Works closely with all areas of Product Development, New Product Commercialization, Business Development, Regulatory Affairs, and Marketing & Sales to continually educate key stakeholders about the safety and efficacy of our existing products and potential future products by performing clinical and scientific due diligence and serving as a spokesperson for both internal and external audiences.
This position is also dedicated to enhancing the understanding and awareness of our products to patients, health care professionals (HCPs), and Key Opinion Leaders (KOLs) through Medical Information.
Supports Director of Medical Affairs in all Medical Strategy for HCP and KOL outreach, patient advocacy, and the communication of scientific data to various audiences in the pre- and post-launch period.
Assignment to the various levels is approved by Corporate Compensation and is based on the required knowledge in the field of work, years of experience, on-going responsibility for highly complex assignments, significance of the scope of responsibility, and the job function's considerable impact within the department and the company, as well as the reporting relationship and required supervisory responsibility.
The Associate Director Regulatory Affairs Advertising and Promotion is responsible for the regulatory review, submission and approval of materials related to labeling and advertising /promotion; ensuring compliance with internal SOPs and FDA requirements and providing regulatory guidance and intelligence to support commercialization strategies.
The Vice President – Product Development will lead Noven’s Product Development function, which is responsible for all aspects of the transdermal drug development process, from product formulation to FDA approval. This includes Noven’s new product ideation team, Pharmaceutics, Analytical Research, Clinical Pharmacology, Clinical Development, Regulatory Affairs and Pharmacovigilance. The Vice President – Product Development is responsible for establishing a culture of innovation married with disciplined processes to develop and advance a pipeline of transdermal products that fulfill unmet patient needs with meaningful patent/exclusivity protections. This officer position will report directly to the CEO and be an important member of Noven’s Executive Team expected to bring scientific/clinical expertise to the analysis of the company’s business opportunities and strategic planning. The Vice President – Product Development will work closely with Noven’s parent company, Hisamitsu, in the drug development process, including bringing Hisamitsu-developed transdermal products to the US market.
To install, calibrate, inspect and repair all levels of instrumentation equipment throughout the facility. Provide process enhancements and continuous improvement as subject matter expert for Calibration.
Provide technical support to the manufacturing, Engineering and other departments / team by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by JDE maintenance system Work Orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.