Regulatory Operations Publisher, eCTD Submissions, Pharma

WearecurrentlyseekingahighlyskilledanddetailorientedPharmassubmissionsspecialisttojoinourteamontaemporarybasis. · Collaborate with crossfunctional teams. · Ensure all submitted documents meet regulatory standards. · ...

We are currently seeking a highly skilled and detail-oriented Pharma Submissions Specialist to join our team on a temporary basis. · Collaborate with cross-functional teams · ...

+ · +Proven experience of successfully completing Global Delivery Model Projects · Pharma Domain Experience · ...

+Job summaryThe Regulatory Expert will be responsible for business development initiatives in identifying new service areas for Life Sciences (Pharma, Biotech & Vaccines) Regulatory Services domain. · ...

We are looking for Health/Pharma related websites having US traffic. · DR must be greater than 40. ...

The Manager, Medical Writing Operations provides support to Medical Writing functions to ensure high-quality, submission-ready documents.Collaborate across functions to collect, compile, assemble, and publish CSR appendices · Perform electronic publishing QC. · ...

The Medical Writing Operations Manager supports Medical Writing teams to deliver high-quality regulatory documents. This role focuses on document quality control and operational support. · Collaborate cross-functionally to collect and publish clinical study report appendices. · P ...

This is a Project Manager position in Raritan NJ with hands on project management skills. · ...

We are currently seeking a dynamic leader for the position of Vice President, · Regulatory Affairs Oncology.The candidate must have recent Oncology NDA submission experience · and submissions worldwide including HTA submissions. · Leading development of all non-clinical · & clini ...

Data Scientist - Gen AI role · Design and implement Generative AI and ML solutions for pharma use cases (drug discovery, clinical trial analytics... · ...

This position provides project support with current Good Manufacturing Practices to clinical supply packaging operations. · Provides guidance on procedures necessary to be in complete compliance with current GMPs. · ...

Dice is the leading career destination for tech experts at every stage of their careers. · ...

+Job summary · The Manager, Medical Writing Operations provides support to Medical Writing functions to ensure high-quality submission-ready documents.+QualificationsBachelor's degree in a relevant scientific/technical field or equivalent experience4+ years of biotech/pharma or C ...

The Manager, · Medical Writing Operations provides support · to Medical Writing functions to ensure high-quality, · submission-ready documents.The role may also support vendor oversight, · training,and the development and maintenance · of tools and training materials for Medical ...

The candidate would be expected to have a good understanding of the Health Authority query process and the submission translation process to help us support new releases of our systems. · ...

The Regulatory Submissions Specialist is responsible for preparing, assembling, processing, formatting, quality controlling publishing submitting archiving submissions (e.g., IND CTA BLA Amendments Supplements Annual Reports IMPD Briefing Documents) to US CA other international h ...

We are supporting a life sciences organization with a regulatory systems modernization initiative and are seeking an experienced Regulatory Publishing professional to support submission data alignment and future-state readiness activities. · This role is highly execution-focused ...

+ Job summary: We are currently seeking a dynamic individual for the position of Associate Director Regulatory Affairs (Oncology). · + Key Responsibilities: · + As Regional Regulatory Lead manage regional regulatory activities · + Supports global regulatory lead in formulation of ...

We are seeking a technically strong HEOR professional with very good communication skills for a newly created and critical Global HEOR position that will focus on a high-profile, first-in-class potential, clinical-stage biologic asset projected to be a multi-blockbuster with mult ...

The candidate would be expected to have a good understanding of the Health Authority query process and the submission translation process to help us support new releases of our systems. · ...