14 days old

Senior Medical Writer

Medtronic
Mounds View, MN 55112
Senior Medical Writer

Location:

Mounds View, Minnesota, United States

Requisition #:

19000LC5

Post Date:

Oct 29, 2019


**Careers That Change Lives**


**Impact patient outcomes. Come for a job, stay for a career.**


The Cardiac and Vascular Group brings all of our cardiac 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 of customers and patients across the globe.


CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.


**A Day in the Life**


This is a Medtronic Coronary Structural Heart (CSH) medical writing position. This individual is responsible for developing Clinical Evaluation Reports (CERs), Post Market Surveillance Reports (PMSRs) and collaborating on a number of other clinical and regulatory documents. This individual is also responsible for administration of the applicable databases. The candidate will partner closely with clinical research, regulatory affairs, quality specialists, and biostatisticians to prepare and timely execute business deliverables.


+ Primarily responsible for writing and maintaining CERs and PMSRs for the CSH portfolio of products

+ Cross-functional collaboration is inclusive of drafting, reviewing, editing and approving clinical and regulatory deliverables.

+ The individual shall proactively collaborate with internal partners (Clinical, Research Development, Quality Assurance, Regulatory and Marketing) on a variety of clinical documents including:


+ Clinical study reports

+ Clinical investigation plans

+ Investigator brochures

+ Evidence gap assessments

+ Marketing and training materials

+ Post Market Clinical Follow-up (PMCF) Plans

+ PMCF Reports

+ Summary of Safety and Clinical Performance (SSCP)

+ Risk Management documents

+ Other documents requiring evaluation of clinical data and/or scientific literature


+ Work with Regulatory Affairs on all phases of regulatory submissions and approvals, including clinical document preparation and review, regulatory document review and the formulation of responses to regulatory agencies stemming from submissions.

+ Collaborate with CSH Clinical and Statistical teams to provide in-depth data description, presentation and analysis; provide clinical literature context and manage data analysis deliverables

+ Develop and maintain in-depth therapeutic and product operation knowledge, applying this expertise to the development of high quality clinical evidence documents for Regulatory submission or to support of cross-functional team deliverables

+ Develop and maintain thorough understanding of clinical research best practices, including the planning, execution, and documentation of clinical trials, related Standard Operation Procedures (SOPs), International Standards Organization (ISO) guidelines and regulatory agencies guidelines on clinical research conduct

+ Create and manage simultaneous project schedules of clinical evaluation documents ensuring successful high quality project delivery

+ Conduct proofreading, assessment of content for completeness, and provide concise constructive feedback to internal partners during review of Clinical and Regulatory documents

+ Seek out and engage regularly with peers, creating an environment of exchange, learning and transparent communication. Shared successes and lessons learned should be leveraged to promote team collective growth and build a foundation of trust

+ Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.


**Must Have: Minimum Qualifications**


+ Bachelors degree required

+ Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience


**Nice to Have**


+ Masters or PhD degree(s) in biomedical sciences or technical disciplines

+ Medical device industry experience or related industry experience

+ Clinical research experience

+ Direct experience with medical and/or scientific writing within the medical device industry, including preparation of Clinical Evaluation Reports and post market surveillance reporting

+ Database management experience in the Administrator capacity (Quosa)

+ Experience conducting scientific literature searches and demonstrated ability to critically appraise relevant literature

+ Familiarity with current regulatory agency guidances and regulations, including EU MDR and MEDDEV Rev 4

+ Cardiovascular knowledge (expertise preferred)

+ Proven track record of adapting to different teams and processes


**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 Day in the Life 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.


**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.


**EEO**


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.


This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees
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.

Categories

Posted: 2019-10-31 Expires: 2019-12-07

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Senior Medical Writer

Medtronic
Mounds View, MN 55112

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