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Senior Medical Writer

2 months ago

Reading, Reading, United Kingdom IQVIA Argentina Full time
Job Overview

IQVIA Argentina is seeking a highly skilled Senior Medical Writer to join our team. As a key member of our Medical Writing department, you will be responsible for leading the development of high-quality medical content for our clients.

Key Responsibilities
  1. Lead the preparation of assigned documents, including confirming scope, templates, and specifications, negotiating timelines, and organizing document reviews.
  2. Plan and organize workload for assigned projects and tasks, identifying project needs, tracking timelines, and implementing customer requests.
  3. Design and develop training materials and input into generic training plans for staff, and plan and deliver workshops or presentations on Medical Writing topics.
  4. Act as project manager for large Medical Writing programs, coordinating activities, focusing on efficiencies, consistency, budgetary concerns, customer liaison, and tracking.
  5. Complete project finance activities, including monitoring and forecasting budgeted hours.
  6. Propose, review, and approve budgets and assumptions for a range of project types within remit.
  7. Represent Medical Writing as reviewer for cross-functional Standard Operating Procedures (SOPs) owned by other operations, and make process improvements to enhance performance.
Requirements
  1. Bachelor's Degree in life sciences related discipline or related field (required).
  2. Master's Degree in life sciences related discipline or related field (preferred).
  3. Ph.D. in life sciences related discipline or related field (preferred).
  4. Typically requires at least 8 years of highly relevant experience and related competency levels (required).
  5. 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 documents (required).
  6. Good understanding of common statistical methods used in clinical trials and/or interpretation of their results (required).
  7. Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output (required).
  8. Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner (required).
  9. Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges (required).
  10. Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements (preferred).
  11. In-depth knowledge of drug development, medical writing, and associated regulations, and good understanding of statistical principles and of medical terminology across a range of therapeutic areas (required).
  12. Excellent written and oral communication skills, including grammatical/technical writing skills.
  13. Confident and effective communication and negotiation skills with customers and project managers.
  14. Ability to effectively manage multiple tasks and projects.
  15. Ability to proactively identify potential issues affecting other functions on the project teams and facilitate appropriate communication.
  16. Identifies creative solutions to challenges that are acceptable to IQVIA and customers.
  17. Must be computer literate.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.