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Job Details

Medical Writing Manager


Irvine, California, United States

Requisition #:


Post Date:

Nov 30, 2020

Location: Remote
(Irvine, CA preferred)

**Careers That ChangeLives**

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 Manager, Scientific
Communications in our Global Medical and Clinical Affairs organization supports
the Neurovascular (NV) operating unit.

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


The Neuroscience
group develops life-restoring therapies and healthcare solutions that span the
care continuum; integrating technologies and applying clinical and economic
evidence to increase patient access, improve efficiency of procedures and
deliver successful patient outcomes.

**A Day in the Life**

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

**Individual ContributorResponsibilities**

+ Writes and edits manuscripts onclinical studies and/or scientific reports including special summariesfrom raw data for submission to regulatory agencies or for in-company use,monographs, comprehensive reviews, scientific exhibits, and other projectsrequiring skill in medical communication.

+ Compiles, analyzes, andsummarizes additional data from other sources as needed.

+ Prepares literature for newproducts, and revises existing literature.

+ Writes and maintains files oninformative journal abstracts according to current or estimated futureneeds.

+ Composes medical papers fromoutlines provided by doctors for presentations.

+ May prepare responses regardingcompany products, drugs, or diseases and refers in-depth technicalinquiries to medical personnel.

+ Requires knowledge of productareas, current developments, and keeping abreast of current literature.

+ Lead thedevelopment and completion of Clinical Evaluation Reports (CERs) as partof design validation for new medical devices to support productregistrations internationally, maintain periodic updates, perform gapanalysis, and revise existing CERs

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

+ Work in across-functional team and draft clinical study reports (CSRs); provide supportwith submissions to regulatory agencies by drafting clinical sections ofglobal submissions (e.g., IDE, PMA)

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

+ Collaborate withRegulatory Affairs and provide support to respond to questions fromregulatory agencies

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

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

+ Participate in theperiodic reviews of recent scientific publications and online contentrelevant to the business; draft article summaries for distribution to keystakeholders

+ Contribute topost-market surveillance activities by keeping abreast of newly publishedscientific literature on assigned devices and report to complaint handlingunit, as required

+ May attend major nationalinternational conferences to keep up to date with advancements in thefield; contribute to the development of conference coverage reports forinternal distribution

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

**People Management Functional CareerStream**

+ Management and supervisoryprofessionals with one or more employees who are focused on tactical,operational and some strategic activities within a specified area. Levelswithin the management career stream typically have six or more directreports.

+ The majority of time is spentoverseeing their area of responsibility, managing performance, developingtalent, engagement and inclusion, communicating business and operationaldevelopments, planning, prioritizing and / or directing theresponsibilities of direct reports.

+ Goal achievement is typicallyaccomplished through performance of direct and / or indirect reports.

+ A key responsibility of roles inthis career stream is managing people. which includes: accountability formentoring, developing and coaching staff on meeting/exceeding performanceexpectations and defined objectives, providing leadership to staffensuring the prioritization of strategic and department level initiativesto include defining performance goals and targets, conducting performancereviews, and staff 1:1s to guide performance management and employeedevelopment efforts and manage toward departmental goals.

**Must Have (Minimum Requirements):**

**To be considered forthis role, the minimum requirements listed below must be evident on your resume.**

Bachelors degree with a minimum of **5** years of experience leading medical/clinical/scientific writing teams and/or
projects, or advanced degree with a minimum of **3** years of experience
leading medical/clinical/scientific writing teams and/or projects

**Nice to Have(PreferredQualifications):**

+ Advanced degree ina scientific discipline (Ph.D., MD, or Pharm. D.)

+ 5+ years direct Medical Writing experience

+ Management experience (managerial, people management). Directexperience as a manager or supervisor leading and managing a team ofprofessionals, and experience hiring, coaching and development teammembers.

+ Experience in themedical device/pharmaceutical field

+ Basicunderstanding of Medical Writing, including familiarity with writingstyles such as American Medical Association

+ Understanding ofglobal regulatory agencies and regulatory processes concerning medicaldevices

+ Expertise inconducting focused literature searches on PubMed, MedLine or other similarmedical literature databases

+ Highly proficientin the use of Microsoft Office applications (Word, Excel, PowerPoint) andEndNote


+ Demonstratedability to meet project goals within a matrix environment; excellentproject management and organizational skills

+ Ability tounderstand and interpret results of published literature and clinicalstudies; working knowledge of statistics is required

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

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

+ Strong verbal,written, and interpersonal communication skills

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

**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

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 10%

**Check out**
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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