Lead the development and implementation of the site R&D strategy including alignment with the site objectives and Global R&D.
Responsibility for leading the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs for the site.
Drive development of protocols/protocol amendments for clinical studies. Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
Provides the strategic direction and clinical development plans (definition and updates). Is a permanent member of Core team, leader of the clinical sub-team and depending on the program, may also be a member of study team…
Actively contributes to the development and implementation of company’s strategy for the area and the standardization of best practices. Supervise projects within the area, proving technical expertise and best practices to the area TMs and ensuring the right networks are developed, internally and externally…
Act as a strategic driver to build and implement a sustainable transversal QMS Procedural Document (ProcDoc) / Training Framework driving the day-to-day GxP development activities
Evaluate operations from a strategic level to ensure that the QMS consistently meet quality and regulatory requirements from a Procedural Document and Training perspective
Act as a strategic driver to evaluate, optimize and implement the pro-active, fit-for-purpose and risk-based Clinical Quality Strategy ensuring compliance during the day-to-day clinical drug development activities. Drive the quality culture and create quality awareness throughout the clinical development organization
As Subject matter expert, you will be responsible for the technical strategic programme in the field of continuous tableting. Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
The Execruit team brings an unparalleled expertise and passion to address your talent recruitment, leadership assessment and development, career development, outplacement and e-learning requirements.