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Senior Medical Writer

Medtronic


Location:
Irvine, CA
Date:
05/17/2018
2018-05-172018-06-16
Job Code:
34591
Categories:
  • Healthcare
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Job Details

Company Medtronic
Job Title Senior Medical Writer
JobId 34591
Location: Irvine, CA, 92604, USA

Description
Senior Medical Writer

Location:

Irvine, California, United States

Requisition #:

17000IR1

Post Date:

Sep 29, 2017

**Careers that Change Lives**

The Senior Medical Writer in our Medical Affairs organization supports the Global Neurovascular business unit. This Senior Writer will develop clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.

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

**A Day in the Life**

+ Lead the development and completion of Clinical Evaluation Reports (CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs

+ Collaborate with the Quality organization and perform Clinical Risk Benefit Analysis (CRBAs) to support risk management activities

+ Work in a cross-functional team and draft clinical study reports (CSRs); provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)

+ Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies

+ Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies

+ For all documents, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers

+ Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stake holders

+ Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders

+ Contribute to post-market surveillance activities by keeping abreast of newly published scientific literature on assigned devices and report to complaint handling unit, as required

+ May attend major national international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution

+ Develop and maintain SOPs and writing tools, such as templates and style manuals

**Must Have: Minimum Requirements**

+ Advanced degree in a scientific discipline (Ph.D., MD, or Pharm. D.) with 3+ years’ experience in the medical device/pharmaceutical field

+ Experience in the development of clinical, scientific, and regulatory documents

+ Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association

+ Demonstrated ability to meet project goals within a matrix environment; excellent project management and organizational skills

+ Understanding of global regulatory agencies and regulatory processes concerning medical devices

+ Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required

+ Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide-range of audiences

+ Excellent writing and editing skills, and a keen attention to detail

+ Strong verbal, written, and interpersonal communication skills

+ Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote

+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment

+ Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases

**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.

**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/employeesIt 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.

As a global leader in medical technology, we serve patients and partner with medical professionals in 120 countries. Below are our main regional offices; key manufacturing, service, and research and development facilities; and Bakken Education Centers for physician training.

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