Principal Engineer, AI Authoring Vertex PharmaceuticalsPrincipal Engineer, AI AuthoringBoston, MassachusettsYou 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.
NewSOP Writer III Integrated Resources, IncSOP Writer IIICambridge, MassachusettsContractorThe SOP writer is also required to be an expert user of the Controlled Document Management System (CDMS) and will lead work flow facilitation of all Procedural Documents within MasterControl, Shire's CDMS.The Consultant SOP Writer must have strong time management and project management skills as well as excellent interpersonal skills and attention to detail to lead content experts through the development of multiple Procedural Documents simultaneously. This includes but is not limited to:Review of regulatory requirements, quality facilitation of procedural document workgroups, authoring, reviewing, editing and quality control of documents, identification and assignment of training in the Learning Management system, and training development and implementation.
NewTechnical Writer Integrated Resources, IncTechnical WriterAndover, MassachusettsContractorSkills 1) Excellent oral and written communications with experience in technical writing of reports and/or regulatory documents 2) Regulatory, GMP or Pharmaceutical experience, preferably in bioprocess or cell line development areas is desirable detail oriented 3) Additional soft skills include - able to work independently, strong interpersonal skills, able to multi-task, team player 4) Advanced use of MS Office Background/Experience 1) Scientific Background; BS or higher Biology, Chemistry, Biochemistry, Molecular Biology, Engineering, or similar 2) 3 – 5 years' experienceFeel free to forward my email to your friends/colleagues who might be available. IT Life Sciences Allied Healthcare CRODIRECT # - (650)-399-0891Gold Seal JCAHO Certified for Health Care Staffing"INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)
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).
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.
Medical Writer Disc Medicine IncMedical WriterMA$117,000–$143,000 / yearCommunicate and coordinate with line-function team members to gather, organize, and compile information towards the development and planning of writing scientific, clinical, and regulatory documents; communicate deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables. RESPONSIBILITIES: Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents; participate in study results interpretations and manage the document review/approval process to capture comments and resolve conflicts, including running round-table meetings.
Principal Medical Writer- MedPubs Focus Synchrogenix Information StrategiesPrincipal Medical Writer- MedPubs FocusMassachusettsFinal 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. Proficient in MS Office Suite (advanced MS Word, PowerPoint and Excel); Adobe Acrobat for developing and editing poster slides, pdf poster layouts and slide sets.
Principal 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.