Sr. Medical Writer

Clinical Project ManagerAt Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.The Clinical Project Manager will be responsible for supporting the development of single- and multicenter clinical investigation protocols, establishing study sites, training site staff, and performing data management and publication duties across multiple studies. The Clinical Project Manager will serve as the sponsor-side monitor, managing multiple aspects of the investigations on various products and technologies. The Clinical Project Manager will support in the creation and oversight of study documentation, records, scientific submissions, and conference materials. The Clinical Project Manager is accountable for the overall project scope, timelines, and budget to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate standards.Essential functions include:Serving as the primary point of contact, with oversight from leadership, for assigned studies, working with Product Development, Sales, Marketing, Regulatory Affairs, and Legal to communicate relevant updates accordingly through the life and closure of the study.Fostering relationships with physicians, sales representatives, and clinical teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection for the assigned study.Supporting the design and review of all study documents for the assigned study, including the clinical study protocol, case report forms and subject questionnaires, informed consent form, electronic data capture (EDC) system, and other study tools.Supporting the sponsor study start-up process by, including but not limited to, contributing to the conduct of the study kick-off meeting, negotiation and execution of agreements/budgets, and ensuring all qualification documents are executed and obtained.With oversight from leadership, supporting the management of project budgets, communicating deviations from budget projections, and proposing solutions for budget deviations. Ensuring timely processing of site payments for assigned study.Ensuring site compliance with applicable regulatory requirements.Providing support to clinical investigators and site coordinators to resolve site-related issues.Ensuring timely completion of patient enrollment and data collection in accordance with protocol requirements.Conducting remote and on-site monitoring including site qualification visits, site initiation visits, interim monitoring visits, and closeout visits, in compliance with standard operating procedures and expectations set by the governing regulatory authority.Supporting the preparation, analysis, and review of clinical study data using basic comparative statistical techniques to support data interpretation and reporting.Supporting generation of reports, conference abstracts, and journal publications in collaboration with leadership and investigators.Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.Ensuring compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to the role.Representing the company in a professional manner and upholding the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Qualifications include:Bachelor's Degree with 2+ years' clinical experience in the Sciences / Engineering / Health Care / Management OR surrogate experience in Medical Device Clinical Affairs, Product Development, Marketing, and Management in a fast-paced environmentExperience with Microsoft Office applications, SPSS or other statistical softwareWorking knowledge of FDA and EU MDR requirements (ISO14155) for clinical trial conductDemonstrated ability and experience with clinical investigators to motivate, lead, and provide support to group towards rapid, compliant enrollmentExcellent oral and written communication skillsAbility to travel up to 10-30% of the timePrevious publication history or contributions to peer-reviewed articles preferredPhysical demands include:Required to sit; climb or balance; and stoop, kneel, crouch or crawlRequired to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 poundsRequired to possess specific vision abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.Our values are:Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.Customer Focused: We listen to our customers' needs and respond with a sense of urgency.Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.Other duties may change at any time with or without notice.