Costa Rica Job Openings
Roche
CMC Model Document Standardization Content Specialist (Temporary)
San Jose
FULL TIME
November 11, 2024
Key Responsibilities:
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Design and model CMC documents for regulatory compliance.
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Collaborate with section leads and subject matter experts to align documentation with standards.
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Standardize data elements, terminology, and business rules within model documents.
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Work closely with the Intelligent Authoring Team to integrate and verify model documents within the system.
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Communicate progress and potential issues to the Product Owner.
Who You Are:
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Strong proficiency in Word, Acrobat, and document management systems (e.g., Documentum, Share Point).
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Meticulous attention to detail, especially concerning data integrity and document formatting.
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Excellent communication skills in English (written and spoken); additional languages are a plus.
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Proven ability to work efficiently both independently and as part of a team, with strong organizational and time-management skills.
Qualifications:
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BA/BS in English, Biology, Chemistry, Pharmacy, or a related field; laboratory assistant degrees (e.g. CTA, BTA, PTA) are also considered.
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3-5 years of experience in a similar role, with substantial knowledge of CMC document authoring/editing for regulatory submissions.
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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!
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.
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