3 Senior Clinical Evidence Specialist - Cardiac Rhythm Management Jobs in Mounds, MN
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Senior Clinical Evidence Specialist - Cardiac Rhythm Management
$109k-132k (estimate)
Full Time | Medical Technology
1 Month Ago
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Medtronic is Hiring a Senior Clinical Evidence Specialist - Cardiac Rhythm Management Near Mounds, MN
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.
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 - $154,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About MedtronicMedtronic benefits and compensation plans
We 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.
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 gaps
- Collaborate, 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 needs
- Develop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear and concise reports
- Identify potential evidence gaps or risks to existing data and work with stakeholders to assess options, track, and communicate risks as needed
- Develop 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 data
- Develop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies’ guidelines on clinical evaluation requirements
- Assess 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 line
- Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
- Address deficiencies and or answer questions from regulatory agencies as needed
- Work in close collaboration with cross-functional stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial design
- Interface with regulators and may lead discussions and develop strategies with cross functional stakeholders to negotiate and influence regulatory reviewers on the clinical evaluation
- Provide guidance, mentoring and coaching to colleagues
- Create and manage project schedule for each document
- May lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical department
- 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
- Proficient knowledge of physiology and/or applicable disease states, medical terminology, CRM therapies and technologies
- Project management experience
- Advanced degree (MD, PhD, PharmD, etc.)
- Experience with medical and/or scientific writing at Medtronic or within the medical device/pharmaceutical industry
- Demonstrated ability to work in a matrixed, global environment
- 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)
- Experience planning and executing internet literature searches using databases such as PubMed
- Experience working with Quosa, Endnote or other literature repository and citation management tools
- Ability to translate engineering and marketing data into a device performance context
- Demonstrated ability to communicate verbally clearly and effectively and in technical or scientific writing, clear and concise writing style
- Demonstrated ability to apply analytical skills to effectively summarize, communicate, and present clinical trial outcomes
- Demonstrated ability to work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Effective organizational, communication, and project team skills; high attention to detail and accuracy
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 - $154,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
About MedtronicMedtronic benefits and compensation plans
We 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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$109k-132k (estimate)
POST DATE
08/02/2024
EXPIRATION DATE
08/15/2024
WEBSITE
medtronic.com
HEADQUARTERS
WASHINGTON, DC
SIZE
>50,000
FOUNDED
1949
TYPE
Public
CEO
PETER B SLONE
REVENUE
$3B - $5B
INDUSTRY
Medical Technology
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About Medtronic
Medtronic is a medical technology and services firm that manufactures devices and therapies to treat for chronic diseases.
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