Senior Clinical Evidence Specialist, NeuromodulationLocation:Rice Creek, Minnesota, United StatesRequisition #:21000USHPost Date:About an hour ago**Careers That Change Lives**In this exciting role as Senior Clinical Evidence Specialist, you will be responsible for reviewing literature, developing evidence strategies, writing reports, publication planning, facilitating publication committees, reviewing marketing materials, and evaluation of physician sponsored studies within the Pain Business and Neuromodulation organization. The SeniorClinical Evidence Specialist may also serve as the clinical representative on cross-functional core teams involving Spinal Cord Stimulator products. This role works independently and under only general direction. Major deliverables are reviewed to ensure clinical, business, and regulatory requirements are met.Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients. Were committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.​We seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader thats why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients. To learn more about Inclusion Diversity at MedtronicClick Here ( Preferred location is Rice Creek, MN; open to remote within the U.S.Ability to travel up to 20-30%**A Day in the Life**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, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication.+ May lead development of assigned evidence strategies for the Pain business. May provide input for broader therapy strategy as a part of the clinical evidence team. This includes interfacing with representatives from key functional groups including Statistics, Clinical Quality, Reimbursement, Regulatory Affairs, Marketing, Medical Education, Legal, International Clinical Research Groups, and Product Development (as needed).+ May facilitate Publication Committees and Plans for assigned studies. May work with Physician Investigators to ensure accurate study publications. May work internally to obtain input on the Publication Plan and updates regularly to address evidence gaps.+ May work with investigators to resolve problems quickly and effectively.+ May serve on cross-functional core teams as the clinical representative+ May work on business collaborations with external partners+ May develop medical evidence report, lead cross-functional gap analysis, and propose future strategy.+ May update and communicate medical evidence assessment and gap analysis.+ Prepares literature for new products and revises existing literature.+ May evaluate external research proposals for scientific soundness. May ensure compliance to milestone-based payment through receipt of reports and approved deliverables.+ Communicates with senior internal and external customers and vendors+ Follows FDA/ISO, Medtronic policies and all work/quality procedures to ensure quality system compliance and high-quality work.**Must Have (Minimum Requirements):****To be considered for this role, the minimum requirements must be evident on your resume.**Bachelors degree required with a minimum of **4** years of experiencein clinical research(i.e., clinical trial/studies/evaluations/evidence/writing)oradvanced degree with a minimum of **2** years of experienceinclinical research(i.e., clinical trial/studies/evaluations/evidence/writing)**Nice to Have (Preferred Qualifications):**+ Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, engineering, statistics, medical science, or other related medical/scientific field)+ Direct experience with medical and/or scientific writing within a medical device industry or related industry+ Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRM therapies and technologies+ Proficient understanding of study design concepts+ Familiarity 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)+ Working knowledge of various writing style guidelines (e.g., AMA) and current publication practices and guidelines (ICMJE)+ Experience planning and executing internet literature searches using databases such as PubMed+ Working knowledge of biostatistics+ Experience working with Quosa, Endnote or other literature repository and citation management tools+ Relevant experience at Medtronic or within the medical device industry+ Experience in technical writing such as clinical study plans, clinical reports, scientific manuscripts, clinical evidence reports+ Working experience with clinical and outcomes research study design, Good Clinical Practices, and global clinical regulations, including FDA regulations and ICH guidelines, for medical devices+ Ability to translate engineering and marketing data into a device performance context**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. Lets 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)Ability to travel up to 10%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 ****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.