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A. MENARINI - Industrie Farmaceutiche

A. MENARINI - Industrie Farmaceutiche

High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. 

These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with more than 135 years of history. Founded in 1886 in Naples under the name of Farmacia Internazionale, in 1915 Menarini moved to Florence where the Group’s headquarters are still located today.

The Menarini Group is present in 140 countries around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of over 17,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients. Our drugs are distributed across 6 continents for the treatment of pathologies in cardiology, oncology, pneumology, inflammation and gastroenterology.

Menarini invests in the future and guarantees drug availability in the present for the improvement of patient health and well-being.

In its 9 Research & Development centers, Menarini’s main focus is dedicated to therapeutic areas with unresolved pathologies, such as oncology and anti-infectives (AMR), where increasing treatment options is fundamental to helping those in need. The Group's pipeline concentrates on innovative drugs and technologies including both small molecule and biologics for hematologic and solid tumors for greater personalized solutions.

The Group has also invested in diagnostics to develop instruments with high speed and precision for diagnoses in various fields such as clinical chemistry, diabetes, immunology, hematology, histology and point-of-care. In addition, Menarini is developing advanced technologies for the analysis of rare tumor cells with single cell precision.

From research to manufacturing, from distribution to scientific information, Menarini's goal is to achieve excellence.
Company
Title

Quality Control Analyst del Laboratorio Chimico
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Main Activities
- Svolgere attività analitiche specialistiche nel campo analitico-strumentale.
- Operare con autonomia all'interno dei lavori che gli vengono affidati dal Supervisore che lo coordina, nell'ambito di obiettivi prefissati o discussi.
- Eseguire tutte le operatività del laboratorio. Interagire autonomamente con altri laboratori / unità, nello svolgimento del lavoro affidatogli. Riportare autonomamente per iscritto i risultati di lavoro.

Fornire supporto per:
- Mantenimento dello stato di qualità dei laboratori, mediante il monitoraggio dello stato di pulizia, ordine e stato fisico (pareti, pavimenti ed arredi);
- Verifica della presenza di DPI, etichette per tossici e nocivi e corretto stoccaggio dei rifiuti;
- Verifica dello stato di calibrazione e manutenzione delle attrezzature (mediante controllo etichetta e del logbook);
- Controllo della strumentazione di stoccaggio (armadi aspirati) presente nei locali di competenza;
- Controllo dei materiali e i reagenti mediante verifica delle scadenze, stoccaggio idoneo e presenza dei MSDS.

Release Analitici:
- Eseguire le analisi e prove (Controlli chimico-fisici e biochimici) al fine di permettere il controllo efficiente ed affidabile delle materie prime, dei processi, degli API, intermedi e delle utilities (acqua
di processo e condensa del vapore puro) nel rispetto delle procedure e dei programmi stabiliti
- Eseguire le attivita analitiche del laboratorio chimico-fisici e biochimici degli studi di stabilità;
- Eseguire il campionamento delle materie prime;
- Eseguire il campionamento delle utilities (Acque di Processo e Condensa del Vapore pulito);
- Eseguire il controllo della cleaning degli impianti (Swab tests ed analisi delle Rinse water).

Laboratory Documentation Management and Training:
- Redigere le procedure del Laboratorio Chimico di sua competenza prima del loro utilizzo;
- Redigere Memo e Report analitici;
- Notificare tempestivamente i risultati non conformi ed eseguire le Investigazioni di Laboratorio, nella gestione degli OOS;
- Redigere documentazione su richiesta del responsabile.

Indagini /Deviazioni /Reclami /Change request:
- Comunicare ed assicurare che le deviazioni relative ad attività legate alle analisi di sua competenza siano opportunamente indagate e risolte;
- Assicurare che le CAPA relative assegnatele siano eseguite nei tempi prescritti,
- Comunicare ed assicurare che le Change requests relative ad attività di competenza siano opportunamente gestite e completate.

Collaborations:
- Fornire supporto tecnico per audit interni;
- Partecipare attivamente alla preparazione delle ispezioni.
- Fornire supporto tecnico per le qualifiche delle utilities/equipment.

Technical skills
• Elettroforesi (gel and capillary)
• Spettrofotometria
• FTNIR
• ELISA Test
• Test Enzimatici
• Test Cromatografici
• Esperienza nei software cromatografici come EmpowerTM.

 

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Medical Manager
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Reporting to: Medical Affairs Director
Location: Florence, HQ


CONTEXT
The Medical Affair Team (Italy) has the primary objective to support he scientific information and development on the Menarini products.
The Medical Manager works closely with the Product Manager. Other internal relationships include relations with MSL Lead, Pharmacovigilance and Regulatory personnel. External relationships include MSLs, Medical Reps, Corporate Medical Managers, Scientific Societies,KOLs

MAIN ACTIVITIES AND RESPONSIBILITIES

  • Cooperate with Product Manager in developing of the medical component of the brand strategy;
  • Develop and execute medical affairs plan for the products;
  • Manage clinical trials in cooperation with Corporate Medical Affairs department, in the role of LOCAL Study Medical Expert;
  • Develop a proper advocacy plan and engage with national Key Opinion Leader;
  • Support MSLs in the execution of the local medical plan;
  • Release scientific trainings to medical reps and MSLs;
  • Create and review promotional materials;
  • Cooperate with other Departments (Regulatory/Market Access/Pharmacovigilance) in the preparation of relevant documents necessary to meet the requirements of local Health Authorities;
  • Medical enquiries management;
  • Support/investigate life cycle management initiatives for the products.

JOB REQUIREMENTS

  • Bachelor's degree in Medicine;
  • Specialization in internistic disciplines or pharmacology preferred;
  • Fluent English in written and verbal format;
  • Optimal use of Microsoft Office (PowerPoint, Excel and Word);
  • Communication and public speaking skills;
  • Relational and organizational skills;
  • Team working skills;
  • Up to 30% overnight travel, including abroad required.
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Medical Science Liaison
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CONTEXT, MAIN ACTIVITIES AND RESPONSIBILITIES
● Works closely with the Medical department to establish a medical foot-print for Laboratori Guidotti.
● Establishes, develops and manages collaborative relationships with key medical experts and opinion leaders of Italy related to any current and future disease areas relevant for Laboratory Guidotti (diabetes area in particular).
● Drives disease awareness in providing external medical disease education and – when appropriate- setting up local scientific programs, such as symposia, regional advisory boards, or scientific meetings in accordance with the respective Laboratori Guidotti disease plans.
● Coordinates and pro-actively contributes to all pre-launch and life cycle activities any pipeline products.
● Provides medical support and medical information on unsolicited HCP requests related to any Laboratori Guidotti in-line and pipe-line products in accordance with the relevant Menarini processes and the Italian regulations.
● Is an active member of scientific and educational interactions with therapeutic specialists on diagnostic and clinically relevant aspects of any therapeutic areas in which Laboratori Guidotti is active.
● Locally facilitates any patient access programs (EAP) to address high unmet medical needs.
● Collects competitive intelligence and market insights within the region on diagnostic methods and treatment paradigms of any therapeutic areas relevant for Laboratori Guidotti.
● Pro-actively supports internal medical knowledge (reps) on any relevant disease and product related aspects.
● Manages/supports local aspects of investigator-initiated trials or other research projects; on request through Global Clinical Operations, supports delivery of patient enrolment in Laboratori Guidotti clinical trials.
● Ensures legal excellence and compliance in all medical activities as per Laboratori Guidotti SOPs and local regulations List the core areas of responsibility.

JOB REQUIREMENTS
● A strong bio-science education background.
● Doctorate degree (MD, PhD, PharmD) is preferred.
● Ability to understand and effectively communicate scientific and medical information to both internal and a variety of external customers.
● Mobile, willing to travel extensively in the region.
● Strong communication skills, open style & pro-active.
● Fluent English and Italian is essential.

BASED: Pisa

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