Regulatory Medical Writing Placement Student 2022
We are seeking highly motivated candidates to join us as a Regulatory Medical Writing Scientist Placement Student in our Regulatory Medical Writing (RMW) department. This position will be part of our Integrated Data Analytics and Reporting (IDAR) Academy, a premier training program focused on developing and inspiring talent in those considering a career in pharmaceutical research and development.
Regulatory Medical Writing prepares high quality clinical documents to support the development, regulatory approval, and maintenance of our products. These documents include clinical protocols, investigator’s brochures, and clinical study reports, as well as summaries of efficacy and safety and responses to health authority questions.
How you can make a difference: Apply your excellent scientific writing skills, your ability to interpret and summarize statistical and medical information, and your attention to detail to support the design of our clinical trials and the reporting of our scientific data, and ultimately to help patients throughout the world.
Upon successful completion of your training your main responsibilities may include (but not be limited to):
- Prepare sections of documents or write basic documents under close supervision, such as protocol/report shells, narratives, simple protocol amendments, and Investigator’s Brochure updates.
- Assist with document quality control, abbreviations, references, literature searches, table creation, and other tasks.
- Learn and follow standard operating procedures, templates, best practices, policies, and style guides.
- Attend cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
The Regulatory Medical Writing Scientist Placement Student may also get the opportunity to contribute to departmental innovation, process improvement initiatives, or exploratory research projects.