What are the responsibilities and job description for the Manager, GRAAS Operations position at The Steely Group?
Responsibilities :
- Manage various Clinical Trial and Marketing Application type submissions and associated Global / Submission Content Plans
- Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
- Serve as primary point of contact between the clients functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system
- Independently remain current on guidance (internal / external) and translate requirements into operational activities
- Effectively represent global submission management expertise on key projects and global workstreams
- Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
- Contribute to the development of the strategy for communicating with global health authorities
- Represent departmental expertise on global work streams
- Initiate, lead and manage process development and improvement
- Lead information system and software update projects as well as ongoing system validations from a publishing perspective
- Provide technical support for regulatory systems
- Manage relationships with contributing functions and affiliates
Basic Qualifications :
