Gehaltsübersicht für Head Of Quality in Basel-Stadt

Medical Director - Translational Medicine (Neuroscience)Job ID 384547BR Mar 05, 2024 Switzerland About the Role 2 Billion plus people are affected by diseases of the nervous system having a dramatic impact on patients and families around the world. Neurologic and psychiatric diseases remain as some of the largest challenges in medicine. Novartis is committed to changing the landscape by developing transformative treatments for important neuroscience disorders. As part of the Neuroscience (NS) departments at Novartis, you will help to develop therapies for patients with neuroimmunological disorders including multiple sclerosis. You will provide medical and scientific leadership and expertise in a role that significantly affects the entire Novartis NS pipeline. You will drive the success of both early and late stage global programs. You will provide scientific expert assessments and support for in-licensing opportunities, including due diligences. Your responsibilities will include:1. Translational Medicine (early clinical projects):• Develop high value decision-strategies for the Translational Medicine component of drug development projects from Research to clinical Proof of Concept or Proof of Mechanism in a single or multiple indications.• Develop and implement study protocols for different types of clinical studies (First in Human, Proof of Concept, mechanistic and safety studies), and other documents such as investigators brochures.• Responsible for clinical monitoring and integrated safety data review during and after the live phase of a study• Represent clinical Translational Medicine aspects to Health Authorities and other stakeholders (e.g. payers, patient advocacy groups)• Innovation: Champion and drive new clinical compound characterization opportunities and profiling approaches 2. Translational Medicine (late-stage clinical projects):In collaboration with the respective Translational Medicine Therapeutic Area Head:• Responsible for implementing studies during the Proof of Concept phase by providing medical and scientific leadership and expertise to all line functions on the project team. This may include methodology studies to identify and validate novel endpoints for early decision making in Proof of Concept studies.• Communicate clinical team matters to Global Project Teams, relevant BioMedical Research and Development boards, and other Novartis Boards as required.• Evaluate clinical centers and foster communication with crucial collaborating investigators, regulatory authorities, and other stakeholders• The work environment is in a matrix structure with cross-functional members from Translational Medicine, Biomedical Research and Development. 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 specialist in Neuroimmunology, you drive the project team clinical strategy. Works globally across various Novartis divisions as well as country organizations as appropriate 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 What you will bring to the role:• Medical Degree and advanced training in neuroimmunology• An expertise in translational or laboratory research. PhD preferred but not required• Record of drug submissions / approval and / or high quality publications in international scientific journals.• Previous relevant & significant clinical study experience: either from pharma/biotech leading early phase clinical trials; a senior role within a CRO responsible for managing the medical relationship with Sponsors; from a relevant academic medical center with PI & co-PI clinical trial experience.• Business fluent in English (written and spoken) 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.We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! 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

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.

Company DescriptionSobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.Job DescriptionWe are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing. The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management.Lead a strategy-driven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory documentAssume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authoritiesProvide leadership and project coordination to cross-functional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documentsLiaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing informationAssume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development programEnsure high technical quality of the documents in compliance with in-house technical requirementsCoach and develop less experienced Medical WritersOversee and coordinate all Medical Writers assisting on documents under your responsibility, including in-house consultants and Medical Writers at CROQualificationsLife Science Master´s degree or PhDA minimum of 8-10 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus in-depth knowledge of regulatory medical writing processesExperience in leading complex global regulatory and clinical writing projects, such as complex CTDs, ODDs, PIPs, briefing documents and regulatory responsesExperience as lead author for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers assisting on documents under your responsibilityClear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed productsAdvanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements)Additional Information  Über das Unternehmen:Sobi

Postdoctoral Position in Natural Product Research (Pharmaceutical Biology) The Department of Pharmaceutical Sciences of the University of Basel is an Academic Drug Discovery & Development Center, which comprehensively covers academic drug research throughout pre-clinical and clinical research phases. The Pharmaceutical Biology Group (Head Prof. Robin Teufel) within the Department is searching for a postdoctoral researcher with training and experience in natural product research, biosynthesis, protein biochemistry and analytical chemistry. Your position A postdoctoral position is available in the research group of Prof. Robin Teufel that focuses on the isolation of bioactive natural products from microorganisms and plants as well as the elucidation of the underlying biosynthetic pathways. You will be exploring enzymes from plant natural product biosynthesis including their mechanistic and structural investigation as well as possible modification by bioengineering for the production of pharmaceutically useful natural products and lead compounds. The place of work is at the Pharmazentrum in Basel. Fluency in English (C2 level) is required. Your profile We are looking for a candidate with a doctoral degree in a field related to pharmaceutical biology, biochemistry or chemistry. Experience in natural product research is required. Knowledge in natural product analysis (especially mass spectrometry & molecular networking, NMR etc.), enzymology, protein design, structural biology, molecular biology, and/or bioinformatics is furthermore advantageous. As a postdoctoral researcher, you will also supervise master students on occasion. We offer you The candidate will join a dynamic multidisciplinary research group of pharmacists, chemists and biologists working on the isolation/characterization of natural products and the underlying biosynthesis in one of the world's hubs for pharmaceutical research. Enjoy the vibrant scientific community at the University of Basel with great possibilities for internal and external collaborations as well as state-of-the-art instrumentation and infrastructure both in-house and close-by. As part of our team, you will receive supportive mentoring, a generous salary and enjoy the high quality of life in Switzerland for two to a maximum of four years. Application / Contact We are looking forward to receiving your online application with the following documents: brief cover letter, up-to-date curriculum vitae (CV) and contact details of 2 referees. The CV should list relevant experience and/or academic coursework, which can confirm the candidate's training in the methods listed above. Please note that we exclusively accept applications submitted through our online application portal. Applications via email, postal services or agencies will not be considered. For general inquiries please send an email to Write an email https://pharma.unibas.ch/en/persons/robin-teufel/ Universität Basel4000 Basel

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The position will report to the Head of Distribution & Regional Quality. The Senior Director, Quality, New Markets will provide GMP/GDP expertise and supervise the affiliate setup, commercial launch, post marketing quality activities (complaint, recall), distribution of IMPs and commercial products within the New Markets for BeiGene. (LATAM, Middle East North Africa, South Africa, Israel, and other countries ) and ensure the compliant affiliate setup, structure, interdependencies and supply with medicinal products. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory expectations and applicable quality standards. Essential Functions of the job: Ensure that the affiliate Quality Management System complies with relevant national and international guidelines and internal policies/global standards/SOPs are met. Assess and revise, as needed, SOPs and identify opportunities to streamline systems and processes. Create and maintain required documents and records in the QMS system. Actively contribute to establish and review Global Quality Standards to ensure compliance with local law requirements. Point of Quality contact for all operational Quality topics for Commercial and Investigational Medicinal Products for New Markets. In country/region product disposition as necessary and collaborate for batch disposition of finished products with Responsible Persons/Qualified Persons as required. Oversee product complaint handling in New Markets. Collaborate with Commercial, Supply Chain, Affiliate Management, Regulatory, Legal, and any additional departments required for launch setup. Ensure that all quality processes are compliant, sustainable and meet Health Authorities expectations. Participate in Due Diligence activities. Support internal audit and Health Authority Inspections. Support functions and SMEs to maintain and improve the inspection readiness process/mock audits. Advise and support agreements (e.g. Quality Distribution, Service, Master, Collaboration) regarding content, implementation, review and updates. Support regulatory filings, as needed. Supervisory Responsibilities: · New Markets Quality Team Experience & Qualifications: Bachelor’s degree in science or combination of education and equivalent work experience Minimum of 12 years pharmaceutical or biotechnology industry experience. Extensive GMP and GDP experience in a quality and manufacturing function. Worked in commercial environment, technical development and clinical environment experience is an asset as well as regional experience in LATAM, Middle East North Africa, South Africa and Israel. Core Knowledge and Skill Requirements: Ability to build up a team and effectively manage staff. In-depth knowledge of GMPs and GDPs. In-depth knowledge of Quality principles, concepts, industry practices and standards. Working Knowledge and experience with regional pharmaceutical regulations and experience in working with regional Health Authorities like ANVISA; SAHPRA and others. Excellent verbal, written and interpersonal communication skills. Ability to work independently with scientific/technical personnel. Experience with regulatory compliance inspections. Apply principles of logical and scientific thinking to a wide range of intellectual and practical problems. Must possess strong presentation skills to speak effectively before groups; ability to respond. Excellent interpersonal skills, including listening, writing, negotiations, facilitations, attention to detail. Strong Project Management Skill Set. Computer Skills: PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio) Veeva Vault Quality Docs; Veeva Vault Quality Suite; Veeva Submissions; SAP UL ComplianceWire; UL LearnShare Ability to work on a computer for extended periods of time Travel: May travel approximately 25 % · BeiGene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Bold Ingenuity Collaborative Spirit Driving ExcellenceÜber das Unternehmen:BeiGene Switzerland GmbH

Laboratory Head in Neuromuscular DiseaseThe 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 We are seeking a Laboratory Head to lead a Neuromuscular Research Group in the Neurotechnologies section within the Neuroscience and Rare Disease (NRD) therapeutic area. The primary focus of the section is on implementing and using novel delivery and RNA/DNA modifying techniques, as well as establishing suitable muscle disease models to develop therapeutics for some of the most challenging neuromuscular disorders. Our section works closely with other sections and groups within NRD as well as laboratories within our Therapeutic Modalities and Pharmaceutical Sciences groups and Data & Analytics to convert hypotheses into innovative therapeutics. Job mission We are offering an outstanding opportunity to lead a lab whose primary focus will be to establish in vitro models of muscle and neuromuscular diseases to better understand pathologies, test compounds, develop biomarkers, and suggest new therapeutic avenues. With a deep knowledge and experience in muscular and/or neuromuscular dystrophies, you will establish a new R&D working group in an exciting and fast-progressing therapeutic area. You will develop new therapeutic strategies and manage research programs in neuromuscular disorders. You will be responsible for applying scientific expertise and judgment to initiate, design, direct, and execute experiments and/or studies in support of research and/or development project goals in a time sensitive manner. You will have tremendous resources and capabilities, and you will be surrounded by world-class scientists and drug hunters in a state-of-the-art new building located at the pRED center in Basel. Your key responsibilities You are leading an effective team of Scientists and Associates to generate models of neuromuscular and muscular dystrophies. You are bringing deep scientific expertise about neuromuscular and/or muscular pathologies, respective disease models, and an overview on therapeutic approaches in the preclinical and clinical space. You possess hands-on experience in patient-derived cellular as well as physiological models. You implement cellular research models with endpoints that support understanding of patient disease and biomarkers. You are leading drug discovery projects and ensure successful translation of pre-clinical programs to a clinical setting. You have experience in preparing high quality documents including technical reports, presentations, SOPs, and experimental protocols. Experience in regulatory filings is a plus. You act as an impactful contributor and/or leader of project teams and seminal initiatives. You foster creativity, productivity, execution with a sense of urgency, teamwork, accountability, cross-functional collaboration, and employee growth and development. Who you are You completed a PhD or MD/PhD in science and bring a minimum of 8 yrs solid research experience (after your PhD) in the muscle biology or neuromuscular field. You bring a proven scientific-track record through impactful publications in the field of muscle biology or neuromuscular disease, patents, or substantial contributions to drug development programs. Experience in drug development is a clear asset for the role. You are a rigorous scientist with a strong expertise in cell-based and animal models of neuromuscular disease, including a solid grasp on the literature of disease mechanism and treatment avenues. You are someone who is driven by the desire to find therapeutics for some of the most devastating disorders. You possess excellent interpersonal and communication skills, enjoy teamwork, diligence and efficiency. You showed your capability to lead an independent research team. You are a kind and influential team leader and a trusted and knowledgeable colleague. You possess the flexibility to rapidly change priorities and deadlines and the ability to lead others through change in a dynamic, fast paced industry and work environment. Working in a multicultural environment motivates you. Our commitment Roche commits to recognising talent and aptitude. We prioritise 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.

EUROFIMA European Company for the Financing of Railroad Rolling Stock is a supranational organization in Basel, Switzerland. EUROFIMA fulfils a non-profit maximizing mission to support the development of public service passenger rail transportation in its 25 contracting states. EUROFIMA provides competitive financing to support its shareholder railways in renewing and modernizing their equipment. As of May 2024 – or by arrangement – we are looking for anRail Finance Manager (80% - 100%), Business Development UnitAt EUROFIMA, we're committed to leading the way in sustainability and responsible investing. Our Front Office unit is at the forefront of this effort with many ongoing initiatives and projects. We're looking for a dedicated professional to join our dynamic team and contribute to our sustainability goals. Responsibilities and Impact: Collaborate with the Treasury & Asset Management unit on projects to measure financed emissions (Scope 1, 2, and 3) Assist in evaluating the ESG risks associated with individual investment portfolios Work closely with the Front Office team, providing support to elevate our sustainability engagements with shareholders using the internally developed Shareholder Assessment Framework Be involved in the EUROFIMA evaluation of Sustainability Reporting Standards Qualifications and Experience: A bachelor’s or master’s degree with a strong foundation in analysis, critical thinking, and problem-solving relevant to fields such as Banking/Finance, Economics, or Sustainability (Candidates with equivalent experience or knowledge in related areas are encouraged to apply) Demonstrated ability to conduct thorough analysis and present data-driven solutions. Experience in tackling complex problems and making informed decisions is essential Advanced proficiency in Microsoft Office, especially Excel, and a strong foundation in programming (e.g., VBA, Python, SQL). Familiarity with web development languages (HTML/CSS) is beneficial Exceptional written and oral communication skills in English, with the ability to articulate ideas clearly and persuasively in diverse settings. Proficiency in additional languages such as German, French, and/or Slavic languages is highly valued and can enhance team collaboration and client engagement Proven ability to efficiently manage and prioritize multiple tasks and projects in a dynamic environment, ensuring timely and high-quality outcomes What we offer: A role at the heart of our sustainability strategy, with opportunities to make a significant impact A supportive, collaborative work environment that values innovation and creativity Comprehensive benefits, ongoing professional development, and a commitment to work-life balance About the Internship: The duration of the internship is 6 months, with a possibility of extension. You will work in our new offices at Meret Oppenheim Platz 1 C in Basel, close to the main train station or from home. We look forward to receiving your complete application in English including your motivation letter/email at Write an email. About us: EUROFIMA is an equal opportunity employer committed to creating a diverse environment and supporting flexible working arrangements. At EUROFIMA, we work in small interactive teams and foster an environment for fast learners eager to create an impact with their daily work. From day one, you will assume a high level of responsibility and independence. If you have any questions concerning the position, please contact Kristina Micic, Portfolio Manager & Lead Sustainability Integration, at Write an email.EUROFIMAFrau Annett StehrHead of People + Culture