Manuscript review for Quality Check and Submission Readiness

I have a machine learning / data science project already completed (writeups + notebooks + slides). I want to convert the best one into real scholarly-style papers that are publishable. · You are a technical writer/editor + research formatting specialist. I am the author. · You m ...

We are looking for an experienced Architectural Designer / Architect to prepare submission-ready architectural permit sets for residential projects in the United States. · ...

I have 3 multiple machine learning / data science projects already completed (writeups + notebooks + slides). I want to convert the best ones into real scholarly-style papers that are publishable. · Important clarifications · You are a technical writer/editor + research formattin ...

Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM. · ...

Key Responsibilities · Prepare CMC sections of BLA · Execute regulatory submission activities using Veeva Vault RIM/Docs · Ensure compliance with FDA ICH and eCTD standards Track document readiness manage timelines and resolve submission issues Support FDA information requests am ...

We are looking for an experienced eCTD Submission Specialist with hands-on experience supporting regulatory submissions in eCTD format. · eCTD submissions · regulatory affairs · ...

· Independently manage CARA structure assembly, submission-readiness formatting, and publishing of Translational Medicine documents including validation reports. · Ensure PRISM compliance, · Mentor train and provide troubleshooting assistance to internal TM personnel and externa ...

Sanofi's contingent workforce program, FLEXT Direct, is seeking a Content Quality & Submission Lead for a 10-month contract with the possibility to extend. · ...

Job summary · The contractor will provide CMC Submission support focused on the compilation, · assembly, and quality control (QC) of CMC content for regulatory submissions.Reporting to the Regulatory Affairs lead, · this role contributes to preparing submission-ready CMC modules, ...

The organization's three lead product candidates are in Phase III with BLAs to follow in the near term. · Currently they are seeking a dedicated and detail-oriented Manager, Data Management to contribute to database development, · data quality oversight and vendor coordination. · ...

Lead the creation of key regulatory documents including clinical overviews summaries and study-specific content for major submissions Draft and update clinical study reports investigator brochures and standard operating procedures Contribute to protocols amendments statistical an ...

We are seeking a detail-oriented Content Quality & Submission Lead (Veeva Specialist) to manage the end-to-end quality, compliance, and submission of digital promotional materials within the Veeva platform. · ...

The Principal Statistician will lead and oversee programming activities for clinical trial data analysis and global regulatory submissions.This role requires advanced expertise in CDISC standards (SDTM , ADaM) , submission deliverables , CSDRG , aCRF ) . · Set and own the statis ...

The Principal Programmer will lead and oversee programming activities for clinical trial data analysis and global regulatory submissions. · This role requires advanced expertise in CDISC standards (SDTM, ADaM), submission deliverables , CSDRG, aCRF), and generation of TLFs in com ...

We are seeking a skilled and detail-oriented creative to help clean up and organize a drawing portfolio. · Review existing drawings and artwork for clarity, presentation, and consistency. · ...

Dice is the leading career destination for tech experts at every stage of their careers. Our client, Complete Staffing Solutions, is seeking the following. Apply via Dice today · Position: Data Mining Analyst · Pay Rate: $30-$40 per hour · Duration: 6+ Months (Contract to Hire) · ...

Arrowhead Pharmaceuticals, Inc. (Nasdaq:  ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead ther ...

We are seeking a dedicated and detail-oriented Manager, Data Management to support data management activities for clinical trials. · ...

I've built a mobile app and everything is ready for Apple App Store submission. · ...

About the Company · The ideal candidate must have experience supporting regulatory submission readiness, with a strong focus on tracking QC deliverables, testing schedules, and resource loading to ensure all activities align with the Client's July 2026 BLA filing commitment. · Ab ...