WE ARE HIRING!

 Data di pubblicazione: 01/12/2021

HTH Venture (www.hthvc.com – new website online soon), a life science venture capital company, is seeking for a brilliant analyst (internship) to support its investment and operational team in the medtech space.

HTH invests in seed to growth stage companies involved in developing breakthrough innovation in the life science sector (biotech, medtech, digital health, consumer health, industrial biotech, etc.).

Your job will involve:

• Scouting and analysing investment opportunities
• Attending sectors' conferences (both in person and virtually)
• Support the team on investments due diligence (technical, business, financial, etc.)
• Support the team in databases creation and updating
• Support HTH’s portfolio companies in value creation
• Analyse market trends to identify opportunities for investment and value creation
• Support HTH in creating due diligence memoranda, companies’ presentation, marketing material for portfolio companies

The ideal candidate should have:

• A great passion for innovation in the medical field
• A strong desire to work in an international environment
• A strong entrepreneurial approach
• An open mind and willingness to work on several different topics

What they are looking for:

• MSc/PhD in biomedical engineering or equivalent (or in the process of obtaining)
• Advanced English (written and spoken)
• Some basic knowledge of venture capital and business analysis
• Some basic knowledge of Microsoft Office Suite or equivalent
• Some sort of international experience (Erasmus, etc)
• Willingness to learn and travel

What they offer:

• A highly dynamic and flexible workplace, in a very enthusiastic and smart young team
• Salary (based on “experience”)
• Meals/refreshments

The person will be based in Bresso (MI) over at OpenZone facilities together with some startups of their portfolio. The position will start in January 2022.

You can submit your application by visiting this link.

 Data di pubblicazione: 26/11/2021

Axxam, a leading provider of integrated discovery services for the entire Life Sciences industries, is currently seeking  a Scientist to strengthen its image and cell-based assay development capabilities for our customer projects. Development and validation of miniaturised, phenotypic cell-based assays for high and medium -throughput screening will be the primary activity of the successful candidate.

Candidates must have a PhD and a thorough understanding of cellular functional assays using mammalian cells and imaging approach, specifically:

• a Ph.D. in biophysics, pharmacology, biotechnology or proven track records and experience in any, but not limiting, of the following fields: autophagy, organelle biogenesis (mitochondrion, nucleus, lysosome), inflammatory pathways, fibrotic pathways, cell differentiation (muscle, neuron)
• skills and research experience applicable to target identification, mechanism-of-action/pathway analysis, and development of cellular assays suitable for imaging applications applying siRNA, shRNA or CRISPR technologies
• relevant experience in recombinant gene expression in mammalian cells using electroporation, lipofection, or other methods
• proven experience in immunofluorescence-based and staining preparation of the samples in miniaturized formats (96-384 well formats)
• proven knowledge of confocal and wide-field microscopy.

The following technical skills would be a plus:

• knowledge of image analysis and data analysis software (e.g. ImageJ/Fiji, MetaMorph, Harmony, R, GraphPad) hands on 3D cell cultures, spheroids imaging
• experience with Optogenetic approaches
• familiarity with lab automation: plates and liquid-handling devices, 96 and 384 well format.

The following soft skills would be advantageous:

• propensity for laboratory work
• strong problem solving
• good mindset for data analysis
• strong team player skills and ability to interact with colleagues and clients
• ability to present results internally and externally in timely and clear manner
• ability to work to tight deadlines
• ability to follow instruction closely, but also to work independently and to be proactive in bringing new ideas and solutions
• multi-focus capability on several projects
• fluent/good spoken and written English.

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.

If your background and personal experience fit this profile, please send your complete application, including cover letter, a brief description of your experience, your CV and a list of references to Axxam's on-line contact centre: http://www.axxam.com/careers/job-listing.

Please add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003".

 Data di pubblicazione: 19/11/2021

Enthera, a biotech company building a pipeline of first-in-class biologics for several underserved autoimmune conditions, is seeking a Chief Scientific Officer (CSO) who will provide scientific vision, leadership, strategy, and management to the Company.

The CSO, reporting into the CEO, will be a key member of the Executive Management Team, and the critical Executive to communicate the Company’s scientific vision and strategy to key stakeholders. In addition, the CSO will be responsible to develop and execute the research strategies that will build a robust and proprietary discovery pipeline with the goal to deliver multiple product opportunities to address serious unmet medical needs.

Responsibilities

• Establish the overall strategy for discovery and preclinical R&D efforts in the fields of autoimmune, chronic inflammation and metabolic conditions that incorporates cutting-edge science that can address serious unmet medical needs
• Build a robust pre-clinical pipeline through both internal R&D efforts and academic collaborations (University of Milan, Humanitas University) by selecting and prioritizng projects based on scientific merit, strategic fit and commercial value
• Build, motivate and lead a world-class research organization that blends internal research capabilities and quality external contract research organizations (CROs) to execute on the drug discovery stratety
• Support the generation of relevant regulatory dossiers (e.g. INDs, IMPDs, CTAs)
• Lead and drive the progress of pipeline programs and collaborations meet to meet corporate objectives, milestones and goals
• Work collaboratively with internal teams, collaborators and consultants to plan and execute on the overall research and development plans
• Develop the translational plans and non-clinical studies to support the Company’s investigational molecules as they advance into the clinic
• Participate in business initiatives that further the strategic and business objectives of the Company and be the scientific lead in representing the research and discovery pipeline
• Communicate scientific progress and issues to the Board of Directors, regulatory agencies as necessary, and at national and international conferences as appropriate
• Lead and manage various relationships and meetings with the external scientific community

Qualifications:

• PhD or MD/PhD in immunology or equivalent
• Must have 10+ years of research and drug development experience with biologics,
• Proven success track record of advancing discovery projects into early clinical development
• Highly accomplished scientific leadership with a passion for research and a desire to make an impact in autoimmune and metabolic disorders
• Prior experience with therapies based on monoclonal antibodies is a must
• Must have excellent interpersonal and analytical skills, as well as high ethical standards and outstanding written and verbal communication skills
• Requires the ability to build strong relationships with key stakeholders
• Must be team oriented and able to invest in the success of others
• An excellent track record of publications in the field of immunology, inflammation, autoimmunity and/or metabolic disorders.

For more information, please write to: info@entherapharmaceuticals.com

 Data di pubblicazione: 18/11/2021

Champions Oncology provides an end-to-end range of oncology research and development solutions and services that improve the productivity of drug development. They're currently looking for a Study Director.

Job Overview

The Study Director serves as the primary point of contact for Champions vast portfolio of client sponsors regarding scientific design, PDX tumor model selection, and project execution. This role is client facing, requires strong customer focus and an understanding of the needs and timelines of the client. and provides expertise to clients on the uses of the Tumorgraft/PDX mouse platform for preclinical drug testing.

Additional Duties Include

Essential job duties include preliminary client study design in collaboration with the business development team, interaction with the Lab and Facilities Operations teams to coordinate study execution, and preparing study protocols/updates/analyses/reports. Collaborates with the Business Development group to enhance client relationships and facilitate continued business for Champions Oncology. The Study Director will be proactive with regards to client needs for ongoing and future studies, provide excellent customer service and mitigate miscommunications that occur in the preparation, execution and delivery of TOS projects.

• Participates as the scientific technical lead in client meetings related to potential and current pre-clinical PDX opportunities.
• Manages studies with highly technical components and expanded endpoints such as Immunograft and Hematological studies involving ex-vivo analyses.
• Determines tumor model status and provides study timelines to BD Director for SOWs pending finalization or finalized.
• Selects tumor source material for generating study mice. Coordinates the implant of models for studies and monitors the each phase of a study
• Defines client scientific requirements and develops study design and protocols according to IACUC guidelines and operational ability.
• Recommends tumor model selection based on needs and availability; suggests replacements when necessary.
• Reviews SOWs to ensure pricing and scope are captured appropriately.
• Reviews formulation documents and ensures all necessary test agents and standards of care are in stock prior to study initiation.
• Organizes kickoff and protocol review meetings with clients and internal staff.
• Monitors ongoing study data to ensure tasks are being completed and any adverse events are identified and communicated to the sponsor in a timely manner.
• Issues directives to the lab based on data and protocol endpoints.
• Performs data and statistical analysis of study data at completion of TOS sponsor studies.
• Provide weekly updates, data analysis, and final reports to clients.
• Recognizes revenue for models/studies for Finance through Salesforce.
• Organizes shipment of samples to the client at the end of a study.
• Interfaces with Business Development, Operations, and other Champions personnel to successfully coordinate projects from start to finish
• Identifies and provides resolution to problems involving ongoing TOS studies.
• Participates and provides feedback in TOS team and TOS Lab Ops/PL meetings
• Represents Champions in the field at client meetings and scientific conferences.
• Identifies potential new opportunities and facilitates ongoing discussions regarding new opportunities with existing clients.
• Deliver customer value in a timely manner, and ensure protocols are accurate
• Works independently and performs other related duties as assigned.

Knowledge, Skills And Abilities

• Depth of scientific knowledge around preclinical research platforms.
• Scientific expertise in molecular biology techniques including those associated with PCR, IHC and cell culture.
• Experience with analyzing flow cytometry data a plus.
• Knowledge of project management and oncology research. Knowledge of in vivo oncology models (Xenograft/PDX) required. Understanding of preclinical drug development a plus.
• Customer service skills, timely decision making, good interpersonal skills and an ability to be persistent while maintaining tact.
• Must have the ability to balance several priorities simultaneously with high attention to detail.
• Ability for frequent adaptation, self-organization, accountability.
• Effective oral and written communication skills are required.
• Knowledge of Microsoft Word and Excel as well as Statistical Software such as GraphPad Prism.

Education And Experience

• Ph.D. degree in chemical/biological science or project management required.
• 3 to 5 years of experience in pre-clinical research or a similar position.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• In carrying out the duties of the job there will be some exposure to fumes and chemical hazards.
• Duties performed occasionally require exposure to blood, body fluid and tissue.
• Must be able to lift and move packages weighing up to 50 pounds.
• Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility

This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.

You can apply to this position by visiting this link.

 Data di pubblicazione: 06/11/2021

AGC Biologics, azienda leader nella Cell & Gene Therapy sta ricercando un CMC Regulatory Affairs Lead.

Attività Principali

• Allestire/ supportare i clienti nell’allestimento delle domande di autorizzazione alla sperimentazione clinica e di immissione al commercio in Italia e all’estero di ATMP coordinando le attività delle diverse funzioni coinvolte;
• Supportare i clienti nella revisione delle sezioni CMC della documentazione regolatoria;
• Assicurare la regulatory compliance tra i documenti regolatori autorizzati e la documentazione interna, ove richiesto;
• Eseguire la valutazione regolatoria delle modifiche supportando QA/QS nella definizione delle attività da pianificare;
• Coordinare e/o supportare i clienti nell’organizzazione di Protocol Assistance, Scientific Advice e meetings presso le agenzie regolatorie competenti;
• Redigere/ revisionare la procedure inerenti gli aspetti CMC regolatory affairs.

Requisiti:

• Laurea specialistica in discipline scientifiche;
• Esperienza almeno 5 anni;
• Buona conoscenza della lingua inglese e del pacchetto Office.

E' possibile candidarsi per questa posizione scrivendo a: Hr.it@agcbio.com.

 Data di pubblicazione: 06/11/2021

AGC Biologics, azienda leader nella Cell & Gene Therapy sta ricercando una risorsa da inserire nel team Process Transfer.

Attività Principali

• Valutare nuove tecnologie da implementare nei processi produttivi lavorando a stretto contatto con i reparti di Sviluppo e Produzione;
• Supportare le attività relative all’introduzione di nuovi progetti nel sito produttivo in qualità di focal point per la raccolta delle informazioni tecniche;
• Facilitare le attività di trasferimento di processi esistenti ad altri siti produttivi di AGC Biologics;
• Analizzare in modo critico i dati generati dai reparti di Sviluppo e Produzione al fine di valutare le performance di processo ed identificare punti di miglioramento;
• Fornire il proprio contributo tecnico nelle investigazioni in caso di deviazioni di processo.

Requisiti:

• Laurea Magistrale in Biotecnologie, Biologia, Chimica e Tecnologia Farmaceutiche;
• Conoscenza delle GMP e dei processi di Upstream e Downstream;
• Preferita esperienza nel settore Cell&Gene (vettori virali e cellule) in ambito Produzione, Sviluppo o Tech Transfer di realtà Biotech;
• Buona conoscenza della lingua inglese;
• Ottime doti relazionali e problem solving.

E' possibile candidarsi per questa posizione scrivendo a: Hr.it@agcbio.com.

 Data di pubblicazione: 06/11/2021

AGC Biologics, leader company in Cell & Gene Therapy is looking for a Legal Affairs Specialist

(temporary contract)

Main Activities

• Ensure AGC Biologics ongoing compliance with data protection laws across Europe, including GDPR and national legislation, working with the HR, Business Development and R&D teams;
• Develop internal privacy programs as well as templates and guidance notes for privacy, data protection, cross-border transfers and other privacy and personal data topics with the aim to manage privacy issues;
• Coordinate the development and application of the Organisation, Management and Control Model, and its relevant procedures, foreseen by Italian Legislative Decree 231/01 for AGC Biologics S.p.A.;
• Organize internal trainings on compliance and legal matters for the AGC Biologics group;
• Assist the Senior Legal Counsel with a broad range of corporate compliance matters (anti-money laundering, ultimate Beneficial Owner declarations, administrative filings, etc.);
• Work with the supply chain department to revise supply agreements and service contracts.

Experience & Education

• Degree in law, with 3/4 years experience with a focus on service agreements (with contractors), privacy and compliance field gained in-house or at a law firm
• Fluent English.

You can apply for this position by writing to: Hr.it@agcbio.com.

 Data di pubblicazione: 06/11/2021

AGC Biologics, leading company in Cell & Gene Therapy is looking for a Buyer.

Main Activities

• Involving in Purchase Orders process in order to be in compliance with all requests in term of delivery time line and Company rules;
• Working with Supply Chain Manager in order to escalate issues and solving shortcomings;
• Monitoring supplier performance;
• Scounting activities if needed;
• Supporting Accounting Dept in case of discrepancies in Invoices amounts.

Experience & Education:

• At least 2 years experience in the same role in a pharmaceutical company;
• Experience working with ERP systems, MSAX / SAP and Microsoft Office applications;
• Good understanding Finance rules;
• Fluent English;
• G ood organization /negotiation skill;
• Work effectively under pressure.

You can apply for this position by writing to: Hr.it@agcbio.com.

 Data di pubblicazione: 06/11/2021

Axxam, a leading provider of integrated discovery services for the entire Life Sciences industries, is currently seeking  a Cell Biologist to strengthen our cell-based assay development capabilities for our customer projects. Development and validation of miniaturised, functional cell-based assays for high-throughput screening will be the primary activity of the successful candidate.

A Ph.D. in Cell Biology/ Molecular Medicine/ Pharmacology is ideal.

Candidates should have a thorough understanding of cellular functional assays using mammalian cells and strong practical experience including:

• cell culture of immortalized and primary cell lines;
• stable and/or transient gene expression in mammalian cells using either electroporation/nucleofector technology or chemical transfection methods;
• generation of clonal cell lines after transfection;
• use of reporter genes (e. g. luciferases, EGFP, GCaMP, YFP) in mammalian cell lines;
• use of luminescence – fluorescence readers (e.g. FLIPR® technology and FD7000 system Hamamatsu);
• familiarity with pharmacological concepts for receptors, ion channels and transporters;
• use of HTRF technology (Pherastar);
• PROTAC and Key cellular assays (e.g. HiBiT complementation, NanoBRET target engagement, NanoBRET and NanoBiT protein-protein interactions);
• Cellular Thermal Shift Assay (CETSA and BiTSA;
• protein degradation assays (e.g dTAG, HaloPROTAC);
• in vitro bioanalytical methods (Western blot, HT-WB and immunoassays);
• basic molecular biology techniques (PCR amplifications, cDNA cloning, vector constructions etc.);
• use of genome editing approaches;
• cytofluorimetric techniques.

The following skills would be advantageous:

• working knowledge of Microsoft Office programs (Excel, Word, PowerPoint);
• use of GraphPad Prism;
• familiarity with lab automation: plates and liquid-handling devices;
• fluent/good spoken and written English;
• ability to follow instruction closely, but also to work independently as required;
• good team player;
• ability to work to tight deadlines with a sense of urgency.

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.

If your background and personal experience fit this profile, please send your complete application, including cover letter, a brief description of your experience, your CV and a list of references to Axxam's on-line contact centre: http://www.axxam.com/careers/job-listing.

Please add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003".

 Data di pubblicazione: 06/11/2021

Axxam, a leading provider of integrated discovery services for the entire Life Sciences industries, is currently seeking  a talented Laboratory Technician to strengthen our activities in the Flavour and Fragrance research. The candidate will participate in the generation, improvement, and functional application of cell-based assays for taste and olfactory receptors.

You are highly motivated and fully committed with a strong profile in Cell Biology and will perform in vitro cell-based signalling studies to characterize different molecular targets.

Requirements:

• Significant hands-on experience in mammalian cell culture
• Transient gene expression in mammalian cells
• Use of reporter genes (luciferases) in mammalian cell lines
• Use of luminescence – fluorescence readers (e.g. FLIPR® technology)
• Knowledge of data analysis software such as Microsoft Excel and GraphPad Prism
• Strong problem-solving attitude and time management skills
• Pharma or biotech industry experience is highly desirable.

Education:

• Biological/Medical Technical Assistant (BTA/MTA).

The following skills would be advantageous:

• Ability to follow instructions closely with a critical alertness
• Spirit for working in autonomy
• Knowledge of Bioinformatics
• Good team player
• Habit to work with tight deadlines.

Axxam is an equal opportunity employer

Axxam offers a stimulating work environment and a competitive salary.

If your background and personal experience fit this profile, please send your complete application, including cover letter, a brief description of your experience, your CV and a list of references to Axxam's on-line contact centre: http://www.axxam.com/careers/job-listing.

Please add to your CV the following statement: "I hereby grant permission to use my personal data in accordance with the Italian Leg. Dec. 196/2003".

 Data di pubblicazione: 27/10/2021

GalSeq S.r.l., CRO autocertificata ai sensi del DM 15.11.2011 con sede a Milano, ricerca urgentemente collaboratori Clinical Research Associate/Clinical Monitor Freelance per attività di monitoraggio di uno studio clinico che si svolge interamente sul territorio italiano.

Si richiede:

•  Certificazione CRA obbligatoria ai sensi del DM 15/11/2011 (studi interventistici).
• Laurea in materie tecnico-scientifiche Vecchio Ordinamento o Specialistica del nuovo ordinamento (Farmacia, Scienze naturali, Biologia, Biotecnologie, CTF, Medicina).
• Precedente esperienza come CRA con esperienza di monitoraggio indipendente di (almeno) 1,5 anni.
• Competenza nell'uso di Microsoft Word, Excel e PowerPoint.
• Conoscenza pratica delle linee guida ICH-GCP e dei requisiti normativi.
• Disponibilità a viaggiare.

Responsabilità:

• Mantenimento della supervisione sulle attività relative al centro sperimentale durante tutto il ciclo di vita del progetto, eseguendo l'avvio, il monitoraggio e la visita di chiusura oltre a mantenere la documentazione appropriata;
• Gestire i rapporti con i centri clinici con monitoraggio ad hoc da remoto e on-site.

Il presente annuncio si rivolge a candidati di ambo i sessi (L. 903/77). I dati saranno trattati ai sensi dell’Art. 13 D.lgs 196/03.

Se interessati, scrivere a: studiclinici@galseq.com

 Data di pubblicazione: 27/10/2021

Newron Pharmaceuticals SpA, a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, is looking for a Senior Clinical Director.

The position reports to the VP Clinical Operations for direct guidance and the CMO for medical issues. The individual will have primarily responsibility for the planning and execution of clinical trials in psychiatry, and/or neurology and for ensuring the medical/scientific validity and integrity of the clinical development program and clinical study protocols.

Depending on the experience and the level of drug program the selected individual may lead one or more clinical trials and may be the clinical lead of a specific drug program.

The candidate will plan, manage and direct day-to-day operations and projects for the Clinical Development department and will play a key role, working with other members of the project team in preparing documents for IRBs/ECs, and regulatory authorities and assist in responding to queries from any of these committees/regulatory authorities.

The selected individual will work closely with clinical operations, CROs, CMC, pharmacovigilance and regulatory department. The candidate will be expected to keep abreast of scientific and clinical advances, professional information, and technology through conferences and/or medical literatures, and to present Newron at external meetings.

Actual position/title will be determined by prior achievements and experience.

Qualifications and Education Requirements

• Preferably an MD in Psychiatry/Neurology
• Minimum 7+ years of experience in Biotech/Pharma/CROs/Academia
• Worked previously in clinical trials/research, not in medical affairs
• Experience in participating in international projects
• Previous experience in authoring protocols/study reports/IBs
• Effective oral and written communication skills
• Experience assisting data management, statistics, clinical operations and reviewing/interpreting clinical trials data
• Comprehensive understanding of pharmaceutical drug development, with excellent working knowledge of good clinical practices and associated FDA, EMA, and ICH guidances in drug development.
• Competent knowledge of standard office-based software (ie Microsoft Office)

Send your application to info@newron.com, message subject “Senior Clinical Director”.

 Data di pubblicazione: 27/10/2021

Silk Biomaterials, a clinical-stage regenerative medicine company, is looking for a Quality Assurance Intern.

The new team player

Are you passionate, hard working and eager to learn from your first great work opportunity? 

The ideal candidate is motivated to work in a fast-paced startup and has a strong desire to grow in a very dynamic and exciting environment.

You will be part of the Quality Assurance Team. In this role, you will understand the purpose and functioning of a QMS, understand the operation of the QMS in the framework of product development, manufacturing and controls; gain ability to work in a company team, ability to meet schedules and goals. This role is perfect for fresh graduates who would like to try their skill-sets in different business areas. You’ll have a chance to put your hands on a variety of activities among different areas of interest and soak in all the knowledge from the diverse teams you’ll be collaborating with.

Your tasks

Under the direction of the Quality Assurance Manager you will be asked to, throughout specific tasks and deadlines :

• maintain the integrated (ISO 13485 and 21 CFR 820) Quality Management System - QMS;
• collaborate in the transition to the electronic-based QMS;
• review of corporate documents ensuring guidelines are always in place;
• prepare and manage creative and effective process maps (flow charts);
• prepare trainings materials;
• collaborate in validation activities;
• collaborate with R&D and manufacturing functions to ensure quality standards are in place.

The ideal candidate is:

Very quick learner, proactive, pragmatic and goal-oriented. Hard-worker and collaborative, able to work effectively in team and interact with colleagues of different areas. Attentive to details, meticulous and patient. Versatile and dynamic, flexible in completing different tasks.

Additional requirements:

• Master Degree in Biomedical Engineering or Management Engineering, Pharmaceutical Chemistry and Technology or related fields;
• High proficiency in English, both written and spoken (C2)
• Good knowledge of Microsoft Office;
• Excellent knowledge in Excel, knowledge of statistics software (Minitab, R, or other);
• Nice to have: knowledge of ISO 13485 and 21 CFR 820.

You can apply to this position by visiting this link.

 Data di pubblicazione: 27/10/2021

For its Corporate Drug Safety Department, Zambon is looking for a Pharmacovigilance Standards & Training Specialist.

JOB PURPOSE

• Maintain Zambon global PV Policies, Procedures and Work Instructions to support efficient PV processes and compliance with prevailing regulations;
• Oversight of relevant worldwide regulations and upcoming changes with potential impact on Zambon PV system to ensure continued adherence to the highest standards;
• Preparation and implementation of PV training programs worldwide, including the annual PV training for all personnel, specific training to PV personnel and service providers on Zambon Policies, SOPs, WIs, and the use of the safety database, in collaboration with relevant internal and external subject matter experts
• Oversight of PV training compliance
• Support case processing and/or aggregate reports preparation and/or signal detection, as needed.

KEY RESPONSIBILITIES

1. Coordinate PV training worldwide in collaboration with other departments (e.g., QA, HR, Affiliates) and monitoring training compliance
2. Conduct training sessions to safety personnel, affiliates, Sales Forces, service providers, as needed.
3. Maintain accurate records of training materials
4. Perform regular screening of PV legislation worldwide and assess the impact on Zambon PV processes
5. Review and update, as needed, PV Policies, SOPs, work instructions, involving the relevant subject matter experts
6. Provide support to case processing and/or aggregate reports preparation and/or signal detection, as needed.

ACADEMIC BACKGROUND

A Bachelor’s degree is required.

PROFESSIONAL EXPERIENCE

A minimum of 3-5 years experience in pharmacovigilance.

Familiarity with operational, quality assurance, and drug safety procedures and regulations.

TECHNICAL SKILLS

1. IT Tools - Preferred: familiarity with Oracle Argus
2. English language
3. Knowledge of PV legislation and guidelines
4. Project Management
5. Preferred: Knowledge of medical devices and/or food supplements legislation

You can submit your application by visiting this link.

 Data di pubblicazione: 27/09/2021

Enthera, a biotech company building a pipeline of first-in-class biologics for several underserved autoimmune conditions, is looking for a Clinical Trial Leader.

Core purpose of the job

• Supporting quality and timely execution of pre-clinical and clinical studies through operational management.

Principal accountabilites

• Management of all operational aspects related to the study conduct.
• Coordinate and supervise activities of multi-functional study team members.
• Reporting to the Chief Medical Officer.

Job requirements

• Degree in scientific disciplines (Medicine, Biology, Pharmacy or Chemistry)
• Deep knowledge and understanding of drug development process, ICH/GCP guidelines
• Solid experience in study management (> 5 years) and ability to coordinate multi-functional study team members by regular tracking of activities to ensure timely and quality data delivery
• Experience in vendors’ selection, contacting and oversight is highly desired
• Budget optimization and cost control attitude
• Strategic support in countries/sites selection with deep understanding of operational implications such as recruitment timelines, site experience and ability to comply quality standards
• Contribute to the development of regulatory documents, responses to Health Authority, EC/IRB and DSMB questions
• Plan, organize and lead Investigator meeting and CRA training & review related material
• Perform ongoing ESP management, performance management and issue resolution Oversee monitoring activities and conduct co-monitoring visits to ensure data quality
• Coordinate pre-audit and CAPA resolution activities ensuring satisfactory outcome
• Adhere to personal development plan and maintain training records to ensure appropriate level of competence in compliance with this job description including GCP, etc
• Previous experience with clinical development of biologics
• Previous experience with GLP-preclinical studies is a big plus.
• Fluent in English (spoken and written).

General skills

• Strong motivation and ability to achieve assigned objectives, timely and with high quality standards
• Organized and used to set KPIs to regularly track activities
• Excellent communication skills, verbal and written
• Ability to work in challenging and rapidly evolving situations
• Proactivity and problem-solving attitude
• Excellent team player
• Personal resilience, perseverance, energy and drive

Applications must address the selection criteria above and include a current CV and covering letter.

Send your application to info@entherapharmaceuticals.com, message subject “Clinical Trial Leader”.

 Data di pubblicazione: 15/09/2021

ItaliAssistenza è alla ricerca di un Business Analyst, con esperienza da 1 a 3 anni nella mansione, da inserire all'interno della divisione Technology Solution Management. La persona sarà coinvolta in progetti afferenti al settore Patient Support Program e si occuperà delle seguenti attività:

• Raccolta e analisi dei requisiti dalle linee di business/clienti
• Produzione documenti tecnici e funzionali rivolti allo sviluppo del deliverable
• Ruolo di collegamento tra il Business e il team di sviluppo-fornitori
• Assicurare la qualità dei deliverables sia in termini di tempi che di qualità (essendo coinvolti in attività di validazione piattaforma)
• Prioritizzare i tasks in base ai business needs oltre che ai requisiti
• Fornire supporto di pre-sales al commerciale di riferimento, con supporto in fase di Demo delle soluzioni applicative ai Clienti e stakeholder istituzionali (Medici, Farmacisti, etc.) e supporto a stesura documenti da allegare alle Proposte tecnico-economiche
• Supportare il Responsabile nelle proposte di soluzioni innovative IT per soddisfare le future esigenze dei Clienti, e partecipare alla realizzazione delle iniziative collegate
• Assistenza tecnica agli utenti finali e sviluppo manualistica e documentazione a supporto degli utenti
• Coordinamento dei servizi di supporto tecnico dei partner tecnologici (tramite piattaforma dedicata di ticketing condivisa con fornitori)

Requisiti:

• Laurea in discipline tecniche o economiche
• Buone capacità di problem solving e team working
• Capacità di produrre documenti di analisi funzionale
• Gradita pregressa esperienza come tester applicativo e/o analista tecnico
• Capacità di esprimersi in modo chiaro e strutturato, tenendo conto delle caratteristiche degli interlocutori e del contesto in cui avviene lo scambio comunicativo
• Buona conoscenza della lingua inglese

È possibile inoltrare la candidatura visitando questo link.

 Data di pubblicazione: 01/09/2021

Zambon company in recent years has expanded to include diverse, even if synergetic, businesses. With human well-being still firmly at the center, on the one hand ItaliAssistenza is Italy’s market-leader in providing solutions for human care in terms of assistance as well as patient support programs. On the other hand, OpenZone has created a scientific campus on the edge of Milan where innovative companies and start-ups are offered real estate solutions with the unique added value of cross-fertilization among people and businesses all focused on improving human life. Other initiatives with a strong digital focus have been kick-started by Zambon and are expected in the near future to provide further exciting business opportunities.

Hierarchically reporting to the CEO of ItaliAssistenza (with an additional functional reporting line to the CEO of OpenZone), the Senior HR Manager will:

• Define and implement the HR action plan consistently with the Company’s goals in cooperation with business functions. Main responsibility is for ItaliAssistenza (healthcare and personal assistance), in addition HR responsibilities for OpenZone (Real Estate, Campus)
• Support line managers in organization design and implementation, advice and support line managers on people management and development
• Plan with line managers staff requirements consistently with function/company’s goals
• Manage the personnel administration function and be responsible for personnel cost planning and monitoring
• Manage annual salary review and bonus payout
• Communicate, coordinate, support and monitor Performance Management Process to ensure time line and quality of the execution
• Manage recruiting and interviewing process, develops job description, counsels managers on candidate selection (internal positions)
• Manage the HCP (Health Care Providers) Recruiting and Training function, including the related database, with a synergetic approach across IA’s businesses
• Develop and deliver employment contracts in accordance with employment law, support potential disciplinary and termination process. Understanding off all legal implications to define a plan accordingly and comply with legal obligations
• Handle procedures related to dismissal, resignation, retirements
• Plan and deliver onboarding and induction process
• Identify specific training needs and collaborates with training manager on training actions/team development actions
• Develop organizational communication
• Implement processes, procedures and tools to ensure HR consistency across Zambon Group

Requirements:

• 6-8 years of experience in HR function in service-oriented companies (preference for people/health care industry, additional experience in HR consultancy is a plus)
• Skills for problem-solving, decision-making and managing complexity
• Track record of organizational change design and implementation
• Analytical skills and capability to understand technical business topics
• Good communication skills and capability to build strong relationships with different levels across the functions
• Strong personal integrity and ethics
• Good English

You can submit your application by visiting this link.