Job Description: CMC Document Modeling Specialist (Regulatory Squad)
Location: San Jose, Costa Rica
Contract Type: One-year temporary contract
Relocation Benefits: Not available
About Roche
At Roche, we are at the forefront of healthcare innovation, with more than 100,000 employees across 100 countries dedicated to improving patients' lives. Our success is driven by our commitment to diversity, curiosity, and cutting-edge solutions. Our mission is to push back the frontiers of healthcare, and we need dedicated individuals to help us in this pursuit.
The Opportunity
We are looking for a CMC Document Modeling Specialist to join our Regulatory Squad within the Intelligent Authoring project. This role focuses on creating and standardizing Chemistry, Manufacturing, and Controls (CMC) model documents to ensure they comply with regulatory standards. You will play a crucial role in making sure our documentation is accurate, consistent, and ready for regulatory submissions.
Key Responsibilities
Design and Model CMC Documents:
Create and standardize CMC model documents in adherence to regulatory compliance requirements.
Collaboration with Teams:
Work closely with section leads and subject matter experts to align documentation with internal and external standards.
Standardization:
Standardize data elements, terminology, and business rules within CMC model documents to ensure consistency.
System Integration:
Collaborate with the Intelligent Authoring Team to integrate model documents into the system and verify their functionality.
Progress Reporting:
Communicate ongoing progress and potential issues to the Product Owner to ensure smooth project delivery.
Who You Are
Skills:
Strong proficiency in Word, Acrobat, and document management systems (e.g., Documentum, SharePoint).
Meticulous attention to detail, especially concerning data integrity and document formatting.
Excellent communication skills in English (written and spoken); proficiency in additional languages is a plus.
Ability to work both independently and as part of a team, with excellent organizational and time-management skills.
Qualifications and Experience:
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 CMC document authoring/editing for regulatory submissions.
Experience managing documentation templates is beneficial.
Why Join Roche?
Diversity and Inclusion: At Roche, diversity is key to our success. We embrace individuality and believe in the power of diverse perspectives to deliver exceptional care.
Work with Impact: Help us ensure that our regulatory documents meet the highest standards of accuracy and compliance, supporting the development of innovative healthcare solutions.
Innovative Environment: Join a forward-thinking team that is constantly pushing boundaries in healthcare and technology.
Roche is an Equal Opportunity Employer
We embrace diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity, national origin, disability, age, or any other legally protected status.
If you are passionate about making an impact through your work, apply now to be a part of our team at Roche!
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