The Position
For our site in Fornovo San Giovanni (BG) we are looking for a CMC Scientific Writer to join our Drug Regulatory Affairs team responsible for the preparation of CMC (Chemistry, Manufacturing and Control) documentation
Tasks & Responsibilities
Tasks & Responsibilities:
In-time preparation, compilation and maintenance of CMC documentation for global submissions based on international pharmaceutical requirements, aligned with the corresponding GxP relevant documentation
Writing the required CMC documentation in close collaboration with co-authors or subject matter experts at the respective manufacturing sites
Coordinating the review and approval cycles for all relevant CMC submission documents among the relevant interfaces within the BI system to ensure regulatory compliance as well as legal and internal requirements
Providing further submission documentation including scientific documents (e.g. statements, justifications, etc.), DMF/CEP documentation for the drug substance in scope and contributes to responses to Health Authority questions on request
In addition, he/she supports the manager in assessing and defining the regulatory impact of internal change requests, manufacturing deviations and risk assessments
Requirements
At least 2-3 years experienced in Regulatory Affairs or Quality Assurance; skill/experience gained in a similar position
Bachelor's degree in Chemistry, Pharmaceutic or Biochemistry
Experience of working in a GMP environment
Native level of Italian language and B2 level of English
Ability to achieve and maintain high standards with meticulous attention to detail
Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales
Teamwork, problem solving and ability to work under pressure
What we offer
For this position we offer a temporary, 1 year contract with an external agency
Free access to the company canteen and ticket restaurants when working remotely according to BI policy
A range of benefits for your physical, financial, social and mental wellbeing (access to gyms, psychologist, volunteering, parental support, company welfare and more)
A support to develop your own professional and personal path that will guide you through our full range of development programs including platforms to learn foreign languages and attend professional courses
In Boehringer Ingelheim we are committed to guarantee equal opportunities; we believe in respect, trust and empathy, in a work environment without discrimination.
We are powered by our people as we know that our differences are our strengths.
We value everyone and each of us feels included, important and at ease.
This job requisition is addressed also for candidates with disabilities and belonging to protect categories following articles 1 and 18, Law *****.
La Nostra Azienda
In Boehringer Ingelheim sviluppiamo terapie rivoluzionarie e soluzioni sanitarie innovative in aree di necessita terapeutica sia per gli esseri umani che per gli animali.
Come azienda a conduzione familiare, ci concentriamo sui risultati a lungo termine.
Siamo convinti che, con persone di talento e appassionate di innovazione, non ci siano limiti a ciò che possiamo ottenere; dopo tutto, abbiamo iniziato con appena 28 persone.
Ora, siamo unazienda farmaceutica guidata da dipendenti in tutto il mondo che coltivano una cultura diversificata, collaborativa e inclusiva.
Perché Boehringer Ingelheim?
Con noi si può crescere, collaborare, innovare e migliorare le vite.
Offriamo un lavoro stimolante in un ambiente rispettoso, amichevole e internazionale, caratterizzato da professionisti con mentalita aperta e orientata allinnovazione dove lapprendimento e lo sviluppo per tutti i dipendenti sono fondamentali, perché la vostra crescita è la nostra crescita.
Offriamo anche uno stipendio competitivo, numerosi giorni di ferie e agevolazioni per il vostro benessere, la vostra stabilita economica e lequilibrio tra lavoro e vita privata.
Inoltre, una palestra in loco (Ingelheim), un medico in sede e i migliori bar e caffetterie per mantenervi energici e in salute.
Per saperne di più sui vantaggi che potrebbero aspettarti, visita la nostra area area Carriere.
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