Project Manager Medical Writing, 60-100% (2190)

Main Responsibilities:

Publications:

• Conducting (systematic) literature review, review manuscript-specific literature
• Developing manuscripts for submission to peer-reviewed journals according to the guidelines
• Responsible for the entire online submission/resubmission processes
• Critically appraise of publications and other documents
• Prepare congress abstracts and presentations as required

AO ITC Reports:

• Writing internal reports as needed, with a main focus on study-specific final and interim reports according to the AO ITC CE style
• Perform literature review as needed
• Audit the final data analysis set in collaboration with the responsible internal partners

AO ITC Documentation:

• Support in the development of AO ITC clinical investigation documents
• Review and provide copy editing service as required

Customer Service:

• Support AO ITC CE's efforts in general, including providing English language support
• Other ad hoc medical writing services, including supporting AO education programs

Other:

• The employee performs all tasks in alignment with the requirements of the ISO 9001 quality management standard and actively contributes to maintaining and improving the quality system.
• The employee undertakes additional responsibilities and duties as assigned by the line manager to support operational and organizational needs related to the Quality Management System.

Main Requirements:

• Minimally a degree in master of science in a biomedical field, preferably an advanced degree (MD, DVM, or PhD)
• 2 - 3 years of experience in clinical research and medical writing
• Experience with basic statistical methods (univariable tests)
• Ability to communicate effectively
• Attention to detail and reliability
• Ability to work both independently and in a team
• Flexibility and customer-focused mindset: Responsible and reliable, able to adhere to timelines
• English as native language or advanced level proficiency