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Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. We are looking for a consultant with demonstrated expertise authoring and compiling FDA New Drug Application (NDA) submissions, specifically NDA Module 2 and Module 5 content in CTD/eCTD format. The ideal candidate will bring strong experience in clinical regulatory writing, integrated summaries, clinical study report development, and NDA submission strategy across small molecule and/or biologic drug products. This is a high-impact consulting engagement offering flexibility, and meaningful work at the forefront of regulatory drug development. Role and Responsibilities In this high-impact consulting role, the Regulatory Medical Writer will provide expert-level authoring and regulatory documentation support across a range of FDA NDA submission programs. Working remotely within a collaborative consulting team, the successful candidate will: • Author, edit, and compile NDA Module 2 clinical summaries and overviews, including Clinical Overview (Section 2.5), Clinical Summary (Section 2.7), Benefit-risk assessments and Integrated summaries of safety and efficacy., • Prepare and/or manage NDA Module 5 clinical documentation, including Clinical study reports (CSRs), Protocols and protocol amendments, Statistical analysis plans (SAPs), Case report tabulations, and listings coordination., • Ensure all documents comply with FDA guidance requirements, ICH CTD/eCTD standards, Good Clinical Practice (GCP), and internal quality and style standards., • Participate in submission planning, document gap assessments, and submission readiness reviews., • Support the preparation of responses to FDA information requests and review comments., • Coordinate timelines and deliverables to support NDA submission milestones., • Collaborate cross-functionally with clinical development teams, biostatistics, data management, pharmacovigilance, regulatory affairs, and medical affairs., • Function as a trusted regulatory writing subject matter expert within client project teams and CMO relationships., • Proactively flag gaps or risks relative to FDA expectations or industry best practices. Qualifications and Education Requirements • Advanced degree preferred (PharmD, PhD, MD, MS, or equivalent scientific discipline), Minimum 8–10 years of pharmaceutical or biotechnology regulatory writing experience., • Direct, hands-on experience authoring FDA NDA Module 2 and Module 5 content., • Strong knowledge of FDA NDA submission requirements, ICH E3 and CTD/eCTD structure, clinical trial documentation standards, and drug development processes. Preferred Skills • Experience with small molecule drug development programs., • Demonstrated expertise preparing integrated summaries of safety (ISS) and integrated summaries of efficacy (ISE)., • Familiarity with publishing systems and eCTD submission platforms., • Prior interaction with FDA review teams or support during regulatory agency meetings., • Consulting experience supporting multiple sponsors or parallel drug development programs., • Excellent scientific writing, editing, and data interpretation skills., • Ability to work independently and manage multiple deliverables in a fast-paced consulting environment. Additional Notes • Candidates who bring experience across both small molecule and biologic programs, or who have supported multiple NDA submissions across different therapeutic areas, will be especially well regarded. The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. DSI reserves the right to amend this description as client program needs to evolve., • This is an excellent opportunity for a seasoned regulatory writing professional seeking to apply their expertise within a dynamic, market-leading consulting organization at the forefront of pharmaceutical regulatory strategy and drug development services., • This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs., • All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.

Job DescriptionATTORNEY WANTED! MINIMAL COURT AND CLIENT CONTACT. $90-$140K EARNING POTENTIAL. REMOTE POSITION. The Federal Appeals Firm (Konoski & Partners, P.C.) Physical Location: Sarasota Florida / New Jersey (Remote or Hybrid-Remote) www.TheFederalAppealsFirm.com About the Firm The Federal Appeals Firm is a national appellate practice focused exclusively on federal appeals of Social Security disability decisions at the district court and circuit court levels. We handle one of the largest volumes of 405(g) appeals in the country, filing across federal circuits nationwide, and have built our reputation on rigorous legal writing and substantive appellate advocacy. We are also an AI-native firm. We do not bolt AI onto a traditional practice we have built our workflow around it from the ground up, with proprietary tools developed in-house and refined through thousands of federal briefs. This is how we deliver appellate-quality work at the volume and consistency our referral partners and clients rely on, and it is a meaningful part of what you will learn and practice here. This is not a generalist firm. We do one thing, we do it at a high level, and we do it differently than anyone else in the space. The Role We are seeking a skilled legal writer to join our team as an Associate Attorney. This position is writing-intensive, AI-augmented, and designed for an attorney who thrives on complex legal analysis, enjoys appellate practice, and prefers substantive brief writing over hearings or client-facing work. You will draft federal briefs challenging Social Security disability decisions issued by Administrative Law Judges, handling all required briefing across the full lifecycle of each assigned case opening briefs, reply briefs, objections to magistrate judge reports and recommendations, post-judgment motions, and any other substantive filings requiring legal argument. All work is reviewed and finalized by senior attorneys prior to filing. What makes this role distinctive is the technology you will work with. The Federal Appeals Firm is an AI-native practice, and our associates draft briefs in close collaboration with Brief Master our proprietary AI system built on the Brief Master Knowledge Core, a curated body of federal Social Security appellate authority developed in-house. These tools are not a substitute for legal judgment; they amplify it. Our most effective work product comes from genuine back-and-forth between attorney and AI, and we are looking for someone who is energized by that mode of practice rather than skeptical of it. You do not need prior AI experience. You do need strong legal writing instincts, intellectual curiosity, and a willingness to engage with these tools as a thinking partner rather than a search engine. We will train you on the systems. This is an excellent opportunity for an attorney who wants to build deep expertise in federal appellate litigation, work at the frontier of how legal writing is actually produced today, and do so without the distractions of a traditional litigation practice. Responsibilities • Draft federal appellate briefs challenging ALJ decisions in Social Security disability cases, including all required briefing at every stage of each assigned case, • Analyze administrative records to identify viable legal issues for appeal, • Conduct legal research across multiple federal circuits, • Evaluate potential cases for merit and assess whether legal grounds support a federal appeal, • Maintain accurate and contemporaneous time records sufficient to support EAJA fee petitions, • Collaborate with senior attorneys who provide final review and oversight on all filingsCompensation & Benefits, • Base Salary: $90,000 (includes a $5,000 annual taxable health insurance stipend; the Firm does not provide group health coverage)., • Salary Range: $90,000 to $110,000 with possible discretionary bonus, is what we consider to be our "base range". Higher earnings may be possible based on production. With discretionary bonuses based on production, high performers can potentially earn $140,000+ per year., • 401(k) retirement plan after two years of service or in accordance with plan terms., • Performance bonuses may be awarded at the Firm's sole discretion based on productivity, work quality, and overall contribution.Qualifications Required • J.D. from an ABA-accredited law school, • Active admission to at least one state bar, • Exceptional legal research and writing skills, • Strong analytical ability and attention to detail, • Ability to manage a high-volume caseload with consistent output and quality Preferred • Experience with federal court briefing or appellate litigation, • Familiarity with Social Security disability law (helpful, but not required for exceptional writers), • Experience with AI-assisted legal drafting toolsHow to Apply Submit application materials directly to the Firm at: appeals@thefederalappealsfirm.com Subject line: ASSOCIATE POSITION (Remote) Include the following: • Resume, • Cover letter, • Two writing samplesApplicants with fewer than five years of experience as a practicing attorney should also include their law school resume so we may review their legal writing coursework. --> SUBMIT BY EMAIL EVEN IF YOU SUBMIT THROUGH LINKED-IN. Writing Assessment Candidates who advance to serious consideration will be asked to complete a writing assessment prior to any offer. The assessment is a drafting exercise designed to evaluate the analytical and persuasive writing skills required for this role. It is unpaid. Details including the prompt, format, and timeline will be provided at that stage. The assessment is extended only to candidates we are genuinely considering. Applicants who are not prepared to complete a writing exercise should be aware of this requirement before applying. Equal Employment Opportunity The Federal Appeals Firm is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by applicable law. This is a remote position.

This is a part-time 12-hours per week, 12 week, unpaid remote internship. Details: This is an unpaid internship, although college credit is available. Writer/Journalist Internship: The role is focused on content creation for BORGEN Magazine or The Borgen Project Blog.

A leading federal appellate firm seeks an Independent Federal Appellate Brief Counsel to join a remote platform focused on Social Security disability appeals.

Sr Medical Writer Publications - Sponsor Dedicated - Remote Based. Mentors and leads less experienced medical writers on complex projects, as necessary.

TSR Consulting is currently seeking a highly motivated Technical Writer / Document Specialist for a hybrid opportunity in New Brunswick, NJ. Role: Technical Writer / Document Specialist. We are looking for a Technical Writer / Document Specialist with strong Regulatory CMC documentation experience i

Are you a Senior Level Strategic Project Manager looking to join an amazing organization and culture?!.Lead and manage construction projects from start to finish, ensuring they are completed on time, within scope and budget.Set and maintain firm construction schedules.Develop detailed project plans

At Kushner, we pride ourselves on our four core values: Be Caring, Be Best in Class, Be Solution-Oriented, and Be Accountable.Our values represent what we strive to achieve every day.Every decision we have to make is guided by the "4 Be's".Our team and passion for the real estate industry

B&D Holdings is a privately held investment and development firm with offices in Warren, NJ.Built upon a dynamic vertically integrated platform, B&D Holdings uses its unique talents and resources to create innovative real estate investment strategies.Our real estate portfolio consists of ove

Environmental Health and Safety.The salary range for this position is estimated to be 0.The salary range for this position is estimated to be $130,000.Additionally, Turner Construction provides flexible benefits, including medical, dental, and vision coverage, financial benefits such as a 401(k) pla

Flexible remote work arrangements to support work-life balance.

TSR Consulting is currently seeking a highly motivated Technical Writer / Document Specialist for a hybrid opportunity in New Brunswick, NJ. Role: Technical Writer / Document Specialist. We are looking for a Technical Writer / Document Specialist with strong Regulatory CMC documentation experience i

Sr Medical Writer, Redaction (Clinical Trial Transparency).

ABOUT K L MASTERS CONSTRCUTION:.K L Masters Construction Company (KLMCC) is widely recognized as one of the Tri-state region’s premier general contractors for large scale residential projects.With a respected track record spanning over two decades, our team has delivered 40 large scale projects on

The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO).

Design Space InPharmatics, a leading international pharmaceutical consulting organization, is seeking an experienced Regulatory Medical Writer to support NDA submission programs for our growing portfolio of drug development clients. In this high-impact consulting role, the Regulatory Medical Writer

Flexibility of a remote environment combined with close partnership and engagement from leadership and study teams. Clinical Project Manager II - Virology (Sponsor Dedicated - US Remote; Preference for Hybrid Foster City, CA). Sponsor Dedicated | Remote (US).

We are seeking a highly organized and technically skilled Survey Project Manager to lead and oversee land surveying projects from initiation through completion.This role involves managing field crews, coordinating with clients and stakeholders, ensuring compliance with regulatory standards, and deli

The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO). Technical Writer and Document Specialist.

Job DescriptionJob Description.Engineers, Certified Inspectors, Landscape Architects, Planners and Land Surveyors.We are committed to creating a personal and professional environment where we can build and focus on helping communities through teamwork and support.Our local offices provide our employ

Data Center Project Manager (Contract) Location: On-site - Franklin Township, NJ 08873.About the Role TEKsystems is seeking an experienced Data Center Project Manager to lead planning and execution for data center initiatives across multiple sites.This role requires strong project leadership, ha

In this hybrid role, you’ll work 3 days in-office and 2 days remote, managing projects that demand precision, communication, and deep technical expertise.

While performing the duties of this job, the employee regularly works in an office or remote setting.

Project Manager II - Inflammation/ Phase 2b (Sponsor Dedicated - Remote; Preference for Hybrid Foster City, CA). While remote/home-based candidates may be considered, priority will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week.

Job DescriptionJob Description.Engineers, Certified Inspectors, Landscape Architects, Planners and Land Surveyors.We are committed to creating a personal and professional environment where we can build and focus on helping communities through teamwork and support.Our local offices provide our employ

The salary range for this position is estimated to be 0.The salary range for this position is estimated to be $150,000.Additionally, Turner Construction provides flexible benefits, including medical, dental, and vision coverage, financial benefits such as a 401(k) plan, Health Savings Account, Flexi

Job DescriptionJob Description.Engineers, Certified Inspectors, Landscape Architects, Planners and Land Surveyors.We are committed to creating a personal and professional environment where we can build and focus on helping communities through teamwork and support.Our local offices provide our employ

At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact.Whether you're starting out in your career or taking your next step as a seasoned professional, the EisnerAmper experience is one-of-a-kind.You can design a career you'll love from to

Environmental Health and Safety.This position is Traveling role supporting our projects in other parts of the country which could include Texas, Maryland, Virginia, Ohio, etc.Position Description: Partner with Environmental Health & Safety (EH&S) and project teams to enforce site compliance with co

The position will be remote to start with but once it becomes onsite, they would want the candidate to be onsite.

ABOUT K L MASTERS CONSTRCUTION:.K L Masters Construction Company (KLMCC) is widely recognized as one of the Tri-state region’s premier general contractors for large scale residential projects.With a respected track record spanning over two decades, our team has delivered 40 large scale projects on

Are you a Senior Level Strategic Project Manager looking to join an amazing organization and culture?!.Lead and manage construction projects from start to finish, ensuring they are completed on time, within scope and budget.Set and maintain firm construction schedules.Develop detailed project plans

This is a fully remote position.

Project Manager I - Cell & Gene Therapy (Sponsor Dedicated - US Remote; Preference for Los Angeles, CA). While remote work is supported, we. Comfortable with remote work but agreeable to.