in the use of data management software and MS Office (Excel, PowerPoint, Word, etc.) and SAS software.Proven ability to working with multiple teams on multiple projects simultaneouslyDemonstrated flexibility when prioritizing work and delivering on goalsExcellent analytical and problem-solving skillsExcellent written, verbal communication and presentation skillsAbility and willingness to travel 30% of the time, primarily via plane or trainAbility to work independently and in a team-oriented environment.English fluent Votre contact Etes-vous intéressé(e)? Merci de postuler directement en ligne.