Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions.  We are on a mission to develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy.  We are currently seeking a dynamic, highly motivated, experienced individual for the position of Senior Manager, Commercial Regulatory Affairs Operations to support commercial regulatory affairs activities at Myovant as the company grows their prostate cancer business. The position reports to the Associate Director, Commercial Regulatory Affairs Operations and the location of the position is in Brisbane, California. 

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Expertise in eCTD submission management, planning, publishing strategy and repository related to the submission of advertising and promotion materials of pharmaceutical products
  • Ensure documents are of high quality and meet US and global technical/electronic document requirements
  • Manage all materials being reviewed in the electronic document management and routing system, Veeva PromoMats, as it relates to submission requirements to FDA via form FDA 2253
  • Assist with submissions to the FDA Office of Prescription Drug Promotion (OPDP)
  • Schedules and track project specific advertising and promotional activities to the US health authority for the regulatory department
  • Work with the relevant brand and/or functional team and outside vendor/agency to ensure all reviewer comments on materials are clarified, reconciled, and/or incorporated into the material prior to routing for final approval of the material
  • Support commercial operations in the Medical/Legal/Regulatory (MLR) review committee process
  • Help with the Scientific Medical Review Committee (SMRC) process by managing the routing, review and approval of materials in Veeva MedComms
  • Other duties as assigned

EDUCATION, EXPERIENCE AND QUALIFICATIONS

Required:

  • BS or BA degree required in life sciences in a relevant discipline.
  • Minimum 8+ years in pharmaceutical or biotech industry with at least 4 years in commercial regulatory affairs specific operations management role
  • Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Experience in VeevaVault preferred.

CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS

  • Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
  • Exercise good judgment and make decision that is appropriate for the organization
  • Results-driven, take initiative and ownership to accomplish work
  • Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
  • Strive for continuous improvement and embrace innovative ideas in daily work
  • Experience in working with detailed operational procedures and validated environments.
  • Working knowledge with eCTD submission requirements and module 1 submissions
  • Working knowledge of U.S. FDA advertising and promotional regulations
  • Working knowledge of FDA standards for advertising and promotion compliance
  • Ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines

DISCLAIMER

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

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