include but are not limited to Ensure compliance with GCP and GLP regulations and guidelines, including oversight of clinical trial activities and documentation. Collaborate with cross functional teams to develop, implement, and maintain quality systems and processes to support clinical operations. Conduct audits and inspections of internal processes, vendors, clinical tri

include but are not limited to Partner and provide support with colleagues in Manufacturing, Regulatory, Clinical, Medical and Technical Operations to ensure that products and processes meet company and regulatory requirements. Manage suppliers in a risk based program, including the following Ensure that products and processes meet company and regulatory requirements. Revi

This position currently has no supervisory responsibilities but may offer this opportunity as the company grows. Qualifications MD Board certified in Neurology and fellowship in Epilepsy is required. 3+ years of experience in a medical lead / safety physician role in academia/CRO/pharma/biotech organization; if only academic 3+ years of experience, clinical trial experien

include but are not limited to Focus on driving growth to meet or exceed sales forecast for Harmony products while ensuring compliant selling activities. Develop business plans for your specific territory and execute all sales and marketing business strategies aligned with Harmony corporate objectives. Cultivate and maintain long term business relationships with key accoun

include but are not limited to Provides support with project completion according to overall development plan, and in compliance with all regulations, guidance, and health authority expectations. Oversees clinical trial conduct including feasibility, study start up, enrollment, study conduct and close out. Collaborates with the department, cross functional teams, and exter

Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems Strong computer, organizational, and analytical skills required Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles

include but are not limited to Analytics and reporting Support Patient Services, Trade, and Market Access excellence by providing analytics and reporting to enable Commercial leadership to manage effectively. Present insights to the Commercial leadership team to foster discussion that effectively drives team understanding of key activities and facilitates data driven decis

include but are not limited to Manage & track progress for ongoing Medical Affairs projects, including developing project charters and plans Plan, implement, and maintain new and existing departmental platforms Oversee vendor management and serve as a liaison between vendors and Medical Affairs staff Collaborate with internal stakeholders including Regulatory Affairs, Clin

include but are not limited to Manage all aspects of the preparation of regulatory documents for submission to global regulatory authorities in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives. Manages EU regulatory submissions in colla

include but are not limited to Provide general administrative support (typing, word processing, presentations, and spreadsheets Support department employees and activities with copying, tracking, distributing, and filing documents, and assembling and mailing documents. Assist with set up and maintenance of the department files. Schedule on and off site departmental meeting

include but are not limited to Provides development portfolio & program management to cross functional, cross divisional teams to drive execution and delivery in early to late phase complex development management programs to meet company strategic objectives. Actively manages cross program interdependencies and trade offs to ensure multiple programs are executed to predict

include but are not limited to Focus on driving growth to meet or exceed sales forecast for Harmony products while ensuring compliant selling activities. Develop business plans for your specific territory and execute all sales and marketing business strategies aligned with Harmony corporate objectives. Cultivate and maintain long term business relationships with key accoun

include but are not limited to Focus on driving growth to meet or exceed sales forecast for Harmony products while ensuring compliant selling activities. Develop business plans for your specific territory and execute all sales and marketing business strategies aligned with Harmony corporate objectives. Cultivate and maintain long term business relationships with key accoun

include but are not limited to The FRM will execute a regional strategic plan through partnership with internal and external stakeholders, which may include call center services (HUB), market access, and/or field partners. After the prescription is submitted, provide relevant office education and awareness to HCP Office which may include formulary coverage/utilization mana