🌎
This job posting isn't available in all website languages
📁
Clinical
📅
20000CEZ Requisition #

Location:  Remote;  Preferred location is Santa Rosa, CA.

 

Careers That Change Lives

 

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 Sr. Medical Writer is responsible for writing clinical regulatory documents supporting clinical report deliverables, ensuring successful preparation of high quality submission-ready documents and effectively utilizing the clinical regulatory writing process. The position will initially focus on development of Clinical Evaluation Reports (CERs), with future additional responsibility for development of other clinical documents such as Post-Market Surveillance Reports, Clinical Study Reports, Annual Clinical Trial Progress Reports, etc.

 

This individual will have demonstrated expertise in collaborating with clinical research team members, regulatory affairs team members, quality specialists, and biostatisticians (which may include vendors or consultants) to complete tasks aligned with critical business timelines.


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


CVG

The Cardiac and Vascular Group (CVG) 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.

 

Within CVG, the Coronary and Structural Heart (CSH) 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
 

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

  • Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication.
  • Compiles, analyzes, and summarizes additional data from other sources as needed.
  • Prepares literature for new products and revises existing literature.
  • Writes and maintains files on informative journal abstracts according to current or estimated future needs.
  • Composes medical papers from outlines provided by doctors for presentations.
  • 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.
  • Primarily responsible for writing and maintaining Clinical Evaluation Plans, Clinical Evaluation Reports,  and Post Market Surveillance Reports, Post Market Safety Update Reports, Post Market Clinical Follow-up Plan, Post Market Clinical Follow up Reports, Summary of Safety and Clinical Performance for all the CSH portfolio of products.
  • 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.
  • 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 (EU).
  • Perform literature searches as needed for drafting document content. Interpret literature information and make recommendations for application to clinical regulatory documents.
  • Collaborate with clinical and statistical teams on in-depth data description, presentation and analysis; provide clinical literature context and convert relevant data and information into a form that meets clinical regulatory document requirements and procedures. Explain data in manner consistent with clinical regulatory requirements.
  • Effectively communicate clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team member accountable to agreed-upon project dates and with an appropriate quality level. Negotiate with functional areas on project outcomes and deliverables to meet conflicting demands. Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
  • Understand, assimilate, and interpret sources of information with appropriate guidance/direction from development teams. Interpret and explain data generated from a variety of sources. Verify that results are consistent with protocols. Challenge conclusions when necessary.
  • Work with Regulatory Quality Assurance throughout clinical regulatory document audit process, answer questions during the audit process (as appropriate), and work with team to draft responses as necessary.
  • Knowledgeable of US and international regulations (e.g. MEDDEV Revision 4 and EU MDR), requirements and guidance associated with clinical regulatory document preparation and submissions. Must continually train/be compliant with all current industry requirements as they relate to clinical regulatory submissions, including electronic submission/approval standards.
  • Serve as a department representative on project teams. Act as Subject Matter Expert for assigned product portfolio.

Must Have (Minimum Requirements):

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

  • Bachelor’s Degree with a minimum of 4 years of medical or clinical writing/publications experience (i.e., developing scientific/clinical publications or reports) or advanced degree with 2 years of medical or clinical writing/publications experience (i.e., developing scientific/clinical publications or reports) 

Nice to Have (Preferred Qualifications):

  • Advanced degree
  • Experience in medical writing within the medical device, bio-tech and pharmaceutical industry in clinical research.
  • Strong knowledge of regulatory guidance relative to Clinical Evaluation Reports - the essential requirements for safety and performance of Medical Devices as defined in the Medical Device Directive and the Active Implantable Medical Device (AIMD) Directive, the MEDDEV, MDR and EN ISO 14155.
  • Experience performing literature searches in PubMed and other relevant platforms.
  • Highly proficient in the use of Microsoft Office suite (Microsoft Word, PowerPoint, Excel) and EndNote Reference Software.
 

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 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)

 
Travel up to 5-10%
 
 
Check out benefits.medtronic.com
 

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Fridley, Minnesota, United States

📁 Clinical

Requisition #: 20000EXR

Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

Learn More

Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

Learn More

Regulatory

Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

Learn More

Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

Learn More

Be part of work that matters. 75 million patients had their health improved by our products last year.

Learn More

WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

Learn More

We value what
makes you
unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

Learn More
The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.