Junior Medical Writer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bj8es

Descrizione lavoro The Junior Medical Writer supports the development of high-quality, accurate, and compliant regulatory and scientific documents. The Medical Writer function is part of the Clinical Development & Operations Department, and this role reports directly to the Medical Writer Lead. Under the supervision of the Medical Writing Lead, he/she contributes to the preparation of documents such as Common Technical Documents (CTDs), Investigator Brochures (IBs), and Investigational Medicinal Product Documentations (IMPDs), while developing the technical and scientific writing skills necessary to grow within the medical writing function. The role offers exposure to cross-functional collaboration and regulatory processes, providing a solid foundation for a career in regulatory and scientific writing.Duties and Responsibilities
- Regulatory Document Preparation: assist in writing, editing, and formatting regulatory documents (CTDs, IBs, IMPDs) in compliance with regulatory guidelines (ICH, EMA, FDA) and Company standards, under the guidance of Medical Writer Lead;




- Data Review andSummarization: support the review and summarization of clinical and scientific data, ensuring clarity and consistency in documents;
- Collaboration: participate in cross-functional team meetings (clinical, preclinical, regulatory, biostatistics, etc.) to gather information and contribute to document alignment;
- Document Management: upload documents on the electronic Common Technical Dossier (eCTD);
upload unpublished reports and publications in the Company Documentations Management System (Docubridge);
perform literature screening on internet and purchase requests to Library;
- Quality Control: perform quality checks on documents for consistency, format compliance, and accuracy, escalating issues to the Medical Writer Lead as needed;
- Regulatory Support: provide administrative and editorial support for regulatory submissions and preparation of materials for authority meetings;
- Continu

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bj8es