Overview:
Vera Therapeutics is seeking a detail-oriented and experienced Director of Marketing Operations to lead the execution and compliance of marketing initiatives in support of our first commercial product launch. This role will manage the end-to-end Medical/Legal/Regulatory (MLR/PRC) review process, oversee FDA promotional submissions, and support key field events and congresses.
As a critical cross-functional partner, the Director will collaborate with Marketing, Regulatory, Legal, Sales, and vendors to ensure timely delivery and compliance of promotional materials and marketing activities in a highly regulated environment.
Key Responsibilities:
- Lead and manage the MLR/PRC review process using Veeva Vault PromoMats.
- Oversee FDA Form 2253 submissions and APLB tracking in partnership with Regulatory.
- Manage version control and distribution of promotional materials.
- Support congress planning and execution, including booth materials and field collateral.
- Ensure SOP compliance, audit readiness, and system governance in collaboration with Compliance.
- Manage vendor workflows across digital, print, and system platforms.
Qualifications:
- Bachelor’s degree in Marketing, Life Sciences, Business, or related field.
- 10+ years of experience in marketing or commercial operations in pharma/biotech.
- 3–4 years managing MLR/PRC processes and FDA submissions.
- Experience with product launches; Subpart H/Accelerated Approval experience a plus.
- Strong project management skills and deep understanding of FDA promotional regulations.
- Proficiency in systems such as Veeva Vault PromoMats and Veeva CRM preferred.
- Experience in rare disease or specialty therapeutics is a plus.
Job sourced from Vera Therapeutics.