A small virtual oncology sponsor is gearing up to run a Transformational Phase IIb/III Trial in 2023. Indication- glioblastoma (GBM). Protocol amendment was submitted in Aug 2022, questions and discussions with FDA required. As of Dec 2022 the sponsor is focusing on closing a funding round, after which operations will ramp up. In addition to […]
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Need for Strategic regulatory guidance and tactical support to further the progress of asset regulatory approval, including guiding direction of FDA communication and responses, submission strategy, health authority Q&A, Advisory Committee and other FDA meetings. Small, Northeast US small drug sponsor, main asset indication: treatment resistant UTI. Timelines: Phase 3 is currently enrolling, expected study […]
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Project Manager – Japan-based for a global labeling optimization project and a labeling text & artwork verification tool project Plan and manage the 2 projects noted above Help update the business cases to get them approved Experience managing vendor selections and implementations a plus Agile and regulatory labeling experience preferred. Business Analyst – Japan-based for […]
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Help required- someone who is very knowledgeable of Veeva APIs. This is probably not a large project, maybe just a couple of hours, but could lead to more. Here is the description of the business problem: we’ve been creating some forms for quick creation of Veeva objects, and that’s working fine… but I’m looking for […]
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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 pages long. TOC to be bookmarked per guidance, hyperlinking throughout report body as necessary and to appendices and attachments. Must be proficient with ISI/TRS Toolbox.
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Expedite, manage and coordinate a multitude of interrelated activities for a submission team in the development of published submissions within the required timelines. Perform post-publishing tasks including organization of submission printing where applicable, to ensure timely dispatch (by agency gateway; CD/DVD/paper; SharePoint upload) and archival of regulatory submissions, and effective maintenance of supporting documentation (e.g. […]
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The Regulatory Operations Leader requires seasoned help for overflow activities, specifically for regulatory strategy related items, not operations. Marketing application filed in November, currently preparing for inspections, intensive labeling and Adprom activities. Further tasks to be discussed. Could be 10- 20 hours a week however to be discussed.
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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 jump in and start adding value in the some of the following areas- Reg strategy, labeling, FDA required updates, interacting with partners, etc. to support […]
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Small anti-infectives, US based (northeast) drug sponsor to conduct 2 studies to support a new drug application. Study start up, first patient in target- end of Q1 2022. Primary Responsibilities The primary responsibilities of this role include but are not limited to: Management and oversight of all technical and building-related operations and services, including responsibility […]
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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. We need both!” Number of hours and duration, not sure, it really depends on the expertise of the consultant. Deep understanding of the regops process, […]
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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 support (have synopsis but not protocol) as well as publishing in the eCTD format. We have done INDs before but always in paper. Have been […]
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Document formatting and publishing expertise needed 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, PADERs Experience with document-level publishing Up to 20 hours a week for one year with the possibility to extend.
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Publishing of Drug Master File, QA of links and documents. Quick end of November project, probably 15 hours.
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Large US hub for one of either Astellas/Takeda/Daiichi Sankyo/Chugai (need mutual NDA in place for LifeSciHub to disclose). Non Clinical Writing and Submissions group within Preclinical and Translational Sciences needs document formatting support for any and all potential content: study reports, publications, submissions, etc. Hours and duration- to be determined. At present the need is […]
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