Medical Writer
IQVIA
Athens, Greece
πριν από 4 μέρες

Regulatory Medical Writer 1 : UK and Europe (Home based / Hybrid)

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Why IQVIA? Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare.

In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

IQVIA offers a competitive salary and great benefits, including a profit-related annual bonus, paid leave, and private health insurance.

Forge a career with greater purpose, make an impact, and never stop learning"

If you are looking to take your medical writing career to the next level as a manager in our team, we will provide you with opportunities to manage programs of studies, build and maintain relationships with key customers, and oversee the training and onboarding of teams.

You will be able to develop your career in our team along either a management or technical route depending on your preference.

Job Overview

We are looking for a Medical Writer to lead straightforward projects, prepare assigned CSR or Protocol documents in accordance with company Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.

You will negotiate timelines and discusses / resolves customer comments, with support from your senior’s as needed support as needed.

You will keep abreast of current medical and / or technical writing / regulatory knowledge, including GCP, along with developments and advances in drug development / medical and / or technical writing.

Responsibilities

  • Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task,
  • confirming templates and specifications, negotiating, and adhering to timelines, organizing document reviews, communicating directly with the customer.
  • Manage day-to-day workload : identify project needs, track timelines and implement customer requests, keeping manager / senior staff abreast of progress on tasks and any potential problems with project work.
  • Attend project team meetings with or without other writers. Participate in / lead comments resolution or similar meetings with external customers.
  • May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).
  • Complete project finance activities, including monitoring and forecasting budgeted hours.
  • Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.
  • Requirements

  • Prior Medical Writing experience with exposure to writing Protocols and Clinical Study Reports is essential.
  • You are educated to at least Bachelor's Degree Bachelor's Degree in life sciences related discipline or
  • related field, however, a MSc or PhD would be a distinct advantage.
  • You will have 1-3 years prior work experience
  • Ideally you will be Familiar with the structural and content requirements of clinical study reports, protocols, and similar documents.
  • If you have a good understanding of common statistical methods used in clinical trials and / or interpretation of their results it would be beneficial.
  • You can integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
  • You have a depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
  • IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

    We believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. Learn more at

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