Writing & Editing jobs in Passaic, New Jersey - Page 3Crear alertas

Would you enjoy learning new things in a fast paced environment? Do you have an appetite for variety and challenging business problems to solve? Are you a great communicator who can clearly articulate and demonstrate the value of Workday solutions to our customers? The Workday Success Plans team wor

The opportunity: Our Accounting Compliance & Reporting (ACR) practice, focusing on helping clients effectively manage global bookkeeping and finance compliance obligations proactively and responsibly in 150+ countries where EY provides ACR services. Applying technical accounting knowledge to analyze

The opportunity: Our Accounting Compliance & Reporting (ACR) practice, focusing on helping clients effectively manage global bookkeeping and finance compliance obligations proactively and responsibly in 150+ countries where EY provides ACR services. Following up on the status of deliverables and ana

Experience with Prudential Financial systems a plus (Oracle, Oracle BI, Essbase/Smartview, & other financial statement applications). This individual will have financial close responsibilities of the Individual Retirement Strategies to ensure that all monthly, quarterly and annual accounting/reconci

The Accounting Implementation Solutions (AIS) team within FSO supports assessing and establishing policyholders, commission, and reinsurance accounting for Life, Annuities and Retirement new business initiatives. The Accounting Implementation - Financial Reporting Manager will partner with project l

Would you enjoy learning new things in a fast paced environment? Do you have an appetite for variety and challenging business problems to solve? Are you a great communicator who can clearly articulate and demonstrate the value of Workday solutions to our customers? The Workday Success Plans team wor

Grant Writer Job Duties: Prepares proposals by determining concept, gathering and formatting information, writing drafts, and obtaining approvals.

Junior Writer Job Duties: • Create effective and compelling copy • Write clear, concise and grammatically correct content that appeals to our various target markets in our brand voice •

Some experience a plus with the special needs community At least 2 years experience required working as an interpreter.

Financial Services - Customer Tax Operations and Reporting - Tax Services Senior Analyst-EDGE. Financial Services - Customer Tax Operations and Reporting - Tax Services Senior Analyst-EDGE. US - Tax - BTS - FSO CTORS Information Reporting and Withholding EDGE Senior Analyst.

As a Senior Copywriter, Style Social, you'll help express the company's voice across fashion, beauty, and home content for social platforms.

Our Financial Institutions underwriting division is seeking a Regional Executive Underwriter to join our growing team in the NYC Metropolitan Area. Regional Executive Underwriter, Financial Lines.

We're seeking a self-starting, experienced Senior Copywriter to concept and craft big ideas that break through, creating stories that move people and strengthen the brand across every channel.

Job DescriptionCompany Description WHO WE ARE fresh is a global company headquartered in New York offering a full lifestyle line spanning skincare, lip care, bodycare, and fragrance in over a dozen countries. But we don’t just aspire to make the best products on the market; we want to be the best beauty brand to work for. We’ve created a warm, inspiring environment with world-class benefits that encourages our teams to dream big, because that’s how we got here. Here at fresh, we intentionally foster a spirit of belonging. We celebrate our diversity and support every employee to feel welcomed, valued, respected, and heard. By embracing curiosity and collaboration, we recognize that our differences strengthen us. MAIN JOB OBJECTIVE As a key leader within our Global Finance team, the Senior Global Consolidation Manager, plays a critical role in guiding decisions by providing insightful financial analysis and ensuring the accuracy and integrity of our global financial reporting. This role involves comprehensive oversight of consolidation processes, collaboration with central departments and markets, and a commitment to fostering a transparent financial environment that contributes to the overall success and sustainability of the organization. The Senior Global Consolidation Manager will be responsible for leading and managing the consolidation of global and market financial reporting for the LVMH Group, ensuring compliance with reporting standards, and driving continuous improvement in financial processes. Job Description JOB RESPONSIBILITIES • Own monthly, quarterly, and annual global consolidation (P&L, Balance Sheet, Cash Flow), • Lead multi-currency consolidation, FX translation, and foreign exchange analysis, • Manage intercompany eliminations, reconciliations, and margin in inventory, • Ensure accurate accounting for complex areas (accruals, provisions, inventory reserves), • Prepare and review Group reporting packages (Actuals, Forecasts, Budget), • Partner with LVMH Group Finance, external auditors, and local finance teams, • Drive close acceleration, process improvements, and control enhancements, • Provide clear variance analysis and executive-ready insights to leadership, • Gain a thorough understanding of Fresh's global financial reporting structure and LVMH requirements, • Become proficient in LVMH consolidation systems and processes, • Establish key relationships with Global Finance, market teams, and external auditors, • Actively contribute to monthly and quarterly financial close processes, • Independently lead multiple complete consolidation and reporting cycles, • Successfully implement process improvements and system enhancements, • Provide strategic financial analysis and recommendations influencing business decisions, • Must be able to remain in a stationary position on average of 7.5 hours/day, • Light to moderate lifting may be required, • While performing the duties of this job, the employee may be regularly required to stand, sit, reach, stoop, kneel, and operate a computer, telephone, and keyboardQualifications PROFILE You have: • 6–7 years of experience in consolidation, audit, or global accounting, • Strong knowledge of IFRS / consolidation principles (US GAAP exposure a plus), • Experience in a large, international, matrix organization, • Hands-on, detail-driven, with the ability to step back and see the big picture, • Comfortable operating in a high-expectation, transformation environment, • Excellent communication skills; able to interact with senior stakeholders, • Fluent in English; French is a plus, • Exposure to Tax & Treasury topics is a plus, • Strong knowledge and extensive use of Excel, including advanced functions (Pivot Tables, V-Lookups, macros), • ERP knowledge (e.g. AX Dynamics, Oracle) Additional Information WHAT WE OFFER YOU Training & Development and Culture • Fresh and LVMH Sponsored Trainings and Workshops for Personal and Professional Development, • Opportunities for networking and building relationships with LVMH Community and Network, • Free professional consultation, referrals and counseling through the Employee Assistance Program (EAP), • Comprehensive paid time off inclusive of Floating Holidays and Summer Fridays, • Fertility Services, Maternity and Newborn Support, Adoption and Surrogacy Assistance, including cryopreservation when part of fertility treatment, • Paid Parental Leave (Inclusive of Maternity, Paternity, Adoption, Surrogacy) at eligibility, • Travel & lodging for those who can’t access care, • Fresh In-Store Discounts and Gratis, • LVMH Group Friends and Family Sales across all divisions within LVMH: Wines and Spirits, Watches and Jewelry, Perfumes and Cosmetics, Fashion and Leather Goods, etc., • Pre-Tax Commuter Benefits through Wage Works The salary range for this role is $120,000 - $160,000 USD. This role is based in Jersey City, New Jersey. All your information will be kept confidential according to EEO guidelines.

Job Description Responsibilities include but are not limited to: Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc. Transmission of Customs Entries to U.S. Customs for import shipments Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations.. Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance. Receiving, reviewing, and processing import documentation for an assigned base of accounts Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available Corresponding with overseas agents and clients Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight Developing and maintaining excellent customer service to internal and external customers Preparing quotations Handling the files from A to Z Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Job Requirements: Minimum 2- 4 years of experience in Import Customs Clearance operations Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) Be able to work independently, multi-task, be a team player and work in a fast-paced environment Possess excellent written and verbal communication skills Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access Experience with the handling of hazardous materials a plus

Job DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3300 employees strong, is seeking a highly motivated and organized individual to fill the position of Import Customer Service Representative – Customs Entry Writer in our Jersey City, NJ office. Responsibilities include but are not limited to: • Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc., • Transmission of Customs Entries to U.S. Customs for import shipments, • Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations., • Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good, • Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance., • Receiving, reviewing, and processing import documentation for an assigned base of accounts, • Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails, • Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions, • Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available, • Corresponding with overseas agents and clients, • Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight, • Developing and maintaining excellent customer service to internal and external customers, • Preparing quotations, • Handling the files from A to Z, • Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Requirements: Job Requirements: · Minimum 2- 4 years of experience in Import Customs Clearance operations · Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) · Be able to work independently, multi-task, be a team player and work in a fast-paced environment · Possess excellent written and verbal communication skills · Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access · Experience with the handling of hazardous materials a plus Our Benefits include: · Medical · Dental · Vision · Flexible Spending Account (Medical and Dependent Care) · 401(k) with company match · Company paid Life Insurance, Short-Term Disability and Long-Term Disability · Paid Holidays plus PTO and Sick Leave · Voluntary Time Off · Employee Assistance Program · Tuition Reimbursement · Employee Referral Program · Employee Discounts When applying, the candidate should include salary requirement. Background check required. Only those considered for the position will be contacted. Thank you for your interest.

Job Description ELLKAY started out providing connectivity solutions to laboratories and within a few years, grew to also provide data management solutions to ambulatory organizations. ELLKAY is now a trusted data management partner in five healthcare segments. ELLKAY’s solutions continue to serve laboratories and ambulatory practices and have expanded to empower hospitals and health systems, healthcare IT vendors, ambulatory practices, health plans, and other healthcare organizations with cutting-edge technologies and solutions that drive their growth and interoperability strategies. Today, ELLKAY remains true to our core values, building strong partner relationships and offering unparalleled service and support while providing innovative, scalable solutions to the challenges our customers face in today’s data-rich world. ELLKAY's experience, customer-focused approach, and reputation for innovation, speed, and accuracy differentiate ELLKAY as a premier partner for your interoperability needs and data management strategy. Job Description: You’ll own product documentation across platforms and products, partnering with Product, Engineering, UI/UX, Support, and the new E‑Learning Manager. You’ll deliver clear, branded, release‑aligned content that supports internal enablement and customer success, while laying the groundwork to modernize and digitize documentation in a searchable portal. Expectations for Your Role BASE (first 6–12 months) • Inventory, standardize, and update priority product/user guides and technical docs., • Establish Information Architecture (IA), style/terminology standards, and a repeatable review process., • Deliver release‑aligned updates (quarterly+), including client‑facing release documentation., • Close the documentation backlog and expand coverage (workflows, quick references, troubleshooting, API docs)., • Introduce lightweight, contextual in‑app help patterns and a knowledge base structure., • Lead the planning and migration path to a modern documentation portal (SSO, versioning, analytics, AI‑assisted search) in partnership with Product, Support, and Engineering., • Write, edit, and maintain end‑user documentation, step‑by‑step guides, and client‑specific quick references., • Create and maintain platform/product technical docs: architecture overviews, data dictionaries, schema references, installation/configuration, and API integration guides., • Produce diagrams and workflow illustrations; ensure accessibility and brand compliance., • Draft and maintain troubleshooting guides, error references, and FAQs., • Collaborate with Product Managers/PMMs and SMEs to capture accurate workflows and release changes., • Co‑develop scripts, storyboards, and captions/transcripts for tutorial videos and WBT., • Manage document IA, versioning, and release notes workflow; enforce style and terminology consistency., • Partner with Support/Delivery to align documentation with ticket trends and onboarding needs., • 4–7+ years of technical writing for software/SaaS; portfolio showcasing end‑user and technical deliverables., • Ability to translate complex healthcare/interop concepts into plain, structured guidance., • Expert writing, editing, and information architecture skills; strong attention to detail., • Proven cross‑functional collaboration with Product, Engineering, and Customer‑facing teams., • Proficiency in Microsoft 365; working knowledge of diagramming tools., • Familiarity with issue tracking and content workflows (e.g., JIRA/Confluence or similar)., • Experience with WBT authoring collaboration (e.g., scripting for Articulate 360/Captivate)., • Backlog burn‑down and release‑aligned updates delivered on time., • Reduction in repeat “how do I…?” tickets; improved internal training satisfaction., • Consistent terminology and IA across products; increased documentation adoption/engagement. ELLKAY offers a comprehensive and competitive benefit package that starts day one! Including: • Medical, Dental, and Vision benefits, • Employer-paid Life and LTD, • 401k w/ matching – once eligibility is met, • Work/life balance, • Paid Volunteer Program, • Flexible working hours, • Generous FTO, • Remote work options, • Employee Discounts, • Working with talented, collaborative, and friendly people who love what they do, • Professional growth within, • Innovation environment At ELLKAY, we are committed to operating as a hybrid workplace, offering employees flexibility in how they structure their time between in-office and remote work. We recognize the significance of fostering connections, collaboration, and creativity within our office culture and its positive impact on our business. Our philosophy of operating as a hybrid workplace underscores our dedication to enabling employees to tailor work-life balance to their individual preferences. For those who do not live within 40 miles of one of our offices, we are open to considering remote work for candidates whose skills and experience strongly align with the role. While we prioritize a hybrid work environment for most roles, we understand the importance of flexibility and are open to remote work for specific positions and specialized skill sets. For more information on our company, visit . ELLKAY LLC is a Smoke-Free Workplace. ELLKAY, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Job Description Senior Grant Writer & Researcher The Senior Grant Writer & Researcher is responsible for leading NJRC’s grant development strategy by securing and managing complex public and private funding opportunities. This role oversees the full grant lifecycle, from prospect research and proposal development to post-award reporting and compliance, and serves as a subject matter expert for research, evaluation, and data-driven storytelling. This is a full-time position, located in Kearny, New Jersey. Key Responsibilities • Lead the research, development, writing, and submission of complex federal, state, local, and private grant proposals., • Develop and manage NJRC’s grant strategy and pipeline in alignment with organizational priorities and funding goals., • Serve as the primary liaison with funders regarding proposal development, reporting, compliance, and renewals., • Collaborate with executive leadership, program leadership, and finance to develop compelling narratives, logic models, budgets, and sustainability plans., • Oversee post-award grant management, including compliance monitoring, progress reporting, and outcome measurement., • Design and support research and evaluation frameworks to assess program effectiveness and organizational impact., • Analyze qualitative and quantitative data to support grant reports, funding justifications, and strategic decision-making., • Maintain high-quality grant documentation, institutional data, and funding records., • Mentor and guide associate-level grant staff, as applicable., • Stay current on funding trends, policy changes, and best practices in nonprofit grantmaking and research. Education • Bachelor’s degree required in History, Economics, Public Administration, Social Sciences, Nonprofit Management, Policy, or a related field., • Enrollment in or completion of a graduate, doctoral, or professional degree program (e.g., MPA, MSW, MPH, JD, PhD, or related disciplines) is strongly preferred., • Candidates currently pursuing advanced degrees, including law students or doctoral candidates with evening or flexible academic schedules, are encouraged to apply., • 5+ years of progressive experience in grant writing and research, with a strong record of securing significant funding from government and/or private sources., • Demonstrated experience leading complex, multi-year, or multi-million-dollar grant proposals., • Experience in the nonprofit or public sector; familiarity with workforce development, reentry, or human services strongly preferred., • Advanced grant writing, editing, and storytelling skills., • Strong analytical, research, and data interpretation skills., • Ability to manage multiple high-priority deadlines independently., • Proficiency in Microsoft Office Suite and grant management or CRM systems., • Strong project management, collaboration, and leadership skills., • Strategic thinking and funding acumen, • High attention to detail and accountability, • Leadership and mentoring ability, • Strong relationship-building and communication skills, • Sound judgment and discretion Salary range is $85,000 - $100,000 annually. Equal Opportunity Employer Statement NJRC is an equal opportunity employer and is committed to creating an inclusive environment for all employees.

Job Description Preview High-volume, family-owned Toyota dealership in Wood-Ridge, NJ seeking experienced Service Advisors who can present value-driven recommendations in a fully digital service environment. Commission-based pay with strong earning potential. About the Dealership We are a family-owned Toyota dealership with a busy, well-run service department handling approximately 1,500 customer-pay repair orders per month, plus warranty work. We are expanding into a new, state-of-the-art facility and operate a fully digital, paperless, touchless service drive. Our advisors work closely with factory-trained and certified technicians, allowing us to deliver accurate diagnostics and professional, value-based service recommendations. Position Overview We are seeking experienced Service Advisors who take a consultative, professional approach to service. This role is ideal for individuals who can explain technician diagnostics, present factory-recommended maintenance and repairs, and help customers make informed decisions — without pressure or gimmicks. Success in this role comes from understanding the product, communicating value and benefits, and building long-term customer relationships. Key Responsibilities • Greet customers and manage the service write-up process, • Clearly explain diagnostic findings from factory-trained technicians, • Present recommended repairs and maintenance based on Toyota factory guidelines, • Communicate value and benefits, not just price, • Utilize a fully digital, paperless, and touchless service system, • Maintain proactive communication with customers throughout the repair process, • Collaborate with technicians to ensure accuracy and efficient workflow, • Build trust, repeat business, and long-term customer relationships What We’re Looking For • Prior Service Advisor experience (Toyota or dealership experience preferred), • Strong communication and customer engagement skills, • Ability to confidently present recommendations and explain value, • Comfortable working in a high-volume environment, • Technically savvy and comfortable with digital tools and tablets, • Ambitious, coachable, and willing to learn and improve Technology & Process • Fully digital and paperless service drive, • Digital vehicle inspections and customer communication tools, • Manufacturer maintenance schedules and factory service guidelines Comfort with technology is required. Compensation & Earning Potential • Commission-based compensation with base salary, • Annual earning potential of approximately $75,000–$130,000+, based on performance, • Strong volume supports consistent earning opportunities, • Paid training and ongoing development Why Join Us • Family-owned dealership with hands-on leadership, • High-volume Toyota service department, • Brand-new facility and modern technology, • Strong technician support and accurate diagnostics Experienced Service Advisors looking for a modern, high-volume Toyota service department with real earning potential are encouraged to apply.

Job Description • Services 75-100+ appointments daily, • Excellent pay plan and bonuses, • Medical Insurance , Life Insurance, Employee/Family discounts, • 401K, • Paid time off. • Excellent customer service, • Knowledge of CDK, • A Team and company attitude to deliver exceptional work to our customer, • Maintain open lines of communications with customers to achieve their expectations, • Ability to upsell clients on needed repairs and maintenance to optimize dealer revenues, • Maintain a clean and effective workstation *Team Player • Professional demeanor and presentation, • Valid Drivers License, • Must be able to pass a DMV license check and background check, • Must have steady and verifiable work history, • 2+ Years at an automotive dealership or shop, • 1+ Year as an automotive Service Advisor/Writer, • Must be able to work well in a team atmosphere For Immediate consideration call 973 785-4710 x6258 Toyota Universe 1485 Route 46 East Little Falls, NJ Company DescriptionToyota Universe is looking for a friendly, well spoken Telemarketer. This position requires a lot of incoming and outgoing phone calls, candidate must be customer friendly and must be able to work well with others.Toyota Universe is looking for a friendly, well spoken Telemarketer. This position requires a lot of incoming and outgoing phone calls, candidate must be customer friendly and must be able to work well with others.

Job Description Neal R. Gross and Co. is a leading Court Reporting and Transcription services company based out of the Washington, DC area with work across the country. Our clients include local, state and federal courts, the House of Representatives, Department of Defense and clients in the private sector. We are seeking experienced Digital Court Reporters to capture the verbatim record of legal proceedings with accuracy, professionalism, and reliability. This role involves both remote and in-person assignments, depending on client needs. We are looking for candidates that can work anywhere from a few jobs a month to 2-3 per week depending on their availability and location. Candidates must be self-sufficient and come equipped with the necessary tools and expertise to perform the work independently. PRIOR EXPERIENCE AND EQUIPMENT IS REQUIRED . Location: IN-PERSON - client sites in your local area Key Responsibilities • Capture clear and complete digital audio recordings of legal proceedings including depositions, hearings, and meetings., • Administer oaths and participate in depositions, hearings, and other legal proceedings, • Monitor and ensure audio quality in real-time, annotating the record with speaker IDs and relevant notes., • Maintain a secure and organized record of proceedings, adhering to legal and confidentiality standards., • Upload and submit audio files and associated annotations through our secure systems in a timely manner., • Communicate with scheduling and production teams to ensure accurate and on-time delivery of materials., • Represent NRGCO professionally in all proceedings and interactions Job Requirements • Minimum of 1 years of experience as a Digital Court Reporter in legal or governmental proceedings., • Proficient in digital recording software, annotation tools, and audio file management., • Strong attention to detail and excellent command of the English language., • Ability to work independently and adapt to dynamic courtroom or deposition environments., • Experience covering multi-speaker and technical proceedings., • Familiarity with court terminology and procedure., • Ability to pass security screening for access to client sites, including government buildings, • Availability for occasional short-notice assignments., • AAERT Certification is strongly preferred Equipment and Software Requirements Candidates must provide their own: • Laptop or computer with digital recording software (e.g., ForTheRecord, Liberty, AutoScript, Soniclear or equivalent), • High-quality microphones and backup recording devices, • Reliable internet access for file transfers and virtual proceedings This is a contract position and compensation is commensurate with candidate's experience. Compensation range is $25-45/hour. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status or other protected classes.

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. Japan. Job Summary: Responsible for the management and execution of various aspects of translational and early-stage clinical studies (implementation, site selection, patient recruitment, vendor selection and oversight, tracking clinical data, etc.) for global clinical studies with adherence to all relevant regulations including FDA, ICH and Regulatory requirements. This is a hybrid position that requires to be in the Paramus office twice a week. Essential Duties and Responsibilities: • Develop and deliver program level translational and early-stage clinical drug development strategy, • Design, plan and execute biomarker strategies to inform indication priorities, commercial differentiation, regulatory strategies, biomarker qualification plan, and that achieve biomarker-driven milestones, such as target engagement, measurement assay development and validation, pharmacodynamic activity, and other biomarker contexts of use in clinical-stage programs, • Integrate with colleagues in discovery research and research-stage project teams to identify translational biomarkers and demonstrate preclinical target engagement, methodology of detection and measurement, proof-of-mechanism, pharmacodynamic activity, PK/PD relationships., • Plan, implement, manage and report for regional or global clinical studies., • Manage and Lead selection process of CROs for regional or global clinical studies., • Direct, oversight and manage the performance of study vendors (e.g. CROs and central labs)., • Provide direction and guidance with the Clinical Lead to achieve project objectives., • Manage and resolve project performance issues (issue management) if they arise., • Manage activities for clinical site selection, investigator meetings and study initiation., • Oversight of patient recruitment and development of recruitment strategies and plans., • Responsible for the creation of study related documentation (protocol, ICF, CRF, operations manuals etc.)., • Tracking clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans., • Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols., • Manage negotiation of clinical trial contracts between investigational sites and CROs., • Oversight of data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan., • Responsible for coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites., • Implement project specific training program and training materials, • Create and maintain clinical SOPs and TMF as part of global QMS and TMF processes., • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma Japan (HQ), external partners and vendors., • Experience in negotiating Master Service Agreements, Project Specific Contracts and Budgets., • Good cross-functional team leader who fosters team spirit and team motivation (teamwork), • Thorough understanding of clinical operations involved as related to the planning, launching, and closing clinical studies., • Ability to anticipate and timely escalate issues and to define appropriate action plans, • Decision-making and problem-solving skills, • Ability to handle multiple tasks and prioritize, • Strong organizational, communication and presentation skills, • PhD and/or MD with 8+ years of experience in pharmaceutical or biotech R&D. MS or BS with 12+ years of R&D experience with progressive levels of team leadership also considered., • Preference for those with 5+ years’ experience as a Translational lead for clinical programs. Experience with Ph2/3 or registrational programs desired., • Excellent understanding of drug development, regulatory processes and clinical development NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $175,000 to $220, 000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training NS Pharma is an EEO employer.

Job Description Neal R. Gross and Co. is a leading Court Reporting and Transcription services company based out of the Washington, DC area with work across the country. Our clients include local, state and federal courts, the House of Representatives, Department of Defense and clients in the private sector. We are looking for experienced Court Reporters to work on a contract basis to visit client sites in their local area. You will use specialized equipment to create an accurate record of proceedings in numerous places including legal courts, non-profit board rooms, and depositions. We are very flexible and looking for candidates that can work anywhere from a few jobs a month to 2-3 per week. Location: IN-PERSON - client sites in your local area • Takes down the proceeding using Machine Shorthand, Voice, or Digital capture, • Capture verbatim proceedings of courts, meetings, depositions, and hearings, • Administer oaths and participate in depositions, hearings, and other legal proceedings, • Transport, set up, and operate equipment to capture the record accurately, • Perform advance preparation for assignments, including building job worksheets, reviewing case information, and ensuring proper hardware setup, • Ensure all exhibits are secured, proper file backups are performed, and required worksheets are completed and uploaded at the close of the proceeding, • Maintain all required reports and logs and respond promptly to communications, • Represent NRGCO professionally in all proceedings and interactions, • PRIOR EXPERIENCE AND EQUIPMENT IS REQUIRED | NO training is provided, • 1+ years working as a Court Reporter, • Strong attention to detail, • Reliably punctual and deadline-oriented, • Can-do attitude and excellent work-ethic, • Ability to work independently, • Organizational and time-management aptitude, • Exceptional problem-solving and communication skills, • Excellent English language skills, • Proficient with technology, • Ability to pass security screening for access to client sites, including government buildings, • NCRA, AAERT, or NVRA certification strongly preferred Here is a link to a day in the life of a Neal R Gross & Co Court Reporter! 20250623_204707000_iOS.MOV Benefits This is a contract position and compensation is commensurate with candidate's experience. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status or other protected classes.

Job Description Our client is seeking a CMC Writer to join their team. & SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. JOB DESCRIPTION: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files KEY RESPONSIBILITIES: • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies. QUALIFICATIONS: • Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint). PREFERRED SKILLS: • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description SUMMARY: • Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities., • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format., • Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals., • Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions., • Ensure compliance with FDA, EMA, and ICH guidelines and internal processes., • Collaborate with cross-functional teams to gather accurate technical information., • Identify and communicate potential regulatory risks; propose mitigation strategies., • Education: Bachelors or advanced degree in Chemistry, Pharmaceutical Sciences, or related field., • Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management., • Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities., • Familiarity with global regulatory frameworks and eCTD submissions., • Excellent technical writing, communication, and organizational skills., • Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)., • Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings., • Ability to interpret and apply regulatory guidelines effectively., • Strong project management and stakeholder communication skills.

Job Description SUMMARY: • Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions., • Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions, • Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions, • Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines., • Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions., • Assess and communicate potential regulatory risks and propose mitigation strategies, • Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications., • Identify, communicate and escalate potential CMC regulatory issues, as needed, • Help establish regulatory CMC submission processes and procedures., • Familiar with eCTD format submission files, • Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications., • Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements., • Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data., • Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing. Education: Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field. Experience: • Prior experience in pharmaceutical or regulatory writing., • CMC (Chemistry, Manufacturing, and Controls) Writer experience.

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