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SUMMARY
The Content Lead – Pharma Content Operations & MLR oversees the adaptation, submission, tracking, and governance of digital content specifically for direct-to-consumer (DTC) healthcare and pharmaceutical web properties. Bridging DTC content strategy, consumer-focused copyediting, and regulatory operations, this role ensures seamless routing of digital assets through Medical, Legal, and Regulatory (MLR) review platforms (such as Veeva Vault).
The Content Lead acts as a core strategic and operational liaison between Brand Teams, Product Owners, Agency Partners, and Regulatory Reviewers. Grounded in a strong background of DTC health communications, they are responsible for maintaining pristine consumer copy standards, evaluating content through the end-user lens, capturing reviewer feedback in real-time, and driving post-review content updates while maintaining regulatory safety.
COMPETENCIES & CORE BEHAVIORS
- DTC Content Strategy & Consumer Focus: Deep expertise in structuring web copy for direct-to-consumer audiences, translating complex clinical/medical jargon into accessible, engaging, and empathetic health content.
- Editorial & Grammatical Precision: Advanced mastery of English grammar, syntax, punctuation, mechanics, and style guidelines across digital channels.
- Regulatory Acumen & Rigor: Deep understanding of regulated pharmaceutical copy life cycles, medical review workflows, claim structures, and consumer FDA compliance requirements (including Fair Balance and ISI placement).
- Cross-Functional Collaboration: Exceptional ability to interface between agency creative partners, enterprise brand managers, and regulatory compliance teams.
- Consumer Advocacy: Strong point of view (POV) on content clarity, tone, and user-centric readability, actively identifying over-promising, ambiguous, or confusing messaging prior to regulatory submission.
- Agility & Adaptability: Ability to thrive in high-velocity environments, pivot quickly based on reviewer feedback, and manage varied tracking systems across multi-team ecosystems.
- Process Leadership: Proactive mindset focused on identifying operational bottlenecks, establishing governance guidelines, and driving continuous workflow improvements.
DUTIES & RESPONSIBILITIES
- DTC Content Strategy & Copyediting: Perform meticulous copyediting and proofreading on DTC web assets to guarantee intuitive user flows, accessible consumer messaging, flawless grammar, and alignment with consumer brand guidelines.
- Workflow Project Management: Project manage end-to-end content workflows and timelines to eliminate bottlenecks, ensure cross-functional alignment, and keep content continuously moving through regulatory and digital production pipelines.
- Veeva & MLR Workflow Management: Manage full-lifecycle digital copy submissions, tactic routing, and approval workflows in Veeva Vault (or equivalent promo-mats platforms), aligning delivery timelines with DTC Brand Teams.
- Live Review Facilitation: Attend and facilitate live MLR review sessions, tracking feedback, annotations, and required editorial adjustments in real-time.
- Design & Editorial Alignment: Partner closely with visual designers and content creators immediately following review sessions to execute required regulatory and consumer-focused revisions accurately.
- Regulatory Guidelines & Governance: Document and maintain continuous operational guidelines based on reviewer feedback (e.g., restricted consumer terms, claim substantiation, framing rules).
- Content Verification & UAT: Assist with content verification during User Acceptance Testing (UAT) to confirm live DTC web deployments precisely match MLR-approved copy, disclaimers, and ISI elements.
- Process Improvement: Evaluate cross-team handoffs and tool usages to develop streamlined content operations and faster submission turnarounds.
REQUIRED EDUCATION
- Bachelor’s degree in English, Journalism, Communications, Marketing, Healthcare Communications, or a related discipline.
EXPERIENCE
- 10+ years of professional experience in digital content strategy, copyediting, or content operations, with a strong background in Direct-to-Consumer (DTC) digital properties within the pharmaceutical, biotech, or healthcare sectors.
- Demonstrated experience developing and refining web content designed specifically for consumer/patient health literacy and engagement.
- Proven expertise in line-editing, copyediting, proofreading, and technical grammar verification for consumer-facing digital experiences.
- Extensive hands-on experience managing digital content through Veeva Vault Promomats (or similar commercial MLR review software like Zinc or Pepper).
- Proven track record participating in and managing live MLR/PMRC review sessions and translating regulatory feedback into actionable edits.
LANGUAGE SKILLS
Professional verbal and written English communication skills. Advanced mastery of grammar, syntax, punctuation, and consumer style mechanics. Ability to articulate complex editorial and design decisions clearly to non-design executives, engineering leads, and business stakeholders.
QUALIFICATIONS
Required:
- 10+ years of digital content strategy, DTC copywriting/editing, or MLR content operations in pharma/healthcare.
- Proven background framing copy for Direct-to-Consumer (DTC) healthcare websites and digital platforms.
- Exceptional proficiency in English grammar, punctuation, usage, and style consistency across digital web properties.
- Demonstrated expertise using Veeva Vault for regulatory submission and tracking.
- Strong grasp of DTC regulatory considerations regarding pharmaceutical claims, fair balance, and Important Safety Information (ISI) web placement.
- Sharp eye for detailed formatting, structural alignment, and consumer readability.
Preferred:
- Background in formal copyediting or editorial quality assurance frameworks for consumer healthcare.
- Experience working within enterprise Content Management Systems (CMS).
- Familiarity with User Acceptance Testing (UAT) processes for DTC web copy verification.
PHYSICAL DEMANDS
Standard office environment demands: ability to sit or stand at a workstation for extended periods, operate standard computer equipment, and participate in hybrid team meetings.
WORK ENVIRONMENT & HOURS
- Work Environment: Remote
- Expected Hours of Work: Monday through Friday, normal business hours.
- Travel: None.
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