Senior Medical Writer

Key Life Sciences; London; On-site; GBP 45,000 - 75,000

Job description

Senior Medical Writer - Biotech Pharma

We are looking for an experienced pharmaceutical Sr. Medical Writer. As a Senior Medical Writer, you will be supporting a top-tier pharma company. You have the chance to help our customer deliver regulatory and submission documents. While being stably employed with us, you will be fully embedded with our client.

Main Responsibilities:

1. Independently produce clinical and regulatory documents in collaboration with Principal Medical Writers. These documents may include clinical study level documents such as clinical summary documents, protocols, CSRs, IBs, briefing books, and response documents, PIPs. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
2. Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
3. Act as the primary contact for the study team in relation to the preparation and timelines (including planning) of assigned documents.
4. Facilitate the review of the documents and ensure 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.

Requirements:

1. Minimum requirement of a bachelor's degree; Master's degree preferred.
2. 3-5 years of Medical Writing experience in relevant pharmaceutical companies combined with scientific and regulatory knowledge (a must).
3. Strong writing skills and the ability to convert scientific data into clear, scientifically sound, well-structured messages.
4. Proficient in independently writing several types of clinical/regulatory documents (protocols, CSRs, etc.), 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.

Please note that prior experience as a regulatory writer (minimum 3 years) in a pharmaceutical setting is mandatory, and only profiles that match the criteria will be considered for the next steps.