What are the responsibilities and job description for the Regulatory Document Associate position at Magnit?
Temp Regulatory Document Associate
Pay Range: $24.89 - $29.27/hr
Onsite Role in Rensselaer, NY
12 Month Contract
Summary: The Regulatory Document Associate for CMC Regulatory Sciences will review draft pharmaceutical regulatory documents to ensure the accuracy and consistency of data and other content included in regulatory submissions and related documents. The Regulatory Document Associate will review content primarily related to biopharmaceutical chemistry, manufacturing, and controls. In addition to data verification and consistency checks, the Regulatory Document Associate may also assist with the coordination of programs and initiatives to help improve data integrity and associated processes within the department. Additional opportunities may arise for a Regulatory Document Associate with copyediting experience.
Essential Duties and Responsibilities include, but may not be limited to:
• Locate appropriate source documents and perform data verification
• Verify consistency of data and content included in multiple sections of submission documents
• Data-verify additional documents produced at IOPS, as needed
• Maintain consistent terminology, names, and abbreviations
• Recommend changes to formatting
• Assist with the creation and maintenance of resources related to document reviews
• Assist in other document quality initiatives and outreach, as needed
Education and Experience:
• Requires a four-year degree in related field
• Previous experience with detailed document review is strongly preferred.
• Experience with or knowledge of biopharmaceutical development, testing, or manufacturing a plus.
Knowledge, Skills, and Abilities:
• Rigorous attention to detail, exceptional organizational and communication skills
• Comfort with technical/scientific content and with navigating multiple systems, and the ability to work well under tight deadlines.
This is a contract position at Regeneron with Magnit Global being the Employer.
To do our best work we need different viewpoints. Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
W2 only, no third party solicitation
Salary : $25 - $29
