Uwe Totzke 28 connections

Developing and supporting Phase I-III clinical trials in accordance with Clinical Development Plans; Clinical Trial Director role; coordinating clinical tasks in submission activities (e.g. CTD compilation); presenting at scientific advice meetings with Health Authorities; supporting business development activities and early development projects; contributing to due diligence assessments of preclinical drugs; supporting communication and alignment between non-clinical research and clinical development

Scientific consultancy; reviewing, editing, or writing from scratch any kind of life-science document in compliance with current guidelines, including literature searches; data management and statistical analyses, if applicable

Building from scratch and heading a high calibre Medical Writing team. Responsible for the department’s profit and loss. Supervised and worked on: over 50 CTDs (incl. new MAA, type-II variations, OTC-switches, and orphan indications), about 20 publications as well as other projects. Co-authored several publications of investigator-initiated trials, based on provided conceptual input or statistical analyses.

Supervision of set-up, validation and automatisation of new laboratory/analytical techniques; writing of validation/analytical reports and SOPs; scientific support to internal departments and clients from the pharmaceutical industry; member of a global MDS scientific committee harmonising analysis procedures

Set-up, supervision and organisation of all central laboratory actions during the conduct of clinical trials in accordance with GCP, the study protocol and sponsor´s requirements