Medical writer jobs in Greenburgh, NY

Our team members are the heart of what makes us better. At **Hackensack Meridian** **_Health_** we help our patients live better, healthier lives - and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change. The **Medical Writer Clinical Trials** is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas into protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. This role will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity. **Education, Knowledge, Skills and Abilities Required** : + Bachelor's degree in a scientific or medical discipline. + Minimum of 5 or more years of experience in clinical healthcare environment. + Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations. + Strong attention to detail and customer service focus is required. + Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills. + Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential. + Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations. + Mandatory education on human subject research and GCP (CITI Training and Certification). + Possesses beginning to working knowledge of subject matter. + Excellent written and verbal communication skills. + Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms. **Education, Knowledge, Skills and Abilities Preferred** : + Higher Education Degree (M.S., PhD, MD). + Knowledge of clinical trials and the regulation (local, state, and federal) of such. + Familiarity with basic scientific and healthcare principles and terminology. If you feel that the above description speaks directly to your strengths and capabilities, then please apply today! 171405 Minimum rate of $63.05 Hourly HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package. The starting rate of pay is provided for informational purposes only and is not a guarantee of a specific offer. Posted hourly rates may be stated as an annual salary in the offer and posted annual salaries may be stated as an hourly rate in the offer, depending on the level and nature of the job duties and credentials of the candidate. The base compensation determined at the time of the offer may be different than the posted rate of pay based on a number of non-discriminatory factors, including but not limited to: + Labor Market Data: Compensation is benchmarked against market data to ensure competitiveness. + Experience: Years of relevant work experience. + Education and Certifications: Level of education attained, including specialized certifications, credentials, completed apprenticeship programs or advanced training. + Skills: Demonstrated proficiency in relevant skills and competencies. + Geographic Location: Cost of living and market rates for the specific location. + Internal Equity: Compensation is determined in a manner consistent with compensation ranges for similar roles within the organization. + Budget and Grant Funding: Departmental budgets and any grant funding associated with the job position may impact the pay that can be offered. Some jobs may also be eligible for performance-based incentives, bonuses, or commissions not reflected in the starting rate. Certain positions may also be eligible for shift differentials for work performed on evening, night, or weekend shifts. In addition to our compensation for full-time and part-time (20+ hours/week) job positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits. HACKENSACK MERIDIAN HEALTH (HMH) IS AN EQUAL OPPORTUNITY EMPLOYER All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.

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

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications Clinical data checking, consistency checking, and editorial review Occasional travel to either Pearl River or Collegeville site for team meetings. 3-5 years BA/BS Additional Information $46/hr 12 months

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.

Infojini Consulting is a full service IT consulting, services, and staffing firm with offices in Secaucus, NJ. Infojini Consulting is recognized as one of the fastest growing IT services and software development Companies. With a partnership of all major technology vendors, Infojini Consulting has built a strong Government and commercial customer base including fortune 100 companies and most state and federal agencies such as State of North Carolina, State of South Carolina, State of Maryland, State of California, State of Pennsylvania, State of Virginia, State of Washington and many others. Infojini Consulting is an equal opportunity employer and considers all qualified individuals for employment irrespective of their race, gender, age, color, sexual orientation. We offer an excellent compensation package Job Description We are looking for Proposal Writer for our office in Secaucus, NJ Please let me know your interest. ASAP Who We Are: Infojini, Inc. is a 3 time award winning company for Fastest Growing in 2014 from Inc.5000, SmartCEO, and Baltimore Business Journal. We are a Maryland Small Business Enterprise, MDOT Certified MBE, IT Service and Staff Augmentation provider in the Baltimore, MD region with a successful track record of 8 years, providing IT Services to our clients. Why Join the Infojini Team? Do you want to be a part of something that's more than just your average job? Infojini is committed to the success of its employees because we believe in the power of a culture based on recognition, collaboration, diversity and a positive work environment to drivebusiness growth. Here at Infojini we are a small business which means you are not just a face in the crowd, you are Infojini. What you do here, WILL matter! This position will receive a base salary commensurate on experience + the opportunity to earn much more with the added sales commission and bonus incentive plan. We have no cap! This position is also eligible to receive Health, Vision and Dental benefits, flex hours, and paid time off. Who we're looking for? Are you an outgoing, well-spoken, polished outside sales professional with a strong desire to succeed? We want you to join our Corporate office in Linthicum Heights, MD! You will be responsible for IT Service Solutions and Staff Augmentation outside sales to build relationships and new business with Commercial clients. The ideal candidate will have experience in Business Development, Staff Augmentation and IT. We are offering an exciting and challenging role building new and lasting relationships with clients across the country, and we hope your first and longest lasting relationship will start with us! Qualifications Qualifications Skills and/or Experience: · Excellent writing and editing skills · Professional experience as a technical, proposal or business writer, preferably with experience supporting sales, marketing and/or proposal departments · Fresher's are also Welcome. Training will be provided. · Ability to write strategic content that addresses client challenges with real-world solutions presented persuasively · Ability to effectively write for multiple projects and varying audiences at the same time · Ability to assess technical requirements and effectively communicate with business and technical experts · Excellent research skills and the ability to incorporate new information into existing content · Excellent timeline management, organizational, prioritization and problem-solving skills · Strong Microsoft Office skills, including Word and Excel · Ability to successfully communicate verbally and in writing with company staff and outside contacts at all levels · Strong customer service and leadership skills and professional demeanor in all business interactions · Bachelor's Degree in English, Communications, Journalism or related disciplines Additional Information All your information will be kept confidential according to EEO guidelines.

JOB DESCRIPTIONS: Grants Specialist - Orangeburg, NY The Research Foundation for Mental Hygiene, Inc. is seeking a full-time Grants Specialist. This individual will be able to work with increasing independence as the position responsibilities are learned. JOB DUTIES: Grants and Contracts Pre-Award (50%) Preparing budgets and budget justifications for grants (federal, state, and private foundation) submissions; good math and editing skills needed. Managing receipt of all grant application components (e.g., biosketches, letters of support, subcontracts, science documents). Compiling and formatting applications to meet details of sponsor specifications. Maintaining organized electronic files of grant application components. Effectively communicates with PIs, co-investigators, consultants, grants offices, etc. to ensure review of all components in a timely manner for meeting submission deadlines. Keeping PIs and others divisional staff apprised of updated institutional, PHS, or foundation regulations. Able to work in a team environment for efficient processing of grant applications. Post Award (20%) Assisting PIs in preparation and efficient submission of annual RPPRs (Research Performance Progress Reports) and semiannual progress reports (NARSAD, etc.), "just-in-time" requests, and no cost extensions including budget preparation, collection of "other support" documents, biosketches, etc. Assisting with prime budget setup and processing of subcontracts. Keeping organized electronic files of post award documents. Other Duties (30%) Assist with monthly review of grant accounts. JOB QUALIFICATIONS: Minimum: • Extensive experience working with Federal grants (NIH, NSF etc.) and associated systems (era Commons, Proposal Central, etc.) • Extensive knowledge of sponsored projects cycle: proposal development, grants management, etc. • Minimum 5 years related experience in an administrative role within a research environment. • Proficiency in Microsoft Office, especially Word and Excel required. • Detail oriented with strong interpersonal, organizational, and writing skills. • Ability to meet deadlines and handle multiple projects simultaneously. • Ability to anticipate, solve problems and implement systems that contribute to an efficient working environment. • High level of computer literacy, especially with spreadsheets & accounting. • Self-directed and self-reliant • Must be well-organized and have excellent interpersonal skills in dealing with a wide variety of personalities Preferred: • Previous work experience in grants management. • Prior experience with specific software such as F-TASK • Bachelor's Degree Background Investigation/Justice Center Review Requirements: Prospective appointees will be: 1) Checked against the Staff Exclusion List (SEL) maintained by the Justice Center for the Protection of People with Special Needs. Prospective employees whose names appear on the SEL as having been found responsible for serious or repeated acts of abuse or neglect will be barred from appointment. 2) Screened against the Statewide Central Register of Child Abuse and Maltreatment (SCR). Prospective employees whose names are indicated on the SCR may be barred from appointment. *The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees, do not participate in any state retirement system, and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer/Minority/Women/Disabled/Veteran Employer. VEVRAA 41 CFR 60-300.5(a) compliant. Applications will only be accepted through website at: ************************* - Click on Employment Opportunities. Applications will be accepted only during the posting dates as listed at the top of the job announcement. Questions regarding this position please email: *************************

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.

How will you make an impact? + The Scientific Writer will have the responsibility for delivering on a specification alignment and research project based off Scientific Compendia (ACS, USP, etc.) + The Scientific Writer will get direction from, and work closely with product management to ensure meaningful progress is being made during the length of the assignment. What will you do? + Owns the editing process for Product Management Specification Documents for a Key Project, in compliance with applicable company guidelines as well as regulatory requirements + Maintains timelines and workflow of writing assignments and ensures timely completion. + Works collaboratively within a matrix environment and interfaces directly and independently with all relevant groups. + Offer suggestions on improving document format to make documents more practical to the target audience.& + Other Tasks as Assigned by Supervisor. Skills & Qualifications + Bachelors Degree required(Chemistry or related Science degree preferred). + A minimum of 2 years of industry technical writing experience. + Microsoft Word, Excel, PowerPoint, and related word processing and electronic publishing tools. + Laboratory experience is a plus. + Strong organizational and planning skills. + Excellent oral and written communication skills; proficient in written and spoken English. Job Type & Location This is a Contract position based out of Fair Lawn, NJ. Pay and Benefits The pay range for this position is $75.00 - $75.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Fair Lawn,NJ. Application Deadline This position is anticipated to close on Dec 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

Job Title: Lead Technical Trainer/WriterDETAILS: • Duration: Direct Hire • Salary: $85,000 - $111,000 depending on experience • Shift: Monday to Friday, standard daytime hours We are currently seeking a Lead Technical Trainer/Writer for a full-time, direct hire opportunity in Yonkers, NY.Primary Objective: To lead technical training efforts in the field and ensure all training programs and materials meet FRA standards and client requirements, while maintaining logistical oversight and instructional consistency across teams.Essential Functions: • Lead training efforts in the field • Draft training materials based on vendor data, draft manuals, and direct observation • Verify compliance with all FRA training requirements, including 49 CFR 238.109 • Proofread and edit vendor documents to ensure completeness and accuracy • Assign and clarify responsibilities when multiple instructors are used in a course • Manage all logistics for training, including personnel, tools, and consumables • Monitor vendor and subcontractor quality during classroom instruction • Deliver training classes covering familiarization, FRA regulations, subsystem integration, and interface • Serve as primary point-of-contact between, vendors, and the Authority • Draft formal communications to, vendors, and the Authority as directed • Coordinate training classes at Authority sites and ensure all documentation and equipment are available • Collaborate with Engineering Department to address technical questions from trainees • Ensure timely delivery of all contract training deliverables to the Authority • Assist in course curriculum design and scheduling for new contracts • Provide written evaluations of courses and instructor performance after each session • Support the Manager and Assistant Manager of Training and Manuals in staff development Education Requirements: • Bachelor's degree (BA or BS) required • Formal technical training (e.g., Military Electronic Courses) a plus Qualifications: • Minimum of 5 years' experience delivering technical training; prior rail car industry experience strongly preferred • Flexible and solutions-oriented approach to field-based problem solving • Willingness to travel at least 20% of the time • Ability to work independently with minimal supervision • Proficiency in Microsoft Word, Excel, and PowerPoint • Experience with Adobe FrameMaker and/or vector graphics tools (CorelDraw, Adobe Illustrator, or AutoCAD) is a plus Work Environment: This role involves both office-based documentation and on-site fieldwork, including coordination with vendors and hands-on engagement with rail cars and training equipment. Candidates should be comfortable navigating both technical documentation and real-world application.Company Overview: Founded in 2010, Top Prospect Group was created with a focus on matching high-quality candidates with top clients while fostering an environment where success is shared by all. In 2023, the company was acquired by HW Staffing Solutions, expanding its service offerings to include technology and professional services.Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume, salary expectations, and any references in your application.#INDTPGSHELTON

Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM&M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We're looking to add an Associate Medical Editor to our Editorial Services team. The Associate Medical Editor role is entry-level and is ideal for individuals with minimal experience in editorial tasks or the healthcare/pharmaceutical industry who are eager to develop their expertise in medical editing. This role will work under supervision to gain proficiency in proofreading, copyediting, and applying the AMA Manual of Style (11th Edition) while becoming familiar with our agency's tools, systems, and workflows. What You'll Do Proofread and copyedit a variety of scientific and medical materials, including manuscripts, slide decks, abstracts, and educational content for healthcare professionals and patients Ensure grammatical accuracy, consistency, and adherence to style guides (including AMA Manual of Style) Verify that content aligns with scientific data, regulatory requirements, and client objectives Collaborate with medical writers, designers, project managers, and account managers to enhance the clarity and quality of deliverables Assist in maintaining consistency and compliance with ethical and industry standards Manage multiple projects under tight deadlines while ensuring high editorial standards What You'll Have Internship to 1 year of experience in an editorial capacity Bachelor's degree in English, Journalism, Communications, Life Sciences, or a related field Proficiency in Microsoft Office Suite; familiarity with editing tools and content management systems is a plus Strong attention to detail and ability to spot grammatical, stylistic, and factual inconsistencies Basic familiarity with medical terminology and scientific content is preferred Ability to learn quickly and work under supervision to develop expertise in medical editing Excellent time management and organizational skills to handle multiple projects What We Offer Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability Benefits 100% company paid 401k plan employer matching contributions Eligibility for company sponsored incentive plans Generous PTO, including a week off in December for the holidays Paid volunteer time off Tuition reimbursement On-site gym and other employee wellness initiatives Employee Assistance Program Comp pay or comp time for onsite weekend work Availability of cell-phone stipends, based on business need Leadership development training program and other career development programs Remote and hybrid work schedule options Salary range: $50,000 - $60,000 annually. Note: Actual salary will depend on background and experience. M/F/D/V Please note, we will only respond to candidates we deem qualified

Our mission is to unlock human potential. We welcome you for who you are, the background you bring, and we embrace individuals who get excited about learning. Bring your experiences, your perspectives, and your passion; it's in our differences that we empower the way the world learns. About the Role: At Wiley, our growing Advanced Engineering book publishing program is bridging the gap between primary research and application and delivering content solutions for the next generation of practicing engineers and researchers. We're looking for someone who shares our passion and who wants to grow with us. As an editor on our global Advanced Engineering team, you'll hit the ground running by acquiring in dynamic and fast-growing areas. You'll seek out and work with subject matter experts at the best universities, companies and organizations around the world, building on Wiley's world-class reputation for quality, impactful and timely publications. You'll acquire content and products in line with our strategic goals for growth. How you will make an impact: Identify and develop global publishing opportunities across a competitive landscape, within traditional book publishing markets and beyond, including digital publishing. Commission individual titles aimed at target markets, meeting sales goals, building financial models, and managing the review process. Negotiate and reach agreement with authors over content, schedules, and contractual arrangements. Build and maintain relationships with authors, book editors, and contributors. Champion projects through the publishing process, proposing and implementing solutions for keeping titles on track, handling author queries, and troubleshooting. Monitor sales results and analyze sales channels to support sales performance of individual titles. Work effectively and collaboratively with colleagues in editorial and allied functions such as content, technology, marketing, and sales. Meet established goals for growth. What we look for: Bachelor's degree Proven experience in publishing, specifically acquisitions experience in Engineering or a closely related field. Proven track record of acquiring and developing successful Engineering products. Demonstrated mastery of publishing systems, cycles and activities. Ability to apply financial understanding of publishing to the overall strategy. Demonstrated ability to effectively analyze potential authors and projects, identify the right projects and shape them for an audience. Excellent written and oral communication and the ability to be persuasive and direct, yet tactful. Ability to negotiate contracts, schedules and other efforts. Project management skills and the ability to work on multiple tasks and agendas. Detail oriented with attention to deadlines and a productive and focused work pattern. Ability to move publication projects smoothly from beginning to end. Ability to build and manage relationships with authors and team members. Self-motivated, curious and a growth mindset Ability and willingness to travel About Wiley: Wiley is a trusted leader in research and learning, our pioneering solutions and services are paving the way for knowledge seekers as they work to solve the world's most important challenges. We are advocates of advancement, empowering knowledge-seekers to transform today's biggest obstacles into tomorrow's brightest opportunities. With over 200 years of experience in publishing, we continue to evolve knowledge seekers' steps into strides, illuminating their path forward to personal, educational, and professional success at every stage. Around the globe, we break down barriers for innovators, empowering them to advance discoveries in their fields, adapt their workforces, and shape minds. Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact ******************* for assistance. We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow. We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. The range below represents Wiley's good faith and reasonable estimate of the base pay for this role at the time of posting roles either in the United Kingdom, Canada or USA. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies. When applying, please attach your resume/CV to be considered. Salary Range: 70,100 USD to 100,500 USD#LI-JG1

Caiman Haiti Foundation is a non-profit corporation that is organized and operated exclusively for charitable and educational purposes. We provide relief to poor, distressed and underprivileged individuals residing in Haiti, by developing academic scholarships and supplying them with educational material. In addition we strive to prepare them so that they may overcome daily challenges by supplying them with food, clothing, medical supplies and other essential items. Job Description Prepare grant proposals by performing research. Look into potential funding sources. Keep careful records to track proposals. Plan fund-raising campaigns. Promote our organization through public relations work. Qualifications Have a bachelor's degree in communications, English, professional writing or a similar major. Outstanding grammar and research skills. Additional Information All your information will be kept confidential according to EEO guidelines.

Job Title: Associate or Senior Editor, BMC Nursing Application Deadline: December 15th About Springer Nature Group Springer Nature is one of the leading publishers of research in the world. We publish the largest number of journals and books and are a pioneer in open research. Through our leading brands, trusted for more than 180 years, we provide technology-enabled products, platforms and services that help researchers to uncover new ideas and share their discoveries, health professionals to stay at the forefront of medical science, and educators to advance learning. We are proud to be part of progress, working together with the communities we serve to share knowledge and bring greater understanding to the world. For more information, please visit about.springernature.com and follow @SpringerNature. About the Brand BMC has more than 25 years of experience in developing open access and provides high-quality, impactful research and a supportive publishing experience for authors. We are committed to publishing the best open access journals in our portfolio of over 250 titles and we strive to drive progress in biology, health sciences and medicine. Visit biomedcentral.com and follow @BioMedCentral About the Role You will contribute to the success of the BMC Series by supporting editorial handling of content in BMC Nursing and by driving the content development of this journal. This is a dynamic and varied role that will give you the opportunity to see content across a broad range of topics and contribute to the success of BMC as a whole. Communication is a key part of this role, as you will need to build excellent and productive relationships with the external Editorial Board who manage the peer review process and with internal teams responsible for journal editorial office support. Role responsibilities: Develop a journal development strategy for BMC Nursing, taking into account individual journal performance and development needs, as well as the overall strategy of the BMC series. Work with colleagues across the Journals group to support subject-specific strategy development at Springer Nature. Identify and commission reviews, collections and supplements, and work with the scientific community to drive these forward. Oversee the handling of the content published in BMC Nursing , primarily by advising on content handled by editorial board members, but also by handling individual submissions yourself where required. Investigate and resolve publishing or research ethics cases, both pre- and post-publication, with the guidance of Springer Nature Research Integrity Group when needed. Engage effectively with other teams to support the resolution of editorial issues and to prioritise author service while maintaining editorial standards Advise on editorial policy development as appropriate. Build strong communication and relationships with Editorial Board Members and authors. Conduct calls with Senior Board Members to discuss journal policy, editorial board recruitment, and content-related matters. Contribute to the recruitment and training of new editorial board members. Support editorial board engagement initiatives across the journals. Organize and lead Senior Board and Editorial Board Meetings, both in-person and online. Ensure that all Editorial Board Members are fully informed of the journal's ethos and editorial policies and have the necessary training to perform their roles effectively. Contribute to the efforts of the marketing team, providing input into marketing plans and activities. Develop journal website content and features that are of interest to the community and raise the profile of the journal website in the online environment. Attend conferences to promote the journal and develop a network of contacts within relevant fields. Increase journal visibility by writing blogs and participating in social media activities to promote journal content and BMC values. Contribute to the culture of the BMC editorial team by supporting your colleagues, covering for them when needed and sharing expertise and experience. Experience, Skills & Qualifications: Educated to PhD or MD level (or equivalent) in a medical or health related field Excellent communication and interpersonal skills, with a customer-focused approach Ability to critically assess manuscripts across a range of topics for novelty, scientific content, and their implications Excellent time management and prioritization skills, able to balance short-term deadlines with long-term goals Previous solid editorial experience in scientific publishing is needed to be considered for the Senior Editor level To apply, please send: A brief cover letter explaining why you would like to join the team, relevant experience, preferred office location, salary expectations and current notice period. A CV detailing your education, employment history, list of published scientific papers, and any achievements demonstrating your suitability for the position. Springer Nature US provides a comprehensive and competitive benefits package which includes the benefit offerings listed below: • Medical, Dental and Vision • 401(k) with company match and contribution • Hybrid office working policy, Summer Hours, and paid time off • Flexible Spending and Commuter programs • Multiple Life insurance options • Disability coverage • Tuition Assistance • Voluntary benefits: Identity Theft Protection, Pet Insurance, and Legal Assistance Insurance • Employee Assistance Program • Family friendly benefits and a variety of employee discounts • An array of Employee Social Networks US Annualized Base Salary Range: $80,000 / Senior Editor: $95,000. The salary offer may vary based on work experience, education, skill level and equity. The US salary range does not align with the salary ranges in other countries when converted to the currency of that country. Springer Nature is an Equal Opportunity Employer that complies with the laws and regulations set forth in the following ******************************************************************************************** poster. At Springer Nature, our mission is to be part of progress - and that begins with inclusion: of people, perspectives, and ideas. We believe that diverse perspectives drive progress, and we are committed to creating an environment where people and ideas can flourish. If you have any access needs related to disability, neurodivergence or a chronic condition, please contact us so we can make all necessary accommodation. Find out more about our DEI work here: ****************************************************************************************** For more information about career opportunities in Springer Nature please visit ******************************************************************* #LI-DT1 Job Posting End Date: 16-12-2025

Company Mission At Playbook we believe that everyone deserves the ability to get ahead with incredible sports & academic programs. Through our best in class technology and integrated platform services we are revolutionizing the way that sports, education, and activity entrepreneurs launch and manage programs for students and communities across the world. We have an amazing list of customers and partners including professional sports teams, fortune 500 companies, and 100's of leading sports and activity organizations across the country. We also have established partnerships with star athletes including Kristaps Porzingis, Didi Gregorius, and over 30 other professional athletes and influencers who embody our values and support our mission. About the Role Playbook is seeking a talented and experienced technical writer to work alongside our development team to create, maintain, and publish articles in our knowledge base for our SAAS serving small sports, fitness, and activity organizations. Additionally, the ideal candidate will help with internal technical documentation and the documentation of developer requirements in Jira. We are seeking an experienced technical writer who is passionate about our mission with strong attention to detail and a track record of efficiently delivering exceptional knowledge base content. It's a bonus if you have experience being part of scrum processes and are able to provide references who can confirm that you write incredibly clear and comprehensive Jira tickets. Tasks, Duties, Responsibilities Writing, publishing, and maintaining high-quality content within the support knowledge base including internal and public facing articles. Communicate complex technical details to audiences of highly variable skill levels. Communicate complex developer requirements to our team of developers in he form of thorough and clear Jira tickets. Assist in creation of onboarding guides (userpilot/appcues). Knowledge, Skills, Competencies Experience in planning, leading, directing, and managing the build out of great knowledge bases for SAAS products. Please share the links to knowledge bases you have worked on including precisely what you did as part of the knowledge base build out and upkeep Strong ability and proficiency writing and communicating with the english language. Familiarity with using front-end online publishing languages including HTML, CSS, AWS preferred. Familiarity with using back-end online publishing languages including python, experience with django preferred but not required Knowledge of UI/UX terminology. Ability to work independently and collaboratively in a fast-paced team environment. Benefits 401(k) and 401(k) matching Paid Time Off Health Reimbursement Account (HRA) Paid Travel Opportunities

Job Description Job Title: Senior Entry Writer - Customs Brokerage Salary Range: $75,000 - $90,000 annually (commensurate with experience) About the Role: We're seeking a highly experienced Senior Entry Writer to join our import operations team. This individual must be able to work independently, manage full-cycle customs entry processing, and troubleshoot complex compliance issues. This is a critical position within a growing brokerage department and requires an expert-level understanding of U.S. import regulations - along with mandatory CargoWise experience. Key Responsibilities: Prepare and file customs entries for ocean and air shipments in CargoWise Classify goods accurately using HTS codes Resolve holds, compliance issues, and CBP requests including CF-28s and CF-29s Work directly with freight forwarders, importers, and government agencies Maintain thorough documentation in compliance with U.S. Customs and PGAs Stay up to date with regulatory changes and proactively inform internal stakeholders Troubleshoot operational delays and provide quick, effective solutions Requirements: 5+ years of experience as an entry writer in U.S. customs brokerage CargoWise experience is required (non-negotiable) Strong knowledge of HTS classification and U.S. Customs procedures Ability to work independently and manage a high-volume workload Experience with ACE and ABI systems Excellent organizational and communication skills Why Join Us: Competitive salary and benefits package Work with a reputable, well-established logistics firm Autonomy and respect for your customs expertise Supportive leadership and a collaborative culture

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

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.