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Cristcot · 2 weeks ago

Senior Manager, Marketing Communications

United States

Full-time

Remote

Senior Level

7+ years exp

Cristcot is 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 develop and execute integrated marketing communications campaigns, manage the Promotional Review Committee process, and ensure compliance with FDA promotional regulations.

Health CareMedicalMedical DevicePharmaceutical

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

Qualification

Pharmaceutical communicationsFDA promotional complianceProject managementDigital marketingMultichannel communicationCross-functional collaborationUlcerative ColitisVeeva PromoMats familiarityReal-world evidence knowledgeCreative thinkingInterpersonal skills

Required

Bachelor's degree in Marketing, Communications, Life Sciences, or related field required

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