Regulatory Strategy to Support Transformational Phase IIb/III

Regulatory Strategy to Support Transformational Phase IIb/III

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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Data Management Lead

Data Management Lead

Small, MA based Phase 3 sponsor in need of a Data Management Lead.  Will report to Head of Biometrics, experienced in all aspects of Data Management.  This role is heavy on vendor management and data management oversight of CROs and external data managers, as well as data management database systems and technologies.

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Regulatory Strategist- Phase 3 Infectious Disease Small Pharma

Regulatory Strategist- Phase 3 Infectious Disease Small Pharma

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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Product Labelling and Artwork PM, Business Analyst/s

Product Labelling and Artwork PM, Business Analyst/s

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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Senior Module 4 Medical Writing Expertise Needed

Senior Module 4 Medical Writing Expertise Needed

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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