Medical writer jobs in New Jersey

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Medical Editor (Healthcare / Life Sciences) | Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data is seeking a detail-driven Medical Editor to ensure the quality, accuracy, and consistency of all client-facing materials. This role upholds the highest editorial, brand, and compliance standards expected across the healthcare and pharmaceutical industry. The ideal candidate has hands-on editorial experience, thrives in a fast-paced environment, and is deeply familiar with AMA style, medical terminology, and client-specific editorial requirements. About the Role The Medical Editor will review, refine, and finalize a wide range of healthcare and scientific materials, including learning and development modules, medically accurate promotional content, disease-state and product white papers, resource guides and other managed markets materials, and both short-form and long-form copy. This role focuses on editorial accuracy, consistency, and layout integrity, working closely with copywriters, designers, account strategy leads, and the broader team to ensure all materials meet agency and client expectations. This is a quality-focused position: you will be responsible for proofreading, editing, implementing corrections, and ensuring assets are fully aligned with client standards and industry requirements. Key Responsibilities Editorial Quality Control Proofread and edit materials for grammar, clarity, consistency, spelling, and accuracy. Apply AMA Style rules and required client-specific editorial standards. Verify medical terminology, numeric values, units, symbols, and data formatting. Ensure accuracy of references, superscripts, and citations, and support preparation of materials for MLR review when required. Brand & Compliance Consistency Ensure content meets each client's editorial style, tone, and branding expectations. Review PI/ISI placement and accuracy when applicable. Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review documents and slides to ensure clean, consistent formatting and layout. Confirm alignment between copy and design elements (tables, charts, visuals, callouts). Identify inconsistencies in spacing, bullets, alignment, and overall presentation. Process & Workflow Execution Manage editorial checkpoints across multiple concurrent projects. Collaborate closely with account strategy leads and the creative team to meet deadlines. Implement QC edits directly within documents. Ensure that all internal edits, client feedback, and MLR-directed changes are accurately incorporated into updated versions and consistently carried through across all files. Ensure that version control, file naming, and document preparation adhere to established agency processes. Serve as the final quality assurance step before client delivery. Requirements Minimum 3 years of editorial or proofreading experience in a healthcare agency or pharmaceutical company setting. Strong knowledge of AMA style and client-specific editorial requirements. Ability to manage multiple projects simultaneously and meet tight deadlines. Experience reviewing medical or scientific content with a strong understanding of pharma-level accuracy requirements. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision. Strong communication skills and the ability to work collaboratively with cross-functional teams. Education Bachelor's degree in English, Communications, Journalism, Life Sciences, or a related field. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process Please send your resume to *******************. Writing or editing samples may be requested during the interview process.

We seek an experienced, detail-oriented Content Editor to join our content team at iQuanti. The Content Editor will be responsible for reviewing and editing content across various client projects, ensuring the highest quality standards, accuracy, and alignment with client specifications. This role will require expertise in the BFSI (Banking, Financial Services, and Insurance) sector, with the ability to review and refine content in multiple formats. As a key part of our content team, the Content Editor will work closely with writers to provide clear, actionable feedback and ensure that all content meets or exceeds iQuanti's editorial standards while aligning with client expectations and brand guidelines. The ideal candidate will have a sharp eye for detail, strong editorial skills, and a deep understanding of communicating complex financial topics clearly and engagingly. Key Responsibilities: 1. Content Review & Editing • Review and edit a wide variety of content types, including blog posts, rich media assets, video scripts, and website copy. • Ensure content is grammatically correct, free from spelling or typographical errors, and adheres to iQuanti's editorial standards. • Line edit to focus on structure, flow, clarity, and conciseness while maintaining the content's original intent. 2. Fact-Checking & Accuracy • Fact-check all content to ensure accuracy, including verifying statistics, data, quotes, and other factual claims. • Ensure sources are credible, up-to-date, and meet the client's approval criteria. • Collaborate with writers to resolve any discrepancies or inaccuracies in content. 3. Client Alignment & Brand Consistency • Ensure all content aligns with client expectations, style guides, and feedback. • Maintain strong communication with clients (via account managers or directly) to clarify expectations and incorporate feedback into content revisions. • Adapt content to suit different clients' specific industry requirements, particularly in the BFSI sector. 4. Content Feedback & Writer Development • Provide writers with constructive, clear, and actionable feedback to help them improve their skills and ensure content quality. • Collaborate with the content team to address recurring writing issues or content trends that need improvement. • Assist in onboarding and mentoring junior writers, offering insights into industry best practices and writing techniques. 5. Quality Assurance • Ensure that all content that is produced meets iQuanti's high editorial and quality standards. • Review content for consistency and ensure it aligns with SEO best practices where applicable. • Perform additional quality checks as needed, ensuring final deliverables are polished and ready for client review or publication. Preferred Qualifications: • 3-5 years experience editing content in the BFSI (Banking, Financial Services, and Insurance) sector. • Strong background in editorial roles, with a proven ability to work across various content formats. • Exceptional attention to detail, with the ability to catch grammar, spelling, and factual errors. • Strong knowledge of SEO best practices and how they apply to content creation and editing. • Ability to adapt to different client voices, preferences, and brand guidelines. • Excellent communication skills, with experience providing clear and constructive feedback to writers. • Familiarity with content management systems (CMS) and project management tools is a plus. • Bachelor's degree in English, Journalism, Communications, or related field (or equivalent experience). Salary - $60K - $70K

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Create documents pertaining to clinical data to support product development, license application, and post-marketing maintenance, on behalf of and in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization (new drug) applications (Clinical Overviews and ICH module 2.7 clinical summaries), and responses to clinical and safety questions from regulatory authorities. • Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents. • Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. • Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project. • Support clinical teams by providing analyses of clinical data, reviews of the medical literature, and similar related activities. Responsibilities • Communicate clinical's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. • Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. • Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. • If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. • Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. •Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. • Develop and sustain constructive relationships within other Pharmaceutical lines including country organizations. • If assigned by manager, serve as the clinical 'point of contact' for all document issues for a given product or set of products. • Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line. Position Comments visible to MSP and Supplier: Additional Skills:Technical Skills: • Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively. • Analytic skills. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them. • Oral presentation skills. Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences • Language skills. High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset. • Personal skills. Strong organizational skills and ability to prioritize multiple projects and meet deadlines. • Interpersonal skills. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors. • Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data. • Software. Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred. • Statistics. Proficiency with statistical concepts Additional Information Regards, Anuj Mehta ************

The Medical Writer in client Medical Pharmaceutical Systems Medical Affairs is responsible for the generation and development of documents relating to Clinical and Human Factors assessments, evaluations and post market surveillance summaries. Within this role, the Medical Writer will write and update Clinical Development Plans, Human Factor Engineering (HFE) Reports and other associated clinical and Human Factors (HF) documents. The medical writer is a pivotal role to ensure compliance with associated regulations and pivotal in ensuring that there is available evidence to support the safety and performance of the products designed, produced and manufactured by the company. The Medical Writer will perform and document systematic literature reviews, critically evaluate identified data, and will interface with various members of the Medical Affairs team and with cross-functional team members in order to achieve high-quality clinical and Human Factors documents. The Medical Writer is also responsible for the development or review of study-related documents, including Clinical and Human Factors study executive summaries and related power point presentations. The Medical Writer will be an integral part of the global Medical Affairs team and will collaborate with Medical Affairs leaders, Clinical and HF program leaders, Clinical and HF specialists and other key associates. The Medical Writer is also responsible for optimizing processes for clinical evaluation and investigation as they relate to medical writing. This role requires great familiarity and application of the associated regulations and guidance, including MDR (2017/745), MDD, MEDDEV 2.7.1 Rev. 4 and other MEDDEV guidances, ISO 14155, 21 CFR 812. This role will report to the Associate Director, Medical Affairs in Franklin Lakes, NJ. Job Functions: Create and update Clinical Development Plans in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR. Contribute to the Summary of Safety and Clinical Performance in alignment with EU MDR. Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as any ad hoc reports required. Develop and manage CER project plans and timelines. Serve as a subject matter expert on clinical aspects of Technical documentation. Analyze available clinical evidence (data held by the manufacturer, published literature) to assist the Medical Affairs team with clinical development strategy. Write and or edit clinical documentation, including but not limited to clinical development plans, HFE reports, Health Hazard Evaluations. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution. Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals or congresses. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. Write and/or contribute to abstracts and submissions of clinical and HF data to various medical device congresses or symposia. Work with Medical Affairs and cross functional associates to ensure high quality submissions and data integrity. Contribute to the development and optimization of Medical Affairs SOPs. Support and assist Medical Affairs team members in the generation of effective visual and written communication. Required Knowledge, Skills and Abilities Strong interpersonal and communication skills. Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives. Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions. Outstanding oral and written communication skills. Proven experience performing literature reviews, analyzing data and communicating outputs. Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role. Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review tools a plus. Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidances, including 2.7/1 Revision 4 and 2.12/2 Revision 2, ISO 14155, ICH guidance including E3 CSR, E6 (R2) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO 14971). Familiarity with FDA guidance documents related to Human Factors Engineering. Demonstrated ability to work independently and as part of a team. Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines. Ability to work with a minimum of supervision. Ability to work in a team environment. Advanced skills using Microsoft Office products such as Outlook, Word, Excel and PowerPoint. Minimum Requirements: Bachelors in a relevant discipline required. Master's degree or PhD preferred 3 years of experience as a medical writer 3 years direct experience working on clinical evaluations within the Medical Device industry. Medical writing certification a plus Experience: literature search engines PubMed, Embase: 1 year (Required) ISO 13485 and ISO 14971: 1 year (Required) EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance: 1 year (Preferred)

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. As a key member of our Clinical Development Team, the Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums. Job Description * Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical and clinical studies. * Prepares clinical reports, summary documents, investigator's brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation. * Works collaboratively, contributing to cross-functional teams and projects. * Develops and drives detailed project timelines according to team-specified deadlines. * Assists in the development of formats and guidelines for clinical documentation. * May prepare scientific manuscripts, abstracts and posters. * May also support clinical research associates and medical doctors in clinical protocol development. * Proactively keeps abreast of professional information, trends and technology through conferences, networking and other information sources and brings forward innovative ideas for consideration. * Perform other duties as assigned. Qualifications * BA/BS required; preferably in a related scientific discipline. * Advanced scientific degree (MS, Pharm D, PhD) is preferred. * 2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (e.g., pharmacokinetic and toxicology summaries and investigator brochures). * Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences. * Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs. * Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed. * Strong project management skills; ability to multitask while driving towards critical deadlines on all projects. * Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. * Excellent written/oral communication skills. Good interpersonal skills; able to establish rapport with all functional leaders, experts and colleagues. * Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions. * Willingness to travel, though travel is likely infrequent. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Job type: Full time About you: Sanofi is seeking a highly organized, detail-oriented Medical Writer to join our team. In this role, you will develop regulatory-compliant clinical documents supporting our product lifecycle while embracing innovative digital solutions. The ideal candidate will possess excellent communication skills, regulatory acumen, and the ability to work independently on multiple projects within tight deadlines. You should have an in-depth understanding of medical terminology and the ability to interpret complex data for various stakeholders. We are looking for a creative and passionate candidate eager to contribute to our mission of developing innovative solutions to improve people's health and well-being. Main responsibilities: Document Development - Create high-quality regulatory-compliant clinical documents supporting product life cycle - Ensure timely delivery while maintaining compliance with company SOPs and guidelines Innovation - Support implementation of new digital technologies and AI solutions - Participate in process improvements for efficiency gains Regulatory Expertise - Prepare clinical documents for registration dossiers and Health Authority responses under guidance - Maintain awareness of regulatory documentation requirements Communication - Work effectively with cross-functional teams - Update relevant stakeholders on project progress and needs - Maintain accurate information in planning, tracking, and reporting tools Coordination - Oversee writing activities from vendors - Review vendor deliverables Quality & Training - Ensure consistent document style and adherence to company standards - Build effective relationships with stakeholders and partners Knowledge Core Experience: Minimum 1 year as medical writer or equivalent experience in Clinical Research preferably in pharma Ability to clearly, accurately, and concisely write/prepare clinical documents in English Experience in preparing clinical documents and regulatory submissions Clinical Development Knowledge: Basic understanding of clinical development processes Knowledge of clinical study methodology and basic statistics Familiarity with regulatory environment and medical terminology Proficient in document management systems and authoring platforms Professional Attributes: Strong attention to detail and deadline management Strong organizational and follow-up abilities Ability to work independently and in global teams Technical skills: Proficiency in electronic document management and Microsoft Office Interest in implementing emerging innovative digital technologies, including AI-assisted document authoring solutions. Education: Advanced scientific degree in life sciences, PharmD, or medical qualification (MD, clinician, nurse practitioner) Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $100,500.00 - $145,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The applicant should have experience using risk management methodologies, tools, incorporate appropriate data and information, and conduct risk calculations. The applicant must understand pharmaceutical and/or device manufacturing processes, design controls, and be able to lead and conduct FMEAs. Specific experience with user/design/process FMEAs for medical devices is desirable. A minimum of Five (5) years experience is required. The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. The applicant must have experience in leading and facilitating teams to finalize reports with approvals per standard operating procedures. The incumbent will work with medical, technical, manufacturing, and quality groups to develop Product Risk Assessments by conducting risk analysis for pharmaceutical products. Job Responsibilities include: • Collate appropriate and pre-populating the document based on product information, patient/user information, and other supporting documents. (the incumbent should have the ability to search these documents, understand the process and extract required information) • Ensure proper formatting, proof read, and route for approval in documentation system. • Maintain and update project status in Microsoft Project, excel. Key Decisions: • Participates in decisions and provides input and prepares product risk management reports regarding the adequacy, accuracy, interpretation, and clarity, and final decisions made by the project team. • Consults with appropriate groups (as required) regarding the acceptability of documentation Key Competencies: Project Management Organization and Time Management Communication (Verbal, Written, and Interpersonal) Qualifications Education/Experience Requirements: • Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry • OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience • Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory • Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required. • Excellent English, writing and oral presentation skills is mandatory • Prior experience with Pharmaceutical Industry is mandatory • Prior experience managing projects is preferred Job Description: Write technical materials, such as SOP's, appendices Additional Information Duties and Responsibilities: • Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology. • Maintain records and files of work and revisions • Edit, standardize, or make changes to material prepared by other writers or establishment personnel • 2+ years experience as a Technical Writer • 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team • Proofing/preparation of documentation

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

Job Description 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 degree or minor in a scientific discipline. You are proficient in PowerPoint and Word, with excellent writing and editorial skills - an English degree or minor is a plus. 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 Powered by JazzHR 2cmcHDJaIx

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 Associate Medical Writer will aid and support to the Clinical Services team on aspects of writing, revising, and annotating promotional medical content. This role will also assist with identifying supporting documentation, organizing references, checking accuracy of cited information, and evaluating literature for appropriate references. The Associate Medical Writer may also be responsible for development of writing projects under direct supervision. Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list) Support the development of high quality, medically accurate derivative content in print or digital format for a limited range of medical communication resources Deliver requested projects per established time lines Assist with literature review to support promotional claims in a variety of promotional medical education and marketing resources Annotate resources and provide appropriate references for Clinical Services team Search, organize, and prepare references and referencing materials for projects to prepare for medical, regulatory, and legal submissions Ensure professional, proactive, and collaborative communication with internal stakeholders Ensure a constant high quality of work in line with science, good publication practice, and company rules and policies Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Develop working knowledge of AMA-style and brand guidelines Promote and adhere to Precision Value and Health's workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration) Required Education: BA/BS in life sciences BA/BS in English combined with 1 year of experience in a pharmaceutical agency, medical communications company or healthcare advertising. Required Experience: 0 - 1 year of experience in the medical communication, pharmaceutical and/or healthcare industry. Required Skills: Knowledge of American Medical Association (AMA) style Proficiency in Microsoft Word, Microsoft PowerPoint, and Adobe Acrobat Familiarity with scientific search engines including PubMed and Google Scholar Required Competencies: Strong written and verbal communication Analytical ability Ability to prioritize deadline-sensitive projects and juggle competing client priorities Team- and detail-oriented Preferred Qualifications: Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.) Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $52,000 - $72,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. This is Direct Hire Position with one of our Clients Job Description- • The Author will provide medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. • This will be achieved by applying analytical skills, functional literacy and expertise in document preparation. • The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator's Brochure, the Annual Safety Report and regulatory briefing documents. • Individual will create and foster an environment of partnership with other members of product teams, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors. RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Author documents such as agency briefing documents, key sections of the Investigator's Brochure, the Annual Safety Report and the core data sheet. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables). • Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management. • Serve as the point of contact (“go to” person) for one or more projects or products. • Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents Technical Skill Requirements: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to think creatively and to develop strategic plans that demonstrate sound judgment. • Exhibits sound project management and time management skills. • Able to interact effectively with all levels/roles of project team members. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise. • Is able to implement systems and processes and suggest process improvements. • Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines. • • Able to complete and turn around high quality outputs with only minimal guidance from management Qualifications • Scientific/medical academic background (e.g. PharmD/PhD or MSc/BSc with experience), or equivalent. • BS degree and 1 or more years of pharmaceutical experience preferred. • An advanced degree preferred and at least 3 years medical writing experience and /or experience in pharmaceutical development. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and non-scientific audiences. • Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Able to clearly articulate scientific and clinical data in all written and verbal communication. • May include a track record of leadership abilities either as a direct supervisor or within a matrix setting Additional Information

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.

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines. Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate. Help to iteratively improve medical writing processes as appropriate. Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations. Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues. Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope. Qualifications Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing. Substantial clinical study protocol writing experience desired. Excellent communication, presentation, and project management skills. Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines. Working knowledge of statistical concepts and techniques. Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results. Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus. Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred. Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

The Medical Writer will primarily work on the development and delivery of high-quality documents such as Clinical protocols, protocol amendments, Investigator's Brochures (IBs), non-clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed-upon timelines. Education and Credentials Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment Bachelor's degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.) Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus. Skills Ability to work independently and collaboratively in a team environment consisting of internal and external contributors Experience in managing multiple projects simultaneously Excellent problem-solving skills with the ability to adapt to changing priorities and deadlines. Excellent interpersonal skills and ability to work with cross-functional teams to meet business objectives. Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe Ability to develop document templates for ongoing and future submissions depending upon the scope of the project. Ability to pivot from one project to another and multitask Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas Ability to move efficiently in a dynamic environment Excellent verbal and written communication and listening skills. Highly proficient with Microsoft Office. Effective time management Bilingual in Mandarin and English is not required, but will be a plus Responsibilities Prepares, edits, and finalizes various documents, medical and technical from non-Clinical / pre-clinical to Phase IV studies. Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing). Collaborates with cross-functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents. Participates in all necessary cross-functional document development meetings (i.e., kick-off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders. Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables. Monitors regulatory, clinical/medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents. Provides editorial or review support for other types of documents as requested. Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 5+ years of clinical research experience Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsContract - $60+/hr.

Period of Performance: Part-time, maximum 30 hours per week, within a three-year contract term starting on or about January 1, 2026 Work Environment: Onsite work required on an as-needed basis Citizenship Requirement: Must be a U.S. citizen Company Overview: About Enlightened: Enlightened is a leading provider of IT and federal program support services, committed to delivering innovative solutions and ensuring mission success. Position Overview: Enlightened is seeking a highly motivated Grant Researcher / Grant Writer. The Grant Researcher / Grant Writer identifies, evaluates, and pursues grant opportunities that support the Port Authority's security initiatives. The role includes researching funding programs, coordinating with internal stakeholders, and preparing clear, compliant grant applications and supporting materials. Key Responsibilities Monitor and research federal, state, and other grant opportunities related to homeland security and critical infrastructure protection. Analyze eligibility and requirements and advise leadership on which opportunities best fit agency needs. Draft, organize, and edit grant applications, narratives, budgets, and required attachments, and coordinate reviews and approvals. Support post-award activities, such as responding to funder questions, assisting with amendments, and preparing required progress documentation. Required Qualifications: Bachelor's degree, preferably in Accounting, Business, Finance, Public Administration, or five (5) years of comparable experience. Strong research and writing skills, with experience in grant writing or grant program administration. Familiarity with federal, state, or local grant processes, particularly homeland security-related programs such as UASI and general reimbursement programs. Minimum of three (3) years of experience managing grant awards, including completing required financial reporting and monitoring project costs, schedules, and budgets. Strong financial analysis, budgeting, and reporting skills, with experience in grant administration or grant-funded programs preferred. Excellent organization and attention to detail, with the ability to manage multiple grants and deadlines. Must be a U.S. citizen. Support post-award activities, such as responding to funder questions, assisting with amendments, and preparing required progress documentation. Benefits: Actual compensation will be determined based on experience and qualifications as well as internal equity and alignment with market data. At Enlightened, we pride ourselves on offering a comprehensive and industry-competitive benefits package to our full-time employees. Our benefits include: Medical/Dental/Vision Insurance with Health Savings Accounts (HSA) Flexible Spending Accounts (FSA) 401(k) Retirement Plan Paid Holidays, Vacation, & Sick Leave Professional Training & Development Reimbursement Please note, these benefits are available exclusively to full-time employees of Enlightened. Equal Opportunity Statement : Enlightened is proud to be an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, disability, or any other federal, state, or local protected class.

Starting at $55,850 MAJOR FUNCTIONThe Grant Writer will be part of the grants department to raise money for the organization's mission. The Grant Writer will search for available grants and research their requirements to find opportunities that align with their organization's mission. Before applying for a grant, Grant Writers will communicate with company leadership to confirm that they are interested in collaborating with the foundation or company offering the grant. After the research phase, Grant Writers prepare several drafts using persuasive language and facts about their organization to explain why they should receive funding and how they would use the money.ESSENTIAL FUNCTIONS Study and understand the history, structure, objectives, programs and financial needs of the organization. Research grant opportunities from government and non-government agencies. Draft grant proposals and supporting documents based on the funding requirements of the organization. Submit proposals to grant coordinators for approval. Respond to internal and external queries on drafted and submitted proposals. Maintain positive relationships with fund providers and other stakeholders. Maintain records and submit reports related to grant opportunities. Assist in the collection of data needed for required grant/contract reports and the creation of reports. Experience with basic financial management skills including developing and monitoring budgets and financial reporting. Work directly with program leaders and Quality Department staff to track grant outcomes in relation to funding requirements. Provide training to new staff on grants management and reporting requirements. Ability to work within a team and support staff. Demonstrate initiative and teamwork in all activities. Other duties as assigned. OTHER FUNCTIONS Support regular staff team meetings and other meetings with scheduling, preparing agendas and materials, facilitating and/or notetaking. EDUCATION & EXPERIENCE Bachelor's degree in English, communications, creative writing or a related area A minimum of two years' experience in grant writing A master's degree is preferred. KNOWLEDGE, SKILLS, ABILITIES AND OTHER Proficiency with Microsoft Office, video Conferencing platforms, and or other database programs a must. Ability to handle sensitive information with confidentiality and respect. High level of accuracy and attention to detail. Excellent knowledge of proposal submission and fundraising process Ability to study and understand programs and funding requirements of the organization Strong research skills and knowledge of information sources Multitasking, organizational and time management skills Ability to handle confidential matters with utmost integrity Working knowledge of computers PHYSICAL & WORK REQUIREMENTS The person in this position needs to occasionally move about inside the office, inside the facility, and occasionally between facilities as needed to perform essential job functions. The person in this position constantly operates a computer and other office productivity machinery, such as a phone or cellular device. The person in this position frequently communicates with employees, senior management, and/or other individuals, so they must be able to exchange accurate information in these situations. Generally, the working conditions are good with little or no exposure to extremes in health, safety hazards and/or hazardous materials.

iFLIP4 is the brand and network for people who care. Our brand, called The Charitable Brand, donates over half of its profits to the charity of your choice. Our network is the place you go to learn about the issues that plague our planet, and to discover the solutions to them. iFLIP4 educates. It inspires. It empowers, all in the name of the world's greatest causes--and the best part: it's driven by you. Pre-launch, we have been featured in the New York Post, and we were unanimously selected to receive the C.V. Starr Social Entrepreneurship Fellowship. iFLIP4.com has been accessed in 100+ countries, and we have hundreds of iFLIP4 Ambassadors (campus representatives) on 45 college and high school campuses in the US, UK, and Canada. Job Description We want to change the world. We're a team of fast-executing social entrepreneurs on a mission to build the future of social change. We're looking for a visionary editor who wants to use multimedia content to change lives, change minds, and equip our generation with tools to change the world. You will be in charge of one of the most integral parts of iFLIP4: content. From articles to videos to interviews to games, iFLIP4's content educates, empowers, fosters discussion and inspires action. We don't want someone who will just say yes and implement every little thing we ask for. What we want is a partner. Someone to bounce ideas off of, someone with a vision for the future of our company, and someone who has the desire and drive to make it a reality. KEY RESPONSIBILITIES Conceptualize and execute iFLIP4's editorial strategy Recruit, train and manage a national network of part-time editors, correspondents, and freelance writers to produce groundbreaking multimedia content Write, copy-edit, code, schedule editorial content, and tailor headlines for social media and SEO Analyze performance metrics for web content and evaluate or change editorial strategy based on findings Work hand in hand with other members of the Core Team to create and distribute innovative content campaigns Qualifications Excellent writing and editing skills Experience recruiting and managing volunteer writers and editors Online content production experience, including knowledge of basic HTML and Content Management Systems (CMS) You understand the type of content Millennials want and how they will interact with it You have a desire to use your leadership, creativity and passion to change the world Additional Information This position will begin as part-time at about 15 hours/week with a small stipend. As we grow and complete our Angel round of funding, we will address expansion to a full time position with a full salary and vested equity. We are located in East Hanover, NJ, and telecommuting is fine with us. If you're responsible, driven, and innovative, we want to hear from you! Preference will be given to those who apply earliest.

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.