FSP Medical Writer – m/f/d
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Job Description
Medical Writer providing high-quality writing for clinical trials in EMEA. Collaborating with clients and ensuring compliance with regulatory documentation.
Responsibilities:
- Provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients
- Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence
- Write and provide input on routine documents such as clinical study reports and study protocols
- Summarize data from clinical studies
- May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs
- Ensure compliance with quality processes and requirements for assigned documents
- May assist in determining best practices, methods, and techniques for achieving optimal results
- Represent the department at project launch meetings, review meetings, and project team meetings
Requirements:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Experience working in the pharmaceutical/CRO industry preferred
- Experience in the therapeutic area of Neurology advantageous
- Solid medical writing skills, including grammatical, editorial, and proofreading skills
- Ability to interpret and present complex data accurately and concisely
- Effective administrative, organizational, and planning skills; attention to detail and quality
- Ability to work on own initiative and effectively within a team
- Effective oral and written communication skills
- Good knowledge of regulatory documentation and drug development process
- Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Benefits:
- extensive benefits package based around the health and well-being of our employees
- award-winning learning and development programme
- flexible working culture
- work-life balance
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