QA Compliance Technical Writer - Integra LifeSciences
Princeton, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
The Quality Compliance Technical Writer will work with Quality system leadership and cross functional owners to create quality system documentation and responses in support of regulatory compliance correspondence. The Quality Compliance Technical Writer will serve as primary writer for responses to external agency inquiries. This role will also work with process owners and the change control team to develop clear and concise quality system documentation, as part of Integra’s Global Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Collaborate with subject matter experts to develop robust and clear correspondence to external agencies.
+ Facilitate the development of quality system documentation, actively participate in development and writing of quality system procedures, policies and work instructions
+ Serve as liaison and subject matter expert guiding and advising internal stakeholders on strategies and best practices for successful documentation writing
+ Author documents using Integra templates, style guides, and other guidance documents
+ Author documents per regulatory authority guidelines and requirements
+ Coordinate internal documentation reviews and successfully lead a project team to consensus
+ Coordinate internal Quality communications, including maintaining the quality system webpage, teams, and SharePoint sites as needed.
+ Supporting quality system record retention
+ Write, format, edit, review and proof quality system documentation and regulatory correspondence for technical and non-technical users.
+ Other responsibilities as required
+ To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
+ Bachelor degree with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience or equivalent education and years of experience.
+ Minmum of 5 years’ experience in med device/pharmaceutical/biotech industry, with at least 5 years of experience as medical writer.
+ Expertise with software and templates commonly used in regulatory medical writing (e.g., MS-Word, Excel, PowerPoint, Adobe Acrobat, EndNote, Reference Manager). Experience with MS-Project preferred.
+ Medical device experience is preferred (510(k), PMA, BLA, HCTP).
+ Advanced technical writing, presentation, bibliographic research and editorial skills.
+ Strong ability to interpret and disseminate relevant product information.
+ Strong organizational skills, attention to detail and proofreading skills. Demonstrated project management skills.
+ Ability to produce reports and documents independently and evaluate the writing of others.
+ Ability to rapidly develop expertise in the company's internal document management system
+ Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles.
+ Positive, flexible, open-minded attitude; thrives in collaborative environment
+ Experience in design control processes is preferred.
+ Comfortable leading teams and educating team members as needed during process of document development
ADDITIONAL DETAILS:
This role is hybrid between Princeton, NJ and remote
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
The Quality Compliance Technical Writer will work with Quality system leadership and cross functional owners to create quality system documentation and responses in support of regulatory compliance correspondence. The Quality Compliance Technical Writer will serve as primary writer for responses to external agency inquiries. This role will also work with process owners and the change control team to develop clear and concise quality system documentation, as part of Integra’s Global Quality Management System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
+ Collaborate with subject matter experts to develop robust and clear correspondence to external agencies.
+ Facilitate the development of quality system documentation, actively participate in development and writing of quality system procedures, policies and work instructions
+ Serve as liaison and subject matter expert guiding and advising internal stakeholders on strategies and best practices for successful documentation writing
+ Author documents using Integra templates, style guides, and other guidance documents
+ Author documents per regulatory authority guidelines and requirements
+ Coordinate internal documentation reviews and successfully lead a project team to consensus
+ Coordinate internal Quality communications, including maintaining the quality system webpage, teams, and SharePoint sites as needed.
+ Supporting quality system record retention
+ Write, format, edit, review and proof quality system documentation and regulatory correspondence for technical and non-technical users.
+ Other responsibilities as required
+ To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
+ Bachelor degree with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience or equivalent education and years of experience.
+ Minmum of 5 years’ experience in med device/pharmaceutical/biotech industry, with at least 5 years of experience as medical writer.
+ Expertise with software and templates commonly used in regulatory medical writing (e.g., MS-Word, Excel, PowerPoint, Adobe Acrobat, EndNote, Reference Manager). Experience with MS-Project preferred.
+ Medical device experience is preferred (510(k), PMA, BLA, HCTP).
+ Advanced technical writing, presentation, bibliographic research and editorial skills.
+ Strong ability to interpret and disseminate relevant product information.
+ Strong organizational skills, attention to detail and proofreading skills. Demonstrated project management skills.
+ Ability to produce reports and documents independently and evaluate the writing of others.
+ Ability to rapidly develop expertise in the company's internal document management system
+ Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles.
+ Positive, flexible, open-minded attitude; thrives in collaborative environment
+ Experience in design control processes is preferred.
+ Comfortable leading teams and educating team members as needed during process of document development
ADDITIONAL DETAILS:
This role is hybrid between Princeton, NJ and remote
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences