7 licensed clinical social worker jobs found

Merck Job Description Associate Principal Scientist, Regulatory CMC - Biologics (R4) This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from Director/Executive Director, the Assoc Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Assoc Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects. The Associate Principal Scientist / Assoc Director responsibilities include but are not limited to: Participation in the...

Merck Job Description Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects. Position Description The Principal Scientist / Director responsibilities include but are not limited to: Serve as a Regulatory CMC Project Lead and provide CMC...

Merck Job Description Job Summary This position provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast-paced, industry-leading, dynamic bio-pharmaceutical company. Core Responsibilities Overarching responsibility and oversight of clinical program execution, providing innovative ideas to achieve organizational objectives. Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting...

Merck Job Description Associate Principal Scientist, Regulatory CMC - Biologics (R4) This Associate Principal Scientist position is equivalent to an Associate Director position. Under direction from Director/Executive Director, the Assoc Principal Scientist is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Assoc Principal Scientist is responsible for the preparation and submission of CMC sections for commercial or new biologics products. The Associate Principal Scientist will assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects. The Associate Principal Scientist / Assoc Director responsibilities include but are not limited to: Participation in the...

Merck Job Description Job Summary This position provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast-paced, industry-leading, dynamic bio-pharmaceutical company. Core Responsibilities Overarching responsibility and oversight of clinical program execution, providing innovative ideas to achieve organizational objectives. Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting...

Merck Job Description Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5) Under general supervision of an Executive Director/Senior Director, the Principal Scientist /Director is responsible for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist and Assoc Principal scientist in support of their assigned projects. Position Description The Principal Scientist / Director responsibilities include but are not limited to: Serve as a Regulatory CMC Project Lead and provide CMC...

Merck Job Description The Translational Biomarkers Organization within Translational Medicine is seeking a highly accomplished Executive Director/ Distinguished Scientist to lead enterprisewide translational pathology biomarker efforts. The Executive Director will define and implement a unified vision for applying anatomic and digital pathology biomarkers to accelerate drug development across therapeutic areas, while providing decisive leadership to unify pathology related functions and elevate scientific rigor across the organization. The successful candidate will collaborate closely with Companion Diagnostics to contribute to diagnostic development strategies-particularly the incorporation and validation of digital pathology approaches to enable companion diagnostic solutions. They will work across a highly matrixed organization-partnering with colleagues in the Diagnostic Development Teams, Commercial, Regulatory, Discovery, and other key functions-to deliver cohesive,...