Study Report QC- Approximately 80 pages of a study report, to be submitted in 510K. Final draft expected to be available April 15, looking for a QC completion date of May 1. Report will be provided electronically. Content QC required- checking study report body content against tables listings and figures. Formatting QC most likely not […]
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Mid sized Northeast US based drug sponsor‘s goal is to update our StartingPoint authoring templates (SP) and incorporate relevant aspects of TransCelerate’s (TCB) Common. Tasks include conducting a Comparison of our current SP templates with TCB’s CPT, identify differences between TCB CPT from current templates; collect feedback from current users within the core team., execute updates to […]
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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 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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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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Large US hub for one of either Astellas/Takeda/Eisai (need mutual NDA in place for LifeSciHub to disclose). Head of Non Clinical Writing and Submissions needing senior MW expertise for writing, QC, lifecycle management, and providing input, guidance and mentoring for less senior members of the team. Hours and duration- to be determined. At present the […]
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