We anticipate the application window for this opening will close on - 22 Jan 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Careers that Change Lives

In this exciting role as a Senior Medical Writer for the Coronary & Renal Denervation Operating Unit, you will have primary responsibility for developing Clinical Evaluation Reports, Post Market Surveillance/Update Reports, Post Market Clinical Follow-up Plans/Reports, Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents. This individual is also responsible for administration of the applicable databases. This individual will partner closely with clinical research managers, regulatory affairs managers, quality specialists, and biostatisticians to develop a schedule and timely execute tasks.

The Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic Click Here

Location: United States and open to remote.

Ability to travel up to 10% may be required, when appropriate.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Primarily responsible for writing and maintaining Clinical Evaluation Reports and Post Market Surveillance Reports for all the Cardiovascular portfolio of products.

• Collaborate (writing, reviewing, editing and approval) with clinical, R&D, quality assurance, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents that require the evaluation of clinical data and/or clinical literature.

• Collaborate with regulatory teams on all phases of regulatory submissions and approvals, including clinical document preparation and review, regulatory document review and the formulation of responses to regulatory agencies,

• Collaborate with clinical and statistical teams on in-depth data description, presentation and analysis; provide clinical literature context and manage data analysis deliverables.

• Develop and maintain in-depth therapeutic and product operation knowledge; apply this knowledge to the development of well written clinical evidence documents and in support of cross-functional teams

• Develop and maintain in-depth knowledge of clinical research best practices, including the planning, execution, and documentation of clinical trials, related Standard Operation Procedures (SOPs), International Standards Organization (ISO) guidelines and regulatory agencies’ guidelines on clinical research conduct.

• Create and manage project schedules for each clinical evidence document

• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities

• Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting. 

Other responsibilities:

• Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures

• Maintain and update spreadsheets tracking the status for CER projects

• Collect and maintain all documents necessary to ensure compliance with SOP

• Compiles, analyzes, and summarizes additional data from other sources as needed.

• May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.