Edwards Lifesciences Principal Medical Writer - Critical Care (Remote, USA) in Irvine, California
Edwards has an exciting opportunity in the Critical Care group, focused on transforming patients’ lives by advancing Critical Care innovations. As an Associate Manager in this role, you will work closely with Regulatory, Quality, R&D, and Clinical professionals and other subject matter experts to create Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements. These reports will be included in the respective technical documentation file to support initial and continued CE Marking and must effectively and clearly describe research results, literature searches and reviews, product use and other required information. You will also ensure that the documents and presentations comply with MED DEV 2.7.1, rev 4 as well as MDD, MDR, and internal processes in terms of content, format and structure.
Note: Position is internally titled Associate Manager, Medical Writing and is an individual contributor (SME) role.
Support regulatory submissions and other associated activities by authoring CEP’s and CER’s in compliance with MDD93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6and providing input from the CER into other reports (e.g. clinical evaluation plans and reports, Postmarket Clinical Follow-up Plans and Reports(MEDDEV 1.12/2, rev 2, MDCG 2020-7, MDCG 2020-8) period safety update reports, post-market surveillance reports, Summary of Safety and Clinical Performance(MDCG 2019-9), etc.), including performing literature searches.
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.
Provide CER author expertise and collaboration with cross functional teams including Regulatory Affairs, R&D, and Quality on Clinical Evaluation Reports and plans throughout product lifecycle. In addition, coordinate reviews with applicable Clinical Evaluators.
Education and Experience:
Bachelor's Degree in in related field , 8 years years experience of related scientific experience Required or
Master's Degree or equivalent in in related field (e.g., M.S., M.P.H.) , 6 years years experience of related scientific experience Required or
Ph.D. or equivalent in in related field (e.g., Sc.D), 4 years years experience of related scientific experience Required
Other: Experience as a medical writer for cardiovascular or medical device company Preferred
Other: CERs (Clinical Evaluation Reports) - EU Preferred
Experience in medical device or related industry; Master's or PhD degree in related field preferred.
Proven successful experience with Class II and Class III devices and Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) development under MEDDEV 2.7.1, rev. 4 required.
Expert knowledge of EU Medical Device Directive and Medical Device Regulation requirements for the submission of pre- and post- market CEP’s and CER’s in accordance with MDD93/42/EEC as amended by 2007/47/EC, MEDDEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6
Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline, PubMed, Google Search)
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
Expert product knowledge including current developments, clinical literature review, and therapeutic and product operation knowledge
Maintain current, in-depth product knowledge including current developments, clinical literature review, therapeutic and product usage knowledge.
Expert understanding of procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Expert knowledge of biomedical statistics is preferred
Familiar with medical devices and devices that utilize software
Strict attention to detail
Interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization. Develop relationships and leverage them to influence change
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Frequently interact with functional peer group managers, normally involving matters between cross-functional teams; often leads a cooperative effort among members of a project team
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.