Senior Medical Writer

hace 5 días

Madrid, España TFS HealthScience A tiempo completo

About this role

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

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

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.

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