Clinical Documentation Specialist

hace 6 días


Madrid, Madrid, España Tfs Healthscience A tiempo completo

About Tfs Healthscience
Tfs Healthscience is a leading global Contract Research Organization (CRO) with over 27 years of experience in the industry. As a full-service CRO, we partner with biotechnology and pharmaceutical companies to deliver tailored clinical research services in over 40 countries.

Our Offerings
We provide flexible clinical development solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our team of experts works closely with clients to understand their needs and deliver high-quality results.

The Role
We are seeking an experienced Clinical Documentation Specialist to join our Medical Writing Department. The successful candidate will work independently on preparing and completing clinical and regulatory documentation 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

Qualifications
* 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. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients. Our estimated salary for this role is $120,000 per year, based on industry standards and market rates.



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