Vertex Pharmaceuticals
Medical Writing Review Senior Specialist (Remote)
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Medical Writing Review Senior Specialist (Remote)
Job DescriptionThe Medical Writing Operations Senior Specialist is primarily responsible for independently performing in-depth quality control (QC) reviews on moderately complex clinical and regulatory documents across multiple therapeutic disease areas. The Sr. MWOS provides QC expertise to the MW Operations team and supports MW Scientists to prepare high quality and compliant documents by assisting with essential tools and technologies.KEY RESPONSIBILITIES:Independently performs content, editing, and formatting QC of moderately complex regulatory and clinical study documents, which may include complex CSRs, complex protocols, Investigator Brochures, and single study Module 2 summaries.Ensures QC reviewed documents are compliant with MWS Style guide and templates.Troubleshoots MWS processes, tools, and technologies and may serve as subject matter expert.Uses electronic document management systems (EDMS) to retrieve QC sources and track document dependencies, such as appendices for clinical study reports.Assists MW Scientists with the collection and maintenance of literature references in Endnote.Contributes to MWS initiatives related to QC, document development, or process improvement (i.e., new tools or systems).Works cross functionally to communicate responsibilities and track deliverables for complex CSR Appendices.Travels to corporate headquarters in Boston up to 1 week per quarter.TECHNICAL AND COMMUNICATIVE SKILLS:Able to work effectively in a remote environment.Exceptional attention to detail.Advanced proficiency with Microsoft Office (including Word, PowerPoint, and Excel) and the use of templates.Expertise using Endnote for citation management.Experience with using in-house style guide standards for editing and formatting.Working knowledge of clinical development and regulatory affairs documentation.Experience retrieving and filing documents within an electronic document management system.Excellent interpersonal, verbal, and written skills with ability to effectively manage stakeholders.Conscientious, self-motivated, organized, and able to independently manage multiple projects with aggressive timelines.Solves routine problems with limited supervision and adapts to new work requests with minimal instruction.REQUIRED EXPERIENCE:A minimum of 4 years of relevant work experience in review and QC of complex clinical and regulatory documents.Pay Range:
$81,600 - $122,400Company InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Have you got what it takes to succeed The following information should be read carefully by all candidates.#J-18808-LjbffrRemote working/work at home options are available for this role.
Job DescriptionThe Medical Writing Operations Senior Specialist is primarily responsible for independently performing in-depth quality control (QC) reviews on moderately complex clinical and regulatory documents across multiple therapeutic disease areas. The Sr. MWOS provides QC expertise to the MW Operations team and supports MW Scientists to prepare high quality and compliant documents by assisting with essential tools and technologies.KEY RESPONSIBILITIES:Independently performs content, editing, and formatting QC of moderately complex regulatory and clinical study documents, which may include complex CSRs, complex protocols, Investigator Brochures, and single study Module 2 summaries.Ensures QC reviewed documents are compliant with MWS Style guide and templates.Troubleshoots MWS processes, tools, and technologies and may serve as subject matter expert.Uses electronic document management systems (EDMS) to retrieve QC sources and track document dependencies, such as appendices for clinical study reports.Assists MW Scientists with the collection and maintenance of literature references in Endnote.Contributes to MWS initiatives related to QC, document development, or process improvement (i.e., new tools or systems).Works cross functionally to communicate responsibilities and track deliverables for complex CSR Appendices.Travels to corporate headquarters in Boston up to 1 week per quarter.TECHNICAL AND COMMUNICATIVE SKILLS:Able to work effectively in a remote environment.Exceptional attention to detail.Advanced proficiency with Microsoft Office (including Word, PowerPoint, and Excel) and the use of templates.Expertise using Endnote for citation management.Experience with using in-house style guide standards for editing and formatting.Working knowledge of clinical development and regulatory affairs documentation.Experience retrieving and filing documents within an electronic document management system.Excellent interpersonal, verbal, and written skills with ability to effectively manage stakeholders.Conscientious, self-motivated, organized, and able to independently manage multiple projects with aggressive timelines.Solves routine problems with limited supervision and adapts to new work requests with minimal instruction.REQUIRED EXPERIENCE:A minimum of 4 years of relevant work experience in review and QC of complex clinical and regulatory documents.Pay Range:
$81,600 - $122,400Company InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Have you got what it takes to succeed The following information should be read carefully by all candidates.#J-18808-LjbffrRemote working/work at home options are available for this role.