Senior Medical Writer

Company: Medtronic GmbH
Location: Mansfield
Posted on: April 8, 2021

Job Description:

The-- Medical Surgical -- Portfolio strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

• SURGICAL INNOVATIONS Integrated Operating Units -- set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck. Surgical Innovations Integrated Operating Units include Advanced Surgical Instruments, Hernia & Wound Management, and Lung Health and Visualization.
• PATIENT MONITORING Operating Unit focuses on solving clinically meaningful problems, with technologies and solutions for blood oxygen management, respiratory compromise, and perioperative complications.
• GASTROINTESTINAL -- Operating Unit has created a business out of disrupting the status quo in the detection, prevention, and treatment of gastrointestinal cancers and chronic diseases.
• RENAL CARE SOLUTIONS strives to improve outcomes, access, and quality of life for patients affected by renal disease. 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. Careers that Change Lives -- The-- Senior--Medical Writer --is responsible for the preparation of documents that support the presentation, publication needs of assigned therapeutic areas including class III and implantable medical devices in the Medtronic Medical Surgical group. A Day in the Life
  • This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) 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.
  • Collaborate with principal investigators, statistical and clinical communications teams on formulating first drafts of manuscripts.
  • Create and manage project schedules for each clinical evidence document. Must Have: Minimum Requirements--
    • Minimum of 4 years medical or clinical writing experience
    • Or Advanced Degree with minimum of 2 years medical or clinical writing experience Nice to Have
      • Masters 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--
      • Knowledge of EU MDD and MDR requirements
        About Medtronic
        
        
        Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
        
        We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
        
        Physical Job Requirements
        
        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. (ADA-United States of America) A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits: benefits.medtronic.com This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here . It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

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