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Senior Transparency Specialist

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

Job Description

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.
Responsibilities:
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 guidances 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 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

About Certara
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
Financial - competitive pay, incentives, retirement plans, income security programs
Health and Wellness - comprehensive benefit package, wellness programs, healthy lifestyle office environments
Work/Life - unlimited paid time off and an employee assistance program
Growth & Development - performance driven environment
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: 987304

Posted On: Jun 14, 2022

Updated On: Jun 25, 2022