Kategorie: Wissenschaft - Forschung - Entwicklung - Chemie

Hobson Prior are looking for a QA Manager to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. This position is on a contract basis, located in Basel. Job Responsibilities: Accountable to work as per the defined strategy for the global clinical audit program (e.g. site, vendor, process). Plan, perform, and report audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach. Facilitate the CAPAs elaboration and follow-up. Develop own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself). Lead the preparation, facilitation and follow up of inspections by national and international regulatory authorities. Raise any serious / continuing non-compliance issues as appropriate. Contribute to process improvements and trouble shooting. You will support the organisation/CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical. Make a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations. Maintain awareness / expertise in international ICH-GCP requirements. Deliver leadership and direction on ICH-GCP related activities / issues. Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions). Highly contribute to develop/imoliprove CQA tools and processes. Represent CQA in internal and external meetings and particularly represent Team Leader CQA when he/she is not available. Key Skills: Excellent English knowledge (written and spoken). Strong writing, communication and listening skills. Proven record of excellent problem solving, risk analysis and negotiation skills Ability to work as a team player and independently. Reliable, conscientious, agile/flexible. Requirements: Bachelor degree or equivalent education/degree in life sciences or healthcare. Experienced in Clinical Research & Development. At least 6 years of experience in pharmaceutical industry/health authority with at least 3 years of experience in Quality Assurance / Auditing within the ICH-GCP environment. Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource). In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices. Previous experience in medical device and/or combination product will be an added value. Previous experience in international cross-cultural relations. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

About our client For our client, one of the leading Healthcare & Life Sciences companies based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role in their Clinical department. This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment. Your mission: - Identify required documentation for global submissions and provide timely preparation of high quality CMC regulatory documentation - Manage the Document Management System and ensure appropriate user access - Continuously identify bottlenecks and possible improvements regarding document management processes; - Assure technical congruency and regulatory compliance (Good Clinical Practices) The ideal candidate: - Minimum Bachelor's degree in the Healthcare & Life Sciences field - Advanced knowledge of clinical documentation (or medical writing) and best practices - 3-5 years of experience in clinical development/operations - Familiar with regulations and guidelines for new chemical entities - Ability to multi-task and work independently under pressure of time Candidates must have a valid Swiss or European permit or work rights to be considered for this position. If you would like to be considered for the role, please apply directly or send your CV to . We look forward to hearing from you!

The company is a medical firm. Provide strategic support for early portfolio management in Cardiovascular, Renal and metabolism (CRM) (at least, 50%) and other key GDD therapy areas (oncology and pharma, TBD) Co-lead strategic engagement with key leaders from the patient community to consult on and inform GDD strategic decision-making (i.e. Patient Advisory Forum) Identify overarching commonalities & topics of specific interest among the patient communities relevant to the early CR&M portfolio and in support of the broader Novartis patient advocacy goals Align, collaborate and co-operate with internal stakeholders to facilitate the inclusion of the patient and caregiver as key external stakeholders 9 years of experience in the Pharma industry. Minimum of 5 years of roles in patient advocacy, communications or related type of role. Exceptional interpersonal and partnering skills with a strategic mindset. Excellent written and verbal communication skills an asset. Proven ability to lead with high impact in a matrix organization. Languages: Fluency (verbal/written) in English is necessary. Desirable requirements Ph.D. in science, communications, law, public health policy, health economics, business administration or other relevant field. Fluency in two to three other major languages is an asset (e.g. German, French, Italian, Spanish).

The company is a global enterprise with core competencies in the Life Science fields of health care and agriculture. The Global Development Leader Oncology (GDL) is as Vice President part of the Late Stage Clinical Development Leadership Team. He/she will be responsible to ensure the development of a global clinical strategy and the operational conduct of global clinical development activities for all clinical development projects within the worldwide Global Clinical Development Organization including multiple programs in the Oncology portfolio with an emphasis on precision medicine. This role includes line management responsibilities of multiple Clinical Development Leaders located in several countries. In addition, the incumbent will be responsible for the clinical leadership of the Global Program Team(s) (GPTs) ensuring appropriate representation of the programs under their leadership internally and externally. Highly successful M.D. with extensive professional and academic experience, preferably with board-certification in oncology or hematology/oncology Experience in late development phases including leading of one or more agents to a regulatory approval is preferred Current knowledge and experience of drug development in patients and regulatory review and responses Knowledge of the whole R&D process and the key drivers for success Strong understanding of the elements of drug development programs Exposure to and understanding of commercial considerations in relation to drug development Able to manage diverse activities to deliver milestones according to set budgets. Sets priorities and organizes a team effectively Able to manage and develop both direct reports and matrixed team members, including performance management and change management Effective resource management including demonstrated fiscal responsibility, Evidence of ability to lead and implement continuous improvement Capable of managing and developing team members from diverse technical backgrounds, including deep technical / scientific expertise Personal Characteristics & Leadership Behaviors Compliant with business processes whilst retaining a flexible entrepreneurial and open-minded approach to new and creative ideas Exhibits good leadership behaviors: Sustain Focus on Performance, Manage Changes, Create an Inclusive Environment, Develop People, Align across the organizations Fluency in English

Die Firma ist die wichtigste Schweizer Institution zur Förderung der wissenschaftlichen Forschung. Leitung des Bereichs Eccellenza/Ambizione/PRIMA in personeller, fachlicher, organisatorischer und administrativer Hinsicht Unterstützung bei der wissenschaftlichen Evaluation von Gesuchen und bei der Verwaltung von Beiträgen, ggf. Betreuung eines der Instrumente Vorbereitung von Unterlagen zu Handen des Fachausschusses Karrieren Mitarbeit bei der konzeptionellen Weiterentwicklung der Instrumente dieses Bereichs Präsentation der Instrumente nach innen und aussen Mitwirkung in Arbeitsgruppen der Abteilung / der Geschäftsstelle Hochschulabschluss mit Doktorat Ausgewiesene personelle Führungserfahrung, insbesondere im Bereich Forschungs- und Projektmanagement, sowie Postdoc-Erfahrung von Vorteil Ausgeprägtes Interesse an der akademischen Nachwuchsförderung Gute Kenntnisse der schweizerischen Forschungslandschaft Organisationstalent, Flexibilität, Kommunikations- und Teamfähigkeit und sehr gute redaktionelle Fähigkeiten Ausgezeichnete Deutsch- oder Französischkenntnisse mit guten Kenntnissen der anderen Sprache und des Englischen

The company is a pharma firm. Program management leadership of cross-functional, strategic, high-business value projects for . Global Development Operations with measureable added business value outcomes and benefits Drive strategic, centralized operational excellence improvement initiatives on GDD and GDO level focused on process re-engineering; producing deliverables such as the project charter, project, plan, change management plan, integrated risk register and business benefit case Drive business transformation in a heavily matrixed environment Apply disciplined, best-in-class project management methodologies (e.g. Agile, Scrum, or equivalent) to the delivery of complex and high visibility projects providing rigorous project planning, risk management, project controls and re-porting following Novartis Project Management framework Act as Scrum Master overseeing daily standups, sprint planning, demos, retrospectives Provide senior level, cross-unit and function (up to DCN - 1 level) stakeholder management to effectively manage change and proactively identify risks and mitigations Understand vision, strategic imperatives, business drivers, and changing landscape. Challenge assumptions of senior stakeholders in order uncover hidden risks and build realistic plans Lead cross-functional, global teams in support of initiative objectives 10. Ability to multi task and manage multiple (5+) projects at one time Develop ideas for changes in process, methods, organization, location, tools and measures of success for achieving business excellence Utilize process improvement methodologies and best practices (e.g. IQP, Lean six sigma, etc.) Help develop and maintain core team processes Prepare roadmap reports for projects to all stakeholders, including engaging with Sr. management stakeholders . Deputize for VDO Global Head Postgraduate degree in technical or business discipline PMP, PMI, PRINCE2, SCRUM or other relevant certifications Fluent English (oral and written) Preferred: a second major European language 5+ years' experience managing teams of 10+ associates 10+ years of project management experience, delivering cross-functional technology solutions in a variety of different styles (Agile, Waterfall, etc.)

The company is for Nuclear Research, physicists and engineer. Are you passionate about communicating fundamental research in the current media landscape? Do you thrive in a fast-paced news environment with many different audiences? CERN offers an exciting opportunity to lead its media relations team and coordinate the Organisation's strategy for engagement with the international media. Master's degree or equivalent relevant experience in the field of scientific journalism or communication or a related field. Experience: Demonstrated experience of professional media communication in a scientific or engineering area. Experience of professional media communication in the field of Particle Physics would be an asset. Demonstrated experience in writing engaging, concise and accessible texts on complex scientific subjects in both CERN's official languages of French and English. Extensive experience of management in the Media Relations area. Technical competencies: Media relations. Strategic communications planning. Crisis communications. Science writing. Behavioural competencies: Demonstrating accountability:Makes appropriate use of the Organization's resources; uses openness and honesty to interact constructively with others. Achieving results: Delivers prompt and efficient service taking into account customer needs; defines clear objectives, milestones and deliverables before initiating work/ project. Building relationships:Relates well to all people regardless of category/level within the Organization; understands how individual differences bring added value to the Organization; promotes complementarities. Demonstrating flexibility:Adapts quickly and resourcefully to shifting priorities and requirements; demonstrates an openness to new ideas and situations. Creating vision and strategic partnerships:Encourages staff members and external stakeholders to take responsibility for achieving CERN's potential; recognizes the benefits of collaboration with external partners, understands their functioning and develops a strong network within the sector. Language skills: French and English: spoken and written, with the ability to understand and speak both languages in professional contexts; and draft texts for publications

The company is a medical firm. Assists in site objectives and budgets that are globally aligned with BT Infrastructure to facilitate the orderly and efficient provision of IT services to the Site. Work to understand and communicate the BT Infrastructure needs within the site of responsibility and ensure BT Infrastructure functional leaders, and Regional Service Delivery Leader, are informed and aligned with the needs of the sites/region. Facilitates problem resolution (between the BT groups) at the site level where possible; this may include resource challenges, project timing, managing local escalations, and local (regulatory) requirements. Fulfills the role of Infrastructure Responsible on designated projects, and operational life-cycle activities for designated local systems. Will also be process owner for selected ITIL processes. Is the local contact and relationship manager for any local site Infrastructure audit activity (Regulatory, Internal Audit, External Audit, ITGC etc.) coordinating with other BT (Information Technology) Infrastructure groups Will develop local policies and procedures to extend the global policies, if necessary to meet local regulatory requirements. Develop and maintain relationship with all local site BT Infrastructure resources and be a mentor and escalation point for individual staff needs as a dotted line manager. Supports the execution of the global BT strategies that are aligned with and drive the overall corporate business strategy with a long term focus of 3-5 years and assist in the development of site/regional strategies to meet site/regional needs if necessary. Manage local communications both internally within BT and externally with the business to deliver proposals, solutions, and mitigate conflict that will drive corporate goals. Bachelor's Degree or equivalent experience; educational concentration in a computer-based discipline (e.g. Computer Science, Information Systems) or a technical discipline (e.g. Engineering, Mathematics) is preferred. Master's degree or post graduate coursework is preferred 8+ years of related experience working with integrated enterprise systems is required, including 2 years of management experience. In-depth knowledge of a regulated industry is preferred. Experience in working within a global, matrix-ed management organization is highly desirable. Good German and English language skills required Pharmaceutical/Biotech or similarly regulated environment experience is preferred.

The company is a pharma firm. Coordinate labeling activities across LPBN. Liaise with internal customers/colleagues and applications' vendors to define applications' roadmap. Support with estimation for CAR related to labeling activities. Coordinate external resources to design labeling templates across LPBN. Maintain the Lonza LPBN's application gaps and help internal Lonza's customers with prioritization. Ensuring the compliance of systems in the portfolio with all relevant local, global, industry and regulatory policies and guidelines. Support standardization of labeling applications, label printers, label materials across LPBN sites Managing the routine operation, development, improvement and standardization of the systems in the portfolio and the associated processes used within Lonza. Provide and communicate explanations to the Lonza LPBN departments in a timely, effective, and professional manner as required. Assist in writing/updating system's documentation. Bachelor's degree - Preferred area of study: Life Sciences / Pharma IT 2 years' plus experience in managing GxP applications for life science, including Computer System Validation activities. Experience in process modeling is an asset Labeling IT Systems Skillsets: 3 years' plus experience implementing labeling systems and performing tasks In a regulated pharmaceutical production environments. (Desirable) Previous experience in one or more labeling solutions, such as (desirable)

The company is a pharma firm. • Lead and manage the global cross-functional CTT to ensure deliverables are met within the established timelines, budget and quality/compliance standards; accountable for representation at all internal meetings related to clinical trials; chair the routine CTT meetings, report study progress and issues/resolution plan at the Global Clinical Team (GCT). Core member of the GCT. • Lead the development of global clinical trial protocol(s) by translating the approved trial concept sheet(s) into efficient, high quality, executable clinical protocols: • Trial planning, execution and close-out. • Accountable for trial level life cycle budget management including forecast and annual cost targets; owner of and accountable for clinical work package; accountable to ensure trial budget is revised when applicable. • Assess trial resource needs in collaboration with GMA Franchise Clinical Operations Head. • Lead the CTT in defining the data review plan and ensure ongoing data review and cleaning activities are meeting the quality standards in support of database locks in collaboration with SDRE, Medical and Data Management. • Ensure third-party Investigator Initiated Trials (ITTs) and Managed Access Programs are conducted appropriately and timely in accordance with SOPs and in collaboration with the Regions and countries. • Advanced degree or equivalent education/degree in life science/healthcare preferred. • Fluent English (oral and written). • 5+ years of operational and managerial experience in planning, executing, reporting global clinical trials in a pharmaceutical company or a contract research organization. • Proficient communication, influencing and negotiating skills. • Strong project management skills and demonstrated ability to meet timelines. • Proven ability to work independently in a complex matrix environment (including remote or virtual team environment). • Experience in developing effective working relationships with internal and external stakeholders • Organizational awareness, including experience working cross-functionally and in global teams. • Strong interpersonal, problem-solving, negotiation and conflict resolution skills. •Established knowledge of Good Clinical Practice, clinical trial design and global drug development process.

The company is a pharma firm. • Lead team of regional Process Control Managers and regional Training Managers to develop functional center of excellence within RE by identifying and implementing best-in-industry practices • Lead the regional group of regional PCMs to drive quality in the region, countries, and sites through risk management, design of programs to improve quality systems and standards, monitoring process, and develop corrective and/or preventive actions, in collaboration with TMO regional heads and the Process Control Global Head • Establish and implement regional strategies and objectives with the goal to increase and sustain a high performance and quality in Trial Monitoring within RE, in collaboration with Trial Monitoring Region and Countries, other GDO functions, and Quality Assurance (QA) partners • Represent TMO in inspections and audits, coordinate activities for preparation, support during inspections, and follow-up on actions and commitments within RE • Lead multi-functional teams within TMO as appropriate to develop and implement multi-disciplinary process & quality improvement solutions/initiatives in Trial Monitoring; in collaboration with the global monitoring excellence team, the Process Control Global Head, and key stakeholders • Ensure consistency, efficiency, and high level of compliance within RE • Be responsible for the oversight and facilitation of quality and process improvement, and for implementing quality control within the TMO function within RE through oversight of Key Quality Indicators and other tools, driving self-inspection activities and providing overall support to Trial Monitoring associates in countries and the region, in collaboration with the Process Control Global Head and the Global Head Training • Advanced Degree or equivalent education/degree in life science/healthcare required (PhD/MD Preferred) • Fluent in both written and spoken English; additional language, if used for local Business purposes • ≥10 years of pharmaceutical clinical drug development experience, in planning/executing and/or monitoring clinical trials • ≥5 years people management incl. leadership of managers and talent development experience required, this may include management in a matrix environment. People management with responsibility for internal resource estimation/allocation required • Demonstrated leadership and accomplishment in all aspects of conducting or supporting clinical trials and programs with cross-functional teams • Strong management, interpersonal, problem solving, negotiation, and conflict resolution skills • Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), regulatory requirements from health authorities (FDA/EMEA), local/National. Novartis experience in these areas is preferred • Proven track record in clinical operations process improvements. Monitoring experience is preferred

The company is a healthcare business. Collaborates with the BU leaders to optimize the Go to Market (GTM) model ​• Proactively bring together all aspects of ComEx (sales execution, commercial skills, compensation) and other resources to the BU, implement the optimal/tailored solution to drive growth and ensure success​• Drive sales execution & effectiveness across the BU to maximize resources & ensure sustainable long-term growth​• Ensures full usage of existing sales tools, showcase value and suggests enhancements where appropriate.​• Ensure all initiatives are measured and tracked in a meaningful way that promotes continuous improvement​• Develop targeting and call planning scenarios, based on data driven decisions, to plan where the Sales Force should spend most of their time, and ensure targeting is optimized for focus campaigns and new product launches/sales initiatives • Uses all available inputs, especially those from sales performance, to understand the commercial training and development needs of the Business Unit. Defines the training plan for those individuals. • Collaborate with the different stakeholders such as CVG commercial excellence and local finance teams to drive set up and execution of sales incentive plans. • Lead territory design exercises through the optimum balance of sales potential, market share, geographical area and critical relationship factors • Lead special program implementation relevant the commercial model (HEART and GTM initiatives in the BU) • Master degree in economics, business administration or equivalent​• 10 years of working experience in business related function / environment​• Experience in a role supporting marketing & sales or in sales management​• Affinity with commercial excellence​• Experience with data analysis​• Having worked in an international company/environment, ideally in the medical device industry​• Experience in working in a complex organization with different countries / cultures​

Die Firma ist eine Pädagogische Hochschule. Fachliche, personelle und finanzielle Leitung der Stabsabteilung Gesamtverantwortung für die interne und externe Kommunikation, das Marketing sowie die Medien- und Öffentlichkeitsarbeit der PH LuzernUnterstützung der Hochschulleitung in sämtlichen KommunikationsbelangenWeiterentwicklung der Unternehmenskommunikation Konzeption und Durchführung von KommunikationsprojektenRedaktionelle Verantwortung für den Tätigkeitsbericht und weitere Publikationen der PH LuzernVertretung der Anliegen von Kommunikation und Marketing in internen und externen Gremien Hochschul- oder Fachhochschulabschluss im Bereich Kommunikation oder gleichwertige QualifikationErfahrung in vergleichbarer Funktion (inkl. Projektleitung, Konzept-, Text- und Medienarbeit, Marketing)Vertraut mit der Zentralschweizer MedienlandschaftHohe Sprach- und Kommunikationskompetenz, vorzugsweise journalistische ErfahrungFundierte Kenntnisse der digitalen Informations- und Kommunikationstechnologien Interesse an Fragen der Hochschulbildung im Allgemeinen sowie der Lehrerinnen- und Lehrerbildung im BesonderenRasche Auffassungsgabe und BelastbarkeitInitiative und engagierte Persönlichkeit

The company is a medical firm.  Contracting & Pricing Lead pricing & gross-to-net strategies for hospital pharmacist-driven brands channel (in close collaboration and alignment with the Sales Team Lead) Own the execution of contracting and tenders, including business case assessment and pricing analysis Portfolio Management & Marketing Lead and develop strategy and customer & portfolio marketing plan for pharmacist- and retail-driven brands Conduct portfolio assessments to identify growth opportunities, and further ways to maximize our economic potential (i.e. COGS strategy, portfolio rationalization, out of stock management, open supply, etc.) Lead, develop and deliver value-added services and programs and promotional materials (where applicable in alignment with global/ teams) Advance innovative programs which improve access to our medicines, such as the capitation model Cross-Functional Leadership & Global Collaboration Leading the cross-functional team with responsibility for generation of customer and portfolio insights, prioritization and balancing of portfolio and customer programs & investments Drive education of FF to ensure and enhance implementation and accuracy of materials, programs and services Share knowledge of local dynamics and insights on the portfolio and customers with global team where applicable as to enable development of core programs/material Ensure close collaboration with supply management teams Customer Engagement & Insight Generation Build relationships with relevant pharmacist associations Optimize Customer P&L for top 10 accounts together with sales lead Define customer objectives and actions per key target groups and input into Key Account Plans & FF objectives Financial Planning, for relevant portfolio: Define portfolio and customer programs with objectives, resources, KPIs and expected returns Budgeting and control of operational expenses and investments for your portfolio Ownership for key financial tasks including the development of annual budgets, operating plan, market sales forecasts, quarterly updates etc. Lead the financial analysis, Latest Estimate and presentation set-up during Operating Plan and Business Review for relevant portfolio Business Development: analysis of global and local business opportunities, including Business Case Preparation)     Ownership & innovative mentality Solid understanding of hospital & pharmaceutical space Five years of relevant experience, which may include management/strategic consulting at a top firm, portfolio/contracting, marketing or financial roles and/or experience working within hospitals or healthcare systems University or University of applied science degree Strong analytical/financial skills with strong business acumen Demonstrated cross-functional leadership experience Excellent verbal and written communication skills including in German and English (French and/or Italian preferred but not required) Willingness to travel up to 25% of the time.

The company is a consulting firm. The Senior Lecturer will take a major role in the compulsory MAVT bachelor course series in the area of dynamic systems and control. Additionally, he/she will be involved in possible new lectures which are in discussion at IDSC. The duties include teaching of lectures, teaching the recitations, developing teaching materials and organizing the corresponding exams. After a successful starting phase, he/she will start building up his/her own independent research group, with the possibility for tenure and promotion to "Titularprofessor" after successful evaluation through the Tenure and Promotion Committee. The successful candidate should hold a PhD in controls (or a related field) and be committed to excellence in teaching. He/She must have previous experience in teaching or co-teaching a lecture/recitation/exercise in academia. The ability to develop and lead an independent, internationally-recognized, externally-funded research program in the area of controls is beneficial at a later stage. For the teaching of BSc courses, proficiency in German is an advantage.

The company operates within the biotech sector. Gives guidance to the organization by communicating a clear innovation vision, setting priorities and explaining the innovation strategy Strong team player and ability to lead cross-functional teams working in a matrix organization Further develops existing predictive algorithms and defines business model Collaborates and co-creates cross-functionally on beyond the molecule solutions in order to achieve highest impact Responds quickly to customers' needs and market changes Ability to create real world data, advanced analytics and outcomes Works in strong collaboration with country leads to co-create solutions and improve the patient care pathway Stakeholder mapping and ability to find win-win solutions for all stakeholders (patients, payer, provider etc.) to customers' challenges based on key insights Develops comprehensive business cases that show value, costs and risks to all stakeholders, as input for effective decision making Effectively navigates Amgen internal processes and governance for innovation/Beyond the molecule solutions Develops material for external use for key beyond the molecule solutions Implements and tracks execution of beyond the molecule solutions at agreed quality level, costs & planning Academic education or experience from similar positions Minimum 5 years of experience in industry 1 to 3 years as a Pharmaceutical Sales Representative Minimum 3 years experience as a Product Manager Tenure at last two jobs for at least 2 years each Documented experience in the area of cardiovascular or other chronic diseases Documented track record of product launch Financial and budgeting skills and experience Fluency in English, both oral and written communications Computer skills (MS Office programs)

Hobson Prior are looking for a Clinical Operations Manager to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. Job Responsibilities: Drive the development of the operational trial related documents and procedures, as well as setting-up the ESPs and supervising the deliverables of all ESP related activities, from specifications to close-out. Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics Committees/Institutional Review Boards, timely completion of electronic Case report Form, Source Data verification progress and query responses timelines. Lead the development of ESP specifications, testing and implementation in collaboration with other functions, and ensure appropriate quality control of deliverables. Manage the selection of ESPs in collaboration with other functions. Supervise the deliverables towards the Contract Research Organization and ESPs selected for the trial, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to the Clinical Trial team. Manage the development of trial-related operational documents. Consolidate information on operational clinical trial level activities for reporting to the CTT by the Senior Clinical Operations Manager (including critical issues and key performance indicators). Resolve operational issues in a proactive and timely fashion. Represent as the communication channel for the Clinical Research Associates to ensure data quality is maintained, in close collaboration with other CTT functions Approve invoices and ensure related payments in a timely manner. Contribute to the Study Master File completeness and readiness for audit/inspection and by performing ongoing quality checks/review. Actively partake to Investigators meeting preparation and presentations and in Site Selection Visits and Site Initiation Visits, as necessary. Key Skills: Strong computer skills including proficiency in Microsoft (MS)-based applications. Strong verbal and written communication skills in English; strong cultural knowledge of national diversities. Excellent interpersonal, communication (written and verbal), collaboration and organizational skills. Self-motivated and able to work independently and proactively. Goal-oriented, able to effectively prioritize and execute tasks in a high-pressure environment. Demonstrate ownership and initiative, decision-making, working flexibility and problem-solving skills. Requirements: Bachelor of Science degree or equivalent University degree in life sciences or healthcare. A minimum of 4 years experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start up to clinical study report. Experience in working in global cross-functional (matrix) and multicultural teams. Experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management. Prior experience as a CRA. Previous experience working with electronic data capture, electronic Trial Master File, and Clinical Trial Management Systems. Excellent knowledge of International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines. Position may require international travel. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. As you develop your career as a CRA or Senior CRA , this role offers you the opportunity to plan and progress your career in the direction you choose. At IQVIA™, we do not believe in a 'career ceiling.' You can make the CRA/Senior CRA role a stepping-stone into wider opportunities like operations management, dedicated customer solutions, and project management. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards. Award winning and innovative, we will give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You will be building a smart and flexible career with no limits. While projects vary, your typical responsibilities might include: Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation Supporting the development of a subject recruitment plan Establishing regular lines of communication plus administering protocol and related study training to assigned sites Evaluating the quality and integrity of site practices - escalating quality issues as appropriate Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution You should have: A Bachelor's degree in a health care or other scientific discipline or educational equivalent At least one year of on-site monitoring experience Alternatively, you should have an equivalent combination of education, training and experience Excellent communication skills in English language including good command of two of the following languages: German , Italian or French You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements. If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team . Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.Forge a career with greater purpose, make an impact, and never stop learning.

Hobson Prior are currently seeking a Pre-Approval Access/Compassionate Use Coordinator to join a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. Job Responsibilities: Creates and maintains strong relationships with key stakeholders and ensures an efficient, effective and compliant PAA/CU management. Accountable to develop and maintain effective working relationships with (G)IMDs, PAA/CU team members, affiliate team and vendors. Manages timely interaction with the Clinical Drug Supply Leads in Pharma Technical in order to ensure proper preparation and delivery of the PAA/CU drug supply. Ensures receipt, filing and tracking of PAA/CU records (SDEAs, Physician's Agreement, Regulatory Requirement Forms, other country specific documents) in the required quality. Represents as the SME for the development of procedures for PAA/CU, supports development of the working practices and processes related to PAA/CU programs, and maintains them up-to date. Manages Touchpoint (filing area, affiliate area) and RecPoint (records) program area according to global standards, including set up, access rights and maintenance of program related documents. Keeps the Compassionate Use Program Database up-to-date and provides regular reports to Senior Management, incl preparation of metrics. Recognises proactively potential delivery issues and risks and ensures corrective actions in case of deviation communicates to stakeholders. Accountable for project management, tracking of milestones and timelines, and timely data entry in CTMS. Proactively incorporates learnings and recommendations from other programs; identifies needs for process standardization, regulatory compliance direction and areas for improvement. Key Skills: High ethical standards. Strong collaboration and teamwork skills, including ability to work across organization at all levels and achieve results within a multi-cultural team. Excellent analytical/problem solving skills. Ability to achieve win-win situations in a complex environment with key stakeholders. Strong project management, organizational and operational skills. Requirements: Life sciences degree or nursing equivalent or post graduate degree in life sciences, medical or equivalent area. A minimum 5 years professional experience in the pharmaceutical/clinical research industry, preferably clinical development. Broad understanding of global expectations of Health Authorities. International clinical trial management experience. Project/program management experience. Excellent knowledge of ICH/GCP. Relevant scientific knowledge. Knowledge of drug development and regulatory requirements for the conduct of clinical trials. Familiarity with clinical operations practices. Fluency in written and spoken English. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Hobson Prior is working with a Swiss clinical stage biopharmaceutical company focused on advancing modern medicine and improving the management of serious diseases. Our client is seeking a Development Project Team Leader to join them on a permanent basis and will be accountable for leading, directing, driving the successful transition of research projects into early clinical development and/or early clinical development projects into late stage clinical development. Job Responsibilities: Accountable to define project path and strategy in alignment with all stakeholders and set clear direction for all contributing parties. Coordinates and delivers strategic input to mid- and long-term project plans including clinical proof-of-concept / development plans. Generates and upholds up-to-date project documentation incl. project plan, objectives, budgets, risk assessment, timelines, communication plan and milestones and keeps all contributors focused and on track. Co-operates with all key functions incl. research, translational science, clinical development, clinical operations, manufacturing, bioanalytics, business, finance etc. and ensures effective cross-functional communication and project execution. You will ensures that team members are aligned behind project objectives and that management and functions understand and support project objectives and provide the necessary resources. Recognises and addresses project relevant risks and issues; drives issue resolution; challenges the status quo; implements pragmatic solutions; does what needs to be done. Accountable to enable and ensure timely decision making by management and team; prepares and presents relevant documentation. Support project in preparing / coordinating internal and external project communications: seminars, abstracts, posters, publications. Organizes project team meetings: invites, capture agenda, minutes, actions and ensure follow-up. Thrives to balance quality, time, and cost to maximize project value. Key Skills: High energy, motivation and drive and proactive. Exceptional organizational skills, focus, and ability to understand complex problems. Good listener, fast learner with exceptional ability to simplify problems, identify key issues, and devise pragmatic solutions while keeping the big picture and ultimate goal in mind. Fluent in English (written and spoken). Excellent computer literacy all standard MS. Requirements: Scientific background (academic or working) in immuno-oncology, oncology and / or immunology required. A minimum of 5+ years of experience as Project Team Leader of or key contributor to early or late stage clinical projects or projects transitioning into clinical development (translational medicine / science. Documented hands-on contribution to at least some key strategic clinical study documents: Translational plans, Ph1 clinical study design, proof-of-concept study designs, pivotal study design, clinical development plans, clinical study protocols, clinical study data evaluation, clinical study reports, regulatory strategy, and commercial strategy. Preferably PhD in life sciences (or MD with scientific education). Good understanding of required contributions from all research and development functions to project progression at any development stage. Good knowledge of GXP and regulatory requirements is admirable. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Hobson Prior are currently working with a leading biotechnology organisation who are focused on the development of pioneering oncology drugs, who are seeking a Clinical Research Scientist to join them on a contract basis. Job Responsibilities: Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective. Support the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Clinical study report preparation. Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. Partake and/or Lead team meetings as required. Key Skills: Ability to work independently. Able to communicate medical or clinical information to a physician. Ability to understand clinical trial publications; understanding of disease. Requirements: Prior experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective. Minimum of 2 years of direct Haematology/Oncology experience in a Clinical Research and Development capacity. Prior experience performing data review in Haematology/Oncology indications (note, this position is different in scope from a CRA position or clinical operations). Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data. Capability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective. Familiarity with Medidata, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work. Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative. Degree in life sciences. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

For one of our clients, a well-established organization focusing on developing innovative medicines for improving people's health and quality of life through a public-private partnership model, we are currently looking for an enthusiastic Post-Registration Clinical Trial Manager for a freelance basis contract . The company is based in Geneva, but working from home is also an option for employees in the EU. As an ideal candidate you should have 7+ years of experience in Clinical Trial management of Phase IV observational studies in emerging markets, and ability to provide strategic input to senior management. As an Post-Registration Clinical Trial Manager you will provide consultancy services for non-interventional and low-interventional (phase 4) studies to the molecule's proposition protocols with respect to oversight of Sponsor operational responsibilities for the feasibility studies in Brazil and Thailand, possibly extending to India, Ethiopia and Laos. Main Responsibilities: Participation in team calls including Pharma partner, CRO and site representatives, plus any third parties as indicated. Provide updates as required to the Director Clinical Operations, Access and Product Management (APM) Project Director (PD), and Medical Director on progress and issues; Identify, develop and ensure delivery of study management plans appropriate to the phase of study and observational/low-interventional nature of the study; Provide strategic input in the overall development of the protocols (identify potential gaps, support the development of budget and timeline to start the study in time, support the development of the data management plan, clarify roles and responsibility if needed etc.); Review/develop SOPs in the context of a non-interventional or low-interventional (as appropriate) study framework; Oversight of site start up activities, execution of the study and closure according to approved timelines, protocol and budget; Lead the Clinical study team and ensure duties and functions are appropriately delegated and documented; Ensure the TMF is set up and maintained with timely complete filing throughout all stages of the Clinical study. Qualifications and Experience: Degree in Life Sciences; 5-7 years of work experience in Global Clinical Trial Management, particularly in post-authorisation studies in emerging markets; Experience living and/or working in developing countries would be a strong asset; Experience within cross-functional development teams, resulting in broad understanding of the multi-disciplinary aspects of drug development; Strong problem-solving skills and analytical capabilities; Detail-oriented with strong organization skills; Fluent in English essential, German or French advantageous; Relevant working/residency permit or Swiss/EU-Citizenship required.

Our Client is an innovative Biotech that has various medical devices at commercial stage and different clinical trial phases. They have a start up feel about them which creates a fast-paced, highly dynamic and entrepreneurial culture with an emphasis on being patient centric. They are currently expanding the structures and processes and are looking for a Medical Manager for a permanent position to be based in the Lucerne area. The ideal candidate should have 3 years of previous experience in Clinical Research. Main Responsibilities Supporting the clinical trial teams in identification of potential new investigators and clinical sites; Developing relationships with these potential investigators and clinical investigators; Knowledge and understanding of scientific data related to the products treatment; Distributing clinical and scientific information related to company's clinical program; Communication with external investigators and clinical research professionals during conferences, scientific meetings, symposia, webinars and individual meetings Contributing the clinical protocol development; Supporting clinical patient enrolment. Qualifications and Experience Advanced scientific degree MD, PhD; Extensive medical, scientific and clinical research knowledge; Previous experience in oncology is preferable; Knowledge in Medical/scientific and clinical research; Excellent presentation skills; Advanced communication and interpersonal skills (both written and verbal) ; Able to work efficiently and collaboratively under pressure; Traveling up to 50-60% of the time (mainly Europe, US on occasion); Relevant working/residency permit or Swiss/EU-Citizenship required.

Our client is an innovative Biotech company, actively engaged in clinical development of first-in-class targeted therapeutics with untapped mode of action, to address unmet medical need in patients with oncology and immunological disorders. Currently in Phase I clinical development and focusing on advancing the clinical program, they are looking for a Project Manager - Clinical Development for a 12 months contract to be based in Basel area . Purpose: The Project Manager Clinical Development will be responsible for the overall conduct of clinical trials from start to closure, as well as from protocol development to final data review and reporting, to ensure completion through all phases on time, within budget and of high quality in compliance with all applicable regulations, ICH-GCP guidelines and standard operating procedures (SOPs). Main Responsibilities: Responsible for the operational conduct and management of assigned clinical trial(s) in close collaboration with other functions, including the development of the clinical study protocols and related-documents Contribute to the development of regulatory documents (e.g. IB / IMPD / DSUR) and responses to Health Authorities/Ethics Responsible for delivering clinical activities on the assigned trials towards the CROs and other vendors and External Service Providers (ESPs) selected for the trial, to ensure compliance with study protocol and in accordance with scope of work/budget Selection and training of ESPs Responsible for the development, management and tracking of the clinical trial budget, including timely and accurate communication for internal reporting, working closely with the HCO Prepare and formulate critical decisions, mapping out options and obtain internal approval Proactively identify deficiencies and new risks in trial conduct, suggest corrective actions in timely fashion and escalate internally, as required Provide regular updating on clinical trial level activities for internal reporting Responsible for the development and management of study timelines, risk and quality plans Organize as required scientific/medical review and evaluation of clinical trial data, including the development of clinical trial reports Responsible for the Trial Master File completeness for audit/inspection readiness and investigator site files Contribute in forecasting drug supply needs Ensure and support feasibility activities as needed Responsible for all study-related meetings and training sessions Supporting in developing internal SOPs and in the conduct of audits, as needed Assume responsibility for other projects or trial-related duties as assigned Qualifications and Experience: MSc or PhD (preferred) in Life Sciences / Healthcare or equivalent 8-10+ years of experience in the Clinical Development and Trial Management (either CRO or industry/biotech experience) Fluent in both written and spoken English. Any additional language is an asset Minimum of 5 years' experience in managing all operational aspects of clinical trials from initiation to closure and in leading the development of study-related documents Previous exposure to working on oncology Phase I and II trials, is a major asset Substantial exposure across the whole Clinical Operations & Development process with particular expertise in oncology / hematology Solid track record on the management of ESPs and Third-Party Vendors Very good knowledge of ICH-GCP and clinical trial process Relevant working/residency permit or Swiss/EU-Citizenship required

Our client is a pioneer in Drug Discovery and Development. As the worlds largest R&D spender in the pharmaceutical domain, they work in a vast number of drugs & therapeutic areas and are highly recognized internationally. They are also a leader in the field of manufacturing and selling of several drugs for the treatment of Cancer. We are currently looking for Global Study Manager on a contract basis to join our client at Basel area. If you have at least 3 to 5+ years of experience, working in pharmaceutical or CRO environment, managing Oncology studies at global level and solid experience in vendor management, this is the right opportunity for you! A Global Study Manager provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. Main Responsibilities: Develop operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management; Build effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables; Develop and maintain effective working relationships with study management team members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams; In collaboration with functional management, coach, mentor, support, and provide study specific direction to Study Management team members; Responsible for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work; Responsible for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions; Responsible for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work; Contribute to the development and management of the study timelines, resources, budget, risk and quality plans; Ensure operational tracking tools are identified, including systems to meet the needs of the operations team and ensure reporting to the Global Study Leader; Develop and manage clinical study budgets (including HQ budget) and contribute to staffing/resourcing plans; Provides operational input into the development of protocol feasibility questionnaires Leads the development and finalization of site feasibility questionnaires; Establish study milestones and ensures accurate tracking and reporting of study metrics; Lead the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the Global Study Leader and Operations Program Leader; Oversee forecasting of clinical/non-clinical supplies; Design drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and Study leaders; Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings; Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits; Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and coordinates any corrective action; Actively partner with Data Management and Clinical Science to oversee eCRF completion and data quality issues; Oversees the maintenance of drug supplies and resolution of issues with input from the Drug Supplies; Coordinates responses to study questions or issues from Health Authorities; Provides operational input into the development and tracking of SMT goals; Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs; Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution; Participates in Product Development Global Operations initiatives and programs as assigned; Maintains oversight and ensures consistency of the operational aspects across studies within a project; Qualifications and Experience: Relevant working/residency permit or Swiss/EU-Citizenship required ; Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock; Experience managing studies within the Oncology therapeutic area; Experience of project managing operational aspects of a clinical study including development of timelines and budgets; Good knowledge of ICH GCP; Proven ability to successfully achieve results within a multi-cultural and geographically diverse team; Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments; Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization; Fluent in both written and spoken English.

Hobson Prior are looking for a Global Studies Manager to join a Swiss global healthcare organisation who are focused on offering medical solutions in order to transform patients' lives. As the Global Studies Manager you will be accountable to provide operational expertise and leadership to one or more cross-functional global Study Management Teams. Job Responsibilities: Responsible to provide direction and leadership to one or more global Study Management Teams. Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. In partnership with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members. Builds and maintains effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables. You will develop and maintain effective working relationships with Study Management Team members, with focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams. Accountable for leading identification and selection of vendors; ensuring appropriate cross-functional input is incorporated into the scope of work. Accountable for assessing feasibility of and driving execution/adherence to protocol amendments or changes to clinical studies, across functions. Accountable for leading identification and selection of vendors; ensures appropriate cross-functional input into the scope of work. Contributes to the development and management of the study timelines, budget, risk and quality plans. Creates team culture and promotes team spirit. Key Skills: Well-developed written and verbal communication skills. Ability to influence at higher levels in the organization. Strong attention to detail. Proficient computer skills. Technical and Business Expertise. Teamwork and Collaboration. Requirements: Life sciences degree or nursing equivalent. Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock. Previous experience of project managing operational aspects of a clinical study including development and management of timelines and budgets. Good knowledge of ICH GCP. Proven ability to successfully achieve results within a multi-cultural and geographically diverse team. Experience of working as part of a large team and leading small study or functional teams. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Mission: * Providing statistical support and input to the design and analysis of clinical studies. * Responsible for the quality and timelines of all statistical and programming deliverables for assigned * clinical studies, including studies for which statistical activities are outsourced to CRO partners. * Ensuring timely availability of complete, accurate and consistent analysis results to support decision making * Working as a key member of the clinical study team. Your main responsibilities: * Provide statistical input to the design, analysis and interpretation of clinical studies * Author statistical sections of protocols and statistical analysis plans * Ensure provision of quality and timely statistical analyses results that support quality and timely decision making * Lead statistical and programming study teams and perform statistical analyses * Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables * Represent statistics within cross functional study teams and provide statistical support and solutions * Assist with in interactions with health Authorities * Maintain current scientific and regulatory knowledge * Provide input/lead internal process improvement * Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs. Your profile: * MSc. or PhD in statistics or related field * Minimum of 4 years' experience as project/study statistician in Clinical Development in the pharmaceutical industry or CRO * Strong statistical methodology knowledge and applications. * Experience using Bayesian designs is a plus * Excellent programming skill in SAS. Experience using R is a plus * Good experience using CDISC standards * Up to date knowledge of regulatory requirements related to statistics * Good communication skills and ability to build positive relationships * Fluent in English To apply: Yanick Millet Associate Consultant Life Science Industry, Biometrics market SEC Pharma TEL: 1 EMAIL:

Alex Tosney is recruiting for a Clinical QA Manager to join a company in the rapidly growing drug discovery area at their site based in Basel on a contract basis for 12 months. The main purpose of the role will be: · Working as per the defined strategy for the global clinical audit program (e.g. site, vendor, process) · Planning, performing, and reporting audits (e.g. site, vendor, process) using considerable latitude in determining best practice and approach · Developing own area of ICH-GCP expertise with limited supervision (e.g. self-training, knowledge acquisition by reading/assisting to course identify by himself) · Leading the preparation, facilitation and follow up of inspections by national and international regulatory authorities · Facilitating the CAPAs elaboration and follow-up · Escalating serious / continuing non-compliance issues as appropriate · Making a significant contribution to ensure that QS documents creation and management is done in accordance with ICH-GCP requirements / regulations · Contributing to process improvements and trouble shooting · Maintaining awareness / expertise in international ICH-GCP requirements · Providing leadership and direction on ICH-GCP related activities / issues · Working closely with Idorsia / CRO Clinical Trial Teams · Supporting internal / CRO staff in order to make a significant contribution to the implementation and maintenance of a robust and compliant clinical Quality Management System and clinical trial framework by different ways (e.g. provide training to CD staff, feedback to ICH-GCP questions) · Highly contribute to develop/improve CQA tools and processes · Representing CQA in internal and external meetings and particularly representing Team Leader CQA when he/she is not available · Performing any other CQA task that could help to achieve a high adherence to ICH-GCP requirements In order to be considered for this role, you will be required to have the following qualifications, skills and experience: · Bachelor degree or equivalent education/degree in (life) sciences or healthcare · Experienced in Clinical Research & Development. Extensive demonstrable experience in pharmaceutical industry/health authority with at least 3 years of experience in Quality Assurance / Auditing (QA) within the ICH-GCP environment. · In-depth knowledge of global ICH-GCP requirements and pharmaceutical industry practices · Ability to work as a team player and independently · Reliable, conscientious, agile/flexible · Proven record of excellent problem solving, risk analysis and negotiation skills · Interest and knowledge of requirements for electronic tools used in clinical trials (e.g. eTMF, ePRO, eSource) · Experience in medical device and/or combination product will be an added value · Strong writing, communication and listening skills · Experience in international cross-cultural relations · Very good English knowledge (written and spoken) This is an excellent opportunity to join a rapidly growing biopharmaceutical company. Please quote reference 46573 in all correspondence.

Hobson Prior are looking for a Scientific Associate to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. Job Responsibilities: In association with the Product technical experts, quality engineering, and suppliers you will be accountable to define equipment required for each test methods, procure and qualify equipment including protocols and reports writing. Create the equipment calibration and maintenance plan. Elaborate/Develop test methods required by product functions to test. Obtain and control test method fixture to requirement. Create test method validation protocol and acceptance criteria 8variable data or attributes), procure tests parts, execute test method validation and write associated report. Transfer method from/with suppliers including equivalency tests method statistical criteria for qualification and validation and execute transfer. Write test method instructions. Manage Product storage and pre-conditioning required prior to testing. Complete all functional test internally and support testing with service Providers for sub-contracted tests. Complete statistical analysis to acceptance criteria and write reports. Where product related, collaborate pro-actively with technical expert for investigations and resolution method instructions. Create and Maintain a laboratory notebook and ensure raw data integrity and accuracy using a four-eyes principle. Analyse any test failure, demonstrating if it is test method related or product related. Apply now: If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page. Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

We have an exciting opportunity available as a medical advisor - medical affairs - Dermatology. This is a fantastic opportunity for an experienced physician to work within a top pharmaceutical company leading development within this therapeutic area. Tasks & responsibilities Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required Provide medical expertise on pipeline development Provide portfolio of data and medical/scientific input to HTA or other market access submissions as required To lead on key congress activities such as Scientific Reviews or Advisory Boards To work collaboratively within the brand team to provide strategic medical and scientific input into brand plans to develop an appropriate product strategy Take responsibility for and manage the execution of the medical strategic plan To provide leadership and support to other Medical Affairs teams (medical liaison and medical information) Requirements Medical Doctor Dermatology/Immunology or Rheumatology experience PhD/MBA - Advantageous Clinical Trials Experience Benefits Comprehensive package Autonomy and independence Opportunity to travel across Europe Senior, strategic, role within a global pharmaceutical company Get in touch... Contact: Adam Bloomfield BSc. MSc. MolMed Specialist Translational, Clinical Development and Medical Affairs Consultant Email: abloomfield (at) barringtonjames.com

I am currently working with a leading global company seeking two expert Dermatologist /internal medicine specialist for a Medical Director / Senior Medical Director level role. One role will focus on early phase and the other role focused in late stage clinical development of innovative molecules for the treatment of multiple disease areas. The Role(s) : The Medical Director is responsible for input and oversight for early / late stage clinical development plans within the Dermatology department, from pre-clinical research, First in Man studies through Phase I / II / III Clinical Trials. The successful applicant(s) will be responsible for leading a cross functional study team and a team of direct reports. The main purpose of the role will be to oversee a series of Dermatology trials, draft study specific documentation such as NDA / CTA submissions and Investigator Brochures, alongside reviewing study data and providing expert advice to aid in the development of their Dermatology portfolio. Further Key Responsibilities : Directing and overseeing clinical research plans, and providing input to help integrate the Clinical Development Plan with the Drug Development Plan Serving as the clinical / medical team expert to provide direction to all project team functions, regularly liaising with KOL's and organizing Advisory Board Meetings Implementing strategies to identify, monitor and resolve clinical / program trial issues Reviewing / monitoring safety study data and providing clinical expertise and content to regulatory documents Proactively and independently find solutions and drive innovation Your Background : Educated to Medical Degree Board Certification or Eligibility in Dermatology or Internal medicine is preferred; will consider candidates with Dermatology Clinical Development experience in lieu of Board Certification Demonstrable experience in Dermatology clinical trial management Ability to influence others; self starter with an inquisitive nature and practical approach to problem solving Demonstrated competence as Study Director / Medical Monitor and prior experience working with the FDA or EMEA on responses to inquiries for study related information is preferred If you're interested, get in touch... abloomfield (at) barringtonjames.com

Die Firma agiert in der pharmabranche. sie sind für die führung des verkaufsinnendienstes verantwortlich dabei wickeln sie die exportaufträge im bereich see-, luft- und strassentransport ab und stehen in direktem kontakt mit den transportunternehmen zudem erstellen und bearbeiten sie die offerten für grosse industriekunden des weiteren sind sie für die personaladministration zuständig und übernehmen assistenzaufgaben für die geschäftsleitung das organisieren von seminaren und kursen rundet ihren vielseitigen aufgabenbereich ab sie haben eine abgeschlossene kaufmännische ausbildung und haben idealerweise erste führungserfahrung gesammelt erfahrung im verkaufsinnendienst ist eine wichtige voraussetzung, exportkenntnisse sind sehr von vorteil gute englisch- und französischkenntnisse sind zwingend sind sie eine organisierte, speditive und mitdenkende mitarbeiterin, welche es schätzt in einem team etwas bewirken zu können?

Die Firma ist ein interdisziplinäres Beratungs-und Forschungsunternehmen für Umwelt, Fachliche Leitung und wirtschaftliche Abwicklung von Projekten▪Aufbau, Pflege und Weiterentwicklung von Kundenbeziehungen▪Akquisition von Projekten in bestehenden Märkten▪Entwicklung von neuen Marktsegmenten und Leistungsangeboten ▪Aktive Mitgestaltung des Wachstums unseres Unternehmens Nach erfolgreichem Abschluss Ihres Hochschulstudiums(vorzugsweise in Archi-tektur, Ingenieur und/oder Umweltingenieurwissenschaften)konnten Sie mehrere Jahre einschlägige Berufserfahrung im Nachhaltigen Bauenerwerben.▪Idealerweise verfügen Sie bereits über ein Netzwerk zu Auftraggebern und Stake-holdern im deutschsprachigen Raum.▪Sie sind kundenorientiert, besitzen Ausstrahlung und Überzeugungskraft und bringen Ihre mehrjährige Expertise in der Beratung gewinnbringend ein.▪Ihre schriftliche Ausdrucksform ist präzise undknapp und Sie wissenauch in mündlichen Präsentationen zu überzeugen.▪Sie kommunizieren mündlich und schriftlich in Deutsch und Englisch gleicher-massen auf hohem Niveau