Unleash your potential & join the innovation

• 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 info@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.

• 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 info@hemex.ch

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

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 info@hemex.ch

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