We anticipate the application window for this opening will close on - 29 Sep 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

In this exciting role, a Senior Medical Writer on the Clinical Evidence team will support General Surgical Technology business. The primary responsibilities are creating and maintaining Clinical Evaluation Reports (CER), and Summary of Safety and Clinical Performance report (SSCP) and Periodic Safety Update Reports (PSUR) etc. that support the presentation, publication, regulatory clinical document submission needs of assigned therapeutic areas including class III and implantable medical devices). This is a dynamic opportunity that will provide exposure to clinical opportunities and cross-functional interactions. May write and edit manuscripts or abstracts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Collaborates with cross-functional team members daily, with the ability to provide solution orientated recommendations.

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics. Led by Mike Marinaro and his new leadership team, we'll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

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

• This role predominantly focuses on writing, editing and reviewing regulatory (e.g., Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance / Periodic Safety Update Report etc.) documents and responses to Notified Bodies.
• Post Market Surveillance activities (monthly literature review of our product)
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
• Collaborate with cross-functional team to assure high quality and successful project delivery
• Seek out and engage regularly with peers, creating an environment of exchange and learning.
• Openly share successes and failures to promote the group’s collective learning. Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.
• Create and manage project schedules for each clinical evidence document.
• Compiles, analyzes, and summarizes additional data from other sources as needed.
• Prepares literature for new products and revises existing literature.

Must Have: Minimum Requirements 

• Bachelor’s Degree with a minimum of 4 years of medical or clinical writing experience or a Master’s degree with 2 years of medical or clinical writing experience.

Nice to Have

• Master’s or PhD degree(s) in biomedical sciences or technical disciplines
• Experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical Evaluation Reports and post market surveillance reporting.
• Clinical research experience.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the succes