Senior Transparency Specialist – Disclosure

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

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services.

• 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

Job Overview

The Senior Transparency Specialist is a leader and subject matter expert in Clinical Trial Postings and Disclosure space who is responsible for oversight, training and mentoring of internal staff as well as having a comprehensive understanding of the organization, organizational process, and structure of deliverables to provide internal and client leadership. The Senior Transparency Specialist demonstrates an understanding of customer needs and expectations and ensures consistency across the products delivered back to the client. The Senior Transparency Specialist keeps up to date on regulations and industry developments in the Clinical Trial Postings and Disclosure landscape and trains internal staff as well as clients on the requirements and expectations.

Responsibilities

• Serve as project lead for pilot projects with new clients
• Manage client communication for day-to-day T&D operations
• Oversee and manage CTP projects in the most efficient and effective manner to complete projects on time and within budget
• Proactively advise the client based on best practices and guidance
• Collaborate with Business Development and Proposals and Contracts teams to ensure that client SOWs correctly capture efficiency and cost impacts for regulatory agency requirements
• Train and mentor Transparency specialists

Education, Experience, Training, And Knowledge

• Bachelor’s degree preferred
• 3 or more years of experience within CRO or pharmaceutical, medical device or biologics industry leading redaction and anonymization
• Extensive knowledge of Microsoft Office Suite products
• Extensive knowledge of clinical trial disclosure requirements
• Proven success in team-based environment

Skills & Abilities

• Proficient understanding of corporate processes that impact the service line
• Demonstrate solid time management skills and is deadline conscious with strong leadership and management of process
• Communicate clear, concise and relevant information in an appropriate business format
• Desires challenges, both technical and interpersonal
• Can manage changing and competing priorities in a fast-paced environment
• Ability to work in a collaborative environment and easily build relationships with others
• Action oriented, always seeking new development opportunities to build knowledge and skills
• Show flexibility to meet project needs
• Proactively maintain working knowledge of transparency regulations and best practices
• Ability to independently direct others to complete projects with a proactive approach and little need for detailed instructions

Other Information

Number of Employees Supervised: 0

Percentage of Travel Required:[X]%

Special Requirements

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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