2206- Senior Transparency Specialist

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

Job Overview:
The Senior Transparency Specialist is a leader and subject matter expert in Transparency & Disclosure (T&D) service line 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 T&D 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 T&D landscape and trains internal staff as well as clients on the requirements and expectations.

* Serve as project lead for pilot projects with new clients
* Manage client communication for day-to-day T&D operations
* Oversee and manage T&D projects in the most efficient and effective manner to complete projects on time and within budget
* Proactively advise the client, such as on risks and benefits of modifications to redaction rules, disclosure of data, and writing in plain language
* 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 and Adobe Publishing products
* Preferred: Working knowledge of Amazon Workspace
* Extensive knowledge of clinical data anonymization related guidance and requirements
* Extensive knowledge of clinical trial disclosure requirements
* Extensive knowledge of plain language summary 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... For full info follow application link.

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: 896342

Posted On: Jan 13, 2022

Updated On: Feb 12, 2022