About the job

ProductLife Group is looking for CMC consultant to support one of our client in Dossier Development Operations.

About us

Group 10
Responsibilities

Acting as or assisting the Dossier development operations Scientific Integrator (SI) on the Chemistry and Manufacturing Controls (CMC) team(s).

Preparation of CMC regulatory dossiers/ CMC writing for Marketing and/or clinical trial applications while respecting the timing as agreed upon by the CMC Team and in line with Dossier development operations agreed best practices, and company processes and procedures.

Preparation of other CMC documents as needed.

Participate in continuous improvement activities relating Dossier Templates and Dossier development operations Best Practices.

Group 11
Education and Experience

Msc or PhD in Science in Organic Chemistry or Pharmacy/Pharmaceutical Sciences or Bioscience Engineering or Life Sciences

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Skills

Affinity with broader Scientific Writing.

Fluent in English, both written and spoken.

Flexible, dynamic and attention to detail.

Assertive, getting things done mentality.