Director project mangement
Criterion Edge
Total years of experience :11 years, 10 Months
Strategic leadership:
• Spearheading a team of 38 project managers, medical writers, and internal teams.
• Demonstrating strategic leadership and operational excellence aligned with FSP budgets, utilization, quality, and regulatory compliance guidelines.
• Employing effective team building and HR leadership strategies to optimize individual strengths and ensure adherence to corporate policies.
Project Management Excellence:
• Implementing robust strategies for client expectations on multiple projects and timelines, ensuring alignment with company initiatives and strategies.
• Overseeing interdisciplinary projects with meticulous attention to budget and performance metrics, contributing directly to seamless and high-quality deliverables.
• Establishing, maintaining, and refining project management processes to align with the annual operating plan that consistently meets and exceeds high-quality standards.
Training and Regulatory Compliance:
• Conducting comprehensive training sessions on methodologies and regulatory updates and supervising regularly to meet the established performance levels.
• Supporting HR activities and performing ongoing performance appraisals for staff development.
Clinical Evaluation and Regulatory Expertise:
• Applying extensive expertise in global regulatory guidelines (FDA, EMA, ICH).
• Reviewing and submitting clinical evaluation packages for over 51 medical devices per EU MDR.
• Assisting in strategic planning with clients, conducting gap analyses, and reviewing diverse documents (CSRs, DSURs, IBAs, INDs, etc.) for regulatory compliance.
Diverse Therapeutic Areas:
• Navigating the regulatory landscape across various therapeutic areas.
• Managing and facilitating submissions in Cardiology, Neurology, Vascular, Gastroenterology, Oncology, Vaccines, Diabetes, Metabolic diseases, Respiratory, Dermatology, Dental, Psychiatry, Immunization, and more.
Operational Strategy and Matrix Management:
• Driving operational strategy, planning, and providing effective matrix management oversight for clinical studies.
• Actively contributing to strategic discussions and decision-making.
Strategic leadership:
• Spearheading a team of 38 project managers, medical writers, and internal teams.
• Demonstrating strategic leadership and operational excellence aligned with FSP budgets, utilization, quality, and regulatory compliance guidelines.
• Employing effective team building and HR leadership strategies to optimize individual strengths and ensure adherence to corporate policies.
Project Management Excellence:
• Implementing robust strategies for client expectations on multiple projects and timelines, ensuring alignment with company initiatives and strategies.
• Overseeing interdisciplinary projects with meticulous attention to budget and performance metrics, contributing directly to seamless and high-quality deliverables.
• Establishing, maintaining, and refining project management processes to align with the annual operating plan that consistently meets and exceeds high-quality standards.
Training and Regulatory Compliance:
• Conducting comprehensive training sessions on methodologies and regulatory updates and supervising regularly to meet the established performance levels.
• Supporting HR activities and performing ongoing performance appraisals for staff development.
Clinical Evaluation and Regulatory Expertise:
• Applying extensive expertise in global regulatory guidelines (FDA, EMA, ICH).
• Reviewing and submitting clinical evaluation packages for over 51 medical devices per EU MDR.
• Assisting in strategic planning with clients, conducting gap analyses, and reviewing diverse documents (CSRs, DSURs, IBAs, INDs, etc.) for regulatory compliance.
Diverse Therapeutic Areas:
• Navigating the regulatory landscape across various therapeutic areas.
• Managing and facilitating submissions in Cardiology, Neurology, Vascular, Gastroenterology, Oncology, Vaccines, Diabetes, Metabolic diseases, Respiratory, Dermatology, Dental, Psychiatry, Immunization, and more.
Operational Strategy and Matrix Management:
• Driving operational strategy, planning, and providing effective matrix management oversight for clinical studies.
• Actively contributing to strategic discussions and decision-making.