Medical Writer

We offer an excellent opportunity to join our Clinical Affairs team, based in Bussolengo (Verona), as Medical Writer.

In this role you will work in a team environment to help develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources.

You will plan and develop clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) reports, as well as a summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.

Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements. You will interact mainly with departments involved in product development (e.g. Innovation, R&D, Regulatory & Quality, Sales & Marketing, PMO) in the company both at local and international level including relationships with US colleagues. You will also engage with external consultants, regulatory agencies and scientific organizations / companies.

What will your contribution be?

• Reviewing medical scientific literature, analyzing clinical risk and providing benefit / risk assessment, write, review and edit CERs to comply with international regulations.
• Write and update coherently and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific / clinical / medical data.
• Prepare and update SSCP, according to the SOP, based on the CER and other sources, including the part for lay persons.
• Write and update CEPs and PMCF Plans.
• Work collaboratively with cross-functional partners.
• Prepare answers to the Notified Body or Regulatory Agency requests.
• Assist with other clinical, marketing and regulatory projects assigned.
• Acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices.
• Communicate scientific content in a clear, concise manner.
• Mentor and train new incoming team members about procedures and best practices.
• Preparing clinical collaterals in collaboration with Medical Affairs and Marketing
• Performing ad-hoc literature searches and analyses
• Where necessary, involve and managing outside consultants, vendors and experts (HCP and technical experts) for the execution of the above-mentioned activities

What are we looking for?

What soft skills are we looking for?

What will you find?

What do we offer?