Clinical Science Manager

Department: Clinical

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Chief Quality, Regulatory, & Clinical Officer

Description

Key Responsibilities

• Oversee the management and implementation of assigned projects. This includes leveraging and expanding experience for future project assignments and developing strategies that align with the company's goals.
• Act as the liaison and primary point of contact for all Clinical Science related issues across Advita’s global businesses.
• Lead specified BU cross-functional project teams in planning and executing pre-clinical and clinical studies. These studies should align with scientific claims and include strategies for preclinical study, clinical research, publication, and marketing communication.
• Establish, develop, and maintain strong working relationships with cross-functional project team members. Coordinate and supervise the activities performed by the Clinical Science team.
• Facilitate early engagement of key surgeon investigators in research strategies.
• Drive the preparation and submission of scientific publications (white papers, abstracts, manuscripts) aligned with claims strategies. Manage publication submission timing to align with key annual scientific meetings/conferences.
• Manage Clinical Science deliverables in collaboration with Regulatory, Quality, Engineering, and business leaders. 
• Educate and mentor team members on medical writing and research best practices.
• Prepare clinical evaluation reports for regulatory submissions, perform data analysis of clinical outcomes, and conduct literature reviews. Ensure compliance with FDA and international standards, including Design Control and Risk Management processes.
• Support risk/benefit analyses conducted by Engineering. Participate in complaint handling, corrective and preventive action, and internal quality audit processes. Provide knowledge and support to operate within company and regulatory guidelines.
• Independently manage multiple medium to large-scale writing/research projects. Ensure that company procedures, processes, and documentation meet required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification.
• Work collaboratively with other functional areas to feed back the analysis of post-market information into Risk 
• Management and the Design and Development process. Assist and support other employees, teams, and sales personnel as necessary.
• Apply the Quality System and relevant Federal and International standards effectively.
• Lead the Clinical Science team

Skills Knowledge and Expertise

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

•  Five (5) years of experience in medical writing or similar field
• Medical/Technical writing skills required
• Experience in systematic literature review required
• Experience in medical devices preferred 
• US and EU clinical trial experience
• Experience in pre-market and post market 

• Detail oriented and strong organizational skills
• Strong interpersonal communication skills
• Strong technical writing and written communication skills
• Working knowledge of Windows based office productivity tools including word processor and spreadsheet