Clinical Documentation Specialist
hace 2 días
About Tfs Healthscience
Tfs Healthscience is a leading global 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 solutions.
Job Overview
We are seeking a highly experienced Clinical Documentation Specialist to join our Medical Writing Department within Project Delivery. This role will involve working independently on preparing and completing clinical and regulatory documentation in assigned Study Teams, according to company policies, SOPs and regulatory requirements.
Key Responsibilities
The successful candidate will have a broad and long experience of all matters within medical writing and will be responsible for:
• Writing and reviewing synopsis and Clinical Study Reports/Clinical Investigation Reports
• Preparing protocols, monographs, patient narratives, and manuscripts for journal publications
• Reviewing of Statistical Analysis Plans
• Co-ordinating the TFS Report Writing Team
• Writing and reviewing Clinical Study Protocols/Clinical Investigation Plans and Subject Information
• Writing and reviewing Investigator's Brochures/Clinical Investigator's Brochures
• Writing and reviewing Investigational Medicinal Product Dossiers
• Writing and reviewing clinical summaries and overviews
• Writing and reviewing publications
• Translating/correcting clinical and regulatory documents
• Actively contributing to the organization and development of routines to enhance the work at TFS
• Writing and reviewing abstracts/posters
• Literature review
• Participating in client meetings regarding project-related issues
• Coaching and supporting Medical Writers
• Advising clients and other Units in methodological and scientific aspects of studies
• Contacting Key Opinion Leaders and Medical Experts working as external consultants
Qualifications
To be considered for this role, you will need:
- A 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. Based on industry standards, we estimate an annual salary of $85,000-$110,000, depending on location and experience.
About Us
Tfs Healthscience has been delivering tailored clinical research services in more than 40 countries for over 27 years. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, we deliver flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
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