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Senior Medical Writer, Coronary and Structural Heart (CSH) - remote

Santa Rosa, CA 95404 Work Remotely
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Senior Medical Writer, Coronary and Structural Heart (CSH) - remote


Santa Rosa, California, United States

Requisition #:


Post Date:

5 days ago

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

**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 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 ajob, stay for a career.**


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.

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 onclinical studies and/or scientific reports including special summaries from rawdata for submission to regulatory agencies or for in-company use, monographs,comprehensive reviews, scientific exhibits, and other projects requiring skillin medical communication.

+ Compiles, analyzes, and summarizesadditional data from other sources as needed.

+ Prepares literature for new productsand revises existing literature.

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

+ Composes medical papers fromoutlines provided by doctors for presentations.

+ May prepare responses regardingcompany products, drugs, or diseases and refers in-depth technical inquiries tomedical personnel.

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

+ Primarily responsible for writingand maintaining Clinical Evaluation Plans, Clinical Evaluation Reports, and Post Market Surveillance Reports, PostMarket Safety Update Reports, Post Market Clinical Follow-up Plan, Post MarketClinical Follow up Reports, Summary of Safety and Clinical Performance for allthe CSH portfolio of products.

+ Develop and maintain in-depththerapeutic and product operation knowledge; apply this knowledge to thedevelopment of well written clinical evidence documents and in support ofcross-functional teams.

+ Develop and maintain in-depthknowledge of clinical research best practices, including the planning,execution, and documentation of clinical trials, related Standard OperationProcedures (SOPs), International Standards Organization (ISO) guidelines andregulatory agencies guidelines on clinical research conduct.

+ Collaborate (writing, reviewing,editing and approval) with clinical, RD, quality assurance, regulatory andmarketing teams on clinical study reports, clinical evidence gap assessments,marketing brochures, post-market surveillance reports, risk managementdocuments and other documents that require the evaluation of clinical dataand/or clinical literature.

+ Collaborate with regulatory teams onall phases of regulatory submissions and approvals, including clinical documentpreparation and review, regulatory document review and the formulation ofresponses to regulatory agencies (EU).

+ Perform literature searches asneeded for drafting document content. Interpret literature information and makerecommendations for application to clinical regulatory documents.

+ Collaborate with clinical andstatistical teams on in-depth data description, presentation and analysis;provide clinical literature context and convert relevant data and informationinto a form that meets clinical regulatory document requirements andprocedures. Explain data in manner consistent with clinical regulatoryrequirements.

+ Effectively communicate clinicalregulatory document deliverables needed, writing process, and timelines to teammembers. Holds team member accountable to agreed-upon project dates and with anappropriate quality level. Negotiate with functional areas on project outcomesand deliverables to meet conflicting demands. Identify and propose solutions toresolve issues and questions arising during the writing process, includingresolution or elevation as appropriate.

+ Understand, assimilate, andinterpret sources of information with appropriate guidance/direction fromdevelopment teams. Interpret and explain data generated from a variety ofsources. Verify that results are consistent with protocols. Challengeconclusions when necessary.

+ Work with Regulatory QualityAssurance throughout clinical regulatory document audit process, answerquestions during the audit process (as appropriate), and work with team todraft responses as necessary.

+ Knowledgeable of US andinternational regulations (e.g. MEDDEV Revision 4 and EU MDR), requirements andguidance associated with clinical regulatory document preparation andsubmissions. Must continually train/be compliant with all current industryrequirements as they relate to clinical regulatory submissions, includingelectronic submission/approval standards.

+ Serve as a department representativeon project teams. Act as Subject Matter Expert for assigned product portfolio.

**Must Have (Minimum Requirements):**

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

+ Bachelors Degree with a minimum of **4** years of medical or clinicalwriting/publications experience (i.e., developing scientific/clinicalpublications or reports) or advanced degree with **2** years of medical or clinicalwriting/publications experience (i.e., developing scientific/clinicalpublications or reports)

**Nice to Have(PreferredQualifications):**

+ Advanced degree

+ Experience in medical writing within the medicaldevice, bio-tech and pharmaceutical industry in clinical research.

+ Strong knowledge of regulatory guidance relative toClinical Evaluation Reports - the essential requirements for safety andperformance of Medical Devices as defined in the Medical Device Directiveand the Active Implantable Medical Device (AIMD) Directive, the MEDDEV, MDRand EN ISO 14155.

+ Experience performing literature searches in PubMed andother relevant platforms.

+ Highlyproficient 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. 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 5-10%

**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.


Posted: 2020-08-28 Expires: 2020-10-23
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Santa Rosa, CA 95404

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