Medical Writing and Information Library Services Leader – Remote

About the position

Responsibilities
• Provide direction, support, and people leadership to Medical Writing team members, Clinical Evaluation Team Leader, and Information Services Team Leader
• Execute on business goals, initiatives, and priorities in a manner consistent with Medical Affairs’ functional plan and the Gore culture by ensuring key performance metrics and measures of success for the team are defined, tracked, and achieved
• Ensure standardization and process expertise across teams to maintain customer satisfaction, high quality medical writing deliverables, and compliance to regulatory requirements
• Establish and maintain the strategic direction for Medical Writing and Information and Library Services to achieve business and functional goals and objectives
• Partner cross-functionally with business leaders and regional partners to identify opportunities for continuous improvement of the clinical evaluation, post-market, or information services systems and processes to ensure compliance with global regulations, alignment with industry best practices, and alignment with business/regional needs
• Deliver experiences and outcomes by balancing people, processes, results, innovation, and creative problem solving
• Ensure appropriate resourcing and resource allocation to achieve functional excellence and meet divisional commitments
• Maintain knowledge of and compliance to industry and regulatory requirements across regions as required to meet business needs
• Oversee Lead Medical Writer activities to ensure appropriate business partnerships within the scope of commitments
• Develop and promote functional excellence, competence, and leadership attributes among team leaders by providing clear expectations and mentorship

Requirements
• Bachelor’s Degree
• Minimum five years’ experience working in the Medical Device, Pharmaceutical, or Bio-tech industries
• Experience working in a regulated environment (US, Europe and/or other regions), including knowledge of industry standards and guidelines related to medical devices or drugs, clinical studies, and quality systems
• Minimum 2 years of experience writing superior technical and/or scientific reports
• Minimum 18 months of demonstrated strong team/people leadership, including the ability to provide constructive performance feedback, build positive relationships, and improve business results
• Demonstrated experience in creating and maintaining an inclusive work environment with clear understanding of equitable practices
• Demonstrated success influencing in cross-functional environments
• Strong interpersonal and communication (verbal and written) skills
• Ability to travel up to 15%

Nice-to-haves
• Advanced degree in a health-related science
• Familiarity with Information Services, methods for literature search strategies, and data resources
• Knowledge of regulations, standards, and industry terminology related to clinical evaluation, post-market clinical follow-up, and post-market surveillance of medical devices (MDR 2017/745)

Benefits
• Comprehensive and competitive total rewards program
• Choice and flexibility in benefits
• Associate Stock Ownership Plan
• Potential opportunities for profit-sharing