Leiden, Gemeente Leiden, South Holland
Module 3 Dossier Development
Our client is a global leader in healthcare and pharmaceutical products, with base in Leiden. The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
As a Technical Writer you will be responsible for the dossier development of CMC Module 3.
- Lead and execute CMC writing for clinical (CTA, IND) and is involved in writing marketing applications sections (BLA, MAA) for vaccines
- Support the CMC functional subject matter experts in the development, authoring, and editing of CMC related technical data for inclusion in Modules 2 and 3 of the eCTD
- Project leadership: independently lead CMC team meetings to resolve reviewer comments on the regulatory dossiers, execute dossier updates and meet regulatory timelines
- Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities
- Perform reviews of dossier documents prepared by other team members for completeness, accuracy, and structure
- Work closely with Regulatory Affairs, Analytical Development, API Process Development, Drug Product Process Development and External Stakeholders to communicate document-specific timelines to team members to ensure timely deliverables
- Educational level on MSc or PhD
- Min. 3 years of experience with CMC module 3 dossier development
- Excellent communication skills in English
The initial contract is until December 2021. An extension for 2022 is expected.
This is a part-time opportunity (24h/w).
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.
This role can be done fully remote, but the candidate needs to be located in The Netherlands.