Job Description Medical Writer
DICE is a leading CRO with over 35 years of experience focused that serves biotech and big pharma companies in Europe and the US. In order to support our growth, we are looking to hire a Medical Writer to join our team.
As a Medical Writer you will be responsible for developing high-quality clinical and regulatory documents for various clients, ensuring they meet all regulatory requirements and company standards.
Job Responsibilities
* Collaborate with cross-functional teams across multiple clients to prepare, write, and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, Module 2 and Module 5 eCTD components, as well as other submission-relevant regulatory documents, in compliance with ICH, company standards and applicable regulatory requirements.
* Lead and manage medical writing activities, including development of timelines, coordination with client study/project teams, and maintaining clear communication with cross-functional team members to ensure on alignment on review cycles and expectations.
* Oversee the document review process by facilitating efficient review rounds, clarifying feedback, and ensuring all comments are appropriately addressed to achieve timely, high-quality final documents.
* Serve as the primary point of contact for sponsor clients throughout the study lifecycle and build strong relationships and ensure client satisfaction through proactive communication and issue resolution.
Qualifications and skills
* Master’s degree in Life Sciences, Nursing, Biomedical sciences, Pharmacy, or related field or similar through experience.
* Minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.
* Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory guidelines
* Excellent communication, and organizational skills
* Attention to detail, ability to work independently and able to distinguish important points from details
* Self-motivated, adaptable and stress resistant
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with document management systems, reference management software, and statistical analysis tools preferred.
Our offer
DICE is a clinical research organization (CRO), that supports clinical studies for pharmaceutical and biotechnology companies. We offer full service projects delivery to our sponsors, and have an internal team that is specialized in clinical data management, bio statistics, central imaging review, medical writing, and medical monitoring.
If you work with us, then we can offer this package:
* A driver’s seat position in clinical research
* A young and dynamic work environment with close contact to our sponsors
* Possibility to grow with and within our company
* An attractive salary with lots of extras, including a long term incentive plan based on company targets
* An easy to reach office in Brussels
* Possibilities to work from home
* A personal development path with tailored courses and training
Take your career to the next level, and apply now. Email recruitment@dice-cro.com