Internship: CMC Writer
THE INTERNSHIP
For our site in Fornovo San Giovanni we are looking for a candidate to join the Drug Regulatory Affairs Department. During this formative period, you will have the opportunity to understand the role and the importance of the function within a company that produces Active Pharmaceutical Ingredients (APIs) destined to the manufacturing of drugs for Human Pharma and Animal Health. Furthermore, you will acquire skills performing transversal activities and dealing with a multinational company context. Definitely something new to learn every day!
Tasks & what you will be learning:
You will work closely with the Scientific CMC Writer. This daily collaboration, together with the collaboration with co-authors or subject matter experts at the respective manufacturing sites, will result in the in-time preparation, compilation and maintenance of CMC documentation for global submissions based on international pharmaceutical requirements, such as:
- Module 3 documents
- Declarations
- Justifications
Requirements:
- Ideally educational background in CTF, Pharmacy or Regulatory Affairs.
- Languages: Fluent Italian and good knowledge of English (level B2).
- Good knowledge of MS Office (especially Word).
- Curious attitude, propensity for continuous improvement, innovation and teamwork.
What we offer:
- 6-months curricular/extracurricular internship with possibility of extension.
- Monthly expenses reimbursement of €1.000 with free access to the company canteen.
- A range of benefits for you physical and mental health (access to gyms, psychologist, volunteering 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.
- Constant support and interaction with our specialists and managers.
We warmly welcome applications from candidates belonging to protected categories, in accordance with Law 68/99.
We foster a workplace built on respect, trust, and empathy—free from discrimination. We are powered by our people, and we believe that our differences are our strengths. Everyone is valued, respected and empowered to be themselves.