Senior Medical Writer

Department: Clinical

Location: US (Remote)

Description

The purpose of the Senior Medical Writer is to provide medical writing and scientific services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

Key Responsibilities

• Prepare clinical evaluation reports for submission to regulatory bodies to support new product registrations or continuing registrations.
• Assist Regulatory Affairs by preparing/reviewing responses to address requests from Regulatory agencies for clinical information regarding Exactech products as part of market authorization submissions and audit response rounds.
• Participate in internal and external audits as necessary to provide responses to requests for clinical information regarding Exactech products.
• Perform data analysis of clinical outcomes data from internal and external sources.
• Perform literature reviews according to recognized scientific methodologies.
• Work with other functional areas to feed back the analysis of post-market information into Risk Management and the Design and Development process.
• Develop and support risk/benefit analyses.
• Independently manage multiple medium to large scale writing/research projects.
• Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.
• Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
• Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines.
• Assisting and supporting other employees, teams, and sales personnel as necessary.
• Practicing Exactech’s Values.
  
  

Skills Knowledge and Expertise

Education:

• Master’s Degree in a related field from an accredited institution required

Experience:

• 5 years of Medical/Technical writing skills required
• Experience in systematic literature review required
• Experience with EU MDR-compliant post-market reporting procedures preferred
• Experience in medical devices preferred
• Understanding of biostatistics preferred

Functional/Technical Knowledge, Skills and Abilities Required:

• Working knowledge of Windows based office productivity tools including word processor and spreadsheet