Medical Writing Director, Italy

Job summary
CROMSOURCE is looking for a Medical Writing DirectorThe Director will be responsible for a variety of regulatory writing deliverablesJoin our team and help improve patients' lives
Job seniority: director level and above
Responsibilities
• Prepare assigned documents in accordance with internal/client SOPs and health authority requirements• Review Medical Writing deliverables and resolve client comments• Keep up with current Medical Writing and regulatory knowledge• Take a leading role in preparing assigned documents• Plan and organize workload for assigned projects and tasks• Manage the document review process• Present on Medical Writing processes at bid defense meetings• Develop and deliver training to the global team• Facilitate project budgeting activities• Create and maintain standard operating procedures and work instructions• Oversee a portfolio of clients• Liaise with clients throughout project lifecycle• Provide scientific and technical guidance to clients and Medical Writers• Provide medical editing review• Keep senior management informed of project status• Serve as primary client contact and representative on project teams
Requirements
• Bachelor's degree in medical-related field or life science• Minimum 10 years of experience as a clinical/regulatory Medical Writer• Experience working on CSR, IBs, Protocols, and DSUR• Understanding of the drug development process• Broad experience managing Medical Writing responsibilities• Experience interacting with cross-functional study team members• Thorough knowledge of clinical research concepts, practices, and regulations• Ability to work independently and under pressure• Excellent project management and communication skills• Fluent in English• Proficient in MS Word, Excel, PowerPoint, Adobe Acrobat, and Outlook
Key Skills Needed
• Medical Writer• CER• Clinical Trials• Medical Writing• Outsourcing• Pharmacology