CMC Scientific Writer

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.

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.

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.