Clinical Development Specialist
hace 4 días
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We offer full service-capabilities, resourcing and functional service (FSP) solutions.
Job OverviewWe are seeking an experienced Clinical Development Specialist - Medical Documentation to join our Medical Writing Department within Project Delivery. As a key member of the team, you will work independently on preparing and completing clinical and regulatory documentation in assigned Study Teams, according to company policies, SOPs and regulatory requirements.
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
- Coordinate 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
- 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
Our competitive compensation package includes a salary range of $90,000 - $110,000 per year, depending on experience, plus comprehensive benefits and opportunities for professional growth and development. You'll be joining a dynamic team that values collaboration, innovation, and making a difference in the lives of patients.
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