Crinetics Pharmaceuticals, Inc
Senior Director, Regulatory Affairs Advertising and Promotion
Crinetics Pharmaceuticals, Inc, California, Missouri, United States, 65018
Senior Director, Regulatory Affairs Advertising and Promotion Categories: RegulatoryCrinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.Position Summary:
Ensure you read the information regarding this opportunity thoroughly before making an application.The Senior Director, Regulatory Affairs Advertising and Promotion reports to the Vice President, Regulatory Affairs and is responsible for reviewing and approving advertising and promotional communications to ensure compliance with regulations, policies and procedures. The position will serve as the lead of the Medical, Legal, Regulatory (MLR) committee and will serve as the primary liaison to the FDA Office of Product and Drug Promotion (OPDP). The position will lead the development of processes and policies to support Crinetics’ commercialization and future marketed products. The position will support Crinetics’ drug development programs as needed.Essential Job Functions and Responsibilities:These may include but are not limited to:Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.Serve as the Regulatory Reviewer and/or chair on Medical, Legal, Regulatory (MLR) committee or other promotional review committees.Serve as primary contact with the FDA Office of Prescription Drug Promotion (OPDP).Working with Regulatory Operations, responsible for 2253 submissions.Monitor competitor space advertising and promotion materials.Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.Implement and oversee MLR documentation system (such as Veeva).Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.Participate in development of program timelines.Monitor, communicate and manage budgets for their functional area.Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and promotion group.Focus on immediate and short-term (
Ensure you read the information regarding this opportunity thoroughly before making an application.The Senior Director, Regulatory Affairs Advertising and Promotion reports to the Vice President, Regulatory Affairs and is responsible for reviewing and approving advertising and promotional communications to ensure compliance with regulations, policies and procedures. The position will serve as the lead of the Medical, Legal, Regulatory (MLR) committee and will serve as the primary liaison to the FDA Office of Product and Drug Promotion (OPDP). The position will lead the development of processes and policies to support Crinetics’ commercialization and future marketed products. The position will support Crinetics’ drug development programs as needed.Essential Job Functions and Responsibilities:These may include but are not limited to:Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.Serve as the Regulatory Reviewer and/or chair on Medical, Legal, Regulatory (MLR) committee or other promotional review committees.Serve as primary contact with the FDA Office of Prescription Drug Promotion (OPDP).Working with Regulatory Operations, responsible for 2253 submissions.Monitor competitor space advertising and promotion materials.Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.Implement and oversee MLR documentation system (such as Veeva).Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.Participate in development of program timelines.Monitor, communicate and manage budgets for their functional area.Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and promotion group.Focus on immediate and short-term (