Unleash your potential & join the innovation

Unleash your potential & join the innovation

Clinical Trial Manager

Liestal, Switzerland
[80-100%] [f/m/d]
  • A minimum of 5 years of clinical trial experience of which at least 2 years as a CTM within a CRO or pharmaceutical company.
  • Experience working across multiple therapeutic pharmaceutical areas, including oncology.
  • Experience in Phase 1, 2 and 3 studies and international studies.
  • Efficient working style and hands-on “start-up” mentality.
  • Strong time management, organizational and communication skills.
  • Computer skills including proficiency in Microsoft Office suite: Word, Excel, and PowerPoint.
  • Strong interpersonal skills, ability to communicate effectively internally and externally. Maturity to support junior colleagues in their professional development. Ability to lead cross-functional teams, influence and motivate others, diplomacy, and negotiation skills.
  • Have a complete understanding of Serious Adverse Event (SAE) reporting, narratives, and follow up of SAEs. Excellent knowledge of international standards (ICH-GCP/ISO, FDA, EMEA).
  • Positive and energetic attitude, customer service oriented. Willing to take the initiative in a dynamic environment. Ability to work independently and as a team member.
  • Based in Northwestern Switzerland region.
  • Master’s or Bachelor’s Degree in a scientific or healthcare discipline required. Therapeutic knowledge is a plus.
  • Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian), any additional languages are a plus.

The CTM is responsible for the delivery of all clinical aspects of the study. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. The CTM will provide clinical study support to the Clinical Research Associates for one or more clinical studies, ensuring efficient delivery of clinical trials.

Responsibilities:

  • Plan, organize and manage multicenter, multinational clinical trials, conduct phase I-IV trials according to protocol.
  • Manage the development of the clinical protocol and related study-related documents. Write clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
  • Lead cross-functional, multinational study teams.
  • Establish working relationships with key opinion leaders (KOLs) to optimize clinical study design, execution, reporting, and publication.
  • Lead investigators’ meetings and protocol training meetings with internal staff.
  • Overall responsibility for all internal clinical meetings related to clinical trials.
  • Report to internal and external stakeholders on study progress and issues, independently provide resolution plan.
  • Overall responsibility for timelines, budget, and resource requirements.
  • Liaise with Medical Safety and test item logistics management.
  • Liaise with Data Management/Biostatistics/Medical writing to analyze clinical trial data, conduct medical/scientific review, final analysis, and interpretation, including developing clinical trial reports, publications, and internal/external presentations.
  • Forecast trial resources and provide budget and quoting/invoicing input to the sales department.
  • Collaborate with external vendors and other 3rd parties, including central lab and imaging vendors.

HEMEX is an equal opportunity employer. All employment is decided on the basis of qualifications, merit and business need. We are committed to providing a truly diverse and inclusive workplace that supports, inspires, and respects all individuals.

  • Join a highly motivated and skilled team working on a variety of medical innovations
  • Office-based employment in Liestal (Switzerland)
  • Pleasant working environment in a dynamic organization

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to barbara.diener@hemex.ch

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.

Vertriebsmitarbeiter im Aussendienst

Deutschland
[100%] [f/m/d]
  • Eine abgeschlossene kaufmännische Ausbildung oder Ausbildung mit medizinischem Hintergrund, Biomedizin, Biotechnologie o.ä.
  • Nachweislich mindestens 3-jährige Erfahrung im Verkaufsaussendienst in den Bereichen Pharma/ BioTech oder Medizintechnische Produkte
  • Freude am Vertrieb und der Kundenberatung
  • Hohe Qualitäts-, Service- und Lösungsorientierung
  • Ausgeprägte Kundenorientierung, Präsentationssicherheit und souveränes Auftreten sowie ein hohes Maß an Verantwortungsbewusstsein, Zuverlässigkeit und Eigeninitiative
  • Sehr gute Team- sowie Kommunikationsfähigkeiten auf Deutsch und Englisch
  • Sicherer Umgang mit MS Office und CRM Systemen
  • Führerschein B
  • Wohnsitz in der Umgebung von München (Verkaufsgebiet)
  • Aus-, Aufbau und Pflege von nachhaltig erfolgreichen Kundenbeziehungen in der Pharma- und HealthCare-Branche sowie bei der Vermarktung unserer gesamten Dienstleistungsportfolios.
  • Auf- und Ausbau des eigenen Vertriebsgebietes in der Region Süddeutschland und Österreich (Wien)
  • Akquirieren neuer Kundenprojekte im Bereich der klinischen Entwicklung
  • Mitverantwortung für die erfolgreiche Umsetzung von Kundenprojekten in enger Zusammenarbeit  mit den involvierten Abteilungen
  • Regelmässiger Austausch mit der Verkaufsleitung und Besuche am Hauptsitz in der Schweiz
  • Konkurrenzbeobachtung
  • Nachführen und Dokumentieren aller Aktivitäten im CRM
  • Teilnahme and nationalen und internationalen Messen, Events und Kongressen
  • Wohnort und Arbeitszeit flexible (HOME Office/ Aussendienst)
  • Festanstellung mit Fixum, Provision & Tagesdiäten
  • Vielseitiges innovatives Arbeitsumfeld mit viel Eigenverantwortung
  • Dynamisches internationales Team und flache Hierarchie
  • Einarbeitung
  • Firmen PKW auch zur Privatnutzung
  • Firmen Notebook und Mobiltelefon

Wenn Sie sich angesprochen fühlen, freuen wir uns auf Ihre Bewerbung. Bitte übermitteln Sie und Ihre Unterlagen (CV, Motivationsschreiben und kurzes Video digital an barbara.diener@hemex.ch

Wir akzeptieren nur Direktbewerbungen von qualifizierten Bewerbern. Anfragen von Headhuntern und Arbeitsagenturen werden nicht beantwortet.

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.

Experienced Regulatory Affairs Manager (Pharma)

Liestal, Switzerland
[50-100%] [f/m/d]
  • University degree in Life Sciences, Pharmaceutical, Medical Sciences, or related discipline.
  • At least 10 years’ experience in the EU and/or the US, in the pharmaceutical and biologics industry.
  • Excellent knowledge of international regulatory standards in the areas of pharmaceutical quality, safety, and efficacy.
  • Experience in CMC writing advantageous.
  • Experience in market access and pricing advantageous.
  • Ability to adapt communication style based on audience and situation.
  • Ability to coordinate and network with various stakeholders simultaneously.
  • Proactive in identifying potential issues and escalating them accordingly.
  • Solution finder with the ability to deal with complex information.
  • Dependable with a high sense of responsibility.
  • Efficient working style and hands-on entrepreneurial mentality.
  • Able to fluently communicate in English and German, any additional languages are a plus.
  • Be (financial) results-oriented for Hemex and its clients.
  • Liaising as Regulatory Expert between the customer and internal staff.
  • Team player who is able and willing to mentor other staff members.
  • Interpersonal adaptability with a positive can-do attitude.

The Regulatory Affairs Manager will be responsible for ensuring compliance with regulatory requirements for pharmaceuticals, biologics, or biosimilars. Functional responsibilities will include:

  • Definition and implementation of regulatory strategies for submissions in CH, EU, and /or the US in collaboration with other functional areas for pharmaceuticals.
  • Lifecycle management and maintenance of documentation, and product approvals including MAA, CTAs, PIPs, Renewals, and Variations.
  • Written, oral, and face-to-face interaction with Health Authorities in connection with product registrations (MAA / NDA), Clinical Trial Applications, Orphan drug designations, and Scientific advice including responding to health authority questions.
  • Get involved hands-on with teams of innovative new healthcare solutions and consult and guide them through product development.
  • Supervision of legal requirements and regulatory records to ensure proper traceability of regulatory history and of actual regulatory status.
  • Solid working knowledge of regulations and guidelines governing drugs and biologics in development, specifically focused on EU, Swiss & US including clinical trials.
  • Proactively identifies regulatory issues and offers creative solutions and strategies including risk mitigation strategies.
  • Keep up-to-date with the requirements of the Medicines Authorities across the CH, EU, and rest of the world (where relevant).
  • Pharmacovigilance experience preferred with Regulatory compliance in safety issues (SLCs, RMPs, DHPCs).
  • Experience with CROs preferred.
  • Where required, undertake departmental tasks and projects outside the area of responsibility in line with departmental and management team objectives.
  • Join a small team of multinational, multidisciplinary, highly motivated experts.
  • Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
  • Ability to independently manage your role and responsibilities.
  • Opportunity to develop yourself and support start-ups developing highly innovative therapies.
  • We’re actively building diverse teams and specifically welcome applications people over the age of 50.
  • Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to barbara.diener@hemex.ch

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.

Experienced Quality Assurance Manager (Pharma)

Liestal, Switzerland
[50-100%] [f/m/d]
  • University degree in Pharmacy, or related discipline.
  • Eligible to act as a Qualified Person (QP/FvP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with EU directives 2001/83/EC and 2001/20/EC and/or Swiss 812.212.1 MPLO respectively.
  • At least 5 years of experience in the EU and/or the US, in the pharmaceutical and biologics industry.
  • GMP Audit experience preferably qualified as Lead Auditor.
  • Excellent knowledge of international regulatory standards in the areas of pharmaceutical quality, safety, and efficacy.
  • Able to fluently communicate in English and German, any additional languages are a plus.
  • Be (financial) results-oriented for Hemex and its clients.
  • Ability to adapt communication style based on audience and situation.
  • Ability to coordinate and network with various stakeholders simultaneously.
  • Proactive in identifying potential issues and escalating them accordingly.
  • Solution finder with the ability to deal with complex information.
  • Dependable with a high sense of responsibility.
  • Efficient working style and hands-on entrepreneurial mentality.
  • Liaising as Quality Expert between the customer and internal staff.
  • Team player who is able and willing to mentor other staff members.
  • Interpersonal adaptability with a positive can-do attitude.
  • Comfortable collaborating with other functions like RA and Clinical Operations.

The Quality Assurance Manager will be responsible for ensuring compliance with rigorous requirements of PIC/S and cGxP. Functional responsibilities will include:

  • Apply GMP requirements consistently, using quality and compliance knowledge base to mentor customers and other staff to expand compliance knowledge, to support and provide timely responses to Customer queries and communications relating to GMP compliance and batch release (Investigational and commercial).
  • Release and certification of products (on behalf of Partner Company) as a Qualified Person (Fachtechnisch verantwortliche Person) for Switzerland (including “rest of the world”) and/or the EEA / EU according to current Swiss legislation and the MRA Switzerland – EU, relevant current EU. directives/guidelines, and in accordance with the requirements of the respective product Manufacturer’s Authorisation (CH / EU / EEA) based on the Quality system of Hemex AG.
  • Responsible for external official contacts (Swissmedic, EMA, FDA, etc.) related to questions of batch release/certification and GMP issues.
  • Responsible for external contacts with partners regarding quality assurance, inspection, and cGMP.
  • Get involved hands-on with teams of innovative new healthcare solutions and consult and guide them through product development.
  • Ensures the maintenance and supervision of the Quality Management System of the contractually agreed quality assurance of the partners of Hemex AG, for the supply chain and distribution, in accordance with cGMP (PIC/S guide, 2001/83/EC and 2003/94/EC) and Dir 2013/C343/01 (GDP), taking into account the Dir 2001/20 / EEC (GCP), Annex 16 (GMP guide) and additional relevant regulations.
  • Undertake audits in the CH, EU, and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
  • Assistance with regulatory inspections and client audits.
  • Keep up-to-date with the requirements of the Medicines Authorities across the CH, EU, and rest of the world (where relevant).

 

  • Join a small team of multinational, multidisciplinary, highly motivated experts.
  • Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
  • Ability to independently manage your role and responsibilities.
  • Opportunity to develop yourself and support start-ups developing highly innovative therapies.
  • We’re actively building diverse teams and specifically welcome applications people over the age of 50.
  • Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to barbara.diener@hemex.ch

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.

Senior Clinical Research Associate

Liestal, Switzerland
[100%] [f/m/d]

Requirements

  • Strong time management, organizational, and communication skills.
  • Strong organization and interpersonal skills, ability to communicate effectively internally and externally. Maturity to support junior colleagues in their professional development. Ability to influence others, diplomacy, and negotiation skills.
  • Computer skills including proficiency in Microsoft Office suite: Word, Excel, and PowerPoint.
  • Able and willing to travel and work remotely at least 50% of the time.
  • Have a full understanding of Serious Adverse Event (SAE) reporting, narratives, and follow-up of SAEs. Good knowledge of international standards (ICH-GCP/ISO, FDA, EMEA). Positive and energetic attitude, customer service oriented. Willing to take initiative in a dynamic environment. Ability to work independently and as a team member. Hands-on “Startup mentality” is a prerequisite.

Educational Requirements:

  • Master’s or Bachelor’s Degree Required, preferably in a scientific or healthcare discipline. Therapeutic knowledge is a plus.
  • A minimum of 5 years clinical trial experience of which at least 3 years as a CRA, preferably within a CRO, medical device, or pharmaceutical company.
  • Fluent in English (oral, written) plus at least 1 Swiss national language (German, French, Italian). Additional languages are a plus.

The CRA will be responsible for managing and tracking the progress of clinical studies at Hemex. Functional responsibilities will include:

  • Manage assigned study sites and multicenter, multinational clinical trials, conduct phase I-IV trials according to protocol.
  • Ensure that Essential Documents are available for filing in the electronic Trial Master File (eTMF). Verify that the Investigator’s Site File (ISF) is maintained in accordance with ICH-GCP/ISO 14155 and local regulatory requirements.
  • Literature and clinical database review to assess feasibility and study design. Screen potential investigators to evaluate capabilities for conducting clinical trials.
  • Conduct and manage monitoring activities (on-site and remote) to ensure that study milestones for sites responsible are met as planned; (i.e., study start-up, recruitment, database analyses, closeout, etc.).
  • Conduct site visits (selection visits, initiation visits, monitoring visits, close-out visits) and write reports to ensure compliance with the protocol, ICH-GCP/ISO 14155, global and local regulations, global and local processes to secure data integrity and patient safety. 
  • Ensure that site personnel is fully trained on all trial-related aspects during Site Initiation Visits (SIV). 
  • Independently manage training and support requests from clinical trial sites. 
  • Proactively identify quality issues at sites; resolve issues and escalate as appropriate. 
  • Support the start-up phase of assigned studies by tracking regulatory submissions and approvals.
  • Manage and maintain information and documentation by updating all electronic systems (eTMF, eCTMS) to track clinical trial progress, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. 
  • Manage organization of audits and assure inspection readiness activities for monitoring and site-related activities; ensure implementation of corrective actions (CAPA) within specified timelines. 
  • Responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations, and SOPs. 
  • Support CTM with the efficient conduct of the trial according to timelines and budget. Provide guidance and regular training to CTA and CRA I.

People Management responsibilities:

  • Collaborate with the Clinical Operations team through different stages of a clinical study.
  • Manage the Sponsor team and Site Staff throughout the assignment.

 

Financial responsibilities:

  • Be (financial) results-oriented for Hemex and its clients.

 

  • Join a small team of multinational, multidisciplinary, highly motivated experts.
  • Modern, inclusive, pleasant working environment in a fast-growing, dynamic organization.
  • Ability to independently manage your role and responsibilities.
  • Opportunity to develop yourself and support start-ups developing highly innovative therapies.
  • Office-based employment in Liestal (Switzerland), 7min by foot from Liestal SBB train station.

If you meet the described profile, we look forward to receiving your CV in English, including supporting documents, by e-mail to barbara.diener@hemex.ch

We only accept direct applications of qualified candidates. Requests from headhunters and job agencies will not be answered.

Bilingual Executive Assistant (Opterion)

Muttenz, Switzerland
[60-80%] [f/m/d]

Opterion Health, a Swiss-based life sciences company, is currently looking for a bilingual (English/German) Executive Assistant to be the supportive force that empowers our leadership team. The ideal person for the job will be a proactive problem solver with excellent communication skills and a meticulous attention to detail. She/he will have experience working in an office environment, performing administrative duties and providing support to the executive team. The position (60% – 80%) is based in Muttenz with the possibility of working from home one day.

Skills & Qualifications:

  • Degree in Commercial or equivalent qualification
  • At least 3 years’ experience as an Executive Assistant or in an administrative role
  • Excellent written and verbal communication skills in English and German
  • Experience in the Pharmaceutical or Life Sciences industry
  • Strong time-management skills and the ability to organize and coordinate multiple projects simultaneously
  • Proficiency in Microsoft Office and other office productivity tools, with ability to learn new software and systems
  • Flexible team player willing to do what it takes to get the job done; independent, adaptable and enjoys a challenge
  • Ability to keep company confidences

Responsibilities include:

  • Supporting the Management team in day-to-day business
  • Planning and orchestrating work to ensure the management’s priorities are met, organizational goals are achieved, and best practices are upheld (e.g., manage agenda, organize meetings and take meeting minutes)
  • Arranging travel and travel-related activities
  • Organizing meetings with Board of Directors, Shareholders, Scientific Advisory Board, Investors and other external parties
  • Coordinating the flow of contractual documents (track of changes, signatures; using DocuSign and other electronic tools) and filing (electronic and physical)
  • Assisting with presentations and other material
  • Perform administrative and office support, such as invoicing, accounting and preparing presentations 
  • Supporting Project Management and Quality Management System
  • Organizing team communication and planning events, both internally and offsite
  • Maintaining professionalism and strict confidentiality with all materials and exercising discretion in dealing with the company
  • Efficient management of the office in Muttenz
  • Permanent contract starting ASAP
  • Competitive salary
  • Flexible working arrangements

Please send your CV to info@opterion.com