Ensure that investigations associated with assigned third party sites are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure.
This role requires a cross - matrix leader to contribute to an integrated strategy across different indications for company'916, and to combination strategies with various internal and external assets.
Ensure the development of appropriate regional regulatory strategy( s ) and their execution for assigned asset( s ) consistent with Medicines Development Strategy and ensure compliance with both government and internal company process / policies.
The candidate will be responsible for leading clinical development team( s ) consisting of physicians, clinical scientists and other function representatives, strategizing development plan, executing clinical trials, and managing the development resources and timeline.
The role will also have a responsibility to establish a structure which can execute against the known and expected demand roadmap and directly support the business objectives underpinned by Digital Analytics and Media solutions.
Responsible for process trend analysis and assurance that processes remain within control parameters. Responsible for resolving process issues/ problems in a manner and timeframe consistent with production and quality goals for specific products.
Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to maximise the likelihood of successful regulatory applications, delivering regulatory approval and reimbursement for all key indications.
Develops / manages the development of local aspects of key study documents, plans & manuals ( e.g., monitoring plan, study reference manual, etc. ); develops local recruitment and other site support materials.
Develop strong partnerships with internal stakeholders in a multi - disciplinary framework ( clinical, safety, regulatory, health outcomes, asset leadership and commercial functions ) to meet product needs.