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Principal Clinical Evidence Specialist, Restorative Therapies Group, Neuromodulation

Medtronic
Fridley, MN 55432
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Principal Clinical Evidence Specialist, Restorative Therapies Group, Neuromodulation

Location:

Fridley, Minnesota, United States

Requisition #:

20000CZQ

Post Date:

Aug 26, 2020


Location: Medtronic Rice Creek, MN


**Careers That ChangeLives**


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 Principal Clinical Evidence
Specialist (CES) is a part of the Pelvic Health evidence strategy team
reporting to the Clinical Research Director for the therapy. The Principal CES
is responsible for reviewing literature, medical evidence gap analysis,
publication planning dissemination, facilitating publication committees,
reviewing marketing materials, authoring new product Clinical Evaluation
Reports (CERs) and evaluation of physician sponsored studies. This position
serves as the global medical evidence liaison with cross-functional
stakeholders including marketing, office of medical affairs, reimbursement,
research, and clinical study teams. The Principal CES may also serve as the
clinical representative on cross-functional core teams. This role works
independently and under only general direction.
Major deliverables are reviewed to ensure clinical, business, and
regulatory requirements are met.


**RTG**


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.


Within
RTG, theNeuromodulation
delivers innovative therapies and solutions for neurological diseases, pain,
and spasticity.


**A Day in the Life**


Responsibilities may include the
following and other duties may be assigned.


+ Writes and edits manuscripts onclinical studies and/or scientific reports including special summariesfrom raw data for submission to regulatory agencies or for in-company use,monographs, comprehensive reviews, scientific exhibits, and other projectsrequiring skill in medical communication.

+ Compiles, analyzes, andsummarizes additional data from other sources as needed.

+ Prepares literature for newproducts, and revises existing literature.

+ Writes and maintains files oninformative journal abstracts according to current or estimated futureneeds.

+ Composes medical papers fromoutlines provided by doctors for presentations.

+ May prepare responses regardingcompany products, drugs, or diseases and refers in-depth technicalinquiries to medical personnel.

+ Requires knowledge of productareas, current developments, and keeping abreast of current literature.


**POSITIONRESPONSIBILITIES:**


+ Leads development of assigned evidence strategies for the Pelvic Healthbusiness. Provides input for broadertherapy strategy as a part of the clinical evidence team. This includes interfacing withrepresentatives from key functional groups including Statistics, ClinicalQuality, Reimbursement, Regulatory Affairs, Marketing, Medical Education,Legal, International Clinical Research Groups, and Product Development (asneeded).

+ Provides project management and assures successful conduct of assignedprojects.

+ Facilitates Publication Committees and Plans forassigned studies. Works with Physician Investigators to ensure accurate studypublications. Works internally to obtain input on the Publication Plan andupdates regularly to address evidence gaps.

+ Work with investigators to quickly and effectivelyresolve problems.

+ Developmedical evidence report, lead cross-functional gap analysis, geographicevidence prioritizations, and propose future strategy.

+ Updates and communicate medical evidence assessment and gapanalysis.

+ Conduct scientific literature review for regulatory compliance purposes,per SOP.

+ Prepare literature review and bibliography for PMA/NDA annual reports asrequested

+ Prepare Clinical Evaluation Reports for new products or therapies.

+ Lead congress planning preparation including initiating meeting requeststo physicians, assigning session note takers, and compiling report outinformation.

+ Provides clinical review of marketing communication materials perstandard operating procedures.

+ May provide input and support for launch, education, and marketing of products.

+ May author/co-author results of studies in the medical literaturefollowing ICMJE guidelines.

+ May interview and participate in hiring decisions for clinicalpersonnel.

+ Mayrepresent clinical on the therapy or product core team, depending on experienceand technical expertise. May beresponsible for Core team deliverables, such as Clinical Strategy for assignedprogram(s) and clinical representation at phase reviews.

+ Developsstudy designs, clinical researchprotocols and strategy on studies to support life-cycle evidence needs (e.g.,feasibility through post-market).

+ Evaluateexternal research proposals for scientific soundness. Ensure compliance tomilestone based payment through receipt of reports and approved deliverables.

+ Follows FDA/ISO, Medtronic policies and allwork/quality procedures to ensure quality system compliance and high qualitywork.


**Must Have (Minimum Requirements):**


**To be considered for this role, the minimum requirements must beevident on your resume.**


+ Bachelors degree required with a minimum of **7** yearsof experience supporting clinical/medical research, or advanced degree with aminimum of **5** years of experience supporting clinical/medical research


**Niceto Have (Preferred Qualifications):**


+ Advanced degree (e.g.,MS, MA, MPH, PharmD, PhD, DVM, MD)in scientific field of study (e.g., biological science, physical therapy,social science, engineering, or other related medical/scientific field).

+ ClinicalResearch experience at Medtronic.

+ Atleast two years of study management experience preferred

+ Experiencein technical writing such as clinical study plans, clinical reports, scientificmanuscripts, clinical evidence reports.

+ Experiencein assessing medical evidence

+ Experiencein publication planning

+ Projectmanagement skills and experience with related tools (Microsoft Project)

+ Familiaritywith ICMJE guidelines and Good Publication Practices

+ Proficientknowledge of medical terminology

+ Knowledgein the areas of neurology and/or psychiatry

+ Workingexperience with clinical and outcomes research study design, Good ClinicalPractices, and global clinical regulations, including FDA regulations and ICH guidelines, for devices, biologics, and/orpharmaceuticals.

+ Proficiencywith MS Excel, Word, Power Point


Competencies


+ Strongcritical thinking and analytical skills

+ Demonstratedability to identify issues and implement solutions, including identifying andinvolving the appropriate decision makers

+ Demonstratedability to motivate and hold individuals accountable to deliverables; ability toachieve objectives and milestones

+ Demonstratedability to identify and adapt to shifting priorities and competing demands, andmaintain composure in difficult circumstances

+ Abilityto provide performance feedback and ability to appropriately respond to feedbackfrom customers and coworkers

+ Willingnessto accept challenging assignments and engage in relevant developmentalactivities

+ Proficiencyin managing multiple tasks

+ Demonstratedability to cultivate relationships with co-workers in a cross-functional environment

+ Demonstratedability to clearly and effectively communicate verbally and in writing

+ Highattention to detail and accuracy


**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 20-30%.


**Check out benefits.medtronic.com**
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.

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Posted: 2020-08-28 Expires: 2020-10-05
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Principal Clinical Evidence Specialist, Restorative Therapies Group, Neuromodulation

Medtronic
Fridley, MN 55432

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