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Principal Medical Writer - Gastrointestinal (GI)

Company: Medtronic
Location: Boulder
Posted on: May 3, 2021

Job Description:

Principal Medical Writer - Gastrointestinal (GI)Location:Mansfield, Massachusetts, United StatesRequisition #:210009H3Post Date:1 day agoCareers That Change LivesIn this exciting role as aPrincipal Medical Writer on the GI Clinical Evidence and Compliance Team,you will primarily focus oncreating and maintaining Clinical Evaluation Plans and Reports (CEP, CER), and Post Market Follow-up (PMCF) Plans and Reports. As Principal Medical Writer, you will provide technical writing, clinical and regulatory expertise to your peers through mentorship, coaching and training. Thisis a dynamic opportunity that will provide exposure to Clinical opportunities and cross-functional interactions.TheGastrointestinaloperating unit develops diagnostic and therapeutic solutions that enable early detection and treatment of gastrointestinal diseases and cancers.The candidate can be based anywhere in the U.S. (Preferred location is Colorado).Travel 25% domestic and possibly international.Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.A Day in the LifeResponsibilities 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.Conducts comprehensive literature searches and performs critical evaluation of clinical evidence (including risk/benefit, State of the Art, etc.) for generation of new/maintenance of existing Clinical Evaluation Reports (CERs) in compliance with the EU Medical Device Regulation, China Order 650, Australia Dept of Health Guidelines, and other geographic regulations as required, or to support product development, risk analysis, regulatory submissions, or due diligence efforts.Assesses on an ongoing basis the quality, scientific validity, and audit-readiness of CERs.Supports internal and regulatory body audits of clinical materials, including remediation of content as required.Analyzes clinical evidence of all kinds (e.g., public, proprietary, published, unpublished) from all sources (e.g., journals, internal documents, regulatory submissions) to assist project proposals and departmental strategies, understanding the levels of evidence required to achieve Regulatory, Marketing, and other departmental goalsMay prepare/support/facilitate publication of high-quality articles featuring results of clinical studies and other forms of clinical evidence in peer-reviewed journalsMay write and edit 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.Drives local evidence gathering dissemination awareness for ERPs, EU Medical Device Regulation (MDR) and other projectsWrites memoranda, executive summaries, presentation media, and other supplementary materials for external and internal needs.Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelors degree and minimum 7 years of medical/scientific writing and/or publication experience or advanced degree with a minimum of 5 years of medical/scientific writing and/or publication experience.Nice to Have (Preferred Qualifications):Experience conducting literature searches and literature reviews.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)Solid understanding of MEDDEV and EUMDRPublication experienceClinical trial experienceExperience with clinical/medical and/or scientific writing at MedtronicProficiency in Microsoft Office programsExcellent interpersonal, presentation and communication skillsStrong team player and work ethicAbout MedtronicTogether, 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.Physical Job RequirementsThe 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)Travel 25% domestic and possibly international.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 at benefits.medtronic.comIt 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.

Keywords: Medtronic, Boulder , Principal Medical Writer - Gastrointestinal (GI), Other , Boulder, Colorado

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