Senior Clinical Evidence Specialist - Cardiac Rhythm Management

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeA Day in the LifeResponsibilities may include the following and other duties may be assigned.Identify, compile and analyze multiple data types (clinical investigation results, literature and clinical experience, preclinical data, etc.) in order to evaluate product safety and performance and identify potential evidence gapsCollaborate, plan and develop clinical evaluations in accordance with relevant guidelines/regulations (i.e. CERs, clinical dossiers) with stakeholders from multiple functions and in compliance with applicable standards and in alignment with business needsDevelop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear and concise reportsIdentify potential evidence gaps or risks to existing data and work with stakeholders to assess options, track, and communicate risks as neededDevelop search strategies to identify and obtain existing, relevant data (internal or external)Stay current on clinical evidence landscape and provide guidance to teams on sufficient dataDevelop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies’ guidelines on clinical evaluation requirementsAssess other technical file documents against clinical data, available current literature and industry state of the art (this may include risk management plans, IFU, etc)Collaborate with other functional groups (R&D, clinical, quality, marketing, etc.) to conduct risk/benefit assessments and evaluate State of the Art for the therapy area and product lineConduct proofreading, editing, document formatting, review comment integration and document completion / approval activitiesAddress deficiencies and or answer questions from regulatory agencies as neededWork in close collaboration with cross-functional stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial designInterface with regulators and may lead discussions and develop strategies with cross functional stakeholders to negotiate and influence regulatory reviewers on the clinical evaluationProvide guidance, mentoring and coaching to colleaguesCreate and manage project schedule for each documentMay lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical departmentMust Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume.Bachelor’s degree with a minimum of 4 years of experience in clinical research/clinical evaluation/clinical evidence, or advanced degree with a minimum of 5 years of experience in clinical research/clinical evaluation/clinical evidence Nice to Have (Preferred Qualifications):Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRM therapies and technologiesProject management experienceAdvanced degree (MD, PhD, PharmD, etc.)Experience with medical and/or scientific writing at Medtronic or within the medical device/pharmaceutical industryDemonstrated ability to work in a matrixed, global environmentFamiliarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4, EU MDR, applicable MDCG)Experience planning and executing internet literature searches using databases such as PubMedExperience working with Quosa, Endnote or other literature repository and citation management toolsAbility to translate engineering and marketing data into a device performance contextDemonstrated ability to communicate verbally clearly and effectively and in technical or scientific writing, clear and concise writing styleDemonstrated ability to apply analytical skills to effectively summarize, communicate, and present clinical trial outcomesDemonstrated ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factorsEffective organizational, communication, and project team skills; high attention to detail and accuracy 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.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.Salary ranges for U.S (excl. PR) locations (USD):$103,200.00 - $154,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About MedtronicMedtronic benefits and compensation plansWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity 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.At Medtronic, most positions are posted on our career site for 3-7 days.