CareersThat Change Lives
Impactpatient outcomes. Come for a job, stayfor a career.
The Cardiac and Vascular Group brings all of ourcardiac and vascular businesses together into one cross-functional,collaborative operating unit to employ the full breadth of our talent,technologies, products, services, and solutions to address the needs ofcustomers and patients across the globe.
CORONARY AND STRUCTURAL HEART provides interventionaldevices to treat coronary arteries that are blocked by atherosclerotic plaqueand devices and therapies to treat structural defects of the heart.
ADay in the Life
This is a Medtronic Coronary Structural Heart (SH) medical writingposition. This individual is responsible for developing Clinical EvaluationReports (CERs), Post Market Surveillance Reports (PMSRs) and collaborating on anumber of other clinical and regulatory documents. This individual is also responsiblefor administration of the applicable databases.This individual will partnerclosely with clinical research managers, regulatory affairs managers, qualityspecialists, and biostatisticians to develop a schedule and timely executetasks.
This position is located in Santa Rosa, Californiaor Minneapolis, Minnesota
Primarilyresponsible for writing and maintaining Clinical Evaluation Reports and PostMarket Surveillance Reports for all the CSH portfolio of products.
Collaborate(writing, reviewing, editing and approval) with clinical, R&D, qualityassurance, regulatory and marketing teams on clinical study reports, clinicalinvestigation plans, investigator brochures, evidence gap assessments,marketing brochures, post-market surveillance reports, risk managementdocuments and other documents that require the evaluation of clinical dataand/or clinical literature.
Collaboratewith regulatory teams on all phases of regulatory submissions and approvals,including clinical document preparation and review, regulatory document reviewand the formulation of responses to regulatory agencies,
Collaboratewith clinical and statistical teams on in-depth data description, presentationand analysis; provide clinical literature context and manage data analysisdeliverables.
Developand maintain in-depth therapeutic and product operation knowledge; apply thisknowledge to the development of well written clinical evidence documents and insupport of cross-functional teams
Developand maintain in-depth knowledge of clinical research best practices, includingthe planning, execution, and documentation of clinical trials, related StandardOperation Procedures (SOPs), International Standards Organization (ISO)guidelines and regulatory agencies' guidelines on clinical research conduct.
Collaboratewith principal investigators, statistical and clinical communications teams onformulating first drafts of manuscripts.
Create andmanage project schedules for each clinical evidence document
Conductproofreading, editing, document formatting, review comment integration anddocument completion / approval activities
Collaboratewith cross-functional team to assure high quality and successful projectdelivery
Seek outand engage regularly with peers, creating an environment of exchange andlearning. Openly share successes and failures to promote the group's collectivelearning.
Administrationof the applicable databases for the activities related to the evaluation ofclinical data, Clinical Evaluation reports and Post Market surveillancereporting.
MustHave: Minimum Qualifications
Masters orPhD degree(s) in biomedical sciences or technical disciplines
Medicaldevice industry experience or related industry experience
Directexperience with medical and/or scientific writing within a medical deviceindustry or related industry including preparation of Clinical evaluationreports and post market surveillance reporting.
Computerskills (Microsoft Word, Excel and Project or equivalent)
Databasemanagement experience in the Administrator capacity (Quosa, Microsoft Access orequivalent)
Experienceconducting literature searches and literature reviews.
Experiencemanaging Endnote Libraries
The above statements are intended to describe thegeneral nature and level of work being performed by employees assigned to thisposition, but they are not an exhaustive list of all the requiredresponsibilities and skills of this position.
The physical demands described within the Day in the
Life section of this job description are representative of those that must bemet by an employee to successfully perform the essential functions of thisjob. Reasonable accommodations may bemade to enable individuals with disabilities to perform the essentialfunctions.
Together, we can change healthcare worldwide. AtMedtronic, we push the limits of what technology, therapies and services can doto help alleviate pain, restore health and extend life. We challenge ourselves and each other to maketomorrow better than yesterday. It is what makes this an exciting and rewardingplace to be.
We want to accelerate and advance our ability tocreate meaningful innovations - but we will only succeed with the right peopleon our team. Let's work together to address universal healthcare needs andimprove patients' lives. Help us shape the future.
It is the policy of Medtronic to provide equalemployment opportunity (EEO) to all persons regardless of age, color, nationalorigin, 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 orlocal law. In addition, Medtronic will provide reasonable accommodations forqualified individuals with disabilities.
This employer participates in the federal E-Verifyprogram to confirm the identity and employment authorization of all newly hiredemployees. For further information about the E-Verify program, please clickhere:http://www.uscis.gov/e-verify/employees