Senior Medical Writer

hace 1 semana

Centro, España TFS HealthScience A tiempo completo

About this role

TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.

The Senior Medical Writer is part of the Medical Writing Department within Project Delivery and will work independently on preparing and completing clinical and regulatory documentation in assigned Study Teams, according to company policies, SOPs and regulatory requirements.

The Senior Medical Writer has a broad and long experience of all matters within medical writing.


Key Responsibilities

  • Write and review synopsis and Clinical Study Reports/Clinical Investigation Reports
  • Prepare protocols, monographs, patient narratives, and manuscripts for journal publications
  • Review of Statistical Analysis Plans
  • Co-ordinate the TFS Report Writing Team
  • Write and review Clinical Study Protocols/Clinical Investigation Plans and Subject Information
  • Write and review Investigator’s Brochures/Clinical Investigator’s Brochures
  • Write and review Investigational Medicinal Product Dossiers
  • Write and review clinical summaries and overviews
  • Write and review publications
  • Translate/correct clinical and regulatory documents
  • Actively contribute to the organization and development of routines to enhance the work at TFS
  • Write and review abstracts/posters
  • Literature review
  • Participate in client meetings regarding project-related issues
  • Coach and support Medical Writers
  • Advise clients and other Units in methodological and scientific aspects of studies
  • Contact with Key Opinion Leaders and Medical Experts working as external consultants

Qualifications:

  • Bachelor’s Degree or relevant experience
  • 4-5 years of relevant experience
  • Knowledge of medical terminology
  • Excellent writing, editing and organizational skills
  • Excellent verbal and communication skills
  • Proficiency in word processing software

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

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