Senior Clinical Trial Manager, Clinical Research Medical Advisor
Syneos Health
Google Cloud Platform
Principal Regulatory Affairs Specialist – CTA, Clinical Research Field
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇭🇺 Hungary
Visit company websiteJob Level
Lead
Tech Stack
Assembly
About the role
- Provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization
- Feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services
- Work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature
- Act as primary point of contact for the sponsors of assigned projects
Requirements
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape
- Proven project management experience, and experience performing effectively in a client facing role
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Excellent negotiation skills
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills
- Understanding of budgeting and forecasting
Benefits
- Competitive salary
- Extensive benefits package based on health and well-being
- Award-winning learning and development programme
- Flexible working culture
- Work-life balance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsglobal regulatory submissionsclinical trial regulatory documentsproject managementbudgetingforecastinganalytical skillsproblem-solving skillseditorial skillsproofreading skills
Soft skills
interpersonal skillscommunication skillsattention to detailorganizational skillstime managementplanning skillsnegotiation skillsteamworkclient-facing skillsadaptability
