Senior Medical Writer
Senior Medical Writer
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Job Description
About this role
TFSHealthScience is a leading global midsize Contract Research Organization(CRO) that partners with biotechnology and pharmaceutical companies throughouttheir entire clinical development journey. Our expertise includes fullservicecapabilities 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 (Max 56)
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
Coordinate the TFS Report Writing Team
Write and review Clinical Study Protocols/Clinical Investigation Plans and Subject Information
Write and review Investigators Brochures/Clinical Investigators 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 projectrelated 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: (Max 56)
Bachelors Degree or relevant experience
45 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. Youll 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 fullservice global Contract Research Organization (CRO) we build solutiondriven 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 decisionmaking 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.
Employment Type
Full Time
