Clinical Document Specialist
hace 3 semanas
**Company Overview**
TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With over 25 years of experience, our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
**Salary & Benefits**
We provide a competitive compensation package of around $80,000 to $110,000 per year, depending on experience, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment.
**Job Description**
As a Senior Medical Writer, you will be part of the Medical Writing Department within Project Delivery and 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
- 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
**Required Skills & Qualifications:**
- Bachelor's Degree or relevant experience
- 4 years of relevant experience
- Knowledge of medical terminology
- Excellent writing, editing and organizational skills
**About Us**
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.
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