Manager Clinical Science

3 weeks ago

Gainesville, United States Exactech Full time
DescriptionThis position is responsible for facilitating the strategic planning and coordination of the Clinical Science team and ensuring high-quality medical writing and research services. The role manages and implements scientific evidence projects, developing cross-functional project teams, and maintaining strong relationships with various stakeholders. 

Key responsibilities: Manage team, manage resources, manage CERs, manage EU MDR, PSUR
Key Responsibilities
  • Project Management and Implementation: Oversee the management and implementation of assigned scientific evidence projects. This includes leveraging and expanding experience for future project assignments and developing strategies that align with the company's goals.
  • Collaboration with Stakeholders: Collaborate with Business Unit (BU) stakeholders to identify scientific claims for Exactech products early in the New Product Development (NPD) process. Act as the liaison and primary point of contact for all Clinical Science related issues across Exactech’s global businesses.
  • Leadership in Cross-Functional Teams: 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.
  • Relationship Building and Team Coordination: Establish, develop, and maintain strong working relationships with cross-functional project team members. Coordinate and supervise the activities of direct reports in the Clinical Science team.
  • Engagement of Key Investigators: Facilitate early engagement of key surgeon investigators in research strategies.
  • Scientific Publications: 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.
  • Clinical Science Management: 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.
  • Regulatory Compliance and Reporting: 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.
  • Risk Management and Quality Assurance: 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.
  • Project and Process Compliance: 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.
  • Internal Collaboration and Support: 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.
  • Company Values and Standards: Uphold and practice Exactech’s values. Apply the Quality System and relevant Federal and International standards effectively.
  • People leadership: Lead the Clinical Science team. 

Skills, Knowledge & ExpertiseEducation: 
  • Bachelor’s Degree in a related field from an accredited institution required; Master’s Degree preferred
Experience: 
  • Five (5) years of experience in medical writing or similar field, with three (3) years supervisory experience 
  • Medical/Technical writing skills required 
  • Experience in systematic literature review required 
  • Experience in medical devices preferred 
  • Experience developing and documenting State of the Art reviews for medical products preferred
  • Experience in project and team management
Skills, Credentials, and Knowledge:
  • 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
About ExactechExactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.

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