Regulatory Writing Expert
$102.41k - $117.78kSonara Inc.
General Information Job Code:SHR-RA-04T Location:Rockville, MD Employee Type: Exempt, Full-Time Regular Telework:Full-time Clearance: None Salary Range: $102,414 - $117,775 Position Overview Are you passionate about building frameworks that uphold ethics and excellence—and turning complex policy into precise, impactful regulatory action? Ripple Effect is seeking a Regulatory Writing Expert that will support development, revision, and finalization of CMS federal rule provisions and related materials (e.g., requests for information (RFIs), notices of proposed rulemaking (NPRMs)) according to the client's regulatory priorities. This work will be completed in close collaboration with subject matter experts in the relevant agency offices and divisions and in compliance with the development stages, timelines, and content focus the client establishes. The Regulatory Writing Expert will also work closely with Ripple Effect team members to prepare materials and train healthcare analysts supporting public comment analysis related to the aforementioned regulatory provisions. Responsibilities Regulatory Writing & Technical Execution: Lead development, drafting, and review of RFIs, NPRMs, and final rules, including provisions, preamble text, and supporting analyses; collaborate with federal clients to create new regulations and update existing ones; ensure all documentation aligns with agency expectations, statutory authority, and regulatory best practices; and review deliverables to ensure quality, accuracy, and compliance. Regulatory Strategy & Communication: Lead client-facing discussions on regulatory approach, strategy, risks, and compliance considerations; prepare formal communications, including rulemaking documents and stakeholder materials; translate complex regulatory content into clear, accessible language for diverse audiences. Regulatory Process & Public Comment Response: Support the full lifecycle of federal rulemaking—including RFIs, NPRMs, and final rules; develop responses to public comments for disposition documents; ensure that stakeholder feedback is effectively represented in final rules. Regulatory Impact Analysis: Contribute to development of regulatory impact analyses (RIA) by synthesizing complex quantitative and qualitative data into actionable insights; support policy and operational decision-making through structured analytical approaches. Compliance & Risk Management: Ensure work processes and products are aligned with relevant federal regulations, CMS guidance, and contractual requirements; identify risks and recommend mitigation strategies; ensure deliverables are of the highest quality and meet compliance, audit, and documentation standards. Requirements Minimum Education & Experience Master’s degree in public health, public policy, medicine, nursing, health policy, government, or related field 8+ years of federal regulatory experience, including drafting HHS rules Additional years of experience may substitute for advanced education Basic Requirements Minimum of 3 years drafting or finalizing HHS regulatory language Demonstrated experience supporting federal rulemaking processes (e.g., RFIs, NPRMs, final rules) Strong understanding of the regulatory development lifecycle for federal agencies Experience contributing to regulatory impact analyses (RIAs) Exceptional written and verbal communication skills, including ability to simplify complex regulatory language Basicknowledgeof Microsoft Office productivity software and collaboration tools such as Microsoft Teams and SharePoint Strong attention to detail Ability to work independently and follow instructions precisely Skills That Set You Apart Experience writing CMS rules such as: Physician Fee Schedule (PFS) Inpatient Prospective Payment System (IPPS) Quality Payment Program (QPP) / MIPS Other ACA-related regulatory provisions Expertise developing and writing RIAs Benefits Ripple Effect rewards our employees for their contributions to our mission in many ways, from competitive pay and exceptional benefits to a range of work/life programs based on your employment classification and personalized preferences. Ripple Effect is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, political affiliation, or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. If you have a disability or special need that requires accommodation during the hiring process, please let us know by contacting our HR department at View email address on click.appcast.io or your recruiter. Eligibility for employment will be verified using E-verify. #J-18808-Ljbffr Sonara Inc.
- Ripple Effect is seeking a Regulatory Writing Expert located in Rockville, MD. The role involves leading the development and revision of CMS federal regulations, collaborating closely with federal clients and subject matter experts. Qualified candidates will have at least...RegulatoryRemote jobFull time
$70.8k - $106.2k
MilliporeSigma is seeking a Quality Assurance Specialist 3 in Rockville, Maryland. You will conduct audits and approve regulatory documentation while training team members on quality practices. A Bachelor's degree in a scientific field and 4+ years of GxP experience are...Regulatory- A regulatory organization is seeking an Expert Advisor for the Botanical Dietary Supplements Herbal Medicines Expert Committee. This role involves serving in a flexible capacity, contributing expertise in discussions, reviewing documents, and participating in various projects...RegulatoryFull timeFlexible hours
- ...policies, and procedures for oversight, inspection, and related regulatory activities. Ability to identify, develop, and/or implement... ...topics involved. Describe your most difficult or challenging writing assignments. Describe your contributions to reports, papers, or...RegulatoryFull timePart timeWork experience placementWork at officeRemote workFlexible hours
- ...field services by providing commercial and technical product regulatory expertise related to low and medium voltage power distribution... ...UL, IEEE, ETL, NEC, IBC) ~ Skilled in documentation, report writing, testing processes, and compliance assessments ~ Ability to...RegulatoryWork at office
- Brief Description Of Position The Regulatory Affairs Headquarters Principal Scientist is responsible... ...for multiple indications. Provide expert regulatory advice to Product Development... ...strategy development, regulatory writing/medical writing, leadership, cross-functional...RegulatoryWorldwide
- ...and treatment delivery models, ensuring care meets clinical and regulatory standards. • Follow infection control and environmental... ...within the facility. • Demonstrate proficiency in reading, writing, speaking, and understanding English for effective communication...RegulatoryFull timeContract workReliefFlexible hours
- ...conditions precedent to ensure strict adherence to state and federal regulatory requirements. Advocacy & Representation: Represent the... ...basis. Technical & Interpersonal Skills Exceptional analytical, writing, and oral advocacy skills. Strong negotiation capabilities...RegulatoryWork at officeRemote work
$210.4k - $331.1k
Job Description Regulatory Affairs Headquarters Principal Scientist is responsible for the... ...multiple indications simultaneously. Provide expert regulatory advice to Product Development... ...Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs,...RegulatoryFor contractorsWorldwide$86.6k - $135.28k
...documents, engage in public involvement programs, and prepare regulatory permits for transportation projects. You’ll have the opportunity... ...The successful candidate will demonstrate solid technical writing skills, have a deep understanding of environmental compliance...RegulatoryFull timeLive inWork at officeLocal areaRemote work- ...candidate to join our talented Team. Job Title: Risk Management Expert Location: McLean, VA Job Summary We are seeking a highly... ...Experience with risk management standards. Familiarity with regulatory requirements and compliance. Ampcus is an Equal Opportunity Employer...Regulatory
- ...into policy and legislation, producing high-quality analytical writing, and contributing to mission-driven programs where your work... ...be used in determining compensation. Maximus will comply with regulatory minimum wage rates and exempt salary thresholds in all instances...RegulatoryMinimum wageFull timeContract workTemporary workWork experience placement
$89.5k - $127k
...Travel 10% Manage Others Yes Managing Editor, RAPS Journal of Regulatory Affairs Location :Rockville, MD (Hybrid or Remote) Key Skills... ...communication Experience :6+ years of experience in editing, writing, journal publishing, and managing end-to-end editorial...RegulatoryTemporary workRemote workWorldwideFlexible hours$174.1k - $272.05k
...D, engineering, manufacturing, quality, regulatory, supply chain, and commercial operations... ...enterprise platforms in life sciences. Expert knowledge of PLM, ERP, and MES business... ...and articulate ideas both verbally and in writing, including the ability to influence at...RegulatoryFull timeTemporary workWork experience placementWork at officeFlexible hours$260k - $270k
Budget Project Management Subject Matter Expert MELE Associates, Inc. is seeking to add an experienced Subject Matter Expert Budget Project... .... Superior communication, organizational, interpersonal, and writing skills. This position is contingent upon contract award....Full timeContract workFor contractors- Sonara Inc. is looking for a Regulatory Writing Expert in Rockville, MD to support federal rule development and revision. This role requires strong regulatory experience and excellent communication skills. As a key player, you will draft proposals and responses for federal...RegulatoryRemote jobFull time
$146.3k - $234.1k
...strategic and technical cross‑functional discussions with CMC team members and external partners. Evaluate and review technical and regulatory submission documents for approval and market launch of development products. Serve as Analytical SME for regulatory filings;...Regulatory$35 - $40 per hour
...contractor works closely with Client Physicians, Regulatory Officers and Pharmacists. Statement... ...by providing editorial support and expert opinion. Deliverables: Monthly... ...Familiarity with IRB requirements. Excellent writing skills. About our Company: - 22nd...RegulatoryHourly payFull timeContract workFor contractorsImmediate startShift work$116.6k - $177.8k
...milestones and initiatives. Work with Quality, Regulatory Affairs, and auditors to provide needed... .... Communication and technical writing skills. Must work effectively with a team... ...Amazon Web Services (AWS). (Preferred) Expert level understanding of the following IT...RegulatoryFull timeTemporary workWork at officeFlexible hours- ...Lending Advisor in Gaithersburg, MD. This role involves serving as the chief contact for customers, adhering to regulatory requirements, and providing expert financial advice throughout the loan process. The ideal candidate should have at least 3 years of mortgage lending...RegulatoryLocal area
- ...hours/week) focuses on creating editorial content that influences public and regulatory policy reforms concerning healthcare and pharmaceuticals. The ideal candidate will have over 7 years of writing experience, particularly in life sciences, and will work onsite 2 days a...RegulatoryPart time2 days per week
- ...Product Manager for a contract assignment with one of our premier regulatory clients in Rockville, MD. The Lead Product Manager is... ...quality of work products. ~ Proficient at technical business writing, including functional requirement specifications, workflows, use...RegulatoryContract work
- ...focusing on creating editorial content to support public and regulatory policy reforms, influencing access to high-quality medicines,... ...engaging stakeholders. The ideal candidate has over 7 years of writing experience in public affairs or corporate communications within...RegulatoryPart timeRemote workFlexible hours
- ...highly experienced Senior Consulting Analyst – Subject Matter Expert (SME) in FHA Home Equity Conversion Mortgage (HECM) loan servicing... ...plays a critical role in ensuring the program aligns with regulatory standards, industry best practices, and mission objectives tied...RegulatoryTemporary workFor contractorsFlexible hours
- Strategic Operations Advisor, Expert Orbis is seeking an experienced Strategic Operations Advisor, Expert to lead program planning and... ...Perform all‑source intelligence research, analysis, and report writing/editing. Travel as required (TDY). Supervisory...For contractorsFor subcontractorWork at officeLocal areaRemote workOverseas
- ...Company Overview Quality Agents, LLC provides expert validation and quality assurance... ...Good Manufacturing Practices (cGMP) and regulatory standards. Position Summary We are seeking... ...loggers. Hands‑on training in technical writing and documentation practices in a regulated...RegulatoryFull timePart timeInternship
- ...all Agency clinical and administrative policies, procedures and regulatory requirements. Is responsible for Agency evaluating and... ...insured automobile or access to adequate transportation. Read, write, speak and understand English as needed for the job. Current CPR...RegulatoryWork at office
$170k - $225k
...contractors on procurement lifecycle stages including bid protests, regulatory compliance, contract claims, teaming arrangements, joint... ...involving government contractors is a plus. Excellent legal writing, analytical, and communication skills. Strong organizational...RegulatoryContract workFor contractorsLocal area- ...models and treatment guidelines to ensure care meets clinical and regulatory standards • Deliver care that aligns with treatment goals... ...within the facility • Demonstrate proficiency in reading, writing, speaking, and understanding English for effective communication...RegulatoryFull timeContract workReliefFlexible hours
- ..., and patient-centered manner. Compliance with all applicable regulatory standards is required. Core Responsibilities and Essential... ...and effectively with team members, both verbally and in writing. Attend and actively participate in staff meetings, in-services...RegulatoryRelief
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