Clinical Documentation and Disclosure Manager - Denmark
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- 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 our company’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.
- To support and develop our company'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 our company’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.
- You will be involved in the ongoing work at our company 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.
- A unique opportunity to get deep insight in all clinical studies planned and conducted by our company.
- 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.
- Degree in life science and knowledge of the pharmaceutical industry
- Drive for and experience with how IT and systems can facilitate processes and procedures
- Familiarity with Documentum-based systems, xml-based tools, and word-processing programs and how they can be applied to clinical documentation and disclosure
- Experience with clinical documentation, ideally related to clinical studies
- Familiarity with global clinical trial disclosure requirements
- Excellent organizational skills and a methodological approach to work; ability to maintain a helicopter view without losing attention to detail
- Ability to work effectively both independently and in teams, plan and deliver activities and projects on time, and take changing circumstances in stride
- Strong interpersonal and communication skills in a global environment
- Fluency in spoken and written English
- Our company is a global pharmaceutical company specialized in psychiatric and neurological disorders.
- For more than 70 years, we have been at the forefront of research within neuroscience.
- Our key areas of focus are depression, schizophrenia, Parkinson's disease and Alzheimer's disease.
- An estimated 700 million people worldwide are living with psychiatric and neurological disorders and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences.
- Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders – we call this Progress in Mind.
- Our approximately 5,300 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales.
- Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries.