* Remote-based position with estimate 25% travel.

Edwards has an exciting opportunity in the Transcatheter Heart Valve (THV) group, focused on developing minimally invasive solutions for patients suffering from structural heart disease. As the Associate Manager, Medical Writing supporting the THV division, you will serve as a medical writer working with subject matter experts to create abstracts, manuscripts, and presentations that effectively and clearly describe clinical trial methodology, data, product use, and relevance. You will ensure that publications and presentations comply with Quality Systems Regulations and applicable regulatory, journal, and other guidelines in terms of content, format and structure.

Job Functions:

* Lead the timely and successful development of high-quality manuscripts, abstracts, and posters, including medical writing, editing, finalizing, and submitting content to scientific congresses and medical journals, to support Edwards Lifesciences' transcatheter heart valve scientific communication plan.
* Work collaboratively with study investigators to develop manuscripts, podium presentations, and posters for publication or presentation at interventional cardiology and cardiothoracic surgery conferences.
* Comply with Quality System Regulations and relevant guidelines for scientific publications, including but not limited to ICMJE and GPP3.
* Assist with Scientific Publications Office (SPO) communication strategy development and documentation.
* Work collaboratively with cross-functional teams, including regulatory, research and development, biostatistics, clinical safety, and marketing to achieve publication and communication goals.
* Actively represent SPO during clinical trial core team meetings, providing clear and timely communication to cross-functional partners about clinical trial-specific publication and podium plans.
* Work collaboratively with clinical research teams, including data mining, compiling, analyzing, and summarizing data for primary and secondary publication and podium projects.
* Maintain current, in-depth product knowledge, including current developments, clinical literature, and therapeutic and product usage knowledge.
* Apply scientific principles, theories, and concepts in developing communication projects.
* Track projects and provide project-related updates to internal and external customers.
* Ability to work with global partners and advisors.

Required Education/Skills/Experience:

* Post-graduate training (MS or PhD) in medical or scientific field.
* Excellent written, oral, and presentation skills.
* At least 8 years of professional medical writing experience, including clinical data analysis, publication development, and publication project management.
* Must have at least a working understanding of interventional cardiology (coronary or structural heart) or have expert clinical experience or clinical trial experience that fulfills this requirement.
* Cardiovascular medical device industry highly preferred.
* Expert understanding and application of GPP3 requirements, ICMJE recommendations, ICH guidelines, and Quality Systems Regulations.
* Expert knowledge of MS Word, Excel, and PowerPoint.
* Expert ability to conduct PubMed literature searches
* Ability to comprehend high-level scientific documentation, including statistical tables and medical literature.
* Must be assertive, persistent, detail-oriented, and have strong organizational skills.
* Experience working effectively with healthcare professionals.
* Exceptional interpersonal skills for working in cross-functional teams with R&D engineers, regulatory specialists, project managers, marketing professionals, biostatisticians, and support personnel.
* Ability to read, write, and speak English fluently.
* Overnight travel across the US and internationally for professional meetings is required.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Associate Manager, Medical Writing, Podium Publications - Transcatheter Heart Valve (Remote Position)

Medical Scientists, Except Epidemiologists (19-1042.00)

Photo

Name

Contact

Summary

Overview

Experience

Education and Training

Skills

Timeline

Tell them why you're reaching out:

I am contacting you because * :

I am contacting you to:

Edit basic information displayed on your Profile

Contact Info

Check your email for submission confirmation and future notifications.

The person you’re trying to reach has disabled the Contact Request option

Contact request cannot be submitted

Success!

Your request is on the way!

Add a Section

Analytics Panel

Choose Design

Choose a Resume

Contact Form preview

Add Content

Custom section

{name}

Finalize Your Profile

How It Works

{name} Tips

Profile preview

Profile Options

Profile Photo

Edit {name}

You might have mistyped the address or the page has moved.

If you got there from another site, we'd appreciate if you

The Bold Profile you're looking for is no longer available.

We've integrated with our largest Resume Building website,<strong> MyPerfectResume</strong>, to help you <br> build a professional Bold Profile. Once finished, your Profile will appear on Bold.pro.

You will be redirected from Bold.pro to MyPerfectResume

Associate Principal Engineer

Use our expert recommendations below to get started.

Tell us about your accomplishments

Add anything else you want to know.

Additional information

What are your affiliations?

Select time slots on the calendar below

When are you available to work?

Fill out this section or it will be deleted

This section can't be empty

What skills would you like to highlight?

Showcase your certifications.

What certifications do you have?

Tell us about your {sectionName}

What interests do you have?

What languages do you know?

Focus on your years of experience or amount of courses you have completed.

Showcase your career overview

Highlight your full skillset on your Bold Profile

Show your skills

What software skills do you have?

Briefly tell us about your background

Share your contact information with {name}

See my work availability

Availability

Available

University Overview

Job overview

Hi, I’m

Not Available

If you plan to reach out about a job, feel free to let me know so I don't miss your message.

What question do you want to ask the candidate?

Search Profiles by Job Title

Bold.pro

Bold Profiles Footer Logo

Search By

Job Title

Bold Profiles

If you are interested in learning more about me, take a look at my work preferences to see if I am a good match for the job.

Would you like to learn more about me? Feel free to select a question below or to

We appreciate your time and input! Your feedback helps us improve.

By filling out this form, you consent to being contacted and agree to our

Desired Job Title

Thanks for letting me see your  [Work Preferences]!  I will be in touch if you are a fit.

I would love to learn more about your [Work Preferences] to see if you are a fit for the role

Work Preference

WORK PREFERENCE

My work preferences are being updated and will be visible shortly. Feel free to check back again soon!

Important To Me

Work Location

Work Type

Driven professional with experience in logistics and warehouse operations, notably at UPS and Leachman Lumber. Excelled in bagging, packaging, and acc

Production specialist with strong background in overseeing manufacturing processes and ensuring operational efficiency. Proven ability to lead teams, 


Dedicated Assistant Teacher with excellent communication and coordination skills demonstrated through previous classroom experience. Compassionate, p

Dynamic professional with a strong work ethic and excellent communication skills, honed at Garden View Care Center. Proven ability to cultivate relati

Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to t

Dynamic Night Auditor with proven expertise at Stay Bridge Hotel in balancing accounts and enhancing customer satisfaction. Skilled in transaction aud


Successful and seasoned insurance professional with expertise in providing wide range of high-quality insurance solutions. Possesses deep knowledge o

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Dedicated supervisor with a proven track record of leading teams to success, consistently surpassing goals and expectations. Creative and driven leade

Proven team player with extensive experience in order fulfillment and customer service, notably at Brilliant Fulfillment and McDonald's. Demonstrated 

Donald Reader

Summary

Overview

Work History

Order picker/ yardman

Heart Valve-shippin an Receiveing

Education

GED -

Skills

Timeline

Order picker/ yardman

Heart Valve-shippin an Receiveing

GED -

Similar Profiles

Lorenzo PatrickLorenzo Patrick

Randy VincentRandy Vincent

Brittania SuerBrittania Suer

Amy JuhlAmy Juhl

Wesley McIntoshWesley McIntosh