As a Senior Medical Writer you will join ICON plc - a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.What will you be doing?Researches, writes, and edits clinical and regulatory documents by applying functional expertise and clinical drug development knowledge. Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents. Exhibits excellent written and oral communication and presentation skills. Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).What do you need to have? - Manages all aspects of the medical writing function.
- Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
- Contributes to clinical protocol development for first-in-human oncology studies.
- Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
- Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
- Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
- Acts as a lead medical writer on complex programs and numerous individual studies.
- Provides scientific and medical writing consultancy to project teams, as requested.
Location: Europe remoteWhat Do You Need To Have - Advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 3 years of experience in a medical writing role in the pharmaceutical/CRO industry. *Note: oncology experience is preferred.
- Excellent regulatory writing skills.
- Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
- Knowledge of current requirements and guidelines applicable to submission documents
- Excellent interpersonal and oral communication skills.
- Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
- Ability to prioritize multiple projects
