Clinical Development Specialist
hace 3 días
About Us
Tfs Healthscience is a leading global contract research organization that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With full service-capabilities, resourcing, and functional service solutions, we help our clients achieve their goals.
Job Description
We are seeking an experienced Clinical Development Specialist to join our team. The successful candidate will work independently on preparing and completing clinical and regulatory documentation in assigned study teams, according to company policies, SOPs, and regulatory requirements.
The ideal candidate will have extensive experience in 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 statistical analysis plans
- Coordinating 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
- Conducting literature reviews
- 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 and Skills
To be successful in this role, you will need:
- Bachelor's degree or relevant experience
- 4 years of relevant experience
- Knowledge of medical terminology
- Excellent writing, editing, and organizational skills
What We Offer
We provide a competitive compensation package, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Our core values of trust, quality, flexibility, and passion shape our culture and work ethic.
Location
Tfs Healthscience operates globally with offices in 17 countries across Europe, North America, Asia Pacific, and the Middle East. The successful candidate will be based in one of these locations.
Salary
We offer a salary range of $120,000 - $180,000 per year, depending on experience, plus comprehensive benefits and bonuses.
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