PAREXEL

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.  Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.

Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and or site specific documents or essential regulatory documents and any updated or amended regulatory documentation.

Compile appendices to clinical study reports in compliance with appropriate regulatory requirements, with support of the project lead and lead medical writer. Work with internal or external Clinical and or Project Leadership functions to ensure that appendix documentation is complete and complies with the relevant guidelines.

Responsible for processing of Individual Case Safety Reports ICSRs from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable 

Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market. Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action. Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions

Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

Principal Medical Writer, will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer, submission coordinator and primary client contact to manage contributions of multiple writers working on related documents.

Clinical Data Analyst works under guidance and supervision of their Line Manager and/or Subject Matter Experts to perform some of the clinical data cleaning activities on assigned projects, commensurate with experience and, or project role.