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Senior Medical Writer, Europe Remote

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Primary Location: Reading, Berkshire, United Kingdom Additonal Locations: Barcelona, Spain,ESP; Frankfurt, Germany,DEU; Milan, Italy,ITA; Oeiras, Portugal,PRT; Paris, France,FRA Full time R1241921

Job description

IQVIA uses Human Data Science — the integration of data science, technology, and human science — to help customers address both current needs and future opportunities. But to get there, to make Human Data Science work, for you, you need a seamless integration of unparalleled data, advanced analytics, transformative technology, and deep domain expertise.

IQVIA is growing and we have openings in our Medical Writing team! Working closely with cross-functional teams you'll be a pivotal member of this expanding team. We are seeking a Senior Medical Writer to act as the Lead on writing projects. Preparing assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. You will be responsible for Performing Senior Review of straightforward medical writing deliverables.

Why IQVIA?

As an experienced Medical Writer, you will gain exposure to a wide variety of study phases and therapeutic areas, benefiting from the infrastructure and stability of a global industry leading company, but with the support and friendliness of a small team. You will work with highly qualified cross-functional teams using well-established processes to produce high quality documentation for our wide customer base - from small biotech to large pharmaceutical companies.

You will benefit from a tailored development plan, with structured mentoring and onboarding


Role Functions

  • Taking 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.
  • Planning and organizing workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
  • Leading meetings on more challenging topics independently.
  • May present on standard Medical Writing processes at full-service bid defense meetings.
  • Assisting in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.
  • May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.
  • Complete project finance activities, including monitoring and forecasting budgeted hours.
  • Proposing, reviewing and approving budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.
  • May take on a small customer lead role or assist an established partnership lead in their role.
  • May represent region or site on a Medical Writing initiative or cross-functional initiative.
  • Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.

Do you meet the Skill, experience and Educational requirements of this role?

  • Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field Req
  • Typically requires at least 5 years of relevant experience within Regulatory Medical Writing Req
  • Experience of writing and in-depth knowledge of Clinical study reports and protocols Req
  • In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report. Req
  • Good understanding of common statistical methods used in clinical trials and/or interpretation of their results Req

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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