Senior Medical Writer

hace 4 semanas


Madrid, 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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