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 to support commercial regulatory affairs activities at Myovant as the company prepares to commercialize their first product for women’s health in uterine fibroids and endometriosis. The position reports to the Senior Director, Commercial Regulatory Affairs and the location of the position is in Brisbane, California.
The Senior Manager will provide strategic advice as well as subject matter expertise to cross-functional teams on matters related to the advertising and promotion of pharmaceutical products for women’s health in uterine fibroids and endometriosis. He/She will serve as the Regulatory Affairs (RA) representative on assigned labeling and product promotion review teams but not limited to review and approve the regulatory content of US materials created for product promotion, disease awareness, field medical materials, sales training, and corporate communications. The Senior Manager will engage business partners for strategic planning on issues pertaining to product promotion and will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Review US promotional materials, disease awareness communications, field medical materials, sales training materials, and corporate communications by attending the Medical/Legal/Regulatory (MLR) review committee and provide regulatory guidance to the cross-functional team responsible for ensuring material compliance with Myovant policies and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
- Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Myovant policies
- Provide training support within Myovant on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
- Provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the Myovant pipeline.
- Ensure stakeholder awareness of proposed and newly approved labeling changes and FDA guidance documents.
- Provide guidance to MLR to ensure appropriate implementation for assigned product, including updating and managing versions of the HCP and Consumer ISI for promotional materials in a timely manner
- Participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; help develop best practices for the commercial regulatory department to establish standards and consistency across company products
- Support timely submission of all applicable approved promotional materials to the FDA on Form 2253s
- Participate in professional associations and training meetings related to advertising and promotion regulatory requirements and relevant medical congresses within assigned therapeutic areas.
- Other duties as assigned
EDUCATION, EXPERIENCE AND QUALIFICATIONS
- BS or BA degree required in life sciences in a relevant discipline. Advance degree MA/MS, PharmD, or PhD preferred
- At least 8 years in pharmaceutical or biotech industry with at least 5 years in regulatory affairs advertising and promotion, which may include relevant PharmD post-doctoral fellowship experience, and recent launch experience preferred
- Proficiency in Veeva, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
CORE COMPETENCIES, KNOWLEDGE AND SKILL REQUIREMENTS
- Solid knowledge of U.S. FDA advertising and promotional regulations
- Experience with FDA standards for advertising and promotion compliance
- Proven track record practicing sound judgment and MLR advice as it relates to risk assessment
- Strong listening, interpersonal communication and presentation skills
- Knowledgeable on industry compliance requirements and enforcement trends
- Proven ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines
- Thrive at dealing with high level of ambiguity and complexity, highly adaptable to different and situations
- Consistently demonstrate a positive, ‘can do’ and service-oriented attitude
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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Equal Employment Opportunity