- Vera Therapeutics (Brisbane, CA)
- Title: Senior Manager, Regulatory Operations and Publishing Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... Regulatory Operations and GXP Information Systems, the Senior Manager, Regulatory Operations and Publishing will be a key contributor to Vera Therapeutics' … more
- System One (Florham Park, NJ)
- …laws and regulations. The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version control, archiving ... Senior Regulatory Operations Associate Contractor ( Publishing ) Must be local for Florham Park, NJ (Hybrid 2-3 days onsite) 12-month contract (renewable) Senior … more
- BeiGene (Emeryville, CA)
- …**Qualifications:** + Successful candidates will have significant experience within a Regulatory Publishing environment including hands on eCTD experience and ... (including scheduling and resource allocation), document format review, submission publishing (including QC), submission dispatch and archiving regulatory … more
- Randstad US (Newbury Park, CA)
- …submissions / Health Authority correspondence + Data Management Point of contact between Regulatory Representatives / CMC, publishing teams and vendor + Support ... regulatory affairs senior associate. + newbury park ,...9 to 5 education: High School responsibilities: + Maintain Regulatory document management and tracking systems + Support Activities… more
- AbbVie (Chicago, IL)
- …Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities: + Leads ... sets to support safety monitoring, signal detection, clinical safety analytics and regulatory submissions. + Leads a team of statistical programmers and manages the… more
- AbbVie (Mettawa, IL)
- …(ie Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.) Responsibilities include the ... the statistical programming activities for studies. + Create documentation for regulatory filings including reviewers guides and data definition documents. + Lead… more
- Eurofins (Indianapolis, IN)
- …develop complex regulatory strategies. + Partners with Client RDE ( regulatory associates/ publishing group) to ensure completion of submission activities. ... of our client's clinical trial portfolio by helping to develop successful regulatory strategies and submissions in support of clinical trials. This position utilizes… more
- Vera Therapeutics (Brisbane, CA)
- …for briefing documents and agency meetings. * Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents. * May ... motivated Associate Director, Project Management. The ideal candidate will work with the Regulatory team to develop project plans and to ensure that these are… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …+ Assists in reviewing change order documents and ascertains impact on current regulatory approvals. + Assists with technical publishing of submissions. + ... **11917BR** **Title:** Specialist I, Regulatory Affairs **Job Description:** This position is responsible for assisting in obtaining regulatory approvals and… more
- ST MICHAEL'S INC (Falls Church, VA)
- …subjects research regulation and policy analysis + Human subjects research regulatory compliance + Publishing formal Human subjects research ... Secret clearance? Do you possess a strong foundation in research ethics, regulatory knowledge, and scientific expertise, especially as it pertains to studies… more
- Randstad US (Los Angeles, CA)
- publishing specialist. + los angeles , california + posted october 3, 2024 **job details** summary + $40 - $43 per hour + contract + high school + category computer ... and mathematical occupations + reference1067925 job details job summary: The publishing specialist serves as the primary point of contact and strategic publishing… more
- Google (Austin, TX)
- …into the 21st century, but move information law forward as well. The Music Publishing team is responsible for commercial and product issues related to Publishing ... agreements with content creators, distributors, record labels, music publishers and publishing collecting societies across all Google products, primarily for YouTube… more
- AbbVie (South San Francisco, CA)
- …viral clearance studies + Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals ... and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents + Demonstrated scientific… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disciplines to organize, formulate and execute timelines for PrM projects including regulatory submission and publishing activities with a high degree of ... independency + Oversight, manage and maintain project deliverables. + Support data reconciliation activities by investigating data inconsistencies and confirming resolutions. **Qualifications:** Successful candidates will be able to meet the qualifications… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …clinical and biomarker data analysis to inform study reports, protocols, and regulatory documentation. + Representing and Publishing Research: Present at ... and functional teams on shared project goals. + External Engagement and Regulatory Support: Collaborate with academic and industry experts while providing guidance… more
- Fresenius Medical Center (Waltham, MA)
- …the development and implementation of systems and procedures used to support regulatory submission (drugs and devices) and publishing activities. + Oversees ... maintenance of an archiving/document management system. + Manages document producing, publishing and tracking for company regulatory submissions and… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Regulatory Affairs Operations Internship Overview The Operations Submission Management ... Intern will support the regulatory operations team by helping to facilitate ...implementation of internal process and standards documents relating to publishing and publishing deliverables. + Suggests and… more
- Abbott (South Portland, ME)
- … regulatory affairs submissions. + Expertise with EDMS (Documentum-based), publishing , and/or registration management systems, Adobe Acrobat, or similar tools. + ... of people. **What You'll Work On** The **Sr. Specialist, Regulatory Affairs** combines scientific, regulatory , and business...area or MBA preferred. + 3-6 years of pharmaceutical publishing experience preferred. + Ph.D. in a technical area… more
- Actalent (Cambridge, MA)
- Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage submission-related ... activities, working closely with regulatory and CMC leads to create content plans and...and CROs. + Strong communication skills. + Proficiency with publishing tools. + Timeline management experience. + Experience with… more
- Organon & Co. (Plymouth Meeting, PA)
- …current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e- publishing requirements. ... **Job Description** **The Position** Reporting to the Director in Organon Regulatory Chemistry, Manufacturing and Controls New Products, the Associate Principal… more