Transparency Specialist II
Posted on :
23-07-2022
Employer Active
1 Vacancy
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Job Description
- 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
Employment Type
Remote
Company Industry
Pharma / Biotech / Clinical Research
Department / Functional Area
Administration
Key Skills
- Management
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