Reset

Job Search
Filters

Use the options below to filter your job search and trigger a more bespoke result.

Search
  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    A leading CRO in the Raleigh-Durham area is currently seeking a regulatory operations leader to oversee the full cycle of regulatory submissions across clients globally. The individual in this position will also be responsible for leading a team of 3-5 direct reports. This organization offers a wide range of clinical research services and solutions to clients globally.

    Responsibilities:

    • Manage marketing applications such as PMA, 510(k), NDA/BLA, NDS, etc.
    • Manage clinical trial applications such as IND, CTE, CTA/CTX, etc.
    • Manage regulatory operations personnel
    • Conduct budgeting and forecasting for regulatory activities
    • Maintain current knowledge of FDA, EMA, and Health Canada
    • Proactively identify possible risks to submission plans; propose risk mitigation strategies
    • Act as system owner for publishing systems and tools such as eCTD, EDMA, and electronic templates

    Skills/Qualifications:

    • Bachelor’s degree in life sciences or related field
    • 10+ years of regulatory operations experience in biotechnology, pharmaceutical, or CRO industries
    • Proficient in CTD/eCTD structure and requirements
    • Expert knowledge of market applications and clinical trial applications, including applicable supplements, amendments, and variations

    This employee-centric organization provides a healthy work-life balance, positive and collaborative culture, and very competitive salaries. Relocation reimbursement is available.

    If interested, please apply directly through the website. For additional information, please contact Holly Witter at Skills Alliance – Raleigh.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    A leading CRO in the Raleigh-Durham area is currently seeking an experienced Senior or Principal Nonclinical Research Scientist to deliver tactical and strategic leadership across many company-wide teams and projects, and serve as the nonclinical product development expert. This organization offers a wide range of clinical research services and solutions to clients globally.

    Key Responsibilities:

    • Responsible for a full range of nonclinical product development activities
    • Proactively identify risks; critically analyze problems
    • Develop contingency plans as required
    • Manage nonclinical components of regulatory submissions such as NDAs, INDs, MAAs, PMAs, and more
    • Manage scope of work, budgets, and timelines for external vendors
    • Plan and conduct facility qualification assessments, audits, and mock inspections

    Key Qualifications:

    • PhD in Toxicology or related field is required
    • 8+ years of relevant nonclinical product development and regulatory experience
    • Experience with FDA required
    • DABT certification is desired

    This employee-centric organization provides a healthy work-life balance, positive and collaborative culture, and very competitive salaries. Relocation reimbursement is available.

    If interested, please apply directly through the website. For additional information, please contact Holly Witter at Skills Alliance – Raleigh.

  • USA

    Competitive Pay + Benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    We are currently working alongside a groundbreaking next generation sequencing company, who is looking to bring power of NGS to help patients afflicted with cancer. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry and bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a General Laboratory Supervisor to join their team. The General Laboratory Supervisor is responsible for running the day to day operations of their CLIA Laboratory, managing personnel performance and schedules, managing personnel performing testing, and reporting test results. You will be transforming cancer care by providing genomic analysis of the disease using non-invasive liquid biopsy methods.

    Key responsibilities:

    • Provide day -to-day supervision of high complexity test performance by qualified testing personnel
    • Monitor test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained
    • Ensure Operational compliance with the clinical laboratory’s Quality Management Systems (QMS) Program and deliver the routine QMS associated metrics
    • Order and manage inventory and install and qualify laboratory equipment
    • Coordinate resources with product development team in the launch of new clinical test products

    Qualifications:

    • B.A., B.S., or M.S. in human genetics or biological science from an accredited institution
    • Five years of high complexity human Genetics clinical laboratory experience as general supervisor including NGS assay
    • Practical and hands-on experience in Quality Management Systems
    • Knowledge or experience with laboratory automation

    This is a great opportunity to work with a growing organization that values work-life balance and team collaboration. Relocation reimbursement is available.

    If you are interested in learning more about this role, apply directly through the website.

  • USA

    Competitive Pay + Benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    We are working with a publicly traded Biopharmaceutical company in Seattle who is looking for a Clinical Data Manager to add to their team full time. This company has a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. With commercialized products as well as ongoing phase II-II trials currently. They boast a great work environment, benefits and work life balance.

    This position will lead and monitor the collection, processing, data entry, and quality control of study data. Responsible for effectively managing timelines, quality and delivery of data for assigned projects that are in support of clinical trials research. She/he will develop and maintain successful working relationships with their team to ensure and maintain data integrity and quality. Apply GCP and GCDMP principles, the CDM will manage the protocol/study specific tasks including coordinating clinical and laboratory database deliverables, working with collaborators on data content requirements, leading data quality and closeout activities throughout the data management lifecycle.

    • 3+ years clinical data management experience
    • Medidata Rave
    • Bachelor’s Degree

    We are looking to move quickly on this position, so please do not hesitate to apply!

  • USA

    Competitive Salary + Comprehensive Benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Location: Seattle, WA

    We are currently partnered with a local biotechnology company who’s focus is specifically within the oncology and hematology space. With 2 products in Phase I clinical trials, and another slated to begin early next year, this company is in a great place to see even more success by the end of the year.

    In this great period of growth, they are looking for a Scientist to join their Immunobiology team. Ideally, this candidate will be directly responsible for evaluation of new mechanisms of action for the development of new drugs, as well contributing to the development and optimization of cellular- and molecular-based assays, using state of the art technologies.

    Qualifications

    • PhD in Immunology, Cell Biology, or related discipline
    • Minimum 5 years of experience in the area of Oncology, direct industry experienced preferred
    • Demonstrated ability to lead projects and ensure timelines are met
    • Expertise in immunology and/or oncology to design and implement cell-based assays and systems, and technical advancement for projects in Applied Research
    • Strong leadership and mentoring experience

    We are moving quickly on this role, so please don’t hesitate to apply as soon as possible.

  • USA

    Competitive Salary + Comprehensive Benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Location: Seattle, WA

    We are currently partnered with a local biotechnology company who’s focus is specifically within the oncology and hematology space. With 2 products in Phase I clinical trials, and another slated to begin early next year, this company is in a great place to see even more success by the end of the year.

    In this great period of growth, they are looking for a Scientist to join their Protein Sciences team. Ideally, this candidate will have strong purification and characterization experience, along with a background of designing and conducting experiments independently.

    Qualifications

    • B.S. with 8 years of direct industry experience OR M.S. with 5 years of direct industry experience
    • Significant experience with Protein Purification, particularly antibodies from mammalian expression systems using affinity, size exclusion, ion exchange, or hydrophobic interaction chromatography
    • Ability to analyze results and perform independent experimentation, with supervisor oversight
    • Ability to multi-task across experiements and projects

    We are moving quickly on this role, so please don’t hesitate to apply as soon as possible.

  • €100000 - €120000 per annum, + Bonus
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is currently partnered with a medium sized medical device company with an important presence across the EU. Our client’s products are crucial to protect patients at hospitals across the world. With a strong portfolio of marketed products and an impressive pipeline, the Senior Manager EMEA Quality vacancy is a great opportunity to join a company that has sustained high levels of growth year after year.

    In this position, you will be developing and implementing a strong quality strategy for our client’s operations across your designated region. You will be interacting with key business stakeholders and make sure regional affiliates comply to the company’s quality management system. You will also be a leading company figure for compliance to the EU MDR.

    Requirements
    – Bachelor’s in a life science related field or engineering degree
    – 10+ years of experience in the medical device industry
    – 5 years of managerial experience in business/corporate or supplier quality
    – Regional quality or regulatory management experience is a must
    – Quality certification preferred (ISO internal/external auditor, Six Sigma or similar)
    – Fluency in English

    For more information on this role, please contact Khephren Mongongu +41 (0) 43 508 29 16. We are looking forward to your application.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is collaborating with a global engineering consultancy based in Basel that serves clients within the (bio)pharmaceutical and medical device industries. On our client’s behalf, we’re currently recruiting for a Qualification Engineer to start an open-ended project at a biopharmaceutical manufacturing site in Luzern, Switzerland.

    Responsibilities

    • Plan, Coordinate and execute all phases qualification activities (IQ, OQ, PQ)
    • Prepare and review (qualification plans, minutes, reports) GMP related
    • documentation
    • Equipment qualification (small size equipment, clean rooms, HVAC)
    • Operational handling of Change Controls, CAPAs
    • Perform risk/criticality assessments

    Requirements

    • Bachelor/Master Degree in technical or natural sciences
    • A minimum of 3 years of working experience within pharma or a biotech company
    • Profound Know-how of Validation requirements according to cGMP
    • Experience in small size equipment qualification, clean rooms and HVAC
    • Fluent English & German

    Our client provides all their project engineers with a competitive basic salary, travel compensation and overtime pay. If you would like to know more about this position, please get in touch with Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to your application.

  • €56000 - €60000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is exclusively collaborating with Takeda to recruit a Validation Engineer specialized in CSV to join Takeda’s manufacturing team in Lessines.

    The Validation Engineer performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    Main responsibilities are:

    1) Prepare and implement the validation documentation required to assure the proper development of a project.

    2) Act as a validation representative for projects, with support of his/her Validation Supervisor: Define and implement all validation activities related to the project. Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor. Provide validation expertise for the development of the project. Conduct the risk assessment related to the project. Review the URS, FS, DS and DR. Prepare the DQ. Review the commissioning protocols and reports to ensure leveraging into qualification. Prepare the IQ, OQ & PQ protocols. Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the Validation Supervisor.

    3) Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

    4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

    6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.

    7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfillment and EHS.

    Required profile:

    • Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
    • Minimum 2 years of experience in Validation/Quality systems Skills: Project management experience Excellent communication skills, fluent in French and good knowledge of English (written and spoken)
    • Familiar with Quality Management and GxP Regulations
    • Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
    • Knowledge of the manufacturing processes
    • Requires excellent analytical skills with systematic approaches to problem solving.
    • Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
    • Sound industry knowledge, project proficiency, and autonomy expected.

    If you would like to receive more information about this position, please contact Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to receiving your application.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is collaborating with an innovative medical device company that is revolutionizing treatment for patients suffering from cancer. Our client promotes a start-up atmosphere and will empower the successful candidate to integrate clinical operations into their quality system.

    Responsibilities:

    • Regular and random QA audits of clinical trials
    • Manage and maintain databases for the quality system
    • Project audit management and staff training
    • Develop the company’s Quality Management System
    • Manage quality issues, CAPAs, and complaints
    • Inspection Readiness / Regulatory inspections / External audits

    Requirements:

    • Medicine/Technical/Scientific degree or equivalent
    • Minimum 5 years of Clinical Quality Assurance experience in the pharmaceutical or medical device industry
    • Experience in auditing and with regulatory inspections
    • Knowledge of applicable regulations (EN ISO 14155, ICH-GCP)
    • Fluency in English
    • Willingness to travel up to 50%

    If you would like to receive more information about this role, click apply or contact Khephren Mongongu +41 43 508 29 16. We’re looking forward to receiving your application.

  • €80000 - €100000 per annum
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Our client, global publicly-traded commercial-stage oncology company developing a different cancer treatment therapy for patients with solid tumors is looking for a new addition to the team in Switzerland.

    This position is responsible for the investigation, repair and/or upgrade of devices within the Global Operations Center. This includes contributing to and maintaining service procedures and work instructions.

    Qualifikationen
    • outgoing and good at building relationships through inspiring trust and confidence
    • a professional image and a very high standard of personal presentation
    • self-motivation and a willingness to work with others toward a shared goal
    • the ability to contribute to a team effort, yet to accept responsibility for an individual role within the team
    • excel at continual learning in a rapidly advancing technological area
    • a tertiary level qualification in electrical or electronic engineering, physics or a related discipline or be able to demonstrate a similar level of knowledge and skill gained by practical experience
    • a solid technical or scientific background gained in industry or academia
    • a current and valid driving license
    • the capacity to take responsibility for the complete installation and commissioning of sophisticated instrumentation and to instruct users in its basic operation
    • ability to diagnose causes of malfunction and to actively resolve customers’ service problems
    • good computer literacy, including familiarity with data system hardware and industry-standard operating systems
    • fluent in English and German (C1 Level)

    If interested in the role, please reach out to Irina Bouras directly on +41/435 082 823 for more information.

  • €55000 - €60000 per annum, company car + home-office equipment
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    The function of the Field Service Engineers to provide expert hands-on technical expertise in all aspects of installation, commissioning, basic customer training, maintenance, fault-finding and customer support in respect of the company’s products, such as state of the art Mass Spectrometry instrumentation and technological solutions for the academic, clinical, government and industrial research markets and users across a wide applications field.

    Field Service Engineer – Home Office based in the region of Western Austria
    Aufgaben/Verantwortlichkeiten

    Working as a member of the Service Team involved in the installation, maintenance, service and technical support of our range of instrumentation, duties will include:
    • familiarization with specific instrumentation prior to installation from issued documentation and/or participation in the final testing process in the factory
    • liaise with customers and colleagues in the site planning process prior to installation
    • inspect, install, set up, test and achieve specifications of systems and accessories at customers’ sites, and deliver basic operator training
    • carry out breakdown and planned maintenance at customers’ sites as part of a team, with a rapid response where necessary
    • provide technical support and assistance to customers and to colleagues, either directly or by remote diagnosis
    • carry out procedures necessary to validate systems to certifiable standards
    • provide technical input to the sales team in non-routine sales cases
    • frequent travel within the EMEA region and occasionally abroad is an essential part of the job

    Specialism in certain products, technologies or ranges may form an additional responsibility that will make use of acquired skills and experience. Accurate record-keeping and timely submission of documentation is pre-requisite.

    Qualifikationen
    • outgoing and good at building relationships through inspiring trust and confidence
    • a professional image and a very high standard of personal presentation
    • self-motivation and a willingness to work with others toward a shared goal
    • the ability to contribute to a team effort, yet to accept responsibility for an individual role within the team
    • excel at continual learning in a rapidly advancing technological area
    • a tertiary level qualification in electrical or electronic engineering, physics or a related discipline or be able to demonstrate a similar level of knowledge and skill gained by practical experience
    • Graduates and Lab Technicians are very welcome
    • a solid technical or scientific background gained in industry or academia
    • a current and valid driving license
    • no visa or other restriction preventing travel in the USA or EU
    • the capacity to take responsibility for the complete installation and commissioning of sophisticated instrumentation and to instruct users in its basic operation
    • ability to diagnose causes of malfunction and to actively resolve customers’ service problems
    • good computer literacy, including familiarity with data system hardware and industry-standard operating systems
    • fluent in English and German (C1 Level)

    For more information about the role, please reach out to Irina Bouras directly on +41/435 082 823.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    My client, a global player in the Medical Devices sector, focusing on the improvement of patient support, is looking for an addition to their RAQA team in Germany.

    Post-Market Surveillance Manager – Medical Devices

    Primary Function of Position:

    Management of regulatory operations, regulatory registrations/filings, post-market surveillance, QMS, liaison with Corporate & EMEIA RAQA teams, advocacy with government bodies and manufacturer associations across Germany. Ensure proper liaison with sales, marketing, and service teams as well as all support functions.

    Roles and Responsibilities:

    • Join the leadership team to ensure compliance of all activities with applicable regulation; guide and influence operational decisions accordingly
    • Identify, develop and implement processes to support compliance activities related to post-market surveillance, including complaint management, vigilance reporting and field actions
    • Represents the company with competent authorities (eg MHRA) and manufacturer associations (eg ABHI) to ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures. o carry out advocacy activities (or through trade associations) to defend and promote company policy objectives before regulatory and policymaking bodies o maintain a constructive relationship with health authorities through frequent and transparent dialogue
    • Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
    • Develop & implement a regulatory strategy to obtain regulatory clearance and enable commercial market opportunities for new products or existing portfolio
    • Act as a liaison between the company to Regulatory affairs and quality compliance EMEIA and corporate headquarters and other international sites in support of regulatory and quality system

    Required Knowledge, Skills, and Experience:

    • At least 8+ years’ experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management, quality manufacturing or regulatory affairs
    • A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
    • Deep knowledge of EU MDD 93/42/EEC, EU MDR 2017/745/EU, US FDA CFR 21, ISO 13485:2016
    • Ability to work autonomously and exercise daily judgment based on the above regulatory knowledge
    • Proven project management experience
    • Team management experience of small team size associated with goals objectives definition/people development
    • Demonstrated organizationally and planning skills, including action-oriented and can-do attitude, focused urgency and driving for results
    • Excellent verbal and written communication and presentation skills, ability to distill complexity and provide clear and actionable direction
    • Orientation for work result details, with emphasis on accuracy and completeness
    • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
    • Language: Fluent English and German

    Preferred Knowledge, Skills, and Experience:

    • Lead auditor certification for ISO 9001, 13485 and knowledge of WW regulations
    • Good knowledge of medical device reprocessing/sterilization or refurbishment requirements
    • Team management experience of small team size associated with goals objectives definition/people development.

    For more information about the role, please reach out to Irina Bouras on 0041/435 082 823.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Our client, global publicly traded commercial-stage oncology company developing and establishing a fundamentally different type of cancer therapy is looking for an experienced Reimbursement Manager to join their team in Germany.

    This position is responsible for supporting the growth and efficiency of the reimbursement organization in Germany including leading and developing our client’s Reimbursement team with currently 6 employees.

    Your responsibilities:

    • Leadership and development of the Reimbursement team with currently 6 employees
    • Support for the growth and efficiency of the reimbursement organization in Germany
    • Establish and maintain relationships with key persons in insurance companies to facilitate the reimbursement process
    • Responsibility for annual audits, identification of training needs and other opportunities for improvement to ensure efficient and high-quality support
    • Identify ways to streamline workflows that result in high quality standards, improved outcomes, and cost savings, in collaboration with the EMEA and the Global Revenue Operations Team

    Key requirements:

    • Several years of professional experience in health care or a degree in social medicine.
    • In-depth experience in dealing with health insurance companies and the reimbursement system in Germany
    • Professional and ethical attitude
    • Experience in employee leadership and communication skills, thanks to which you can communicate according to the individual needs of the individual and can be prepared for different contact persons
    • Dedicated, self-reliant, resilient and networked thinking.
    • Secure handling of MS Office applications

    For more information, please do not hesitate to reach out directly to Vasil Mihaylov

    +41 (0) 435 086 961

  • Competitive salary + benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    An exciting medium size, privately owned CRO is looking for a CRA II or Senior CRA for their operations in Italy.
    It is a great opportunity for an experienced Clinical Research Associate or a CRA II/Senior CRA to undertake more responsibilities and work on challenging studies, in complex therapeutic areas in a company that offers great career progression opportunities as they expand their European Operations as well as close collaboration with management.

    You would be responsible for overseeing the monitoring and start-up activities for their Italy operations.

    This Senior Clinical Research Associate role is an office-based position based in Milano, offering the possibility to be an integral part of the Italian operations. It is a permanent role and there is a competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5299.

  • Competitive salary + benefits
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    An exciting medium size, privately owned CRO is looking for a CRA II or Senior CRA for their operations in Germany.
    It is a great opportunity for an experienced Clinical Research Associate or a CRA II/Senior CRA to undertake more responsibilities and work on challenging studies, in complex therapeutic areas in a company that offers great career progression opportunities as they expand their European Operations as well as close collaboration with management.

    You would be responsible for overseeing the monitoring and start-up activities for their German operations.

    This (Senior) Clinical Research Associate/CRA II role is a homebased role in Germany. It is a permanent role and there is a competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5299.

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Our client is very exciting and growing pharmaceutical company, that develops treatment for oncology patients. For their EMEA HR team based in Switzerland, we are currently looking for a Payroll Specialist EMEA. In this position you can expect a broad and exciting area of ​​responsibility in an international and very dynamic environment.

    Payroll Specialist EMEA

    Responsibilities:

    • Process the entire payroll cycle, from data collection to final approval for multiple countries (DACH and Sweden) in cooperation with client’s external providers, ensuring accurate and timely processing of employee changes.
    • Responsible for the calculation of options and share programs as well as the coordination with the team in the USA
    • Primary point of contact for internal and external concerns regarding questions related to payroll and social insurance
    • Coordination and control of the salary certificates as well as the responsibility for the annual accounts
    • Processing withholding tax and family allowances
    • Accident and illness reporting and coordination with client insurance
    • Support for quarterly audits (OR and SOX audits)
    • Calculation of provisions (overtime and holidays) in collaboration with finance and external payroll providers
    • Coordination and contact person for A1 confirmations
    • Support in projects and process improvements as well as HR system implementation
    • Support in Personnel Administration

    Requirements:

    • Completed basic business education and training in human resources
    • Several years of experience in payroll function in an international, fast-moving environment and preferably experience with German market
    • Understanding and experience in managing complex payroll process in a multi country
      environment or in a company providing service to multiple customers
    • Experience working with / managing external partners, e.g. payroll provider would be an asset
    • Ability to work independently and across teams whilst keeping open communication with key stakeholders.
    • Figures oriented, exceptional attention to details
    • Excellent organizational and problem-solving skills.
    • Highly customer-focused approach and developed analytical skills with positive can-do attitude.
    • Excellent knowledge of MS Office especially Excel
    • Mother tongue German and business fluent in English, French would be an advantage


    Looking forward to your application.
    For more information please contact Maja Vidovic, Recruitment Consultant DACH, M: 0041 22 518 82 49

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Our client is very exciting and growing pharmaceutical company, that develops treatment for oncology patients. For their EMEA HR team based in Switzerland, we are currently looking for a Payroll Specialist EMEA. In this position you can expect a broad and exciting area of ​​responsibility in an international and very dynamic environment.

    Payroll Specialist EMEA

    Responsibilities:

    • Process the entire payroll cycle, from data collection to final approval for multiple countries (DACH and Sweden) in cooperation with client’s external providers, ensuring accurate and timely processing of employee changes.
    • Responsible for the calculation of options and share programs as well as the coordination with the team in the USA
    • Primary point of contact for internal and external concerns regarding questions related to payroll and social insurance
    • Coordination and control of the salary certificates as well as the responsibility for the annual accounts
    • Processing withholding tax and family allowances
    • Accident and illness reporting and coordination with client insurance
    • Support for quarterly audits (OR and SOX audits)
    • Calculation of provisions (overtime and holidays) in collaboration with finance and external payroll providers
    • Coordination and contact person for A1 confirmations
    • Support in projects and process improvements as well as HR system implementation
    • Support in Personnel Administration

    Requirements:

    • Completed basic business education and training in human resources
    • Several years of experience in payroll function in an international, fast-moving environment and preferably experience with German market
    • Understanding and experience in managing complex payroll process in a multi country
      environment or in a company providing service to multiple customers
    • Experience working with / managing external partners, e.g. payroll provider would be an asset
    • Ability to work independently and across teams whilst keeping open communication with key stakeholders.
    • Figures oriented, exceptional attention to details
    • Excellent organizational and problem-solving skills.
    • Highly customer-focused approach and developed analytical skills with positive can-do attitude.
    • Excellent knowledge of MS Office especially Excel
    • Mother tongue German and business fluent in English, French would be an advantage


    Looking forward to your application.
    For more information please contact Maja Vidovic, Recruitment Consultant DACH, M: 0041 22 518 82 49

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is currently partnered with a leading Biopharmaceutical company based in Northern part of Switzerland. For this purpose, our client is looking for a Manager Analytical Development and Quality Control to join their team on a 12 month rolling contract.

    Job REQUIREMENTS:-

    • Related pharmaceutical experience combined with B.Sc. degree 10+, M.Sc. 7+ or PhD 5+ years of relevant working experience in analytical development and/or quality control for parenteral products including sound understanding of microbial testing/monitoring.
    • Skilled in the application of cGLP/cGMP.
    • Extensive analytical development background and hands-on experience with working knowledge of chemistry, analytical or pharmaceutical science.
    • Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
    • Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation
    • Experience with Investigational New Drug (IND), New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.
    • Excellent interpersonal/ organizational skills and the ability to multi-task.
    • Strong oral/ written communication skills, proficiency in English. German/French is a plus.
    • Ability to travel ca. 10% domestic and internationally.

    Job Responsibilities:-

    • Contribute on the development and implementation of analytical strategies for development stage projects to achieve optimal results.
    • Identify analytical science capabilities and technology tools needed to enable sterile manufacturing process development, QC testing, and new drug candidate formulation development for parenteral formulations.
    • Apply scientifically driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for parenteral drug products.
    • Manage CRO/CMO for analytical activities
    • Provide technical input in the investigation of OOS and OOT investigations
    • Review technical documents for regulatory submissions.
    • Write specifications for parenteral formulations.
    • Provide support and contribute to other analytical activities as necessary.
    • Contribute on the robust analytical CMC development strategies, plans, timelines and budgets and track status, progression, critical success factors and risk factors in the ongoing and planned CMC development projects.
    • Method transfer to contract manufacturing organizations.

    For more information please contact Heena Verma @ +41 (0)447982410

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance is currently partnered with a leading Biopharmaceutical company based in Northern part of Switzerland. For this purpose, our client is looking for a Scientific Associate Analytical Development and Quality Control to join their team on a 12 month rolling contract.

    Job REQUIREMENTS:-

    • Apprenticeship, college-, or university-degree or equivalent education in the field of chemistry, biochemistry, biology, pharmacy, or chemical engineering. A minimum of 4 years of work experience in the analysis and method development for parenteral drug products.
    • Skilled in the application of cGLP/cGMP.
    • Extensive analytical development background and hands-on lab experience of analytics for sterile drug products.
    • Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation
    • Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
    • Prior experience with complex parenteral products and medical devices.
    • Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
    • Excellent interpersonal/ organizational skills and the ability to multi-task.
    • Strong oral/ written communication skills, proficiency in English. German/French is a plus.
    • Computer literacy (e.g. Waters Empower, ELN).

    Job Responsibilities:-

      • Organization and execution of lab work for client parenteral drug products
      • Implementation of new analytical techniques required for parenteral drug products
      • Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, content and potentially genotoxic impurity determinations
      • Conduct of release and stability tests under cGMP and non-GMP
      • Planning and execution of method transfers and validations including respective documentation
      • Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability and transfer
      • Assurance of adequate maintenance and operation of analytical equipment according to GMP

    For more information please contact Heena Verma @ +41 (0)447982410

  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    My client are a global leader in the medical device industry. Currently undergoing a global procurement transformation programme, they are seeking an experienced IT Procurement Specialist with a previous track record negotiating IT Professional Services agreements. Ideally this experience will have come in a global, complex and private sector company structure.

    The role:
    This role sits in the established Global Procurement function and within the IT Category. Focusing on leading high-value negotiations of contract renewals and RFPs for new requirements in IT Professional Services. You will be working alongside the internal IT function and liaising with stakeholders and suppliers regularly.

    Key accountabilities:
    The key objective is to provide innovative and consultative IT procurement leadership in order to add value, drive innovation and protect profits in-line with the corporate vision and values. In addition to this you will also:

    • Negotiate the renewal of IT Professional Services contracts.
    • Lead and execute sourcing strategies across the full procurement lifecycle
    • Develop continuous improvement action plans and execute. Monitor changes and adjust plans as needed to sustain performance results.
    • Secure price, capacity & service levels in line with commitments to the business.
    • Establish & maintain relationships with key stakeholders and their teams to ensure understanding of their needs and to facilitate the appropriate level of challenge.
    • Provide market and financial insights relevant to the subcategory and input to the internal financial planning and review processes.
    • Implement best practice for areas of responsibility. Participate in team knowledge transfer.

    Required Experience:

    • Education – Bachelor Degree or equivalent
    • Proven background in managing global IT Professional Services procurement agreements
    • Excellent stakeholder management skills
    • Experience of IT procurement in a fast-paced private sector function across all IT services
    • Self-sufficient and strong work ethic
    • Commercially aware and financially astute with recent experience in large scale Private Sector IT procurement projects
    • Experience managing multiple IT tenders simultaneously
    • Experience with Supplier Relationship Management
  • Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Our client is very exciting and growing pharmaceutical company, that develops treatment for oncology patients. For their Global Operations Center, we are currently looking for a Service Technician, to support their team in Switzerland.

    Service Technician

    This position is responsible for the investigation, repair and/or upgrade of client’s devices within the Global Operations Center. This includes contributing to and maintaining service procedures and work instructions as they pertain to the GOC.

    Responsibilities:

    • Investigate, repair and/or upgrade of client’s devices as required
    • Document service actions by completing forms, reports, logs, and records.


    Your profile:

    • Diploma as Elektroniker EFZ or equivalent
    • Ability to perform lead free soldering
    • Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail
    • Must have good written and oral communication skills
    • Ability to multi-task, perform efficiently, and independently
    • Good mechanical aptitude
    • Basic understanding of schematics and diagrams (is an advantage)
    • Ability to use basic electronic and digital trouble shooting devices to include Digital Multi-meters (DMMs)
    • Ability to learn testing and troubleshooting of medical devices involving specialized and generic test equipment and software diagnostic tools.
    • Ability to use hand and power tools safely and effectively.
    • Knowledge of ESD protocols and practices (is an advantage)

    For more information please contact Maja Vidovic, Recruitment Consultant DACH,

    M: 0041 22 518 82 49