PRINCIPAL MEDICAL WRITER – Neurovascular (remote)
The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.
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
In this exciting role as a Principal Medical Writer in the Clinical Sciences, Strategy, and Communications group of the Neurovascular Operating Unit, you will have primary responsibility for leading and developing clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards. This is a dynamic opportunity where you will also be involved in global clinical development activities and clinical strategy. The candidate can be based anywhere in the U.S.
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.
- Lead the development and completion of Clinical Evaluation Plans/Reports (CEPs/CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CEPs/CERs
- Work in a cross-functional team and draft clinical investigation plans (CIPs), clinical study reports (CSRs), investigator brochures (IBs), and Annual Progress Reports
- Develop clinical evidence generation strategy – contributing to new product development programs and clinical strategy for regulatory approvals and market access for Neurovascular products
- Provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)
- Collaborate with the Quality organization and perform Clinical Risk-Benefit Analysis (CRBAs) to support risk management activities
- Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
- Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies
- For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers
- Conduct literature searches and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders
- Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
- Contribute to post-market surveillance activities by keeping abreast of newly published scientific literature on assigned devices and report to complaint handling unit, as required
- Develop and maintain SOPs and writing tools, such as templates and style manuals
- May attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor’s degree and a minimum of 7 years medical/scientific writing / clinical evaluation experience;
- Or advanced degree and a minimum of 5 years medical/scientific writing / clinical evaluation experience
** Preference would be given to candidates with Advanced degrees (PhD, MD, etc.)
Experience in preparation of Clinical Evaluation Reports (CERs) from start to finish
Proficiency with European Union Medical Device Regulations (EU MDR) and guidance
Thorough understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
Nice to Have (Preferred Qualifications):
MD or PhD degree in biomedical sciences or technical disciplines
Experience with clinical trials, clinical/medical and/or scientific writing or publication at Medtronic
Regulatory: CE and 510(k) or PMA submissions, FDA processes and guidelines; Knowledge of 21 CFR 806 and 21 CFR Part 7
Experience with medical writing tools and database (e.g., Endnote, Cite-While-You-Write) and technical publication tools (i.e., Adobe Acrobat, Publisher, MS Project)
Proficiency in Microsoft Office programs 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)
Additional Information
- Posting Date: Aug 14, 2022
- Travel: No