Clinical Documentation Specialist
hace 3 días
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 (FSP) solutions.
As a Senior Medical Writer within our Medical Writing Department, 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
- 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 Healthscience
You will require a Bachelor's Degree or relevant experience, with 4 years of relevant experience. Knowledge of medical terminology is essential, as is excellent writing, editing, and organizational skills.
What We OfferWe provide a competitive salary, estimated to be around $85,000 - $110,000 per year, depending on experience, plus comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment.
At Tfs Healthscience, we value collaboration, innovation, and making a difference in the lives of patients. Our core values of Trust, Quality, Flexibility, and Passion shape our culture and work ethic, guiding us to deliver tailored clinical development solutions to biotechnology and pharmaceutical companies.
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