Edwards Lifesciences Senior Manager, Medical Writing - Transcatheter Heart Valve in Irvine, California
Edwards is the global leader in transcatheter heart valve replacement technologies designed for the nonsurgical replacement of heart valves. Delivered via catheter while the heart is beating, these valves can enable patients to experience a better quality of life sooner than patients receiving traditional surgical therapies. Launched commercially in Europe in 2007, and in the United States in 2011, our transcatheter aortic heart valves are now available in more than 70 countries and are the most widely used transcatheter heart valves in the world.The Senior Manager, Medical Writing is responsible for managing a team and activities within medical writing projects in accordance with all applicable regulations, Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs).
Manage and oversee the work of a team of medical writers and clinical information professionals to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department
Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle
Identify risk, develop and lead in the implementation of broad and more complex strategies which may include negotiations with internal and external parties
Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional teams to understand upcoming medical writing needs and manage resourcing and assignments to ensure timelines are met
Review and interpret study data analyses and provide guidance to teams to improve efficiencies
Contribute to the generation of product life cycle plans (e.g., post-market surveillance).
Other incidental duties
Education and Experience:
A Bachelor's Degree in a related field is required; Experience in medical writing and clinical data analysis is required
A Master's Degree or equivalent in a related field is preferred
A demonstrated track record in people management is required
Experience with Class III devices and CER development under MEDDEV rev. 4 preferred
Experience working in a regulated industry preferred
Proven successful project management leadership skills
Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline or PubMed)
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Maintain current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
Expert understanding of medical writing procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Expert product knowledge including current developments, clinical literature review
Expert therapeutic and product operation knowledge
Expert knowledge of biomedical statistics
Expert knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre- and post-market clinical trial data and reports
Familiar with the coronary interventional and structure heart environments and current treatment options or have other clinical and/or clinical trial experience that fulfills this requirement.
Expert understanding of Good Clinical Practice requirements and ICH guidelines
Demonstrated ability to manage the assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of medical writing to the business
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross-functional and cross-business relationships to maximize best practice sharing and team effectiveness.
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.