Publishing Lead Apply Now

Job Family

Regulatory

City

La Tour-de-Peilz

Region

Vaud

Country

Switzerland

Contract Type

 

Posting Start Date

11-Mar-2021

Company Overview

Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com    

Job Description

Reporting to the Senior Publishing Manager, the Publishing Lead is responsible for:

• Managing external partners (CROs) in charge of the major publishing activities such as NDA, BLA, MAA and others


• Providing support to the Subject Matter Experts (SME) for the use of the different submission-related tools such as eCTD tracking tables, eCTD viewer, document management


• Improving processes and good practices for handling submitted regulatory documentation and publishing activities


• Interacting with IT to ensure there is no interruption in business activities caused by technical issues


• Assisting the system owner during publishing system updates such as overseeing the execution of the UAT, OQ and PQ tests in the framework of the CSV (computerized system validation) activities


• Interface with other business units


• Archiving submissions dossiers

Job Responsibilities

• Manage submission tracker for specific major submissions


• Maintain excellent collaboration with external partners in charge of the publishing activities


• Provide training and support to SMEs on Publishing related tools and process


• Maintain Publishing related documentation (training materials, procedures, instructions, user guides …)


• Perform Business Administration activities for Publishing related tools


• Archive Submission Dossiers and ensure their traceability across systems


• Interface with other business departments and with IT team for Publishing related activities


• Ad interim, could act as delegate of the Senior Publishing Manager for outsourced activities

Minimum Requirements

• BSc, MSc in scientific, IT or administrative discipline or equivalent experience


• Minimum 6 years’ experience Pharmaceutical Industry


• Minimum 3 years’ in similar role

Experience:

• Min 5 years’ experience performing Regulatory Operations support in pharmaceutical industry


• Min 5 years in creation and publication of electronic submissions in eCTD format


• Managing service providers


• Publishing and EDMS software


• Electronic submissions (e.g., eCTD, NeeS)


• FDA and ICH requirements pertaining to eCTD submissions and data standards


• Advanced MS Word skills


• eCTD and eCTD validation criteria knowledge

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