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Regulatory Operations Specialist I/II

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

At Certara, we accelerate medicines to patients by partnering with life science innovators.
In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:
informed decision-making & reduced clinical trial burden
higher R&D productivity
improved patient outcomes & increased patient access to medicines
accelerated regulatory approval
Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.
Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.
Synchrogenix, a Certara Company: Achieving Regulatory Success
As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.
Synchrogenix's people are at the core of our success, and our most successful people are:
collaborative and value being part of a team
experts with a thirst for continued learning
consultative with an ability to articulate process and expertise
deadline-driven and able to operate in a fast-paced environment

Regulatory Operations Specialist I/II
Job Overview:
The Regulatory Operations Specialist I/II will serve as an internal team member for electronic submission publishing projects, primarily in eCTD format. He/she will collaborate with colleagues and clients on routine, project related matters. The Reg Ops Specialist will be responsible for completing tasks assigned in order to support team members in meeting submission deadlines.
Responsibilities:
Prepare, compline, scan, render, and maintain regulatory submissions to regulatory health authorities
Prepare documents for electronic submission publishing by using MS Word formatting, content templates or MS Word Styles as directed
Publish documents by creating bookmarks and hyperlinks into submission files according to Synchrogenix and client policies
Track document publishing progress for eCTD submissions by using Synchrogenix tracking tools
Perform quality control reviews and follow Synchrogenix procedures to identify, document, and remediate findings
Track and report time spent on completing project tasks
Generate meeting agendas, minutes and scheduling for project meetings with clients
Education, Experience, Training, and Knowledge:
Bachelor's degree or equivalent experience
1-4 years of prior work experience in US eCTD submission requirements; experience in Canada and EU eCTD submission is a plus
Strong computer skills, including proficiency with MS Office, Adobe Acrobat and Microsoft Word functionality in terms of formatting document using content templates or MS Word styles
Prior experience working in a professional environment that demands high utilization of computer and communication skills

Skills & Abilities:
Excellent IT/computer skills
Excellent written and verbal communication skills
Ability to compile regulatory submissions with supervision by team leaders
Work in a role that demands strong attention to detail and organizational skills in a fast-paced environment
Use simple rules, common sense and experiences to identify issues in the work product

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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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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Job Posting: 897776

Posted On: Jan 15, 2022

Updated On: Feb 14, 2022