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 looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director, Commercial Regulatory Affairs. The position reports to the Vice President, Commercial Regulatory Affairs. The location of the position is in Brisbane, CA.
The Associate Director, Commercial Regulatory Affairs 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 men’s health in prostate cancer. The Associate Director will serve as the Regulatory Affairs (RA) representative on assigned labeling and product promotion review teams. The Associate Director has responsibility for reviewing and approving the regulatory content of US materials created for product promotion, disease awareness, field medical materials, sales training, and corporate communications. The Associate Director 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.
He or she will provide the regulatory aspects for the review and approval process for product promotion materials for prostate cancer working collaboratively with senior legal, medical and commercial colleagues. This role involves interacting with commercial, medical and legal on a regular basis. The candidate will have direct influence on the decision-making processes within the medical/legal/regulatory (MLR) review committee within the scope of the advertising and promotion of marketed products and commercial compliance for Myovant.
Essential Duties and Responsibilities
- Reviews 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
- Review and revise regulatory policies to ensure compliance with FDA requirements
- In collaboration with the VP of Commercial Regulatory, serve as the contact for communications with the Office of Prescription Drug Promotion (OPDP) for assigned products
- As needed, provides 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
- In collaboration with their manager, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products within the Myovant pipeline.
- Ensures 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
- In collaboration with their manager, 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
- Ensure 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
Core Competencies, Knowledge, and Skill Requirements
- Solid knowledge of U.S. FDA advertising and promotional regulations
- Direct experience communicating and negotiating with OPDP
- Direct experience leading a recent product launch preferred
- 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, verbal, and written communication and presentation skills
- Knowledgeable on industry compliance requirements and enforcement trends
- Strong interpersonal, communication and leadership skills
- Proven ability to prioritize and to manage multiple competing tasks and demands and meet critical business timelines
- Bachelor of Arts or Science required in life sciences in a relevant discipline.
- Advanced degree MA/MS, PharmD, or PhD preferred.
- At least 5 years in pharmaceutical or biotech industry with at least 3 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
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
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