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Clinical Documentation and Disclosure Manager Copenhagen Denmark,  


Posted on : 12 June 2017

Project Description

Clinical Documentation and Disclosure Manager Location Region Hovedstaden City Copenhagen Department Research and Development Application deadline 23 June 2017 Description A permanent, full-time position as Clinical Documentation and Disclosure Manager is currently open within the Publications & Clinical Trial Registry (CTR) Department in the Medical Documentation Division, Clinical Research & Development.Clinical Research & Development is responsible for planning, coordinating, and executing Lundbeck s clinical development programmes worldwide and reporting the results of these programmes. The Medical Documentation Division is a diverse group with different nationalities and professional backgrounds. We are currently more than 20 employees who are engaged in reporting results from the clinical development programmes, from clinical documentation to support marketing authorization applications, to high quality clinical publications to support marketed products and those under development. This includes the timely posting of Clinical Study Protocols and Results in the public domain, primarily on ClinicalTrials.gov, in accordance with increasing demands in external regulations and disclosure requirements.To support and develop Lundbeck s activities and procedures in these exciting areas, we are recruiting a Clinical Documentation and Disclosure Manager.Your job and key responsibilities:The position covers the breadth of Lundbeck s clinical development programmes and contains 2 key responsibilities, equally divided between work on regulatory documents and work on clinical trial registries, namely:Managing clinical documentation (including clinical study reports and clinical summaries) in a Documentum-based system; ensuring the electronic integrity of the documentation and compliance with internal and external standards and requirements; assisting in the production of documents; and performing quality control of these documents.Registering protocols and posting results for studies on ClinicalTrials.gov and on the European clinical trials registry; ensuring content compliance with external requirements. You will be involved in the ongoing work at Lundbeck to evaluate trends, identify areas for improvement, develop and maintain processes and systems to optimize efficiency, and ensure quality in clinical documentation and the rapidly evolving disclosure area.All these activities will be planned and executed both independently and in close collaboration with the clinical team and experts in the organization.We offer:A unique opportunity to get deep insight in all clinical studies planned and conducted by Lundbeck. We invite you to be part of the Medical Documentation Division, where we share the common aspiration of becoming world class in communicating clinical information. We are imaginative, passionate, and responsible towards our deliveries, colleagues, and society. Ethics and transparency are key drivers. We offer a positive and engaged working climate and we have a strong study pipeline. Our preferred candidate has the following personal and professional qualifications:Degree in life science and knowledge of the pharmaceutical industryDrive for and experience with how IT and systems can facilitate processes and proceduresFamiliarity with Documentum-based systems, xml-based tools, and word-processing programs and how they can be applied to clinical documentation and disclosureExperience with clinical documentation, ideally related to clinical studiesFamiliarity with global clinical trial disclosure requirementsExcellent organizational skills and a methodological approach to work; ability to maintain a helicopter view without losing attention to detailAbility to work effectively both independently and in teams, plan and deliver activities and projects on time, and take changing circumstances in strideStrong interpersonal and communication skills in a global environmentFluency in spoken and written EnglishFurther information:Please contact Senior Manager: Kerstin Dahlstr

Locations

Region Hovedstaden Copenhagen

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