Edwards Lifesciences Associate Manager, Medical Writing - Surgical (Remote, USA) in Irvine, California
Provide guidance, develop, and lead medical writing projects, timelines and activities.
• Plan, develop and lead the completion of complex medical writing projects PMAs (Pre Market Approvals), MDRs timelines and activities in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.)
• Act as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR compliance, etc.)
• Provide direction and guidance for smaller projects to execute tactical medical writing projects and/or initiatives. Provide mentoring and knowledge transfer for Medical Writing team members
• Other duties as assigned
Education and Experience:
Bachelor's Degree in relative field and 8 years of related scientific experience or
Masters Degree in relative field and 6 years of related scientific experience or
Ph.D., MD, Sc.D in relative field and 4 years of related scientific experience
Experience as a medical writer for medical device company preferred.
Experience authoring or supporting CERs (Clinical Evaluation Report and associated methods), EU required.
• 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 documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
• Extensive understanding of related aspects of the medical writing processes and/or systems
• Extensive knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
• Extensive editing and proofreading skills
• Extensive knowledge of biomedical statistics
• Extensive knowledge of US FDA and EU Medical Device Regulation requirements for the submission of pre- and post- market clinical trial data and reports.
• Strict attention to detail
• Strong results orientation and adherence to confidentiality
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Ability to discuss complex scientific and technical subjects with Investigators and KOLs
• Ability to provide leadership and guidance; skilled in coaching and training techniques
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and product development team
• Ability to consult in project setting within specific sections of clinical trial design, methods and data dissemination
• Ability provide project specific leadership to outsourcing partners on a task level
• 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 15,000 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.