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Medical Writer, In Vitro Diagnostics

Pharmaceutical Research Associates, Inc

Reading

Remote

GBP 100,000 - 125,000

9 days ago

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Job summary

An established industry player is seeking a Senior Medical Writer to join their team, focusing on in vitro diagnostics and medical devices. This role offers the opportunity to work closely with a leading organization, ensuring compliance with IVDR while generating critical clinical performance documents. Ideal candidates will have over five years of experience in medical writing, a strong understanding of IVD clinical trials, and proficiency in Microsoft Word. Join a supportive and innovative environment where your contributions will lead to improved health outcomes for patients and smarter decisions for healthcare professionals.

Qualifications

  • 5+ years experience in Medical Writing is essential.
  • Familiarity with IVDR and advanced knowledge of IVD clinical trials.

Responsibilities

  • Support data generation through literature searches and data collation.
  • Generate and update clinical performance reports annually.

Skills

Medical Writing

IVDR Compliance

Literature Search Protocols

Data Generation

Microsoft Word

Microsoft Office Suite

Education

Bachelor's degree

Master's degree

Medical Technology Certification

Job description

Overview

Senior Medical Writer position, Maidenhead (Eng), Galway (Ireland) or Jena (Germany) - In Vitro Diagnostics/Medical Devices

You will be partnering with a well-known leader in in vitro diagnostics, who offer a broad range of innovative ways for hospitals, labs, blood banks and clinics to diagnose and monitor health conditions with greater accuracy, speed, convenience and cost-efficiency. The result is smarter decisions for physicians and better health outcomes for patients.

Here in the ICON Strategic Solutions team, we are in an established partnership to supply a FTC (until end 2025), full-time, Senior Medical Writer with considerable Medical Devices experience.

Responsibilities

In order to ensure product continuity on market and IVDR Compliance (Submission, Implementation, periodic update of the Clinical Performance Documents (CPR)), we are now recruiting for a Medical Writer to partner with a Medical Devices Pharmaceutical Company.

The Medical Writer will support data generation through literature searches and data collation and dissemination. This will be in support of on-market products going through IVDR remediation. It is expected that the Medical Writer will generate the initial clinical performance report, which then will be updated on an annual basis.

The candidate will be skilled in medical writing (with >~5 years' experience in Medical Writing), developing literature search protocols, and interpreting and selecting relevant scientific literature. Proficiency in Microsoft Word, including creating, tracking changes, and formatting documents to a final signable state, is essential.

We are recruiting professionals ideally located near Maidenhead (England), Galway (Ireland) or Jena (Germany).

Qualifications

Education & Experience

Minimum BA or BS and solid related experience (ideally over 5 years' Medical Writing experience is essential); Master's degree or Medical Technology Certification, and a familiarity with IVDR.

Technical skills/Knowledge/Abilities

  1. Strong medical writing skills
  2. Deep understanding of IVDR and applications
  3. Advanced knowledge of IVD clinical trials
  4. Proficient computer skills including Microsoft Office Suite

Why 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.

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.

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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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