16 projects found
hands on regulatory strategist
A small, Arizona based sponsor currently in Phase II with a leading candidate in oncology, among others, looking to explore with FDA their Phase II as a transformational trial, protocol…
Northeast US based drug sponsor in need of Regulatory Affairs consultant. There is a Head of Regulatory at present but is overloaded, needs an experienced second pair of hands to…
Not an urgent need but looking for expertise in this area to bring in ad hoc. Must be totally proficient in word, ectd templates, formatting for submissions. Looking for independent…
Small CA based biotech in need of an independent expert who knows both Veeva (any vault) AND regops. What we’re finding is that people either know one or the other. …
Document formatting project. required: Proficient in MS Word and Adobe PDF Proficient in ISI Toolbox Formatting experience Familiar with Veeva Vault (preferably Submissions Vault) Experience with report-publishing; i.e., CSRs, IMPDs,…
Publishing of DMF, QA of links and documents. Quick end of november project, probably 15 hours.
40 PDF study reports to be prepared for submission starting Oct 12, finishing Nov 9. Mostly tox approx 20 pages long plus attachments, some clinical. Longest study is approx 70…
Project starting Oct-Nov timeframe, not sure exactly when. Looking for a commitment to the equivalent of three weeks over the course of 2 months. Submission publishing- Docubridge a plus, RegDocs365…
Document formatting for submission. Nov-Dec timeframe, probably about 3 weeks full time spread out over 2 months. Not sure exactly when it’s starting, would like to secure a commitment to…
· Verify study, country, and site level TMF completeness and generate missing documents lists and queries as necessary. · Perform TMF reviews on site, country, or study level · Ensure…
5 PMTA submissions- pre market tobacco authorization. Not eCTD- “eTDD” elements of eCTD but not fully eCTD format. First one was supposed to be complete by July 31, each subsequent products one week…
Small Seattle based sponsor working to bring 3 compounds to market- oncology, Covid19 vaccine and schistosoma disease. Content is in various stages of completion- mostly drug substance. Need medical writing…
Full time 6-9 month role to work with a consulting team at a Tier 1 NJ based (mix of remote/on site) drug sponsor to define and implement a central data…
Submission Publishing, QA & QC · Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines. …
Engagement Description: Provide document formatting, report level publishing and other related activities as mutually agreed upon
