Senior Medical Writer

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.

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About this role

As part of our SRS team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

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 years of relevant experience
• Knowledge of medical terminology
• Excellent writing, editing and organizational skills

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 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. 

#Together we make a difference