W L Gore & Associates - Phoenix, AZ
posted 1 day ago
About the position
We are looking for a Medical Writing and Information and Library Services Leader to provide ongoing team leadership for medical writers supporting product development, regulatory, clinical, and commercial activities and Information Services associates supporting commercial, technical, and medical functions. In this role, you will aim to characterize, improve, and communicate quality, efficiency, and the value of the teams' work. Success will require working cross-functionally with key stakeholders and team members to provide high quality and compliant plans and reports required by authorized medical device regulatory bodies. This position offers multiple work arrangements: on-site at our Phoenix 1 facility in Phoenix, Arizona, hybrid or fully remote work allowed in most locations within the United States, depending upon the responsibilities of the role and business needs.
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
