Isabelle Blanc Email & Phone Number

Lyon, Auvergne-Rhône-Alpes, France

Lyon, Auvergne-Rhône-Alpes, France

*Direct all operations of Regulatory Submissions Dpt*Oversight of program, oversee regulatory submissions to ensure accuracy and timeliness*Identify and implement improvement to regulatory submissions processes, SOPs*Oversee hiring, training, evaluation and retention of employees

Lyon, Auvergne-Rhône-Alpes, France

*Propose and develop new regulatory submissions strategies to sponsor and maintain submission timelines with challenging clinical trials *Bid defense preparation and attendance *Line management of Regulatory Submission Managers

Région De Lyon, France

* Coordinate and oversee clinical trial submissions activities and maintain submission timelines * Maintain ongoing Sponsor contact for submission-specific issues * Independently interact with Sponsor, sites, IRB/ECs, regulatory agencies and Medpace team * Provide submission advice and guidance to Medpace team to ensure compliance with appropriate regulations and requirements * Prepare project/country-specific Informed Consent templates and negotiate/review content changes from sites * Provide oversight of Clinical Trial Submissions Coordinators and Project Assistants * Review pertinent regulations and guidances to develop proactive solutions to regulatory issues and challenges * Line management of Regulatory Submission Coordinators local team

Région De Valence, France

- Management of European clinical studies: regulatory submissions, budget review, study documents writing, sites coordination and monitoring.Therapeutic areas: orthopaedics (hip, shoulder, knee)

Grenoble

- Regulatory submission (IEC, Central Authorities, others) - Interface between the sponsor and the investigator networks- Organisation / Participation in investigator meeting, experts committee- Writing / review of study documents (protocol, ICF, clinical report)- Budget review, bid defense- Cross-functional team-work, management and co-ordination of CRA team and subcontractors - Participation in sites visits, audits and inspection- Writing of project management plan and monitoring plan - Pharmacovigilance management- Quality process manager, draft and update of SOPs- Working knowledge of Microsoft Office - GCP EU, GCP FDA, GMP, ISO9001, ISO13485 knowledgeTherapeutic areas: Oncology, multiple sclerosis, nutrition for multicentric Phase II/III and observational studies in France and Europe sponsored by pharmaceutical laboratories with French subsidiaries, biotechs, food industry and medical device companies

Grenoble

Therapeutic areas: Pharmacology, nutrition, medical device for monocentric studies in the clinical unit (60 beds)Study set-up phase: protocol and affiliates documents writing, regulatory submission to IEC and ANSMStudy duration phase: quality control of the study, reports/meetings with the sponsor, safety reports writingStudy close-out phase: databasis cleaning for snapshot, participation in blind review meetings, clinical report review, end of study information to IEC and ANSM

Grenoble

Therapeutic areas: Diabetes type II, arterial hypertension, pediatric traumatology, rheumatology, pneumologyFeasability, prestudy visits, monitoring visits, closure visits, queries resolution in France for Phase III studies sponsored by pharmaceutical laboratories with French subsidiaries