Transparency Specialist II

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

Job Description

Job Overview:
Transparency Specialist II prepares clinical trial transparency writing, data and document anonymization, and quality control review activities in accordance with sponsor requirements and international regulations, working with client teams from multiple functions. Transparency Specialist II may work on anonymization and/or redaction of study or dossier level datasets and documents, clinical trial protocol and/or results postings, and/or plain language summaries of clinical trials. The Transparency Specialist II is responsible for leading internal teams and performing as client leads, informing clients of the transparency requirements for various transparency deliverables.
Process regulatory documents per client specifications and rules or according to Synchrogenix standard rulesets and guidances, under agreed timelines, and within agreed quality standards
Anonymizing and/or redacting protocols, SAPs, CSRs and other applicable documents in support of transparency activities
Drafting registrations and results disclosure information and harmonizing content across multiple formats (tabular, synoptic, textual summary) in accordance with regional/national disclosure laws and client policy.
Drafting non-scientific language summaries of clinical trial results (plain language summaries)
Quality-control review of draft registrations and results, anonymized/redacted outputs, plain language summaries, as well as protocols, SAPs, CSRs and other applicable documents in support of Regulatory/Medical Writing activities
Outlines requirements from international disclosure laws, guidance, Client policy and interprets requirements as appropriate for the type of study (eg phase, marketing status, location of investigators) and recommends information to be disclosed in various transparency deliverables.
Maintain up-to-date industry awareness and understanding of regulation/standards
Education, Experience, Training, and Knowledge:
Bachelor's degree or equivalent experience
2+ years of experience in clinical trial transparency
Extensive knowledge of Microsoft Office Suite products and Adobe Publishing products
Preferred: knowledge of Amazon Workspace
Familiarity with clinical trial documents and knowledge of clinical study and clinical development design
Skills & Abilities:
Meticulous attention to detail
Strong organizational and time management skills
Communicate clear, concise and relevant information in an appropriate business format
Be tolerant of some degree of ambiguity
Ability to work in a collaborative environment and easily build relationships with others
Show flexibility to meet project needs
Ability to handle multiple projects simultaneously
Ability to adapt best practices in a changing regulatory landscape
Ability to understand, train, and apply Sponsor guidelines and requirements related to clinical trial disclosure
Understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission

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... 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: 996045

Posted On: Jun 30, 2022

Updated On: Jul 26, 2022