Medical Writing Manager

Join to apply for the Medical Writing Manager role at Zimmer Biomet At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. What You Can Expect Primary responsibilities for this position include supervision and support of medical writing (MW) professionals in the development of clinical documentation supporting a wide range of Zimmer Biomet portfolio products. This position will provide leadership and direction on the MW processes as well as on the coordination of clinical evidence and post‑market surveillance activities required under European Medical Device Regulation (MDR) for registration and continued commercialization of medical devices. These activities are performed in close collaboration with other functional areas including regulatory affairs, quality, development engineering and product management to ensure product registrations are supported by adequate clinical safety and performance data according to global regulations. How You'll Create Impact Manages the coordination and timely execution of clinical evidence reporting activities including the preparation of Clinical Evaluation Reports, Periodic Safety and Performance Update reviews as well as periodic evaluation of clinical evidence to provide evidence on the safety and performance of Zimmer Biomet’s medical products, in light of current state‑of‑the‑art and alternative treatments, in accordance with global regulatory requirements. This includes but is not limited to Clinical Evaluation Plans, Clinical Evaluation Reports and SSCPs. Effectively oversees, supervises, directs, delegates, assists, and advises a team of medical writing professionals by planning, coordinating and reviewing work assignments, coaching and providing appropriate feedback, developing programs for training and growth of employees, creating group objectives and managing to achieve them. Provides performance input to senior management. Develops and maintains a positive, respectful and motivating team atmosphere. Influence others within a team to take action; interacts effectively with various functional groups; contributes significantly towards the establishment of best practices; serves as a resource and mentor. Independently identifies potential barriers to project completion and proactively implements effective strategies to avoid such barriers. Effectively communicates to all levels of the organization. Supports the development and management of policies and procedures in the field of Medical Writing and Clinical Evidence. Oversees and implements Corrective and Preventive Action tasks as assigned and supports regulatory remediation of clinical reports as required. Supports the Clinical Evidence tasks for regulatory submissions for product registration / certification as well as the review of NB (or other authorities) questions as a result of the submissions, ensuring timely and high quality responses. Proactively and positively manages changes in business priorities, identifies potential issues, plans mitigations and escalates appropriately to senior management. Delivers results, drives for continuous improvement. Sets high performance expectations and holds himself and his team accountable for the results expected. Acts with a sense of urgency. What Makes You Stand Out Proficient in English – written and spoken. Proven experience with global regulations for product surveillance, risk management and clinical evidence (e.g., EU Medical Device Regulation). Demonstrated technical and medical writing competence. Excellent written and verbal communication skills with direct reports, team members, regulators/auditors and senior levels of management. Minimum 5 years Medical Writing Experience required. Previous people management experience required. Ability to critically assess clinical information. Individual must be comfortable multitasking and managing many simultaneous requests in conjunction with other management stakeholders. Strong organizational skills, attention to detail and proofreading skills. Understanding of statistical methods. Ability to critically analyze and interpret scientific data. Have an analytic and strategic mindset. Ability to work within tight deadlines, adjust to changes in priorities. Ability to function independently. Ability to identify problems and research possible solutions. Takes actions that are best for the company versus his or her individual unit. Encourages and supports information sharing and collaboration across teams and departments. Demonstrates sound business ethics; shows consistency among principles, values and behaviors. Strong ability to interpret and disseminate relevant clinical studies / medical product information. Proficiency in MS Office applications and proficiency in or ability to learn EndNote or Reference Manager or other similar software tools needed for performing the job. Basic understanding of regulatory compliance for medical devices. Your Background Requires a Bachelor’s degree (Master’s Degree / Ph.D. preferred) in health, life sciences, or engineering; a minimum of 5 years of experience in medical device quality, regulatory, clinical or engineering disciplines, or an equivalent combination of education and experience. Minimum five years’ successful experience in a medical device clinical strategic and/or management role. Strong project management and technical/medical writing skills. EOE/M/F/Vet/Disability Seniority level Mid‑Senior level Employment type Full‑time Job function Health Care Provider Industries Medical Equipment Manufacturing #J-18808-Ljbffr