Senior Manager, Marketing Communications

Cristcot

About The Position

We are seeking a strategic and detail-oriented Senior Manager of Marketing Communications to lead all communications efforts for the launch of a new pharmaceutical drug and device targeting Ulcerative Colitis (UC). This role will be responsible for developing and executing integrated marketing communications campaigns, managing the Promotional Review Committee (PRC) process, and ensuring compliance with FDA promotional regulations. The ideal candidate will have deep experience in pharmaceutical communications, regulatory review, and cross-functional collaboration. Primary Relationships: Within Cristcot, the Senior Manager of Marketing Communications will collaborate closely with Commercial teams (Sales, Marketing, Market Access), Medical Affairs, and Corporate Communications to ensure alignment of messaging and execution for launch. Outside Cristcot, the Senior Manager of Marketing Communications will manage relationships with agencies and vendors to deliver high-quality communication materials and campaigns. The activities of the Senior Manager, Marketing Communications will include, but are not limited to: Marketing Communications and Operations Develop and implement comprehensive marketing communications plans to support the UC product launch. Collaborate with brand, medical affairs, and commercial teams to ensure alignment of messaging, materials, and implementation. Drive metrics reporting and analytics among partners and internal stakeholders to ensure timely and actionable performance reporting and optimization planning Provide budget oversight by maintaining and managing master Marketing budget including monthly financial tracking across budgeting, invoicing, and vendor payments Content Execution & Management Oversee execution of branded and unbranded content for HCP and patient audiences. Manage review and approval processes to ensure compliance with regulatory and legal standards. Maintain content repositories and ensure timely updates across platforms. Monitor performance metrics and optimize campaigns for engagement and ROI. Project Management for Marketing Launch Activities Lead overall project management for marketing launch initiatives, ensuring timelines, deliverables, and dependencies are met. Serve as the central point of contact within the marketing team for coordinating plans and tracking progress across stakeholders. Drive status reporting and issue resolution to keep leadership informed and launch activities on track. Promotional Review Committee (PRC) Management Serve as the primary liaison and coordinator for PRC operations, ensuring timely and compliant review of all promotional materials. Prepare, organize, and track all promotional materials for timely submission and approval through the PRC workflow. Define and document PRC processes, including submission workflows, timelines, and escalation protocols. Coordinate with Medical, Legal, and Regulatory (MLR) reviewers to ensure materials meet FDA standards for fair balance, accuracy, and substantiation. Maintain tracking systems for FDA submissions, version histories, approvals, and compliance documentation, including OPDP correspondence and advisory comments. Regulatory Compliance & FDA Engagement Ensure all promotional materials adhere to FDA regulations, including labeling, advertising, and post-approval communications. Monitor FDA guidance and enforcement trends to proactively adjust communication strategies. Lead internal training on promotional compliance and PRC best practices. Conduct periodic reviews of live materials to confirm ongoing adherence to regulatory and company guidelines. Cross-Functional Collaboration Partner with internal stakeholders including Regulatory Affairs, Medical Affairs, Legal, Sales, and external agencies. Support field force enablement through development of training materials and interactive detail aids. Manage agency relationships and oversee creative development and production.

Requirements

Bachelor’s degree in Marketing, Communications, Life Sciences, or related field required; Master’s degree preferred.
Minimum 7 years of experience in the pharma or biotech industry, including at least 3 years focused on marketing, communications or customer engagement.
Proven experience managing PRC/MLR processes and FDA promotional compliance.
Strong ability to craft compelling, clear, and compliant messaging for diverse audiences.
Excellent project management skills with experience managing multiple priorities in a fast-paced, regulated environment.
Proficiency in digital marketing and multichannel communication strategies.
Exceptional collaboration and interpersonal skills; ability to influence across teams.
Creative thinker with a passion for innovation and continuous improvement.
Willingness to travel up to 20% for conferences and team meetings.

Nice To Haves

Master’s degree preferred.
Strong understanding of Ulcerative Colitis or immunology therapeutic areas preferred.
Familiarity with Veeva PromoMats or similar promotional review platforms preferred.
Experience launching both drug and device products preferred.
Knowledge of real-world evidence (RWE) and patient-centric storytelling preferred.
Priority consideration will be given to applicants that reside within the Central and Eastern time zones.

Responsibilities

Develop and implement comprehensive marketing communications plans to support the UC product launch.
Collaborate with brand, medical affairs, and commercial teams to ensure alignment of messaging, materials, and implementation.
Drive metrics reporting and analytics among partners and internal stakeholders to ensure timely and actionable performance reporting and optimization planning
Provide budget oversight by maintaining and managing master Marketing budget including monthly financial tracking across budgeting, invoicing, and vendor payments
Oversee execution of branded and unbranded content for HCP and patient audiences.
Manage review and approval processes to ensure compliance with regulatory and legal standards.
Maintain content repositories and ensure timely updates across platforms.
Monitor performance metrics and optimize campaigns for engagement and ROI.
Lead overall project management for marketing launch initiatives, ensuring timelines, deliverables, and dependencies are met.
Serve as the central point of contact within the marketing team for coordinating plans and tracking progress across stakeholders.
Drive status reporting and issue resolution to keep leadership informed and launch activities on track.
Serve as the primary liaison and coordinator for PRC operations, ensuring timely and compliant review of all promotional materials.
Prepare, organize, and track all promotional materials for timely submission and approval through the PRC workflow.
Define and document PRC processes, including submission workflows, timelines, and escalation protocols.
Coordinate with Medical, Legal, and Regulatory (MLR) reviewers to ensure materials meet FDA standards for fair balance, accuracy, and substantiation.
Maintain tracking systems for FDA submissions, version histories, approvals, and compliance documentation, including OPDP correspondence and advisory comments.
Ensure all promotional materials adhere to FDA regulations, including labeling, advertising, and post-approval communications.
Monitor FDA guidance and enforcement trends to proactively adjust communication strategies.
Lead internal training on promotional compliance and PRC best practices.
Conduct periodic reviews of live materials to confirm ongoing adherence to regulatory and company guidelines.
Partner with internal stakeholders including Regulatory Affairs, Medical Affairs, Legal, Sales, and external agencies.
Support field force enablement through development of training materials and interactive detail aids.
Manage agency relationships and oversee creative development and production.