Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and system description and validation summary reports.
Support and participate in the development of forward-looking strategies, market positioning and product profiles for CNS pipeline products by synthesizing primary and secondary inputs that will inform the lifecycle plan.
The Director of Medical Affairs Engagement will engage specific thought leaders, patient advocacy groups, government agencies, and academic centers within a defined area to establish collaborative medical relationships with the goal of improving patient care in addiction treatment.
Contribute to the development and cultivation of long-term strategic medical partnerships with specific clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders with designated region.
Identify, establish, and maintain clinical and scientific relationships with Thought Leaders (TLs) in both academic and community settings including individual physicians, researchers, managed markets medical and pharmacy directors.
Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, Clinical Quality Assurance, Knowledge management Services, and Biostatistics, in preparation of clinical and regulatory documents.
The ideal candidate should have an established track record of solving complex technical problems, have creative scientific skills, excellent communication skills, both oral and written, and thrive in a cross-functional team environment.