Senior Clinical Evaluation Medical Writer - CRDN
USA-MN, United States
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 LifeCareers that Change Lives
In this exciting role as a Senior Medical Writer for the Coronary & Renal Denervation Operating Unit, you will have primary responsibility for developing Clinical Evaluation Reports, Post Market Surveillance/Update Reports, Post Market Clinical Follow-up Plans/Reports, Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents. This individual is also responsible for administration of the applicable databases. This individual will partner closely with clinical research managers, regulatory affairs managers, quality specialists, and biostatisticians to develop a schedule and timely execute tasks.
The Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
To learn more about Inclusion & Diversity at Medtronic Click Here
Location: United States and open to remote.
Ability to travel up to 10% may be required, when appropriate.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Primarily responsible for writing and maintaining Clinical Evaluation Reports and Post Market Surveillance Reports for all the Cardiovascular portfolio of products.
Collaborate (writing, reviewing, editing and approval) with clinical, R&D, quality assurance, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents that require the evaluation of clinical data and/or clinical literature.
Collaborate with regulatory teams 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,
Collaborate with clinical and statistical teams on 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; apply this knowledge to the development of well written clinical evidence documents and in support of cross-functional teams
Develop and maintain in-depth knowledge 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 project schedules for each clinical evidence document
Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities
Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.
Other responsibilities:
Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures
Maintain and update spreadsheets tracking the status for CER projects
Collect and maintain all documents necessary to ensure compliance with SOP
Compiles, analyzes, and summarizes additional data from other sources as needed.
May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.
Requires knowledge of product areas, current developments, and keeping abreast of current literature.
Must Have (Minimum Requirements):
In order to be considered for this position, the following requirements must be evident on your resume.
Bachelor’s degree
Minimum of 4 years clinical/medical/scientific writing experience
OR
Advanced degree and a minimum of 2 years clinical/medical/scientific writing experience
Nice to Have (Preferred Qualifications):
Advanced degree (PhD, PharmD, MD or MS)
Medical writing and/or clinical research experience within a medical device industry
Proficiency with European Union Medical Device Regulations (EU MDR)
Experience conducting literature searches and literature reviews
Experience with coronary or peripheral products
Experience in preparation of Clinical evaluation reports and post market surveillance reporting.
Proficiency with current EU MDR regulatory agency guidance and regulations
Experience with medical writing tools and database (e.g., Endnote, Cite-While-You-Write) and technical publication tools (i.e. Adobe Acrobat, Publisher, MS Project)
Excellent scientific writing skills
Strong data extraction and analysis skills
Proactive with a sense of urgency in managing job responsibilities
Self-motivated and able to work independently.
Analytical thinking and inquisitive mindset
Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint)
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. Let’s 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 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.
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
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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
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.
In addition to Base Salary, this position is eligible for a Sales Incentive Plan (SIP), which provides the opportunity to earn significant incentive compensation for achieving or exceeding your goals. Learn more about total rewards here.
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About MedtronicWe 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.
ApplyJob Profile
Ability to travel up to 10% may be required
Benefits/PerksCareer development opportunities Competitive compensation Competitive compensation plans Competitive salary Diverse Team Diverse team environment Flexible benefits package Healthcare access Remote work option Wide range of benefits
Tasks- Collaborate on regulatory documents
- Develop clinical evaluation reports
- Documentation
- Ensure compliance
- Manage project schedules
- Reporting
Access Adobe Analytical Cardiology Clinical evaluation Clinical evidence Clinical Research Clinical trials Collaboration Compliance Data analysis Data Extraction Documentation Editing Education Excel Healthcare Healthcare Access Inclusion Marketing Medical device Medical Device Regulations Medical Technology Medical Writing Microsoft Office MS Project PowerPoint Presentation Proofreading Quality Assurance R Regulatory Affairs Regulatory Submissions Reimbursement Reporting Risk Management Sales Teams Word Writing
Experience5 years
EducationAdvanced degree Business MS Technical
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9