Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on developing new and maintaining the best standard of surgical and minimal invasive treatments for patients suffering from heart valve disease.
The Clinical Affairs Senior Specialist, Medical Writing will collaborate with internal and external stakeholders to compile, edit, and publish clinical research deliverables. This includes but is not limited to comprehensive clinical study reports, study protocols, annual reports, investigator brochures, informed consent documents, risk/benefit analysis, and integrated summaries from raw data supporting submissions to regulatory agencies.
Develop complex medical writing documents/deliverables, and provide input on templates for assigned project(s)
Serve as the medical writing lead for negotiating deliverables, timelines, and resolving project-related issues with cross-functional stakeholders.
Work closely with Regulatory, Quality, R&D, clinical professionals and other subject matter experts to support and provide input to Clinical Evaluation Plans and Reports (CEP & CER) to support EU MDD and MDR requirements
As necessary, act as medical writing representative in core team meetings providing updates on clinical affairs reports and regulatory submissions (US and international).
Support and provide input on other complex cross-functional deliverables (e.g., risk management review, IFUs, SSED) utilizing technical knowledge.
Provide leadership, training, and guidance and act as a mentor to less experienced medical writers.
Cross-train and provide backup support to regulatory writing team.
Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing.
Other incidental duties assigned by Leadership
Education and Experience:
Experience as a medical writer for cardiovascular or medical device company
Formal experience with regulatory medical writing
General knowledge of statistical methods/basic biostatistics
Ability to read, understand, and compile data from publications, clinical studies, and similar sources of data.
Conduct literature searches and reviews, including developing search strategy, manage associated documentation, and prepare literature summaries.
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)
Extensive editing and proofreading skills
Excellent written and verbal communication skills including customer negotiating and relationship management skills
Excellent problem-solving, organizational, analytical and critical thinking skills
Proven expertise in Microsoft Office Suite including Word, PowerPoint, and Excel
Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content
Good leadership skills and ability to influence change
Strict attention to detail
Ability to interact professionally with all organizational levels including internal and external customers
Ability to manage competing priorities in a fast paced environment
Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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.
For Colorado Residents Only:
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
The base pay range for this position is $99,000 to $116,000
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences Corp