The Manager, Regulatory Operations will support the Regulatory Affairs team by managing submission activities, including document processing, eCTD publishing, and archiving. They will also develop and maintain regulatory templates and ensure all submissions comply with global regulatory requirements.
The Senior Director will lead the development and execution of the company's publication and scientific congress strategy across clinical programs. This role involves partnering with cross-functional teams to translate clinical data into impactful scientific communications while managing external vendors and publication infrastructure.
The Senior Clinical Trial Manager oversees the operational execution of clinical trials, ensuring adherence to protocols, GCP, and ICH guidelines. They manage CRO interactions, study timelines, and cross-functional relationships to ensure high-quality data and successful trial completion.
The Senior Director will lead global pharmacovigilance operations, strategy, and compliance, ensuring adherence to international regulatory requirements. This role involves managing vendor relationships, overseeing safety databases, and providing leadership to the Drug Safety and Pharmacovigilance team.
The Associate Director drives promotional effectiveness analytics for TRUTAKNA by building response models and interpreting program ROI to optimize promotional investments. Additionally, the role supports patient-based demand forecasting and partners with cross-functional teams to translate business questions into clear analytical plans.
The Associate Director of Commercial Operations manages the day-to-day delivery and communication of US field operations and administration. They are responsible for optimizing CRM systems, designing territory strategies, and overseeing incentive compensation plans while collaborating across commercial and medical functions.
The Senior Director HR Business Partner will build and drive the People Strategy for the R&D and Regulatory functions. They will partner with HR subject matter experts to support talent acquisition, total rewards, employee relations, and leadership development.
The Associate Director provides quality oversight for clinical development activities and serves as a key partner to clinical study teams. They are responsible for managing quality events, CAPAs, and ensuring compliance with global regulatory requirements and inspection readiness.
