CERNER ENVIZA -AN ORACLE COMPANY – Medical Writer – RWE (F/M)/CDI
Please apply directly on our career page: https://careers.cerner.com/job/99623BR
Cerner Enviza an Oracle company is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Cerner Enviza is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
Thanks to our Business growth Cerner Enviza is looking for a new talented Medical Writer for the Real-World Evidence (RWE) Domain. In this role, you will be tasked with creating protocols and reports for diverse medical studies. You will be expected to act as a scientific/medical expert and express complex data in a concise and easy-to-read way. In order to be successful, this person will require an excellent attention to detail and the ability to work both independently and efficiently within an interdisciplinary team.
Recognized as an Expert, the Medical Writer will collaborate closely with account managers and projects managers to deliver compelling content to differentiate our dynamic and multicultural company from competition.
Possibility to work remotely depending on current location.
- Write, review and edit protocols, reports and other study-related documents for non-interventional and pharmaco epidemiology studies, according to regulatory requirements and standard operating procedures; Main therapeutic areas: oncology and rare diseases;
- Prepare manuscripts for publications, posters and slide decks;
- Prepare and present data interpretation reviews to clients;
- Act as scientific/medical advisor for the review of electronic case report forms in line with protocol and study requirements;
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for style, grammar, format, and consistency;
- Work on a variety of projects at the same time;
- Work effectively with other teams in Cerner Enviza, particularly Data Management and Statistics Teams;
- Ensure projects are delivered according to defined timelines and budget.
- Bachelor’s Degree or equivalent in a relevant scientific field (e.g., Pharmacology, Physiology, Biological and/or Medical/Health Sciences), higher degrees (PhD/MSc) preferred;
- Strong writing experience within a pharmaceutical company or CRO, with a focus on the writing of protocols and study reports according to ICH guidelines, and preparation of manuscripts for publication (comparable to 3+ years’ experience);
- Fluency in English (C2);
- Intellectual curiosity and creativity;
- Excellent communication skills – able to distill issues, manage client expectations and act as a trusted advisor in a timely manner;
- Ability to work effectively in a team in a fast-paced and dynamic environment;
- Excellent time management and organization skills;
- Flexibility and adaptability to changing requirements and timelines according to the clients’ needs;
- Ability to manage multiple priorities, work efficiently under pressure and consistently meet tight deadlines.A first experience with patient-centric studies, namely Epi. Studies, HEOR, Patient Reported Outcomes (PRO) studies will be a plus;
- A first experience or knowledge of databases – SDNS, CPRD, JMDC; MarketScan, Optum -, in any of the major markets (EU-5, Japan, US, Israel, etc..) will be a plus.