Location: Remote (Irvine, CA preferred)
Careers That Change Lives
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.
The Medical Writer in our Medical Affairs organization supports the Global Neurovascular (NV) and Cerebrospinal fluid (CSF) operating unit. This Writer will develop clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.
Impact patient outcomes. Come for a job, stay for a career.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Responsibilities may include the following and other duties may be assigned.
- Writes and edits manuscripts 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.
- Compiles, analyzes, and summarizes additional data from other sources as needed.
- Prepares literature for new products, and revises existing literature.
- Writes and maintains files on informative journal abstracts according to current or estimated future needs.
- Composes medical papers from outlines provided by doctors for presentations.
- May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.
- Requires knowledge of product areas, current developments, and keeping abreast of current literature.
- Responsible for the development and completion of Clinical Evaluation Reports (CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs
- Collaborate with the Quality organization and perform Clinical Risk Benefit Analysis (CRBAs) to support risk management activities
- Work in a cross-functional team and draft clinical study reports (CSRs); provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (e.g., IDE, PMA)
- 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 stake holders
- 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
- 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
- Develop and maintain SOPs and writing tools, such as templates and style manuals
To be considered for this role, the minimum requirements must be evident on your resume.
- Bachelor’s Degree with a minimum of 2 years of medical or clinical writing/publications experience (i.e., experience in the development of clinical, scientific, and regulatory documents) or advanced degree with 0 years of experience
Nice to Have (Preferred Qualifications):
- Advanced degree in a scientific discipline (Ph.D., MD, or Pharm. D.)
- Familiarity with Adobe Illustrator/InDesign, experience with data visualization and scientific illustrations preferred for this role.
- Experience in the medical device/pharmaceutical field
- Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
- Understanding of global regulatory agencies and regulatory processes concerning medical devices
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases
- Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
- Demonstrated ability to meet project goals within a matrix environment; excellent project management and organizational skills
- Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required
- Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide-range of audiences
- Excellent writing and editing skills, and a keen attention to detail
- Strong verbal, written, and interpersonal communication skills
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
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 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. (ADA-United States of America)