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Senior Medical Writer

ICON Strategic Solutions

United Kingdom

Remote

GBP 80,000 - 100,000

8 days ago

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Join a leading clinical research organization as a Senior Medical Writer, where you will play a pivotal role in supporting a top-tier pharmaceutical client. This position offers an exciting opportunity to produce high-quality regulatory documents, collaborate with experienced professionals, and ensure submission-ready materials across various therapeutic areas. With a focus on scientific clarity and precision, you will leverage your expertise to transform complex data into well-structured documents. Embrace the chance to make a significant impact in the healthcare industry while enjoying the stability of a reputable organization. If you are passionate about medical writing and thrive in a dynamic environment, this role is perfect for you.

3-5 years of Medical Writing experience with strong regulatory knowledge.
Ability to convert scientific data into clear, structured messages.

Produce clinical and regulatory documents in collaboration with Principal Medical Writers.
Act as the primary contact for study teams regarding document preparation.

Medical Writing

Regulatory Knowledge

Scientific Data Interpretation

Lean Writing Strategies

Document Preparation

Bachelor's Degree

Master's Degree

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 summary documents, protocols, CSRs, IBs, briefing books and response documents, PIPs. 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.

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Minimum Requirements:

Minimum requirement of a bachelor’s degree; Master's degree preferred.
3-5 years Medical Writing experience & other relevant pharmaceutical experience combined with scientific and regulatory knowledge.
Strong writing skills and the ability to convert scientific data into clear, scientifically sound, well-structured messages.
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.

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