Medical Writer jobs in New Brunswick, NJ

Key Responsibilities: Develop and pitch engaging cardiology content ideas with strong clinical relevance. Assign and edit cardiology news and feature articles for a professional medical audience. Collaborate with writers, editors, and marketing to create compelling newsletters and promotional content. Oversee and streamline editorial workflow to ensure timely publication. Partner with internal teams on special projects and campaign support. Cultivate and manage a network of expert freelance medical writers. Qualifications: Minimum 8 years of editorial experience in health, science, or medical journalism. Strong working knowledge of cardiology and the medical news landscape. Proven ability to assign clear and effective story ideas and edit for accuracy, clarity, and relevance. Skilled at translating complex medical information into accessible language for clinical professionals. Comfortable working in a fast-paced, virtual environment with tight deadlines. Collaborative, detail-oriented, and editorially rigorous. Education: Bachelor's degree in Journalism, English, Life Sciences, or a related field. Advanced degrees or relevant clinical experience a plus.

A leading global investment firm is seeking a Managing Editor to lead and evolve its flagship daily macroeconomic commentary. This is a rare opportunity to shape and front one of the most influential daily products in global markets-serving an audience of senior investors and policymakers around the world. What You'll Do: Own the editorial direction and daily execution of a high-impact institutional macro product. Collaborate with elite economists and investors to extract, sharpen, and communicate market-relevant insights with clarity and depth. Ensure a consistently high tempo: this is a daily product, and the rhythm demands focus, judgment, and pace without sacrificing quality. Act as the editorial lead and the public voice-hosting podcasts, authoring editor's notes, and helping shape how the product shows up externally. Drive continuous evolution-format, frequency, tone, and delivery-based on audience needs and data. Maintain a high editorial standard while managing a fast-moving, high-output workflow. Who You Are: A macro-literate editorial leader, likely from a background in financial journalism, investment research, or strategy. Adept at shaping raw ideas into elegant, persuasive content for a sophisticated audience. Confident interfacing with senior thought leaders and contributing to intellectual framing and messaging. Comfortable fronting content: articulate on audio/video, credible in high-level forums, and thoughtful in written commentary. You understand the pressure and opportunity of a daily cycle-and you thrive in it. Why This Role: The product is already a trusted read for many of the most important decision-makers in global markets and government. You'll have the chance to elevate both its content and its voice. You'll be trusted with significant influence and backed by world-class resources.

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

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

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

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

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

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 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

Manager, Scientific Communications About you A smart, strategic, collaborative expert in science with a love for communications who wants to make a difference for clients and teammates alike. You have an outlook that is: Team oriented: “we” over “I” Positive and inspirational Energized and creative Humble and inquisitive Agile and adaptable About us A small, fast-growing agency with big reach. We have a simple but powerful belief: every patient, disease and therapy are different - therefore every message, stakeholder and challenge need to be approached in a unique way. We comprise: Storytellers Strategists Scientists Writers Designers Digital natives Creatives About the role As manager, scientific communications, you will provide counsel to internal teams and clients on using scientific information accurately and creatively to define communications strategies and craft stories that resonate with key audiences: primarily physicians but also media and consumers. You will take the lead in creating content for various communications platforms, such as social channels, websites and medical congresses. Other key responsibilities include performing research and educating internal teams on the scientific landscape and differentiation of drugs, devices, and health service; providing counsel on navigating issues related to data; and working directly with scientists and other client personnel to develop and articulate science and data-related key messages/stories. Required Skills/Attributes Strategic Storyteller: Adept at translating complex technical information into compelling narratives for scientific audiences, through both written and verbal channels, including presentations. Dynamic Communicator: Your verbal, written, and presentation skills are exceptional, allowing you to confidently convey ideas and foster collaboration. Results-Driven Innovator: You are a proactive problem-solver with a strong sense of ownership, always seeking creative solutions and demonstrating flexibility to achieve goals. Collaborative & Independent: You thrive in a team setting, readily contributing and adapting, while also possessing the ability to work independently and manage multiple tasks effectively. Intellectually Curious: You have a broad interest in scientific and health specialties and stay current with evolving digital and social media trends. NYC Hybrid Commitment: You are able to work our hybrid schedule from our NYC location. Credentials/Experience MSc or PhD in life sciences, PharmD, or equivalent 2-4 years of experience working for a PR/comms company; alternatively, experience in med ed, med ad/mktg, etc. Demonstrated experience with social content creation in research/Pharma; or in-house in the communications department of a university, research institute, scientific publication, pharma company, etc. dna was recently the winner of MM+M small healthcare agency of the year. dna prides itself on delivering a difference making employee experience. We invest in our team and put culture front and center through a variety of programs, policies and events. It's all about growth and opportunity. If you are looking for a company where you will have the chance to contribute, grow and set a career path that meets your interests and delivers on your ambitions, dna is an ideal employer. We are small meets big - giving our clients and employees the benefits of both. As a global agency, we have staff in 10 markets on four continents. Yet, our close-knit agency environment will ensure that you will have ample opportunity for visibility with senior management who will make a personal investment in your career. And, as part of a large global IPG network with seamless integration with our sister agencies, such as Weber Shandwick and large advertising agencies, you'll have access to world class resources and endless exposure to the most cutting-edge marketing approaches. If you are ambitious, energetic and excited to have a voice in shaping an agency and the future of healthcare communications, we hope you'll join us. We're an agency whose fast pace of growth and influence, is matched only by the advancement opportunities we offer our employees. dna - Health Means Everything. The legal info We make our careers website accessible to any and all users. If you need an accommodation to participate in the application process, please contact us at JobAppAccommodation@cmgrp.com. This email address is not for general employment inquiries or vendors; rather it is strictly for applicants who require special assistance accessing our employment website. Due to volume, messages sent to this email address that are not related to an accommodation cannot be answered. The Weber Shandwick Collective recognizes that your health and wellbeing are a priority. This is why we offer a full suite of benefits including: Medical Dental Vision 401k (with employer match) Tuition Reimbursement Juice Money - $60 monthly reimbursement to be used towards purchases that nourish your health, mind, body, and soul MyDays - Flexible holiday schedules Short-Term Disability Paid Employee Family Leave Family Building Benefit NYC Salary range: $90,000 - $105,000 Where an employee or prospective employee is paid within this range will depend on, among other factors, actual ranges for current/former employees in the subject position; market considerations; budgetary considerations; tenure and standing with the company (applicable to current employees); as well as the employee's/applicant's background, pertinent experience, and qualifications. Weber Shandwick is proud to be an Equal Opportunity/Affirmative Action employer. Weber Shandwick recruits qualified applicants without regard to race, color, religion, gender, age, ethnic or national origin, protected veteran status, physical or mental disability, sexual orientation, gender identity, marital status or citizenship status. #LI-JR2 We make our careers website accessible to any and all users. If you need an accommodation to participate in the application process, please contact us at JobAppAccommodation@ipgdxtra.com. This email address is not for general employment inquiries or vendors; rather it is strictly for applicants who require special assistance accessing our employment website. Due to volume, messages sent to this email address that are not related to an accommodation cannot be answered.

**_What Medical Writing contributes to Cardinal Health_** The Medical Writer is a member of the Medical Segment Clinical Affairs team and is responsible for researching, creating, editing and coordinating the production of clinical documents; with a focus on Clinical Evaluation Reports and Post Market Surveillance Plans and reports required for CE marked devices. The Medical Writer will plan and develop high quality clinical documents to support Medical Segment devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs), Post Market Surveillance Plans and Reports as required by EU regulations and other global regulations. Additional responsibilities include providing input to product development and post-market sustaining core teams. Additional responsibilities may be assigned. The Medical Writer has medical writing and project management experience, a thorough understanding of research methodology, the ability to develop high-quality clinical documents and to manage multiple projects simultaneously. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required. **_Responsibilities_** + Write clinical evaluation reports (CERs) and post market surveillance and post market clinical follow-up plans and reports. + Perform gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements. + Work with internal teams to gain cross-functional inputs and approvals + Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. + Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner. + Perform comprehensive literature searches to support assigned product lines. + Consistently apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures + Assist in development of processes Collect and maintain all documents necessary to ensure compliance with SOP **_Qualifications_** + Bachelors in a relevant discipline or master's degree or PhD preferred or equivalent work experience + Minimum 3 years medical writing experience preferred + Proven experience performing literature reviews, analyzing data and communicating outputs, preferred + Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role, preferred + Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams, preferred + Demonstrated ability to build positive constructive relationships with cross-functional team members + Demonstrated high level of personal integrity, emotional intelligence, flexibility Knowledge of MDD, MDR and MEDDEV requirements, preferred + Proficient scientific writing skills + Experience creating and performing literature searches in Embase, PubMed and Google Scholar + Proficient in Microsoft Word, Excel, PowerPoint. + Strong data extraction and analysis skills + Proactive with a sense of urgency in managing job responsibilities + Self-motivated, able to work independently and manage multiple projects simultaneously. + Analytical thinking and inquisitive mindset + Ability and desire to develop good working relationships internally and externally **_What is expected of you and others at this level:_** + Applies comprehensive knowledge and a thorough understanding of concepts, principles and technical capabilities to perform varied tasks and projects. + May contribute to the development of policies and procedures + Works on complex projects of large scope + Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives + Completes work independently; receives general guidance on new projects + Work reviewed for purpose of meeting objectives + May act as mentor to less experienced colleagues **Anticipated salary range** : $94,900 - $135,600 **Bonus eligible** : No **Benefits** : Cardinal Health offers a wide variety of benefits and programs to support health and well-being. + Medical, dental and vision coverage + Paid time off plan + Health savings account (HSA) + 401k savings plan + Access to wages before pay day with my FlexPay + Flexible spending accounts (FSAs) + Short- and long-term disability coverage + Work-Life resources + Paid parental leave + Healthy lifestyle programs Application window anticipated to close: 7/25/2025 *if interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. \#LI-MP1 _Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._ _Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._ _To read and review this privacy notice click_ here (***************************************************************************************************************************

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.

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.

WRITER You will be working with a team management consulting team principal on social media and marketing strategies, to research, write, and edit marketing assets that support programs and campaigns, including white papers, and case studies. Another focus will be to create content that is on-brand, on-message, and narrative-driven as well as ensuring our social media accounts are up-to-date and well-managed. About you… Portfolio or website with varied and relevant long-form and short-form writing samples 2+ years of content /white paper writing experience Previous writing experience on technical subjects. Excellent proofreading skills Understanding of Search Engine Optimization and keywords You have… Excellent verbal and written communication skills Strong organizational skills Strong attention to detail Ability to write effectively on subjects with little to no prior knowledge Ability to work well independently and collaborate effectively with a team Ability to manage projects and complete tasks by meeting timelines and goals Ability to work in a fast-paced, high-volume environment Tech savvy: Strong knowledge of computer basics and Microsoft Office (especially Word, PowerPoint and Outlook) Working knowledge of Adobe Creative Suite (Photoshop, InDesign and Premiere) is a plus Deep understanding of using the Web as a research tool Social Media and blogging experience, as well as familiarity with blog content management systems is a plus

Job Title: Chief Editor, Nature Geoscience Application Deadline: July 16, 2025 About Springer Nature Group Springer Nature opens the doors to discovery for researchers, educators, clinicians and other professionals. Every day, around the globe, our imprints, books, journals, platforms and technology solutions reach millions of people. For over 180 years our brands and imprints have been a trusted source of knowledge to these communities and today, more than ever, we see it as our responsibility to ensure that fundamental knowledge can be found, verified, understood and used by our communities - enabling them to improve outcomes, make progress, and benefit the generations that follow. Visit group.springernature.com and follow @SpringerNature / @SpringerNatureGroup About the Brand Nature Portfolio is a flagship portfolio of journals, products and services including Nature and the Nature-branded journals, dedicated to serving the scientific community. Visit nature.com and follow @Nature / @NaturePortfolio About the Role Nature Portfolio is looking to recruit a Chief Editor for Nature Geoscience . This job is offered on a full-time, permanent basis and can be located in our New York, Shanghai, or Beijing offices on a hybrid working model. Nature Geoscience (***************************** is a prestigious journal that welcomes research across the span of the Earth sciences. In addition to publishing original research, the journal publishes Editorials, Comments, Reviews, News & Views and Correspondence across all topics concerned with geoscience, as well as from a diverse range of voices. We are now looking for an ambitious and dynamic Chief Editor, who will help further establish and maintain Nature Geoscience as the leading publication in the field. Working within a dynamic editorial and publishing environment that also includes Nature Climate Change and Nature Sustainability among others, this demanding and stimulating role calls for a keen interest in the practice and communication of science. Responsibilities: Leading an in-house team of professional editors and working closely with them on all aspects of the editorial process, including manuscript selection, commissioning, editing of Reviews, Perspectives, Comments, and News & Views, and writing for the journal. Ensuring all content published in the journal is of the highest quality and covers the spectrum of research in the journal's scope. Developing the journal's content in ways that are appropriate to the audience, that will strengthen its impact, and that will support the Nature Portfolio's strategic aims. Liaising with the scientific community through institutional visits and international conferences - willingness to travel globally is essential. Experience, Skills & Qualifications: Essential: A PhD, with a strong track record in research relevant to the fields covered in the journal A broad knowledge and understanding of the topics the journal covers A keen interest in research both within and beyond your specialty The ability to absorb and understand new areas of research Excellent literary and communication skills Leadership qualities and strong interpersonal skills Commercial awareness A positive attitude to change Desirable: Postdoctoral experience Previous editorial and/or managerial experience To apply, please submit the following: a CV a statement (maximum 1,500 words) that encapsulates your vision for the journal's content, competitive position, and longer-term development a brief cover letter explaining your interest in the post and your salary expectations. Application Deadline: July 16, 2025 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: $130,000 - $145,000. This role is eligible for an annual performance-related bonus plan. 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, we value the diversity of our teams and work to build an inclusive culture, where people are treated fairly and can bring their differences to work and thrive. We empower our colleagues and value their diverse perspectives as we strive to attract, nurture and develop the very best talent. Springer Nature was awarded Diversity Team of the Year at the 2022 British Diversity Awards. Find out more about our DEI work HERE. If you have any access needs related to disability, neurodivergence or a chronic condition, please contact us so we can make all necessary accommodation. For more information about career opportunities in Springer Nature please visit our career page HERE. #LI-EG1 Job Posting End Date: 17-07-2025

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.

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

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.