Dossier Creation

This individual will be responsible for delivering CMC documentation (dossier and supporting documents)to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application. · Co-authors/authors scientific content for CTD Q ...

We are seeking a skilled OSINT researcher to assist in the creation of a detailed dossier.The candidate will be responsible for gathering and analyzing publicly available information to compile insights that meet our project's needs. · ...

This position will coordinate activities with all functional departments in support of regulatory filings. Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. · ...

Looking for a Wikipedia editor to execute a compliant, low-risk Wikipedia strategy for a small online platform in the sports/fitness space. · ...

+This role is a premier opportunity to write and edit high-quality medically relevant documents for assigned therapeutic areas. You will ensure the successful preparation of submission-ready documents and the effective implementation of the writing process. · ...

A high caliber researcher / EA is needed to help identify and deeply profile ultra premium prospects for a high ticket advisory program. · The ideal candidate will have experience researching high net worth individuals, founders, or executives and be able to capture nuance and t ...

The Regulatory Publishing Associate is responsible for the planning, publishing and review of regulatory submissions to global Health Authorities within required timeframes. · The primary accountability for this role is focused on the lifecycle submissions portfolio, but there i ...

Job summarySubmission Publishing Contractor: · Veeva Publishing experience is Good to have but not Mandatory · ...

Provide regulatory support and expertise associated with US and global submission requirements. · ...

The Regulatory Publishing Associate is responsible for the planning, publishing (eCTD, NeES, paper), review and delivery of regulatory submissions to global Health Authorities within required timeframes. · The primary accountability for this role is focused on the lifecycle submi ...

The Medical Writing Specialist supports the development, · review, · and dissemination of scientific materials.The role focuses on delivering high-quality,evidence-based, · and compliant scientific content. · ...

This is a HEOR Scientist role responsible for developing Health Economics and Outcomes Research studies relating to health economics, epidemiology, quality of care, and market access for Zeposia IBD indications. · Make recommendations on external collaborations. · Collaborate eff ...

The Quality Assurance Assistance in the Quality Assurance group plays a major role in maintaining and improving the Global Quality Systems. · This individual works independently to maintain systems and address internal and external customer needs.With general instruction on new a ...

ThisproductionDocumentation Analystroleisfullyremoteandrequires effectivecollaborationacross technicalfunctions todeliveron timelines for submissions. · ...

This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application. · Co-authors/ authors scientific content for CTD ...

We are seeking an experienced Regulatory Affairs professional. · FDA Submissions & Regulatory Documentation.Author, compile, and submit FDA regulatory dossiers. · ...

This individual will be responsible for delivering CMC documentation to support the regulatory strategy for the Cell Therapy clinical portfolio. · Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy. · Plan and facilitate submission ki ...

This individual will be responsible for delivering CMC documentation to support the regulatory strategy for the Cell Therapy clinical portfolio.The role requires effective collaboration across technical functions to deliver on timelines for submissions. · ...

This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application. · Co-authors/authors scientific content for CTD ...

The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation to support the regulatory strategy for ...