PRC Coordinator

The PRC coordinator is responsible for driving the material review process at the regional and across European affiliates. He/ She will be responsible for ensuring localization and accurate translation of the materials in all major European languages and subsequently for initiating, tracking and driving completion of the review of the translated materials at the affiliates across Europe. This person will be responsible for keeping himself/ herself updated on the changes in local affiliate regulations or industry code impacting material review process. The PRC coordinator will analyze the process execution, provide weekly dashboard to the operations team and suggest improvement to drive efficiency. The person will also have the responsibility of ensuring that relevant work instructions or SOP’s are up to date and will support corporate compliance and S&G office to conduct monitoring of the material review process.

On a daily basis they will interact with the SMA regional team, with the local affiliate PRC coordinators/team, SMA marketing, medical and regulatory leads as well as the regional SMA legal to ensure materials are expedited in the most efficient and lean manner. The PRC coordinator will also be responsible for onboarding and coordinating training of new team members on the SMA materials review process and providing access to the Biogen materials review tools (e.g., Zinc MAPS,
Veeva
Vault).