Medical Writer - Remote
Flagstaff, AZ Flagstaff, AZ Estimated:
$75.
6K - $95.
7K a year Estimated:
$75.
6K - $95.
7K a year 4 days ago 4 days ago 4 days ago About Us:
Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry:
Saving lives and improving the quality of life for patients is at the core of everything we do.
This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others.
Learn more at gore.
com/products/industries About the Role:
We are seeking a Medical Writer to join our team in the Office of Medical Affairs.
The writer will be primarily responsible for creating and updating regulatory documents for medical devices required by applicable regulations.
These documents include Clinical Evaluation Plans (CEP), Literature Search Protocols, Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans, Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and other post-market reports.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities:
Write, edit, and review reports Manage projects Gather appropriate input from stakeholders, and analyze relevant data Collaborate on decisions, facilitate document review process, and meet deadlines Work with product teams across one or more therapeutic application areas to develop and/or update product-specific regulatory documents Complete documents in accordance with internal procedures/templates and external guidelines and regulations Maintain compliance with training expectations Perform additional responsibilities as required within the scope of the position Required Qualifications:
Bachelor's degree plus a minimum of 3 years experience in medical writing and/or regulatory writing, OR an advanced degree in a health-related field Demonstrated experience in critical and written analysis of medical literature, clinical data, or relevant documents for regulatory submissions Excellent computer skills including MS Office (Word, Excel, PowerPoint) Highly organized, self-motivated, and extremely detail-oriented Excellent written and verbal communication skills Proven ability to work independently with minimal supervision, meet deadlines, and manage multiple projects simultaneously Ability to collaborate across departments and relate effectively to people at all levels of the company Ability to travel up to 5%
Qualifications:
Training and degree in science, engineering, or medical field Prior experience in the medical device and/or pharmaceutical industry Experience with writing document types specific to the role or experience with regulatory writing relevant to the role, and familiarity with EU Medical Device Regulation 2017/745 (MDR) Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed.
For fully remote roles, the following locations are not eligible for new fully remote work arrangements:
Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer:
At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits.
Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program.
Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development.
Learn more at gore.
com/careers We believe in the strength of a diverse workforce and inclusive work environment.
In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Gore is committed to a drug-free workplace.
All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the U.
S.
Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA employer.
(Applies to all positions in the U.
S.
) Our Talent Acquisition Team welcomes your questions at gore.
com/careers/contact #LI-ASC #LI-Remote.
Estimated Salary: $20 to $28 per hour based on qualifications.
$75.
6K - $95.
7K a year Estimated:
$75.
6K - $95.
7K a year 4 days ago 4 days ago 4 days ago About Us:
Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry:
Saving lives and improving the quality of life for patients is at the core of everything we do.
This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others.
Learn more at gore.
com/products/industries About the Role:
We are seeking a Medical Writer to join our team in the Office of Medical Affairs.
The writer will be primarily responsible for creating and updating regulatory documents for medical devices required by applicable regulations.
These documents include Clinical Evaluation Plans (CEP), Literature Search Protocols, Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans, Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), and other post-market reports.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities:
Write, edit, and review reports Manage projects Gather appropriate input from stakeholders, and analyze relevant data Collaborate on decisions, facilitate document review process, and meet deadlines Work with product teams across one or more therapeutic application areas to develop and/or update product-specific regulatory documents Complete documents in accordance with internal procedures/templates and external guidelines and regulations Maintain compliance with training expectations Perform additional responsibilities as required within the scope of the position Required Qualifications:
Bachelor's degree plus a minimum of 3 years experience in medical writing and/or regulatory writing, OR an advanced degree in a health-related field Demonstrated experience in critical and written analysis of medical literature, clinical data, or relevant documents for regulatory submissions Excellent computer skills including MS Office (Word, Excel, PowerPoint) Highly organized, self-motivated, and extremely detail-oriented Excellent written and verbal communication skills Proven ability to work independently with minimal supervision, meet deadlines, and manage multiple projects simultaneously Ability to collaborate across departments and relate effectively to people at all levels of the company Ability to travel up to 5%
Qualifications:
Training and degree in science, engineering, or medical field Prior experience in the medical device and/or pharmaceutical industry Experience with writing document types specific to the role or experience with regulatory writing relevant to the role, and familiarity with EU Medical Device Regulation 2017/745 (MDR) Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's remote working policies, from the country in which they are employed.
For fully remote roles, the following locations are not eligible for new fully remote work arrangements:
Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer:
At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits.
Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program.
Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development.
Learn more at gore.
com/careers We believe in the strength of a diverse workforce and inclusive work environment.
In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
Gore is committed to a drug-free workplace.
All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the U.
S.
Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA employer.
(Applies to all positions in the U.
S.
) Our Talent Acquisition Team welcomes your questions at gore.
com/careers/contact #LI-ASC #LI-Remote.
Estimated Salary: $20 to $28 per hour based on qualifications.
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