• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA • Write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, internal/external facing labeling documents (eg, CCDS/CCSI, annotated draft labels, IFU, patient leaflets, etc), and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc) • Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards • Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences • Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content • Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations • Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents • Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents • Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas.

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including but not limited to FDA and EMA • Write and edit a wide range of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and components of regulatory submission dossiers (eg, NDA, IND, MAA) such as Module 2 and 5 summary documents (eg, SCS, SCE, ISS, etc) • Ensure that all written materials strictly adhere to regulatory guidelines, industry standards, and internal quality standards • Analyze complex scientific and medical information, including clinical trial data, translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences • Work closely with cross-functional teams (eg, clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc) to ensure comprehensive and accurate document content • Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress • Provide teams with guidance about best practices and industry standards, offer solutions to authoring hurdles, support interaction and understanding across functional areas

• Write and edit a wide range of regulatory documents • Perform independent QC reviews of documents produced by the regulatory writing function • Verify the accuracy and internal/external consistency of documents • Define and confirm the scope of QC activities with document authors • Review documents for adherence to applicable style guides • Proofread and copyedit text to ensure clarity and accuracy • Support preparation and inspection‑readiness of technical documents • Communicate QC findings clearly and constructively to stakeholders • Facilitate the efficient project management of individual document workflows • Contribute to the continuous improvement of QC tools, checklists, and processes

Role Description This is a remote position. Calling All Local Experts: Get Paid to Share Your Family Adventures! - Do you know exactly which park has the cleanest bathrooms? - Is your camera roll 90% "hidden gems" and 10% blurry photos of your kids eating ice cream? Mommy Poppins—the ultimate resource for family fun—is looking for savvy, creative parents to join our team of Local Writers. We want the "in the know" parents who love discovering the best things to do in their city and want to get paid to spread the word. The Gig in a Nutshell: - This isn't your typical 9-to-5. It’s a flexible, creative outlet designed to fit between school drop-offs and soccer practice. - Write & Review: Craft engaging articles about the best playgrounds, kid-friendly cafes, and weekend events in your area. - Take Great Pics: Snap high-quality photos. Bonus if you can also film quick, fun Reels/TikToks while you’re out exploring with your family! - Be the Expert: Share your authentic "mom-hacks" for navigating local attractions. Why You’ll Love It: - Total Flexibility: Work from your couch (or the carpool lane). - VIP Access: Get invited to press previews, museum openings, and cool local events. - Build Your Brand: See your name and creative content featured on a platform that reaches millions of parents. - Cash for Fun: Turn your family outings into a paycheck. Qualifications - You live for a good weekend itinerary. - You have a sharp eye for photography and catching fun moments that make people feel like they are there with you. - You’re a clear, witty writer who can tell a story without the fluff. - You’re already the "go-to" person in the group chat for local recommendations. Requirements - Live in the Hudson Valley or surrounding areas. - Be in the know: Mommy Poppins' writers are expected to cover kid-centric topics such as playground openings, children's theater, and the best places for animal encounters, etc. - This is a work-from-home, freelance 1099 contractor opportunity. - Compensation is a flat fee of $50 per post & $50 per reel (negotiable after 6 months). Benefits - Flexible work schedule. - Opportunity to attend local events. - Exposure on a widely recognized platform. - Monetization of family outings.