Senior Medical Operations Manager
ArdelyxAbout the role
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:The Senior Medical Operations Manager will support the continuous improvement of complex processes and activities in the department. This role will work closely with internal and external stakeholders to support on-time and on-budget execution of the Medical Affairs strategic and tactical plans, including scientific communications, medical information, field medical, and educational initiatives. This role is responsible for delivering monthly, quarterly, and ad hoc departmental activity reports. This position will report to the Associate Director of Medical Operations and will work closely with all Medical Affairs functional areas, cross-functional partners, and external stakeholders to drive success in the Medical Affairs strategic and tactical plans. This position is remote or field-based.Responsibilities:
- Provide strategic operational leadership for key Medical Affairs initiatives
- Implement continual process improvements for Medical Affairs functions and areas of responsibility
- Establish trusted peer-to-peer relationships with internal partners
- Effectively manage multiple vendor and agency relationships, ensuring that Ardelyx interests are well represented and addressed
- Organize departmental meetings including setting agendas and managing project updates
- Develop and maintain monthly departmental reports for all functional areas
- Manage MRC process using Veeva MedComms
- Support Medical Education Grant and Investigator Sponsored Trial (IST) process
- Support partnerships with external agencies and partners
- Manage departmental training activities, including maintenance of learning management system
- Oversee contracting and processing of SOWs and consultant agreements
- Support monthly and annual budget tracking
- Represent Medical Affairs on cross-functional teams
- Bachelor’s degree with 8+ years of experience in Medical Affairs or related fields within the pharmaceutical or biotechnology industry or equivalent experience
- Experience using Veeva MedComms or PromoMats
- Experience with other workflow management software (i.e Smartsheet, ZS, Visio, Cybergrants)
- Strong attention to detail and ability to work independently
- Experience supporting teams and projects within a dynamic environment
- Ability to make appropriate decisions to operationalize and move key projects forward
- Ability to effectively manage multiple priorities and projects
- Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
- Excellent written and verbal communication skills
- Ability to travel up to 20%
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