Responsibilities

• Compliance & Regulatory Oversight
• • Ensure all content adheres to local legislation, Fair Balance standards, FDA regulations, and internal policies
• • Validate claims and data with current, authentic references; manage citations and versioning
• • Align copy with brand standards and medical/legal/regulatory (MLR/PRC) requirements
• MLR/PRC & FDA Submission Support
• • Review and support content through internal MLR workflows and submission processes
• • Implement edits and annotations required by reviewers while maintaining clarity and accuracy
• • Follow linking & anchoring procedures through Veeva PromoMats during document submissions
• Content Development & Editing (Omnichannel)
• • Conceptualize, write, and update copy for digital assets (emails, banners, websites, social media, sales materials, slide decks) and print assets (posters, patient guides, conference materials, etc). Focus will primarily be on emails

Requirements

• BA and/or BS—or relevant health science discipline
• 10+ years in a medical communications, marketing, or advertising agency or similar setting; client side experience a bonus
• Hands-on experience with MLR/PRC workflows and regulatory writing and editing
• Proven portfolio across print and digital assets
• The candidate should have biopharma copywriter experience and ability to build commercial assets
• Exposure to GenAI tools/prompt engineering
• Understanding of US medical and pharma landscape
• Veeva PromoMats experience (MLR/PRC), including reference linking & anchoring
• Strong conceptual abilities and a passion for creative writing
• Editorial precision; exceptional attention to detail and fact-checking

Preferred

• Jira or similar work management tools
• Microsoft 365 (Word, Outlook, Teams, OneDrive, etc)
• Generative AI platforms (e.g., Jasper AI) for content ideation and drafting.
• Understanding of accessibility (e.g., WCAG), data privacy (e.g., HIPAA where applicable), and social media platform policies (organic vs paid)
• Figma design program
• Adobe Acrobat/Acrobat Reader