In Vitro Diagnostics (IVD) Documentation Specialist (Remote)

ThermoFisher Scientific

Austin Texas

United States

Other
(No Timezone Provided)

Job Title: In Vitro Diagnostics (IVD) Documentation SpecialistRequisition ID: 174462BRWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.Location/Division Specific InformationAustin, TX (Remote)| Clinical Sequencing Division - IVD product development technical writerHow will you make an impact?The Clinical Next Generation Sequencing Team is seeking an experienced and highly motivated document specialist for the generation of design control documents, test plans/reports, SOPs, and other documentation related to the development of an invitro diagnostic oncology workflow including sample prep, library preparation, sequencing and variant reporting for global regulated markets. The position involves applying experience in product development, quality and regulatory documentation to support the R team in drafting documentation for new product development towards regulatory submissions. The candidate will have strong time-management and organizational skills, excellent proofreading and editing skills, strong understanding of regulated product development process (CE-IVD or US IVD) and QSR systems, and the ability to collaborate effectively with different functional groups including R, Regulatory, Quality, Product Management, Manufacturing and external partners.What will you do? Prepare new product development documentation including study plans/reports, SOPs, and other technical documents.Proofread and ensure documents meets Quality and Regulatory requirements, guidelines, policies, and procedures.Facilitate and track the document routing and approval in collaboration with Core Team members and Document Management System change analysts.Actively participates with cross-functional new product development teams to ensure documents are in compliance with design controls per ISO 13485 and FDA QSR.Generate templates and guidance documents in partnership with Regulatory and Clinical Affairs, Quality/Design Compliance and other stakeholders.Standardize and streamline documents and documentation system in coordination with R team and managers.Aid in preparation of documents for regulatory submission.Proactively solicit information from other experts within the company as needed (e.g. R, Manufacturing, QA, QC, Legal).How will you get here?EducationBA/BS Degree, at least 5 years industry experience.MS Degree, at least 3 years of industry experience.ExperiencePrior experience writing and coordinating documents required.Understanding of Quality Systems Regulations and Good Documentation Practice.Familiarity with phase-gate product development process.Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products.Experienced using electronic Document Management Systems.Highly skilled at using Microsoft Office (Word/Excel), able to create and manage styles, permissions, macros etc.Experience in a lab setting in life sciences and/or an understanding of molecular biology and associated techniques (Preferred).Experience in Quality Assurance is a plus.Knowledge, Skills, AbilitiesExtremely organized and detail-oriented professional with excellent proofreading and editing skills.Ability to complete tasks in a fast-paced, cross functional environment with multiple concurrent projects.Driven to deliver quality results on time and in a highly ethical and professional manner.Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective.Must be tolerant to change, ready to take on new challenges and open to learning new skills.At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

In Vitro Diagnostics (IVD) Documentation Specialist (Remote)

ThermoFisher Scientific

Austin Texas

United States

Other

(No Timezone Provided)

Job Title: In Vitro Diagnostics (IVD) Documentation SpecialistRequisition ID: 174462BRWhen you're part of the team at Thermo Fisher Scientific, you'll do important work. Surrounded by collaborative colleagues, you'll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.Location/Division Specific InformationAustin, TX (Remote)| Clinical Sequencing Division - IVD product development technical writerHow will you make an impact?The Clinical Next Generation Sequencing Team is seeking an experienced and highly motivated document specialist for the generation of design control documents, test plans/reports, SOPs, and other documentation related to the development of an invitro diagnostic oncology workflow including sample prep, library preparation, sequencing and variant reporting for global regulated markets. The position involves applying experience in product development, quality and regulatory documentation to support the R team in drafting documentation for new product development towards regulatory submissions. The candidate will have strong time-management and organizational skills, excellent proofreading and editing skills, strong understanding of regulated product development process (CE-IVD or US IVD) and QSR systems, and the ability to collaborate effectively with different functional groups including R, Regulatory, Quality, Product Management, Manufacturing and external partners.What will you do? Prepare new product development documentation including study plans/reports, SOPs, and other technical documents.Proofread and ensure documents meets Quality and Regulatory requirements, guidelines, policies, and procedures.Facilitate and track the document routing and approval in collaboration with Core Team members and Document Management System change analysts.Actively participates with cross-functional new product development teams to ensure documents are in compliance with design controls per ISO 13485 and FDA QSR.Generate templates and guidance documents in partnership with Regulatory and Clinical Affairs, Quality/Design Compliance and other stakeholders.Standardize and streamline documents and documentation system in coordination with R team and managers.Aid in preparation of documents for regulatory submission.Proactively solicit information from other experts within the company as needed (e.g. R, Manufacturing, QA, QC, Legal).How will you get here?EducationBA/BS Degree, at least 5 years industry experience.MS Degree, at least 3 years of industry experience.ExperiencePrior experience writing and coordinating documents required.Understanding of Quality Systems Regulations and Good Documentation Practice.Familiarity with phase-gate product development process.Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD) products.Experienced using electronic Document Management Systems.Highly skilled at using Microsoft Office (Word/Excel), able to create and manage styles, permissions, macros etc.Experience in a lab setting in life sciences and/or an understanding of molecular biology and associated techniques (Preferred).Experience in Quality Assurance is a plus.Knowledge, Skills, AbilitiesExtremely organized and detail-oriented professional with excellent proofreading and editing skills.Ability to complete tasks in a fast-paced, cross functional environment with multiple concurrent projects.Driven to deliver quality results on time and in a highly ethical and professional manner.Demonstrated resourcefulness, strategic and analytical thinking, and directed toward achieving objective.Must be tolerant to change, ready to take on new challenges and open to learning new skills.At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.