London, UK
Posted: Sep 17, 2024
RemoteFull-time
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Skills Required
Medical Writing
Proficient
Nice To Have skills
Job Description

As a Senior Medical Editor you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client.

The position is home based anywhere in Europe or UK. Your contribution will be in the field of solid and liquid tumors. While working for our client, you will be able to profit from ICON through continued learning opportunities and building a longer-term career.

This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Medical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors. The Senior Medical Editor performs the activities with minimal oversight needed


What you will be doing:

  • Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the Style Guide and submission standards.
  • Verify data in documents against the source tables, figures, and listings and format tables according to standards.
  • Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and companyy's style guides.
  • Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).
  • Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.
  • Proofread documents against the standard templates to ensure compliance with required sections and text.
  • Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.
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Company/Employer
ICON Strategic Solutions
Additional Info
Min. Experience
-
Job Location
Remote
Job Type
Full-time
Job Seniority Level
Mid-Senior level
Job Duration
-
Language(s)
English
Est. Budget/Pay Rate
To be discussed
Est. hrs
-
Optimal Job Start
-
Job Industry
Pharmaceutical Manufacturing
Job Function
Marketing, Public Relations, and Writing/Editing
Applicant Countries
United Kingdom,
Job Ref
J247EE1499CE5