Abbott Senior Medical Writer (m/f) in Hannover, Germany
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
In Germany, Abbott has approximately 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. St. Jude Medical is now Abbott.
Abbott Established Pharmaceutical Division (EPD) is looking for a
Senior Medical Writer (m/f)
based in Hannover, Germany
Position is limited until June 30th, 2020
Medical writing and project management for periodic reports (e.g. PSURs, DSURs) within the Periodic Reporting and Medical Writing Group. Independent analysis of pharmacovigilance safety data based on applied clinical experience, current standards of medical care, and compliance with regulatory guidelines.
Providing expertise and support for local affiliates in local preparation of periodic safety reports.
Participates in the identification, direction, and implementation of strategic business initiatives within the Periodic Reporting and Medical Writing Group and leads such initiatives when related to local periodic safety report preparation.
Co-maintenance of templates and the Global Periodic Safety Report Timetable.
Expert on applicable writing styles and standards, ensuring deliverables meet organizational, regulatory, and customer needs.
Utilizes a variety of resources to generate medical safety conclusions/assumptions and demonstrates sound medical judgment regarding causality based on the application of clinical experience, standards of care, and regulatory guidelines.
Understands regulatory framework, trends & requirements related to pharmacovigilance, clinical studies and global drug development, in particular in regards to periodic and aggregate reporting. Has a deep understanding of document quality standards and attention to detail.
Actively contributes to minimizing patient and product risk by conducting pharmaceutical and medical assessment of information on drug risks including adverse reactions, drug interactions, toxicity and medication errors during periodic report preparation. This includes the consideration if safety data qualify as a new safety signal or as a new identified or potential risk, or may potentially alter any previous signal or risk assessments.
Licensed physician or graduate with a Health Sciences degree (e.g. Master, PhD) or medically trained person with extensive job-related experience.
Minimum 5 years pharmaceutical industry or clinical experience, or the like.
Experienced professional operating within the international arena, and working across functional areas.
Understanding of medical conditions and disease state entities, able to critically evaluate medical data.
Proficiency in the use of Microsoft Excel, Word, Power Point, Outlook, e-room technology, and good eCTD knowledge and formatting skills (e.g. ISI Writer).
Very good communication and presentation skills (oral and in writing) in English.
Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.
Do you like the sound of this job and think you’ve got what it takes?
Then send us your CV today. We look forward to receiving your application.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org