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.
#J-18808-Ljbffr