Medical Writing Specialist
Req #: 160005GR_en
Location: Marsa MRS 3000, MT
Job Category: Clinical Affairs
Date Posted: 10/19/2017 10:11:47 AM
Baxter Healthcare Corporation has several positions open for Medial Writers in Malta. The healthcare industry requires that we abide by regulations from all around the world. Part of the requirements is to produce annual documents which describe the safety and efficacy of our products. We are looking for individuals to write the clinical section of these documents. The ideal candidates must have a scientific background and be fluent in English (both writing and speaking).
The Job holder will be required to :
- With oversight, develops high quality clinical documents ensuring scientific excellence. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information, and ensuring delivery within timelines. Clinical documents may include investigator brochures, protocols, clinical study reports, integrated reports, Sections of submissions per regulations, clinical sections of PBRER/PSUR/RMP/ACO/CERs and so forth
- Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable).
- Work closely with cross functional team members
- Develop knowledge of all therapeutic areas.
Who you are:
- Have experience in scientific and/or medical writing
- Have experience in the analytical evaluation of scientific data
- Hold Strong organizational skills and meticulous attention to detail.
- Able to apply global regulatory authorities’ regulations and/or guidance
- Able to manage multiple projects with competing priorities.
- Hold good communication skills
- Possess knowledge of computer software (especially Microsoft Word and Adobe Acrobat products; Microsoft Project and Visio are a plus).