Medical Writer

Baxter International

Marsa, Malta

Summary

The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce clinical documents which can be used to support the safety and efficacy of our products. We are looking for individuals to write and edit clinical documents to support regulatory submissions for Baxter products. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking).

What you'll be doing

With oversight, develops high quality clinical documents ensuring scientific excellence and regulatory compliance. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines.
Clinical documents may include protocols, clinical study reports, investigator brochures, integrated reports, clinical sections of core technical documents/new drug applications/briefing documents per regulations.
Ensure compliance of clinical documents with Baxter procedures, national and international regulatory requirements and guidelines.
Collaborate with cross functional team members and serve as MW representative at study team meetings.
Prepare document timelines, with guidance from manager, as needed.
Develop knowledge of one or more Baxter therapeutic areas.

What you'll bring

BS or MS in scientific or clinical discipline with excellent writing skills.
2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory.
Knowledge of computer software Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus.
Experience in scientific and/or medical writing.
Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner.
Strong organizational skills and meticulous attention to detail.
Familiarity with clinical trial-related and regulatory clinical submission templates and documents.
Apply global regulatory authority regulations and/or guidance.
Manage multiple projects with competing priorities.
Work in a team environment.
Demonstrate good communication skills.