Joeyn Meike Flauaus

Managing of project operation activities: ensuring translation of project strategy into an operational plan. Main focus late stage Clinical Development.

Regulatory CMC Manager (CMC Project Coordinator, CMC Regulatory Consultant & CMC Writer): - Responsible for Regulatory Compliance of drug products - Evaluation of Change Controls (regulatory aspects) - Responsible for preparation of CMC dossiers in CTD format for international registrations and maintenance of marketing authorizations worldwide (e.g. approvals, registrations, renewals and variations to marketing authorizations) - Coordination of requests from Authorities worldwide

Carry responsibility for individual projects (e.g., as submission MW lead) – prepare all types of clinical development related documents in close collaboration with clinical development, project management, biostats and regulatory affairs; supervise and monitor activities of external & internal writers; lead project meetings. Keeping up-to-date in this rapidly changing environment of clinical development and clinical documentation.

Planning of conferences, involvement in the selection of conference themes, search for speakers, writing & editing of brochures etc.

Writing of columns on virtually any topic. Coordinate with editor to verify dates and deadlines for publication.

Public relation officer: answering of enquiries from individuals, journalists and other organizations.

Carry responsibility for individual projects – write documents, lead project meetings with clients, coordinate other writers to provide support in preparing documentation (writing and QC), plan timelines.

Strategic consulting of the pharmaceutical industry; realization of drug launches and re-launches: planning of press conferences, writing of press reports and fact sheets (e.g. on diabetes, COPD, insomnia, multiple sclerosis); designing and writing of newsletters; carrying out stakeholder mappings and media audits.

Specialization in Cell Biology, Phytohormones & Environmental Law