Vera Therapeutics, Inc.
Director, Marketing Operations
Vera Therapeutics, Inc., Brisbane, California, United States, 94005
Overview
Vera Therapeutics (Nasdaq: VERA) is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Veras lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once-weekly injection that blocks BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating atacicept in other immunologic disorders and is developing VT-109 and MAU868 in preclinical development. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture and guide everything we dofrom hiring great people to advancing our mission and improving medical treatment for patients with immunological diseases. Position Summary
The Director, Marketing Operations reports to the Vice President, Commercial Operations and plays a critical role in ensuring the compliant and efficient execution of marketing initiatives within the pharmaceutical industry. This role is responsible for overseeing the end-to-end MLR/PRC review process and providing operational support for congresses and other key field-facing events. Responsibilities
Own and manage the MLR (Medical/Legal/Regulatory) review process, including meeting calendars, routing materials through Veeva Vault PromoMats, and documenting approvals to support the launch of the companys first commercial product Act as a point of contact between Marketing, Regulatory, Legal, Sales, and vendors for project timelines, task management, and review coordination Lead the APLB (Advertising and Promotional Labeling Branch of CBER) submissions in partnership with Regulatory Affairs, including preparation and submission of Form FDA-2253, maintenance of submission logs, and follow-up tracking Setup and manage the distribution and version control of marketing collateral to ensure Sales and other customer-facing teams access only current, approved materials Manage vendor project workflows including digital deployment partners, print fulfillment, and system integrators Collaborate with marketing and event leads to plan and execute congress-related deliverables (e.g., booth materials, signage, digital assets, leave-behinds) Partner with Compliance to reinforce SOPs for promotional material usage and system governance Participate in training sessions and monitor system workflows to ensure audit-readiness and adherence to regulatory expectations
Qualifications
Bachelors degree in marketing, Life Sciences, Business, or related field Minimum 10+ years of marketing operations or commercial operations experience in the pharmaceutical, biotech, or healthcare industry, including 34 years managing the Medical/Legal/Regulatory process and submission of materials to the FDA Experience working on product launches; experience with a Subpart H/Accelerated Approval product is a plus Familiarity with CRM systems, marketing automation tools, and content approval platforms Understanding of FDA promotional regulations and OPDP requirements for submission of promotional materials; organized and process-driven with strong project management skills Collaborative team player with excellent communication and documentation skills Detail-oriented, quality-conscious, and comfortable working in a regulated environment
Preferred
Hands-on experience with Veeva Vault PromoMats, Veeva CRM, or equivalent systems Experience supporting PRC/MLR reviews and/or submitting FDA-2253 forms Knowledge of specialty therapeutics or rare disease markets Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices. For this role, the anticipated base pay range is $223k - $240k. The exact base pay offered will depend on factors including geography, qualifications, skills, and experience. Details
Seniority level: Director Employment type: Full-time Job function: Management and Manufacturing
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Vera Therapeutics (Nasdaq: VERA) is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Veras lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once-weekly injection that blocks BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating atacicept in other immunologic disorders and is developing VT-109 and MAU868 in preclinical development. For more information, please visit: www.veratx.com. Our values are the cornerstone of our culture and guide everything we dofrom hiring great people to advancing our mission and improving medical treatment for patients with immunological diseases. Position Summary
The Director, Marketing Operations reports to the Vice President, Commercial Operations and plays a critical role in ensuring the compliant and efficient execution of marketing initiatives within the pharmaceutical industry. This role is responsible for overseeing the end-to-end MLR/PRC review process and providing operational support for congresses and other key field-facing events. Responsibilities
Own and manage the MLR (Medical/Legal/Regulatory) review process, including meeting calendars, routing materials through Veeva Vault PromoMats, and documenting approvals to support the launch of the companys first commercial product Act as a point of contact between Marketing, Regulatory, Legal, Sales, and vendors for project timelines, task management, and review coordination Lead the APLB (Advertising and Promotional Labeling Branch of CBER) submissions in partnership with Regulatory Affairs, including preparation and submission of Form FDA-2253, maintenance of submission logs, and follow-up tracking Setup and manage the distribution and version control of marketing collateral to ensure Sales and other customer-facing teams access only current, approved materials Manage vendor project workflows including digital deployment partners, print fulfillment, and system integrators Collaborate with marketing and event leads to plan and execute congress-related deliverables (e.g., booth materials, signage, digital assets, leave-behinds) Partner with Compliance to reinforce SOPs for promotional material usage and system governance Participate in training sessions and monitor system workflows to ensure audit-readiness and adherence to regulatory expectations
Qualifications
Bachelors degree in marketing, Life Sciences, Business, or related field Minimum 10+ years of marketing operations or commercial operations experience in the pharmaceutical, biotech, or healthcare industry, including 34 years managing the Medical/Legal/Regulatory process and submission of materials to the FDA Experience working on product launches; experience with a Subpart H/Accelerated Approval product is a plus Familiarity with CRM systems, marketing automation tools, and content approval platforms Understanding of FDA promotional regulations and OPDP requirements for submission of promotional materials; organized and process-driven with strong project management skills Collaborative team player with excellent communication and documentation skills Detail-oriented, quality-conscious, and comfortable working in a regulated environment
Preferred
Hands-on experience with Veeva Vault PromoMats, Veeva CRM, or equivalent systems Experience supporting PRC/MLR reviews and/or submitting FDA-2253 forms Knowledge of specialty therapeutics or rare disease markets Vera Therapeutics Inc. is an equal-opportunity employer. Vera Therapeutics is committed to fair and equitable compensation practices. For this role, the anticipated base pay range is $223k - $240k. The exact base pay offered will depend on factors including geography, qualifications, skills, and experience. Details
Seniority level: Director Employment type: Full-time Job function: Management and Manufacturing
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