CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention (Leiden, Nederland), we are searching for a Consultant RA-CMC.


Keywords

• Regulatory Affairs
• CMC dossier development
• Module 3
• IND / IMPD
• MAA / BLA

Profile
As Consultant RA-CMC you ensure compliance with regulatory agency regulations and interpretations. You will prepare responses to regulatory agencies' questions and other correspondence. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for new drug application and investigational new drug applications.

Who we're looking for
The ideal candidate has at least a BSc. degree in (bio)pharmaceutical area. You have experience in dossier development of Module 3 IND/IMPD or MAA/BLA. You are able to work in a Documentum System. You have hands-on dossier development experience and RA-CMC guideline knowledge.


Additional vacancy information

Reference	:	A2000192
Contract	:	Temporary contract with CLS Services
Education	:	WO/MSc. HBO/BSc.
Employment terms	:	Contract until the end of 2021 Salary: max. 7400 Days of leave: 25 + 11 See here our other employment terms for this vacancy
Publication date	:	25-2-2021
Location	:	View location with Google Maps
Contactperson	:	Aniek Vugts
		+31 (0)31 (0)88 22 77 555

Apply
Please apply online here for this job (Job Ref: A2000192). You can also check our other vacancies. You can also follow us on Twitter.

Ben jij net afgestudeerd en op zoek naar een startersfunctie? Heb je affiniteit met zorg en ICT en ben je analytisch sterk? Dan zijn wij voor onze vestiging in Amsterdam op zoek naar jou! Als Junior Integratie Specialist zorg jij dat de systemen en apparatuur van externe leveranciers en instanties naadloos communiceren met ons ZIS/EPD (zorginformatiesysteem/elektronisch patiëntendossier). Jij helpt ChipSoft met het bouwen aan duurzame informatie-uitwisseling in de zorg.

Heb je vragen over een vacature of ChipSoft? Onze recruiters zitten voor je klaar. Bel ons op werkdagen via +31 20 4939000. Je kunt ook mailen naar

werken@chipsoft.nl

.

Zie je geen passende vacature, maar kun jij ChipSoft wél versterken?
Stuur dan een open sollicitatie.

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Vaccines & Prevention (Leiden, Nederland), we are searching for an Analytical Project Manager.


Keywords

• Communication skills
• Immunological assays
• GxP
• Clinical development of vaccines
• Team player

Profile
Do you want to be involved in the immunological evaluation of new vaccines? Do you have experience in immunological assays but you do not want to be in the lab anymore? Then this is a nice opportunity for you!
As Analytical Project Manager, you will assist in the timely and correct sample analysis of clinical samples, either in house or out sourced to CRO’s or partners. For out sourcing, you are responsible for monitoring the sample analysis in out sourced activities. For in house activities, you are responsible for co-ordination of the clinical sample analysis. The required activities must be executed, documented and reported according to Good Clinical Laboratory Practice (GCLP) quality requirements. Additionally, you will be responsible for organising the clinical samples in the Biobank system and will assist in shipments and co-ordination of sample analysis of the clinical studies.


Who we're looking for
The ideal candidate has a B.Sc. (HLO) in biological/medical sciences with some experience in the immunological assays that are performed. Preferably, you have experience with the clinical development of vaccines and/or GxP experience. We are looking for someone who has excellent communication skills and is quality minded. Are you not afraid to show initiative and a great team player? Then we are looking for you!

Company profile
Janssen Vaccines & Prevention B.V. is part of Johnson & Johnson, one of the biggest and most respected health care companies in the world. They are dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacturing, and marketing of novel vaccines to prevent some of the most devastating and complex infectious diseases. These range from respiratory infections like respiratory syncytial virus (RSV) to human immunodeficiency virus (HIV) and pathogens of global concern, such as Ebola and COVID-19.
In this organisation, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. They are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen. The offices of Janssen Vaccines & Prevention are located in Leiden, The Netherlands.


Department
The Clinical Immunology department is responsible for the immunological evaluation of vaccine candidates in clinical trials. Hereto, the department executes the immunological strategy supporting the clinical development, and ensures the development, and validation of the required immunological assays, as well as the clinical sample analysis. Typical assays to determine the immunogenicity of vaccines are antibody ELISA, T cell ELISpot, Intracellular Cytokine Staining, and virus neutralisation assays.

Additional vacancy information

Reference	:	A2100044
Contract	:	Temporary contract with CLS Services
Education	:	HBO/BSc.
Employment terms	:	Salary: >3085 Days of leave: 25 + 11 Project for at least 1 year See here our other employment terms for this vacancy
Publication date	:	2-3-2021
Location	:	View location with Google Maps
Contactperson	:	Claudia Erwich-Faaij
		+31 (0)31 (0)88 22 77 555

Apply
Please apply online here for this job (Job Ref: A2100044). You can also check our other vacancies. You can also follow us on Twitter.

SAP eWM Logistics Consultant Publish Date: Dec 23, 2020 Location: Amsterdam, Amsterdam, NL Company: Atos SAP and Atos go way back. Our long-standing gold partnership and joint expertise mean that there is no one better placed to propel your career in SAP. Here at Atos you will have the opportunity to guide industry-leading companies through intelligent enterprise transformation. Your background, technical expertise and solid consulting skills in SAP will be put to the challenge on a daily basis. Our varied client projects will have you using SAP’s newest technologies at all project phases. As an SAP Logistics consultant at Atos you’ll be part of our global SAP team of over 13,000 SAP professionals in 42 countries. Within Atos Netherlands we are currently expanding our SAP Practice and are looking for an experienced SAP Logistics Consultant consultant to join our team. Role Of course, we don’t need to tell you what an SAP Logistics Consultant does, but we can tell you about SAP the Atos way. Many of our current projects entail transforming existing SAP landscapes to our own platform Canopy or our partner’s hybrid cloud platforms (Microsoft Azure, Google Cloud Platform, SAP Cloud Platform and Amazon). Being an SAP Logistics Consultant at Atos is a challenging role that will vary with each different project, but fundamentally you will be involved in the presales, design, specification, build, test and go-live phases of the required SAP solution at each client. You understand the challenges and developments that our clients face within their logistic processes. Some recent projects included: Improving sales and operations planning at a top pharmaceutical. Realigning logistic and maintenance processes at a government organisation. The team and Atos Just like you, our SAP consultants all possess just the right blend of technical expertise and business acumen, combined with a passion to deliver world-class solutions to our customers. Together we are a team and therefore value each members’ input. Your ideas and vision as an Atos SAP professional will help to shape the future of our SAP Practice. Join our winning team of over 700 SAP professionals in our region. Our company culture is down-to-earth, open, professional and inquisitive. It’s easy to see that we love to learn, and that we love to share knowledge. For that reason, we continually invest in our employees’ knowledge. In fact, our senior and junior SAP consultants enjoy mutual coaching and hereby both broaden each other’s knowledge and horizons. Not only that, but we also pay it forward: Atos stimulates IT knowledge at HBO’s and universities through local IT projects. Our consultants can work together with students on exciting projects in robotics, supply chain, image recognition and more. And did you know that Atos is the Olympic Games’ IT partner? As a consultant you can be there! And that’s just one of our international opportunities: at Atos we encourage our employees to take on international projects if they so desire. Who are you? As an experienced SAP Logistics consultant, you know your skills and we don’t need to bore you with a lengthy list of requirements. In a nutshell, you have a proven project track record within SAP SD and preferably eWM. To fit in with your new Atos SAP colleagues you have the same DNA: a true consultant: naturally inquisitive, structured and analytical, you have a thorough understanding of logistic business processes and subsequent challenges, you are always top of the (digital) developments within the industry, a vibrant SAP network and a feeling for commercial opportunities, you have broad exposure within SAP Logistics is a definite benefit: SD, MM, (e)WM, Pur, TM, GTS, S/4 Sales & Distribution, S/4 Sourcing etc, you’re fluent in both Dutch (required) and English. How to apply Due to the GDPR we kindly ask you to submit your application not via e-mail but via the button below. About Atos Atos is a global leader in digital transformation with 120,000 employees in 73 countries and annual revenue of € 13 billion. European number one in Cloud, Cybersecurity and High-Performance Computing, the Group provides end-to-end Orchestrated Hybrid Cloud, Big Data, Business Applications and Digital Workplace solutions through its Digital Transformation Factory, as well as transactional services through Worldline, the European leader in the payment industry. With its cutting-edge technologies and industry knowledge, Atos supports the digital transformation of its clients across all business sectors. The Group is the Worldwide Information Technology Partner for the Olympic & Paralympic Games and operates under the brands Atos, Atos Syntel, Unify and Worldline. Atos is listed on the CAC40 Paris stock index.

Business Engineer Finaps is an inspiring and fun place to work, where we are proud of the solutions that we deliver. At Finaps we work with small teams that can design, build and run our clients' business solutions. We believe that our people are our greatest asset. We have consolidated the classic roles and responsibilities of the IT chain and don't discriminate between consultants, developers or scrum masters. We're all engineers, no individual is an island. Together, we are much greater than the sum of our parts. Do you want to fill the gap between business and IT? At Finaps we believe that information technology can help businesses to achieve their goals. To realise this, we need highly creative, talented people who have an eye for clients and processes and are passionate to develop web or mobile applications and grow with us. Do you want to be involved in dedicated work and really make a difference for your clients? Then drop us a line. "Our people are our greatest asset" Is this you? Do you enjoy creating things and solving puzzles? Do you have a passion for IT? Are you skilled in process analysis? Are you skilled in translating requirements into client solutions? Are you creative and business-oriented? Do you have a sense of responsibility? Bonus points if you have: Experience with commercial software development and with front-end design. This is who we are We are determined We are limitless We are collaborative We are proud of what we do and the solutions that we deliver Join the team Apply with a motivation letter and CV Apply

Mambu is the SaaS banking engine powering innovative loan and deposit products, the lean alternative to cumbersome core banking systems.  Helping clients to successfully start up business ventures, transform existing operations, launch new products and expand into new markets. Mambu provides financial institutions of all sizes with the agility to rapidly design, launch, service and scale their banking and lending portfolio.  We believe that a great company is built on great people. We are proud to have brought together incredibly bright minds to help make financial services ready for the 21st century. Our clients understand what it takes to succeed in a fully digital world and our team is a trusted partner in their endeavours. To continue our success story we are looking for an Integration Consultant to work with our Delivery team and our customers or partners in defining technical solutions to project components. If you are thrilled by the opportunity to join our multi-national team on its unique mission - we need to talk and will be excited to hear from you. More about us: To stay on top of the latest Fin-Tech trends and our success stories, please follow us on LinkedIn For more details regarding our global career opportunities, please visit Career Site

Vacature Consultant Cloud Data management (medior-senior) Ben jij een hands-on specialist met goede communicatie-vaardigheden? Wat wordt je rol Je helpt klanten om complexe uitdagingen in hun data infrastructuur op te lossen. Je werkt samen naar de oplossing, van ontwerp, implementatie tot de overdracht naar Operations. Je stuurt junior (collega) engineers aan. De doorlooptijd van projecten varieert van 1 week tot 2 maanden. Daarnaast ondersteun je salesmanagers bij het binnenhalen van nieuwe opdrachten. Wat is de basis voor jouw succes Een HBO-opleiding/werkniveau 5+ jaar ervaring met enterprise storage- en backup oplossingen Ervaring met een Data Management technologie (bijv. Rubrik, Veritas of Veeam) Je bent analytisch, conceptueel, zorgvuldig, communicatief en je kan snel schakelen tussen meerdere projecten Je woont in NL en beheerst de Nederlandse en Engelse taal Pre’s Enige consulting ervaring Ervaring met cloud services op AWS, Azure of Google Bij OSP kun je doorgroeien tot Lead Consultant Onze klanten, waaronder banken, zorginstellingen en gemeentes, nemen beslissingen op basis van grote hoeveelheden data. Hun bedrijfsvoering wordt meer data-driven. Maar data staan al lang niet meer alleen lokaal. Private, public Cloud en on-prem oplossingen veroorzaken een gefragmenteerde en gedistribueerde data-spiegel, -silo’s en -verkeer. Daardoor ontstaan uitdagingen rond data control, protection, backup en (disaster) recovery. En er is er een groeiende druk door wet- en regelgeving. OSP helpt met oplossingen voor professioneel Cloud Data Management. We zijn technische specialisten in producten van Rubrik, Veritas en Cloudian. Wat mag je van ons verwachten? Een vast dienstverband Een uitstekend salaris plus prestatie-bonus Uitdagende projecten en een steile leercurve Opleidingsbudget en trainingsdagen Mobiliteitsbudget of auto van de zaak Laptop naar keuze Vergoeding voor mobile telefoon Pensioenregeling Je komt bij ons werken in een modern en gezellig kantoor met uitzicht over de rivier de Vecht. Je collega’s zijn (technisch) specialisten in hun vakgebied. De sfeer is informeel en gezellig en geeft ruimte aan het individu. Geen koffieautomaat, maar een goede espresso of cappuccino. En ‘s middags eten we aan onze grote lunchtafel. Het kantoor ligt op 10 min. loopafstand van het station. Contactpersoon Claartje van Heusden +31 20 49 50 222 We waarderen een korte toelichting waarom je solliciteert en geknipt bent voor deze baan.