Senior Medical Writer
As a Senior Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
As a Senior Medical Writer you will be supporting a Top-5 pharma company. You have the chance to help our customer to deliver best-in-class regulatory and submission documents.
While being stably employed with ICON, you will be fully embedded with our client.
Responsibilities :
Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers . These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports.
This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
- Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
- Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
- Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.
Minimum requirement of a bachelor’s degree; Master's degree preferred
3-5 years Medical Writing experience or other relevant pharmaceutical experience combined with scientific and regulatory knowledge
Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.
Proficient in independently writing several types of clinical / regulatory documents (mainly CSRs, Protocols) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.
LI-Remote
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