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Medical Writing Manager, Clinical Research - Medical Evidence (Cardiac Surgery)

Medtronic
Mounds View, MN 55112
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Medical Writing Manager, Clinical Research - Medical Evidence (Cardiac Surgery)

Location:

Mounds View, Minnesota, United States

Requisition #:

210001RY

Post Date:

Feb 18, 2021


**Careers That Change Lives**


In this exciting role as the **Medical Writing Manager** for the Medical Evidence group within Cardiac Surgery Clinical Research, you will be responsible for managing a team of Medical Writers and drive consistency in processes and project management to obtain CE-mark (re)certification.In addition, this position will be a key point of escalation in resolution of program issues and risks, working closely with senior leadership across groups and regions to address.


This position requires a broad set of capability and experience in medical writing, regulatory, program management, and business functions including strong skills in leadership, analysis, communication, stakeholder management, and influencing others to deliver expected results.


Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio.


Key Technologies:


+ Surgical heart valves

+ Cardiac OR solutions (e.g., blood management, cannulae)

+ Extracorporeal life support

+ Coronary artery bypass grafting (CABG) solutions


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.


To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)


This role is primarily located in Mounds View, MN; however, can be located anywhere in US as it can be remote-based as well.


Ability to travel up to 25%


**A Day in the Life**


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


+ Lead and manage a team of Medical Writers and drive consistency in processes and project management to obtain CE-mark (re)certification.

+ Ensure timely delivery of Clinical Evaluation Reports and other EU MDR-associated deliverables (PMCF Plan, SSCP, PMSR, etc.).

+ Proactively identify MDR gaps and innovate to address these with stakeholder alignment.

+ Cultivate strong relationships with key cross-functional team members and stakeholders to align on timing of deliverables, clinical strategies and subject matter expertise input.

+ Represent Clinical in project teams across therapy areas.

+ Lead program execution to enable results and maintain commitments, including escalation to management for resolution of non-standard solutions.

+ Partner with other Medtronic program leaders to ensure coordination of activities and timelines with an eye to efficiently use resources and effectively drive change.

+ Develop recommendations and prepare executive-level presentations for Key Stakeholders.

+ Responsible for management of issues associated with program interdependence, resource allocation and financial management; partner with change and communication leadership on communications and organizational change management issues.

+ Partner with EU MDR Subject Matter Expert(s) regarding common Medtronic interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance.


**Must Have (Minimum Requirements):**


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


Bachelors degree required and a minimum of5years of experience in scientific/medical writing/publications or advanced degree with a minimum of3years of experience in scientific/medical writing/publications


**Nice to Have (Preferred Qualifications):**


+ PhD, MD, Doctoral degree with preference towards healthcare, medical, or scientific profession (e.g., nursing, medicine, epidemiology, pharmacology, biological science or other related medical/scientific field).

+ Clinical Research and/or medical writing (CER) experience at Medtronic or within a medical device industry.

+ Experience in cardiovascular therapies, specifically with structural heart therapies.

+ **Management experience (managerial, people management). Direct experience as a manager or supervisor leading and managing a team of professionals, and experience hiring, coaching and development team members.**

+ Advanced ability to understand and apply practical medical/scientific and product knowledge in a competent and consistent manner for Medical Affairs activities


Competencies:


+ Solid critical thinking and problem-solving skills

+ High attention to detail and accuracy; ability to work independently; accountable for outcomes

+ Proven ability to develop trusted relationship and collaborate with co-workers and functional partners in a matrixed organization

+ Proficient computer skills with experience in Microsoft Office Word, PowerPoint, and Excel.


**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).


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 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: 2021-02-23 Expires: 2021-05-02
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Medical Writing Manager, Clinical Research - Medical Evidence (Cardiac Surgery)

Medtronic
Mounds View, MN 55112

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