BackgroundOur client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for an experienced International Project Manager to work at their Swiss HQ on the borders of France & Germany at a senior level in Drug Regulatory Affairs and liaise with affiliates
Primary DutiesResponsible for providing international regulatory strategy, maintaining knowledge of international regulatory legislation/guidelines, liasing & coordinating submissions & affiliate/partner activities for NCE dossiers and life cycle of marketed products, responding to questions from Health Authorities, coordinating registration samples, archiving submitted dossiers & relevant HA communications, evaluate relevant sections of contracts & quotes.
QualificationsLife science graduate with sufficient regulatory affairs experience to have a good grasp of international regulatory legislation/guidelines. Able to work in a multicultural environment, display excellent communication & interpersonal skills and work independently as well as in teams. Fluency in English is an absolute requirement.
Click to Apply or email your CV to
BackgroundOur client is a leading biopharmaceutical company focused on the discovery, development and commercialisation of innovative drugs for diseases with significant unmet medical needs. A new vacancy has arisen for a (Senior) Clinical Project Scientist to work in a team of 10 other clinical research professionals on early clinical development projects within the CNS area at their Swiss HQ on the borders of France & Germany.
Primary DutiesYou will contribute to study design, manage & monitor a clinical trial from set up to completion independently, perform literature reviews and contribute to project specific documents including Clinical Development Plan, Investigator Brochure, Annual Reports, Risk Management Plan, Publication Plan. You will also maintain contact and organise meetings with Key Opinion Leaders, answer questions from Health Authorities, and present and defend the project to external experts. As a Senior Clinical Project Scientist you will also be involved with regulatory submissions, deputise for the Clinical Program Head and coach junior team members.
QualificationsPhD, MD, MSc or equivalent life science degree with 5y+ clinical research experience (particularly in the CNS arena) in the pharma/CRO industry for a thorough understanding of clinical drug development (from preclinical to commercial), a sound knowledge of regulatory requirements/ICH-GCP guidelines, and a proven record of writing protocols (PhI/II), managing studies & contributing to project related regulatory documents. You will be familiar with the area of CNS medicine (anxiety, psychatry) and understand the competitive landscape to identify its impact on the project. With an ability to handle and oversee multiple tasks simultaneously, you are able to adapt quickly to change and capable of prioritising workload in a high-pace environment. Good communication, interpersonal & persuasive skills are required for working in a matrix organisation. Fluency in written/spoken English is an absolute requirement and knowledge of German is advantageous. To apply for this position, you should have the legal right to work and live in the EU and to participate in the international travel commitment of the role. Travel commitments are <5%.
Click to Apply or email your CV to
Contact Lynne Dowse or Peter KingTel01753 868 960Fax01753 859 172Email
Blue Heron Ltd,
Heronwood, St Leonard's Hill,
Windsor, Berkshire SL4 4AT