Senior Medical Editor

3 weeks ago

Remote, United Kingdom ICON Full time

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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 mínimal oversight needed
- 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 Incyte 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.
- Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 6+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).
- Strong working knowledge of the editorial and publishing activities within Clinical Development.
- Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.
- Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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