CMC Model Document Standardization Content Specialist (Temporary)

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
We are seeking a dedicated CMC Document Modeling Specialist to join our Regulatory Squad within the Intelligent Authoring project. This role focuses on creating and standardizing CMC model documents with adherence to regulatory standards, ensuring consistency and accuracy.

QUALIFICATIONS:

• BA/BS in English, Biology, Chemistry, Pharmacy, or a related field; laboratory assistant degrees (e.g. CTA, BTA, PTA) are also considered.
• 3-5 years of experience in a similar role, with substantial knowledge of CMC document authoring/editing for regulatory submissions.
• Experience managing documentation templates is beneficial.
  This is a one-year temporary contract.
  Relocation benefits are not available for this job posting.
  Join us to make an impact by ensuring our regulatory documents meet the highest standards of accuracy and compliance. Apply today to be a part of our innovative team at Roche!
  Who we are
  At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
  The Roche Services & Solutions as well as People Support Solutions organisations located in San Jose provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the Americas region. Today Roche employs altogether around 800 employees in Costa Rica.
  Roche is an Equal Opportunity Employer

• Design and model CMC documents for regulatory compliance.
• Collaborate with section leads and subject matter experts to align documentation with standards.
• Standardize data elements, terminology, and business rules within model documents.
• Work closely with the Intelligent Authoring Team to integrate and verify model documents within the system.
• Communicate progress and potential issues to the Product Owner.