Are you a motivated Medical Writer that has experience in the drug development process? Would you like to work for a leading international company where you will be rewarded for your contributions? How does working in an autonomous role where you can develop and progress sound?
The Senior Medical Writer under the supervision of the Head of Medical Affairs Unit, will autonomously carry on the work within the scope of its activities by collaborating with the Direct Manager to define priorities and manage loads. is responsible for drafting, editing and reviewing preclinical/clinical documents. Develops abstracts and scientific manuscripts reporting clinical trial results, as well as slide and poster presentations, always working in compliance with regulations, Good Clinical Practices, ICH guidelines and company standard operating procedures.
Job responsibilities:
- Draw up, edit and review preclinical/clinical documents such as clinical study reports, study protocols, patient information and informed consent forms and other medical and regulatory documents;
- Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations;
- Prepare regulatory and preclinical/clinical documents for drug development and registration activities;
- Take ownership of a given assignment, proactively consulting with Biometrics staff, Pharmacovigilance and Clinical Operations Units for information or guidance, as necessary;
- Coordinate and manage documents to produce submission-ready content for customers;
- Perform literature searches and reviews as necessary to obtain background information for the development of documents;
- Be familiar with, and works in accordance with Regulations, Good Clinical Practices and ICH guidelines and Company Standard Operating Procedures;
- Create and maintain document changes audit trails;
- Review the quality and accuracy of documents in English.
Experience and qualifications required:
-Master’s degree in biomedical/scientific disciplines; - At least 3 years of experience as medical writers;
- Knowledge of medical concepts and terminology;
- Good knowledge of the drug development process, ICH-GCP guidelines and the methodology of clinical research;
- Fluent in English, specific knowledge of biomedical English is required;
- Planning and organizational skills;
- Communication skills;
- Team-working oriented.