Principal Engineer, AI Authoring Vertex Pharmaceuticals IncPrincipal Engineer, AI AuthoringBoston, MA$166,640–$250,000 / yearYou will tackle complex engineering challenges, including automated document workflows and Retrieval-Augmented Generation (RAG)-based architectures, to support the creation of high-quality, compliant, and efficient regulatory documents. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
Pocket-Lint - Streaming & AV Author Valnet Tech SitesPocket-Lint - Streaming & AV AuthorBoston, MARemoteValnet , founded in 2012, is a global digital publishing and media investment Company that owns and operates over 25 authoritative brands across diverse verticals, including entertainment, sports, technology, automotive, gaming, lifestyle and travel. Pocket-lint is a leading authority on consumer tech, digital entertainment, and smart home gear, reaching millions of readers with up-to-the-minute news, authoritative reviews, and deep-dive guides.
Director, SDS Authoring Services 3E CompanyDirector, SDS Authoring ServicesMA8+ years of experience in SDS authoring, chemical regulatory consulting, product stewardship, or a related field, including 7+ years of leadership experience managing global teams and developing people leaders. Reporting to the Associate Vice President, Delivered Services, you will lead a global team responsible for delivering approximately 20,000 SDSs annually across a diverse portfolio of customers with varying service levels and turnaround expectations.
Vigilance Writer LancesoftVigilance WriterActon, MARemote$43The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements;serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities;works on problems of diverse scope where analysis of data requires evaluation of identifiable factors;demonstrates good judgment in selecting methods and techniques for obtaining solutions;and networks with senior internal and/or external personnel in own area of expertise. Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements.
Vigilance Writer StratAcuity Staffing Partners IncVigilance WriterActon, MARemote$40–$45 / hourThe Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA.
Technical Writer StratAcuity Staffing Partners IncTechnical WriterLexington, MA$35–$40 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Regulatory Writer I OraRegulatory Writer ITown of Andover, MAOur Regulatory Writer I is responsible for researching, writing, and editing materials for regulatory submission to the FDA from pre-clinical to clinical trials Phase 1 - 4. This is an individual contributor working on a team as an active partner in regulatory project planning and execution reporting to the Manager of Regulatory. Ora's Regulatory Writer I will work collaboratively with our Clinical Project Managers, Clinical Trial Associates (CTA) and cross-functional departments such as Clinical Operations, Quality Assurance, Operations and Chemical Manufacturing Control (CMC).
NewPrincipal Medical Writer-nonclinical focus Synchrogenix Information StrategiesPrincipal Medical Writer-nonclinical focusMassachusettsPossesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.
Tech Writer-Tech III - AMZ9674280 Amazon.com IncTech Writer-Tech III - AMZ9674280Boston, MA$125,800–$170,200 / yearMust have one year of experience in the following skill(s): (1) designing and producing content for a technical audience that includes data scientists or business consumers of AI technologies; (2) experience using content publishing tools such as Oxygen and XML to write, format, manage, and publish technical content on the web; (3) creating large writing projects of at least 500 pages from scratch; (4) using metrics to develop content strategies; (5) writing example code in one or more programming languages, such as Python, Java, JavaScript, Ruby, C#, or Go. Position Requirements: Bachelors degree or foreign equivalent degree in Computer Science, Engineering, English, or a related technical field and five years of experience in the job offered or a related occupation.
Senior Regulatory Medical Writer, Client-embedded, FSP Thermo Fisher Scientific IncSenior Regulatory Medical Writer, Client-embedded, FSPFramingham, MA$110,000–$125,000 / yearAs one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. The successful candidate will have a proven track record in authoring clinical regulatory documents; ideally they will also bring the versatility to author and support preclinical regulatory documents as part of a broader regulatory writing portfolio.
Senior Medical Writer (Remote) MMSSenior Medical Writer (Remote)Boston, MARemoteFull timeWrite and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.
Senior Medical Writer, Promotional Review Thermo Fisher ScientificSenior Medical Writer, Promotional ReviewWaltham, MassachusettsReviews promotional and non-promotional materials for clinical and scientific accuracy against source documentation, reviews context and tone of language for compliance with FDA-OPDP requirements and assures appropriate level of language for intended audience. At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy.
Senior Writer/Editor, Committee on Publication Christian ScienceSenior Writer/Editor, Committee on PublicationBoston, MassachusettsUnder the direction of the Editorial Activities Manager, the Senior Writer and Editor will be responsible for assisting in many areas of the Committee work: Gaining an understanding of the landscape or atmosphere of public thought as the context in which impositions on the public regarding Christian Science are addressed and healed; Praying specifically for healing of impositions and in support of essential activities in which the office and Committees in the field are engaged; Actively engaging with Committees on Publication in researching, writing, and/or editing corrective responses; Drafting content that provides information and guidance to Committees on Publication worldwide; Writing and/or editing corrective responses to Christian Science references in the media, academia, clergy, letters, books, etc., as well as responding to other outside correspondence and inquiries; Direct contact with the public, including communication with media, and — on occasion — giving talks to public groups, and meeting with scholars, authors, and students; Attending daily, weekly, and monthly staff meetings essential to advancing the corrective work of the office; this may include final preparation of an extensive document that is discussed during weekly corrective meetings; Contributing to the planning and facilitation of meetings with Committees on Publication; Leading the preparation, writing, and editing of regular Trends in Thought bulletins; Leading a team focused on correcting impositions on the public in regard to Christian Science presented on Wikipedia and other online encyclopedias; Responding to questions, drafting content, and helping to clarify issues in websites and social media pertaining to Christian Science; Contributing to the Manager’s Office seasonal newsletters and other materials; Assisting with other projects as assigned. The practical work includes but is not limited to writing and editing corrective responses for the media and academia, answering inquiries from the general public and church members, researching needed topics, working closely with Committees on Publication in various jurisdictions on corrective cases, and working to correct misinformation that appears on websites and in social media.