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Associate Principal Regulatory Writer-Clinical Team
Certara
Company Overview Certara optimizes R&D productivity, commercial value, and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA. As Certara’s regulatory science division, Synchrogenix, a Certara company, assures and accelerates regulatory success through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Synchrogenix’s proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency. Position Overview: Clinical Focus Associate Principal Regulatory Writers are critical members of Synchrogenix’s regulatory services team. They do more than prepare high-quality documentation for regulatory submissions; they help streamline the regulatory documentation process and provide strategic guidance and best practices for our clients. The Associate Principal Regulatory Writer (APRW) is a significant contributor to document authorship in various therapeutic areas and global markets. The APRW will be the project leader and authoring contributor for all types of client engagements while mentoring others to authorize regulatory documents.
What we offer:
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Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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Requirements for the Role:
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Associate Principal Regulatory Writer-Clinical Team | Nationwide, |
Certara | 2 Weeks Ago |
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