Technical writer jobs in Lakewood, NJ - 32 jobs

This position is NonExempt. Hours over 40 will be paid at Time and a Half. Writes a variety of technical articles, reports, brochures, and/or manuals for documentation for a wide range of uses. May be responsible for coordinating the display of graphics and the production of the document. Familiar with variety of the field's concepts, practices and procedures. Relies on experience and judgment to plan and accomplish goals. May lead and direct the work of others. A wide degree of creativity and latitude is expected. May require a bachelor's degree or 4-6 years experience. NOTES FROM MANAGER: Technical writer to reformat our Risk Management Plan (RMP) documentation. Existing RMP documents are a critical part of the company's product definition. These documents need to be reformatted to include updated definitions and references. The senior technical writer should preferably have experience working with FDA - or other regulated industry - practices and ISO systems. Qualifications Required: • Proficient in Microsoft Word: advanced editing, commenting, routing, formatting • Proficient in Microsoft Excel: editing, formatting Prior experience Technical Writing in the medical device industry needed with particular emphasis in writing SOPs and document changes. Additional Information

Company Culture & Values At WESCORP, we value people who show up ready to work hard and do things right. As a family-owned company since 1962, we take pride in building things that last - starting with our team. Our culture is built on trust, accountability, and mutual respect. We believe in putting in an honest day's work, supporting one another, and holding ourselves to high standards of quality and performance. Whether you're working on the shop floor, in engineering, or supporting operations, you'll be part of a team that values reliability, craftsmanship, and a hands-on mindset. We're not looking for shortcuts - we're looking for people who take ownership, stay focused, and care about the work they do. If that sounds like you, you'll find a long-term home here. Job Summary The Technical Writer is responsible for preparing, maintaining, and organizing the documentation that supports our engineering and production processes. This includes maintaining travelers, work orders, and other paperwork associated with manufacturing orders. The Technical Writer will work closely with Engineering, Quality, and Production to translate complex technical content. Key Responsibilities Review technical specifications and flow down requirements into the work order traveler Conduct research, including reading source material and meeting with subject matter experts Organize and maintain documentation in accordance with the QMS Work with engineering, quality, and production teams to gather needed information Track revisions and ensure the most current versions of documents are available Support audits and reviews by providing documentation as requested Help standardize templates and formatting for consistency across documents

We are seeking an innovative and technically skilled IT Business Analyst with 5+ years of experience, preferably in pharmaceutical sales and distribution. The ideal candidate will possess expertise in SAP S/4HANA (SD, FI, MM, PP, QM modules) and Vistex Revenue Management in a business facing role, with a strong understanding of core business processes such as finance, supply chain, sales, and revenue management. This role requires a blend of business acumen and technical capability to analyze requirements, design solutions, and drive process improvements. The candidate will work closely with different teams to understand business needs, support data-driven decisions, and apply modern technologies such as AI, automation tools, and machine learning to improve processes and drive innovation. ESSENTIAL DUTIES AND RESPONSIBILITIES Collaborate with business users to elicit, analyze, and document functional and non-functional requirements. Identify and drive process improvement initiatives to optimize operational efficiency and ensure compliance with industry standards and best practices. Perform data analysis to uncover actionable insights, identify root causes of issues, and detect trends that inform strategic decisions and continuous improvement. Create and maintain key artifacts including process flows, data flows, system architecture diagrams, business cases, functional specifications, and other documentation to support solution design, implementation and stakeholder understanding. Collaborate with technical teams to ensure proper configuration, integration, and optimization of solution. Lead and support testing activities, including system validation and facilitation of User Acceptance Testing (UAT), ensuring solutions meet defined requirements and quality standards. Assist in change control, deployment planning, and execution to ensure smooth transitions and minimal disruption to business operations. Develop and manage project plans, timelines, and deliverables, ensuring successful execution of initiatives within scope, budget, and schedule. Develop, maintain, and enhance dashboards and reports using tools such as Microsoft Fabric BI to support real-time business intelligence and performance monitoring. Conduct user training sessions and create documentation to support the adoption and effective use of new technologies, systems, and processes. KNOWLEDGE / SKILLS /COMPETENCY Excellent verbal and written communication skills, with the ability to convey complex concepts clearly to both technical and non-technical audiences. Exceptional organizational, prioritization, and time management skills, with the ability to manage competing priorities and adapt to changing business needs. Analytical mindset with the ability to define and solve complex problems, even when faced with incomplete or ambiguous information. Self-driven and proactive, with the ability to work independently and take ownership of tasks with minimal supervision. High level of initiative and accountability, consistently driving tasks to completion and delivering results. Requirements EDUCATION/EXPERIENCE Bachelor's degree in business administration, Information Systems, Data Analytics, or a related field. 5+ years of experience as a business analyst, preferably within the pharmaceutical sales and distribution industry. Industry-specific knowledge of the generic pharmaceutical sector is desirable. Hands-on experience with SAP S/4HANA modules (SD, FI, MM, PP, QM) and Vistex Revenue Management is strongly preferred. Experience working with pharmaceutical-specific processes such as Government Pricing, Medicaid, Chargebacks, Fees and Incentives or Gross-to-Net (GTN) calculations is desirable. Knowledge of regulatory and compliance requirements in the pharmaceutical industry. Other Preferred Skills and Experience: Microsoft Fabric or similar platforms for data analytics, reporting, and business intelligence. Salesforce Service Cloud for customer support operations. Tracelink Serialization or similar for pharmaceutical product tracking and compliance. Cloud platforms such as Microsoft Azure or Amazon Web Services (AWS). Project management expertise, including certifications such as PMP or Agile, and hands-on experience with tools like Planview, JIRA, ALM, Microsoft Project, and Azure DevOps. Cloud-based AI/ML platforms such as Azure AI, Google AI, or AWS ML. Python, R, and SQL for data analysis, automation, and predictive modeling. RPA platforms (e.g., UiPath, Automation Anywhere) and implementing automation solutions. WORK ENVIRONMENT The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is: Frequently required to sit and/or stand, walk, talk and hear. Constantly required to use hands and fingers to operate office machines and equipment. Frequently required to reach with hands and arms. Occasionally required to stoop, kneel and crouch. Required to occasionally lift, carry, push, pull, or otherwise move objects. Occasional travel required between various locations in US and some international travel. The work environment characteristics described here are representative of those that an individual encounters while performing the essential functions of this job. Zydus Pharmaceuticals (USA) 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. Zydus is committed to providing reasonable accommodation to, among others, individuals with disabilities and disabled veterans. If you need an accommodation because of a disability to search and apply for a career opportunity with Zydus, please contact us and let us know the nature of your request. Salary Description $140,000-$160,000

Take the next step in your career path and join a team that facilitates the efficient operation of our Group Underwriting organization. As the Group Underwriting Senior Technical Writer in Group Benefits Underwriting, you will collaborate with colleagues in Underwriting, Underwriting Operations, and other functional areas to ensure that our colleagues have all the information needed to perform. This requires being systematic in analyzing, developing, validating, and publishing information about processes, policies, and our systems. This role also requires an ongoing evaluation of the information management and communication approach and continuous improvement of our processes, based on input from our colleagues and industry best practices. **You are:** + A team member who can manage multiple priorities, and who is passionate about logically organized and comprehensive information for our Group Underwriting colleagues. + Work together with teammates, content contributors, SMEs, leaders, and other interested parties on projects and to consistently improve our information management approach. + Skilled in documentation tools like Microsoft Word, SharePoint, and other web based knowledge management or online help systems; familiarity with policy administration systems is a plus. + Ability to interpret and document sophisticated underwriting processes, risk assessment criteria, and decision-making frameworks. + Comfortable working with underwriting teams, product managers, legal, and IT to gather source material and validate content. + Familiarity with regulatory standards and documentation practices in insurance. **You have:** + Proficiency in writing and editing technical content related to complex business processes, preferably in regulated industries such as insurance or healthcare. + A 4-year college degree in English, Communications, Technical Writing, or a related field, or equivalent work experience. + Knowledge of Group insurance products and services (a plus). + Project management experience (a plus). + Familiarity with process improvement and process design (Lean Six Sigma). + Experience completing tasks in a disciplined manner and meeting deadlines. + Optional: Ability to develop training materials using instructional design principles. **You will:** + Independently lead the development of reference information for complex projects to support the effectiveness and efficiency of our Group Underwriting organization. This information is commonly related to new products, policies, systems, tools, and processes. + Create Underwriting-specific content for our Information Management System (IMS). + Occasionally lead the weekly publication of the newsletter for all of Group Underwriting. + Lead the review process of existing Group Underwriting policies with team members. + Collaborate with the Information Management and Learning team to coordinate and work together on projects, and at times manage communications. + Collaborate with various areas including compliance, legal, and IT. **Location:** + Preferred location is Guardian's Office in Bethlehem, PA. 3 days onsite Hybrid **Salary Range:** $67,450.00 - $110,815.00 The salary range reflected above is a good faith estimate of base pay for the primary location of the position. The salary for this position ultimately will be determined based on the education, experience, knowledge, and abilities of the successful candidate. In addition to salary, this role may also be eligible for annual, sales, or other incentive compensation. **Our Promise** At Guardian, you'll have the support and flexibility to achieve your professional and personal goals. Through skill-building, leadership development and philanthropic opportunities, we provide opportunities to build communities and grow your career, surrounded by diverse colleagues with high ethical standards. **Inspire Well-Being** As part of Guardian's Purpose - to inspire well-being - we are committed to offering contemporary, supportive, flexible, and inclusive benefits and resources to our colleagues. Explore our company benefits at *********************************************** . _Benefits apply to full-time eligible employees. Interns are not eligible for most Company benefits._ **Equal Employment Opportunity** Guardian is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, race, color, creed, religion, sex, affectional or sexual orientation, national origin, ancestry, marital status, disability, military or veteran status, or any other classification protected by applicable law. **Accommodations** Guardian is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Guardian also provides reasonable accommodations to qualified job applicants (and employees) to accommodate the individual's known limitations related to pregnancy, childbirth, or related medical conditions, unless doing so would create an undue hardship. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact applicant_accommodation@glic.com . **Current Guardian Colleagues: Please apply through the internal Jobs Hub in Workday.** Every day, Guardian helps our 29 million customers realize their dreams through a range of insurance and financial products and services. Our Purpose, to inspire well-being, guides our dedication to the colleagues, consumers, and communities we serve. We know that people count, and we go above and beyond to prepare them for the life they want to live, focusing on their overall well-being - mind, body, and wallet. As one of the largest mutual insurance companies, we put our customers first. Behind every bright future is a GuardianTM. Learn more about Guardian at guardianlife.com . Visa Sponsorship: Guardian Life is not currently or in the foreseeable future sponsoring employment visas. In order to be a successful applicant, you must be legally authorized to work in the United States, without the need for employer sponsorship.

Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a Pharmaceutical Technical Writer to join their New Brunswick, New Jersey 08901 team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail. Full-time Onsite Direct Hire Pay Rate: DoE Job summary: Perform investigation's and assist manufacturing and packaging operations on investigations, Product quality complaints. Assist in cross functional investigations for out of specification (OOS), out of trend (OOT), Laboratory Events, CAPAs, and change controls. Areas of responsibility: Ensure timely closure of all manufacturing/packaging and Quality Management System records. Organize and participate in and reviews of cross functional investigation's Represents Operations at cross-functional meetings. Work with process owners and SMEs to implement agreed upon procedural documentation and to develop cross-functional process models Collect input from stakeholders and consolidate comments for conflict resolution Drive the improvement in established KPI's / metrics for manufacturing and packaging departments Assist operations in responses to any internal audit, corporate audit, or regulatory audit observations involving manufacturing or packaging Control. Travel Estimate: Up to 5% Required Qualifications: Associate degree in Life Sciences, Pharmacy, or equivalent required. Minimum of three (3) years working in a pharmaceutical environment with at least two (2) years of experience within manufacturing area. Demonstrated excellent communication: verbal, written and presentation skills. A self-starter with a hands-on approach and a can-do attitude. A team building champion driving innovative cross functional synergies. Excellent project management and problem solving skills. Excellent computer skills; MS Office (Word, Excel, PowerPoint), Track wise, EDMS, Outlook. Knowledge of GDP, GMP, QA Documentation, QA Batch records, Quality Systems, Archiving, Retrieval, EDMS workflow, Document Life Cycle and Audit Compliance. The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates. About ProStaff Workforce Solutions We are a fast growing and successful agency that treats all its clients and candidates with a personal touch. ProStaff Workforce Solutions is a group of industry experts-many hailing from larger agencies-who know their business well and enjoy working in a more hands-on and flexible environment, with attention to detail. Our mission is to match quality people with quality jobs and quality companies to maximize productivity and profitability. We develop long-term relationships and provide a level of customer service and expertise that instill confidence and trust in our client companies and candidates. Our Values • Integrity • Commitment • Quality • Diversity Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities. #IND1

Buzz Clan is a business consulting company collaborating to provide Oracle and other software advisory services & implementation Services specialists by our Public & Private sector clients. We have been catering to wide-ranging technologies and platforms and have consistently been delivering the best available talent to Fortune 500 clients across different industry verticals and public sector clients of North America. I would like to discuss the opportunity with you. Please go through the job description and let me know if you are interested in applying for this position. Additional Information All your information will be kept confidential according to EEO guidelines.

Ventures Unlimited is a service centric organization. Our success begins with our ability to apply our relationships, leverage technologies, and identify talent - often in combination - to an endless array of real-world customer needs Job DescriptionTitle: Technical Writer Location: Hopewell, NJ Type: Fulltime// permanent Interview Process: Phone and Skype Hire Compensation: Base Salary + Benefits + Relocation expenses (if required) Start Date: ASAP Domain: Financial & banking Description: • The Technical Writer/Presentation Specialist will be a member of architecture team, helping to deliver technical solutions and strategies. • Bachelor's degree, or equivalent work experience • 5+ experience in creating presentation materials • 5+ years technical writing experience • Advanced PowerPoint skills • Analytical Thinking • Strong aptitude towards IT • “Eye” for design and creativity • Passion for learning new technology ideas/concepts • Strong ability to lead and collaborate • Advanced Excel skills • Basic Visio skills Responsibilities: • Produce high quality PowerPoint presentations • Translate ideas into easily digestible language/diagrams • Able to grasp high level technical concepts, then translate to laymen • Technical writing experience • Collaboration with technical teams to gather ideas • Creates many different types of documentation (IT strategies, Whitepapers, Technical diagrams) • Work directly with Senior Execs. • Sense of urgency, Well organized and routine updates. Qualifications• Bachelor's degree, or equivalent work experience • 5+ experience in creating presentation materials • 5+ years technical writing experience • Advanced PowerPoint skills • Analytical Thinking • Strong aptitude towards IT Additional Information Contact "Mohit Maurya" for more details at ************ Ext:141

The Business Analyst (BA) for EHS Technology acts as a critical link between DPR's EHS business function and technology and innovation (T&I). This role works closely with EHS, Data Engineering, Data Analytics, and other integrated workgroups to understand business processes, identify opportunities for improvement, and translate those needs into actionable system requirements. The BA ensures that technology solutions implemented by DPR's Construction Technology team are grounded in real-world business and operational needs to deliver measurable value in efficiency, visibility, and integration across the enterprise. Key Responsibilities Discovery & Analysis * Partner with teams to document current-state workflows, system touchpoints, and pain points across Environment, Health, and Safety processes. * Conduct interviews, workshops, and process reviews to understand workflows, integrations, and reporting requirements. * Identify and prioritize business requirements, translating them into clear functional and non-functional specifications. * Quantify process gaps and potential impacts using data-driven analysis and benchmarking. Solution Definition * Co-develop future-state process maps, data models, and system designs with internal team. * Translate business needs into user stories, use cases, or requirement documents for internal or external development teams. * Support "build vs. buy" analysis and vendor evaluations by defining functional fit and value alignment. * Participate in design sessions to ensure requirements are understood, feasible, and traceable through delivery. Implementation Support * Partner with Solution Architects and/or System Administrators to validate solution configurations against business requirements. * Support user acceptance testing (UAT) by developing test cases, coordinating participants, and documenting results. * Capture feedback from pilot implementations and contribute to iteration and improvement before full rollout. * Assist in the development of training materials and user documentation for end users and super users. Data & Insights * Help define data structures and reporting needs that enable visibility into enterprise EHS data. * Support the development of dashboards and KPIs in collaboration with System Administrators and BI teams. * Ensure data integrity and alignment across systems during transitions or integrations. Continuous Improvement * Monitor performance and adoption of implemented solutions, identifying opportunities for refinement. * Document lessons learned, process improvements, and reusable templates for future initiatives. * Participate in DPR's Project Controls & Assurance Integrated Work Group (IWG) to share learnings and align priorities across initiatives. Qualifications * 5+ years of experience in similar roles, ideally with exposure to construction and Environmental, Health and Safety. * Strong process analysis and documentation skills, including the ability to create process maps, swimlane diagrams, and data flow diagrams. * Experience gathering and translating requirements for EHS, RMIS, ERP, CRM or similar systems. * Familiarity with systems such as Power BI, Hammertech, Riskonnect, Autodesk Construction Cloud, CMiC, Workday, or comparable platforms. * Excellent communication, facilitation, and analytical skills with the ability to translate between technical and operational audiences. * Bachelor's degree in Business Administration, Information Systems, Data Analytics, Computer Science, or Communications preferred. Success Criteria * Clearly defined and prioritized business requirements that result in effective, scalable technology solutions. * Accurate and up-to-date process documentation supporting continuous improvement. * Strong alignment between business workflows and system functionality. * Positive feedback from users on clarity, usability, and impact of deployed systems. * Demonstrated contribution to measurable improvements in productivity, visibility, or data quality. In compliance with local law, we are disclosing the compensation, or a range thereof, for roles in locations where legally required. Actual salaries will vary based on several factors, including but not limited to external market data, internal equity, location, skill set, experience, and/or performance. Salary is just one component of DPR's total compensation package. Pay Range: $75,000 to $125,000. DPR Construction is a forward-thinking, self-performing general contractor specializing in technically complex and sustainable projects for the advanced technology, life sciences, healthcare, higher education and commercial markets. Founded in 1990, DPR is a great story of entrepreneurial success as a private, employee-owned company that has grown into a multi-billion-dollar family of companies with offices around the world. Working at DPR, you'll have the chance to try new things, explore unique paths and shape your future. Here, we build opportunity together-by harnessing our talents, enabling curiosity and pursuing our collective ambition to make the best ideas happen. We are proud to be recognized as a great place to work by our talented teammates and leading news organizations like U.S. News and World Report, Forbes, Fast Company and Newsweek. Explore our open opportunities at ********************

The company is a long time client - and the HR contact is someone I have worked with at various clients over a 15 year period. They are anxious to fill this role. Please note - The Client is not able to sponsor for this role. Job Description IT Business Analyst Are you passionate about leveraging technology to drive innovation? Join our team as an IT Business Analyst and play a pivotal role in transforming business processes through emerging technologies. 📍 Location: Hopewell, NJ (Hybrid) 🕒 Type: Full-Time | 5+ Years Experience 🔍 About the Role: As an IT Business Solutions Specialist, you'll collaborate with cross-functional teams to analyze business requirements and implement solutions that enhance efficiency and compliance. Your expertise in AI, RPA, and ML will be instrumental in automating processes and driving innovation within our pharmaceutical sales and distribution operations. 💼 Key Responsibilities: Analyze and document business requirements across finance, sales, distribution, and pricing. Design and implement AI, RPA, and ML solutions to automate and optimize processes. Develop and maintain dashboards and reports using tools like Microsoft Fabric BI. Ensure optimal configuration and integration of enterprise systems including SAP S/4HANA, Vistex, Tracelink, and Salesforce. Lead IT projects, manage timelines, and coordinate with internal and external stakeholders. 🎯 Qualifications: Bachelor's degree in Business Administration, Information Systems, Data Analytics, or related field. 5+ years of experience in business analysis, preferably within pharmaceutical sales and distribution (S&D). Proficiency in SAP S/4HANA modules, Vistex Revenue Management, and Microsoft Fabric BI. Experience with AI/ML platforms and RPA tools like UiPath or Automation Anywhere. Strong analytical, problem-solving, and communication skills. 🌟 Preferred Skills: Experience with data warehouse platforms and ETL processes. Familiarity with cloud services such as Microsoft Azure or AWS. Project management certification (e.g., PMP, Agile). Experience with predictive analytics and data-driven decision-making using ML models. 📩 Ready to Make an Impact? If you're ready to drive technological innovation within the pharmaceutical industry, we'd love to hear from you! Apply now and be part of our forward-thinking team. Please note - Candidates must be a U.S. Citizen or Permanent Resident.

The medical writer will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure. Key Responsibilities: Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs. Act as a member of clinical trial teams Follow and track clinical documentation milestones Write/edit other strategic documents, as required Required Qualifications: Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medical writer in the pharmaceutical industry PhD with at least 1 year experience as a medical writer in the pharmaceutical industry Excellent writing and effective communication skills Proven interpersonal, organizational and problem-solving skills in a matrix management environment. Knowledge of FDA and ICH guidelines Skilled in clinical data interpretation Proven experience writing/supporting major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.) Preferred Qualifications: Knowledge of drug development and regulatory requirements to guide document organization Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role. SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package. SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Artech Information System , a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you. Position: Medical Writer Location: Pennington, New Jersey-08534 Duration: 6 Months Job Description: Scientific Writer for Aggregate Reports: Coordinate and author documents needed for regulatory submissions (eg, CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members. Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents. Review and edit documents as required. Considerable experience in Assignment on Cross Functional Teams would be an advantage. Qualifications: PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator's Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs. Additional Information All your information will be kept confidential according to EEO guidelines.

Bioclinica is one of the leading global CRO company which focuses on bringing efficiency to the clinical trials. We have a premier global research network-and the only one with investigator sites in the U.S., Europe, Latin America, and Asia. We are headquartered in Doylestown, PA. Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. We serve more than 400 pharmaceutical, biotechnology, and device organizations Job Description The Medical Writer will be responsible for the creation and development of all study start-up documents such as the Site Manual and associated forms, as well any required Protocol Amendment Impact forms and Compliance Reports for the life of each study. The Medical Writer is also expected to provide guidance and support to the Clinical Project Management Team, including the review of Project-Specific Work Instructions and attending document-related Sponsor calls. Primary Responsibilities Performs study start up responsibilities by: Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels Creating, modifying and finalizing Image Quality Assessment/Photograph Quality Assessment (IQA/PQA) Summaries Creating, modifying and finalizing Quality Control (QC) Summaries Creating, modifying and finalizing Study Start-Up related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections and Deviation Reports Creating, modifying, and finalizing Key Points Documents (KPDs) from CRs Creating, modifying and finalizing paper Source Documents based on ToOs Creating, reviewing, modifying and finalizing MedComm Meeting Minutes Attending internal and external meetings relating to the Site Manuals, IQA/PQA/QC Summaries, CRs/KPDs, Source Documents and any other MedComm-related study start-up documents Running Scheduled Tasks for generating MedComm webpages Maintaining MedComm document webpages Checking MedComm webpages for errors Performing Project Close-outs as they occur based on receipt of Study Closure forms Reviewing and updating Charter Training Slides (CTS) and CTS quiz(zes) as needed Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, etc.) by filling out and collecting signatures on group training forms as required Manages the clinical study document development process by: Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled Providing guidance to assigned Project Teams and Project Team members Providing language updates, as required, for all MedComm document templates as needed Creating Final Effective documents Secondary Responsibilities Maintains Quality Service and Departmental Standards by: Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Updating department SOPs and Work Instructions as needed Assisting in establishing and enforcing departmental standards Contributes to team effort by: Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Participate in internal training activities Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by: Staying up-to-date on response criteria publications posted by Medical Communications Participating in Medical Writing Training activities, including creating/reviewing training modules Participating in Clinical Project Management Training activities, including creating/reviewing training modules Attending and participating in applicable company-sponsored training Qualifications Education: Bachelor's Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred Experience: 1+ years medical writing experience required 2+ years of experience in pharmaceutical/clinical/imaging research preferred Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access) Understanding and knowledge of medical and/or clinical trial terminology desired Additional skill set: Ability to work in a group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Organization and time management skills for managing multiple projects concurrently Additional Information Working conditions: Travel: 0-5% Lifting: 0-10lbs Other: Computer work for long periods of time EEO Statement Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic

Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link. Additional Information

Please, review and apply for this position through the QCI system following the link below (Copy and Paste): http://jobs.qcitech.com/jobseeker/Medical_Writer_J02141793.aspx *You can apply through Indeed using mobile devices with this link. Additional Information

THE COMPANY Octane Learning is a professional learning and medical communications agency, working exclusively for pharmaceutical, biotech, medical device, and healthcare companies. We advise on learning strategies and create the right experiences, including online study, virtual, in-person and hybrid workshops, reference resources, sales/corporate training events, and more. We also work strategically with clients to create medical education for and outreach to healthcare professionals (HCPs) so they can make informed decisions in their practices. As we are rapidly expanding and have an opportunity for a Scientific Writer/Content Specialist to join our team in Princeton, New Jersey. THE LOCATION This position requires work to be performed from our Princeton, NJ offices. THE WORK Reporting to the Director of Content and Strategy, you'll develop the content for: (1) several different styles of training, primarily interactive media such as eLearning, instructor-led courses/workshops, videos, and print resources; and (2) medical communications activities such as advisory boards, symposia, and speaker slide decks For these materials, within the constraints of our/clients' guidelines, you will: Review client's goals and strategy When appropriate, develop learning objectives, appropriate for the audience (role, level) Create or select content (medical, legal, regulatory) that is accurate and flows logically Apply general instructional design techniques, including (where appropriate) creating exercises and assessments, feedback, virtual meeting needs, ensuring materials are suitable for later translation, etc. Obtain and incorporate input and insights from clients, subject matter experts (SMEs), key opinion leaders (KOLs), and other team members Reference the content according to the established referencing standards Provide additional strategic support, such as attending and developing executive summaries from advisory board meetings Content spans life science company requirements, from medical to policy and procedures, compliance, etc. You'll be working primarily in Microsoft Word and Microsoft PowerPoint, often inside existing templates. You will work closely with internal team members to ensure successful project completion and delivery. You'll also collaborate with your colleagues in the creative and development departments to help deliver the content in a way that is most impactful for the learner. This may involve a casual conversation or a brainstorming session to generate new ideas for presenting the information. There will likely be opportunities for additional work in curriculum design, audit and gap analysis, content creation for marketing collateral, as well as learning strategy, as the workload presents, and your capacity/interest aligns. As our work is collaborative, it will be necessary to work from our Princeton, NJ office, with some flexibility. THE CANDIDATE You have a Masters or Doctoral degree in a medical/scientific discipline. You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus. You have the ability to convert scientific data into a clear, scientifically sound, well-structured 'story'. You are well-organized, with strong attention to detail. You have good presentation, communication, and interpersonal skills. You should have the capacity to: Work in a fast-paced environment, pivoting to the highest priority or client need Bring creative ideas to the presentation and delivery of content Faithfully execute written and verbal instructions and seek clarification, when needed Work within established timelines and our clients' regulated environments Attend project and client meetings, sometimes presenting your work Consider or explore the needs and perspective of your audience Speak your mind if you feel a project or process can be improved Learn new things and cultivate your capabilities as the workload may dictate THE FIT We are more interested in finding the right talent and attitude than the exact match to a list of skills and qualifications. We're looking for someone that is excited and motivated to learn new things in creating learning/training/medical communications resources in scientific, compliance, and regulatory areas. BENEFITS Retirement Plan Matching Medical Insurance Dental Insurance Vision Insurance Disability Insurance Paid Time Off

Moorestown

Full-time Description We are seeking a highly skilled and detail-oriented Technical Business Analyst to join our team at our Iselin, NJ location. The ideal candidate will be a bridge between our business units and technical teams, possessing a unique blend of business acumen and deep technical skills. This role is crucial for eliciting and documenting requirements, ensuring seamless development and integration, and providing ongoing support and analysis to drive business solutions. The successful candidate will have hands-on experience with SQL, Azure DevOps, and a strong problem-solving mindset. This is a full-time on-site position at our Iselin, NJ office. ESSENTIAL DUTIES AND RESPONSIBILITIES: Requirements Elicitation & Management: Elicit, analyze, and document business requirements from various stakeholders for new and existing projects. System Development Support: Work directly with developers to provide clarification on requirements, participate in unit testing, and offer feedback on development efforts. Quality Assurance & Testing: Assist with and participate in the testing of software integrations and RPA (Robotic Process Automation) implementations to ensure they meet business and technical requirements. Data Analysis & Troubleshooting: Perform root cause analysis and troubleshooting for reported issues from business units, including database investigation. Database & Scripting: Write and maintain SQL stored procedures and queries (INSERT/UPDATE statements) to support business operations and reporting. Reporting & Business Intelligence: Create, maintain, and support SSRS and Power BI reports to provide actionable insights to the business. System Maintenance: Create and maintain workflows within our proprietary case management system. Knowledge of BPMN a plus. Triage: Assist in the triage of incoming support tickets. REQUIREMENTS/SKILLS: Proven experience in a technical environment Strong proficiency in SQL, including writing complex queries, stored procedures, and performing data manipulation language (DML) operations Hands-on experience with Azure DevOps (ADO) for creating and managing work items, backlogs, and boards. Experience with SSRS and Power BI for report creation and data visualization. Experience in troubleshooting and root cause analysis of technical issues. Familiarity with software development lifecycle (SDLC) methodologies, including Agile/Scrum. Excellent communication, analytical, and problem-solving skills. Ability to work independently and as part of a cross-functional team. PREFERRED QUALIFICATIONS: Bachelor's degree in Computer Science, Information Systems, or a related technical field; or 5+ years Business Analyst experience Knowledge of RPA principles and implementation. Experience with Python and/or Powershell for scripting and automation is a plus. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit, talk, or hear. The employee is occasionally required to stand, walk, use hands to finger, handle, or feel; reach with hands and arms, and stoop, kneel, or crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. We offer a comprehensive compensation and benefits package, which includes a salary commensurate with your experience and accomplishments. If you possess the requisite qualifications and are seeking the challenge of working in a dynamic, growing firm, please submit your resume. **Because of the high volume of applications received, only qualified candidates will be contacted for consideration.** All applicants applying for U.S. job openings must be authorized to work in the United States. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the Firm. Salary Description $75,000-$90,000/Annually

Grant Writer - Jamesburg, NJ (Hybrid) Shift: Full-Time, Monday - Friday, 8:30 AM - 4:30 PM About Us: Operating in 21 counties throughout the state, Easterseals New Jersey offers various disability and mental health services to help people with various needs address life's challenges. Annually, Easterseals New Jersey serves over 4,000 individuals at our over 100 sites with direct services, advocacy, and education. We believe everyone, no matter their circumstance or level of ability, deserves the opportunity to increase their independence and achieve their goals. Focusing on ability over disability, our family of over 1,000 well-trained and passionate staff members works in partnership with individuals and families to bring equality, dignity, and opportunity. What You'll Do: The Grant Writer will focus on grant writing, revenue growth, and strategic collaboration by securing funding, managing grants, and identifying new revenue streams. They will work with internal teams to align funding priorities, develop proposals, and drive innovative partnerships. Key responsibilities include: Research and identify potential public and private grant opportunities aligned with Easterseals NJ's mission and program needs. Write, prepare, and submit compelling grant proposals, ensuring accuracy, completeness, and alignment with funder guidelines. Manage the full grant lifecycle, including proposal development, submission, follow-up, and reporting. Assist in identifying alternative revenue streams to expand Easterseals NJ's programs and services, including partnerships with corporate sponsors, community organizations, and other stakeholders. Research market trends, community needs, and competitor activities to identify opportunities for expansion and innovation. Assist in drafting business plans, program proposals, and financial projections for new initiatives. Work closely with program directors, finance, and marketing teams to ensure alignment of funding priorities with Easterseals NJ's overall mission and strategic goals. Who You Are: Education: Bachelor's degree in business, communications, nonprofit management, or related field (Master's preferred). Experience: 3-5 years of experience in grant writing, fundraising, or business development, with expertise in proposal development for social services, health, or disability sectors, and proficiency in data analysis tools to evaluate program outcomes and grant effectiveness. Requirements: Proven track record in securing grants and building successful business partnerships, along with expertise in government regulations and compliance for disability services and nonprofit funding. Skills: Exceptional written and verbal communication skills for crafting persuasive grant proposals and presentations, along with strong project management and organizational abilities to handle multiple projects and deadlines efficiently. What We Offer: Competitive Pay & Benefits - Including Medical, Dental, Vision, and Flexible Spending Accounts Employer-Paid Coverage - Life, AD&D, and Long-Term Disability Insurance Retirement Savings - 403(b) Plan with Employer Match Generous Time Off - Paid Time Off, Holidays, Medical Leave, and PTO Buy-Back options Convenience & Support - Direct Deposit, Payroll Cards, Mileage Reimbursement, and Employee Assistance Program Wellness & Recognition - Wellness Program, Referral Bonuses, and a Recognition Program Training & Development - Paid Orientation and Ongoing Training Easterseals NJ provides a comprehensive benefits package. For full details, visit ******************** Easterseals Is An Equal Opportunity Employer As one of our core values, we strive to provide equal opportunity to all of our employees without regard to their age, gender, religion, race, color, national origin, marital status, sexual orientation, or disability which is unrelated to the ability to perform essential job functions, unfavorable military discharge (except dishonorable), veteran status, marital status, parental status, genetic information, source of income or other legally protected categories in accordance with applicable law with regard to receipt of services, appointment or election to voluntary office or hiring for, assignment to, or promotion in staff positions.

At MJH Life Sciences our success is measured by your success! If you set your standards high and want to contribute to a winning team, we'll provide you with every opportunity to help grow our company and your career. Our associates come from all backgrounds, sharing one key quality: determination to succeed. We value being Service Focused, having a Passion for Winning, Innovation, Respect, Integrity, and Teamwork. Nothing means more to us than hiring people with these attributes. If you believe you're right for the job, this is the place to prove it! As a Medical Writer with the Enterprise Content Team at MJH Life Sciences , you will play a vital role in developing educational content for healthcare professional audiences. This position offers the opportunity to work on a wide range of projects, including discussion guides, slide decks, and video-based tools, while collaborating with leading experts across diverse fields. Your work will contribute to creating high-quality, scientifically accurate content that helps improve patient care outcomes. Key Responsibilities: · Conduct extensive literature reviews on various disease states, therapeutic advancements, and clinical data. · Comprehend and apply relevant evidenced-based medical literature, clinical practice guidelines, and disease-state information for the development of content across various therapeutic areas (eg, identify levels of evidence, clinical trial data, clinical utility of therapeutic choices and unmet needs in treatment landscapes, product-specific education) · Develop relevant, accurate, and high-quality content for digital, print, video, and event deliverables, ensuring adherence to in-house and AMA style guidelines. · Write, edit, and revise content independently throughout the project lifecycle, incorporating feedback from faculty, internal teams, and other stakeholders. · Ensure the scientific and clinical accuracy of all materials through comprehensive fact-checking of referenced literature. · Attend professional conferences and events to capture key presentation highlights and create content for project deliverables (minimal travel required; 2-3 days per month). · Collaborate effectively with cross-functional teams, including internal professional services, to ensure project success. Interface regularly with clients, key thought leaders, and faculty during meetings and project discussions. Compensation Range: $55,000- $60,000 per year, depending on qualifications. Eligible for annual company bonus program or commission incentive based on role. The compensation offered to the candidate selected for this position will depend on several factors, including the candidate's educational background, skills, and professional experience. Benefits Overview: We're proud to offer a comprehensive benefits package, including: Hybrid work schedule Health insurance through Cigna (medical & dental) Vision coverage through VSP Pharmacy benefits through OptumRx FSA, HSA, Dependent Care FSA, and Limited Purpose FSA options 401(k) and Roth 401(k) with company match Pet discount program with PetAssure Norton LifeLock identity theft protection Employee Assistance Program (EAP) through NYLGBS Fertility benefits through Progyny Commuter benefits Company-paid Short-Term and Long-Term Disability Voluntary Term Life & AD&D Insurance, plus Universal Life Insurance options Supplemental Aflac coverage: Accident, Critical Illness, and Hospital Indemnity Discounts and rewards through BenefitHub #LI-Hybrid MJH Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. All employees of MJH Life Sciences are employed “At Will.” This means that either the employee or the Company is free to end the employment relationship at any time, for any reason, with or without cause and with or without notice.