Medical writer jobs in Bristol, PA - 82 jobs

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

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

Principal Medical Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. **What You Will Be Doing:** - Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. - Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. - Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. - Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. - Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. **Your Profile:** - Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. - Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. - Strong understanding of regulatory requirements and industry standards for clinical writing. - Exceptional writing and editing skills, with a keen eye for detail and clarity. - Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. - A commitment to maintaining high standards of quality and compliance in all medical writing activities. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

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

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

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

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

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Looking for Medical Writers in Springhouse, PA Client -Johnson and Johnson Please share the updated resume at sweta(at)irionline.com Additional Information

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 Additional Information Job Description: Write technical materials, such as SOP's, appendices 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

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.

Principal Medical Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer at ICON, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information. Your expertise in medical writing will be crucial in supporting our clients' submissions to regulatory authorities and ensuring compliance with industry standards. What You Will Be Doing: * Leading the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity. * Collaborating with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development. * Providing guidance on best practices for medical writing and ensuring adherence to regulatory requirements and internal standards. * Mentoring and training junior medical writers, fostering a culture of excellence and professional growth. * Staying current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs. Your Profile: * Advanced degree in life sciences, medicine, or a related field; relevant certifications preferred. * Significant experience in medical writing, particularly in regulatory submissions and clinical documentation. * Strong understanding of regulatory requirements and industry standards for clinical writing. * Exceptional writing and editing skills, with a keen eye for detail and clarity. * Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders. * A commitment to maintaining high standards of quality and compliance in all medical writing activities. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us. Remote Employee Value Proposition: At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. This is an exciting opportunity to experience multiple facets of medical writing in a dynamic, collaborative, and cross functional environment. Position Summary: The Senior Medical Writer, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval. Performance Objectives: Responsible for the development of high-quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including but not limited to Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments,. Collaborate with Global Development Teams and Clinical Development to ensure alignment with program objectives. Participates in Global Medical Writing initiatives on clinical development cross-functional teams. Assists with development and implementation of Medical Writing processes improvement in line with SOPs. Owns and updates assigned Medical Writing SOPs, as necessary. Education/Certification Requirements: Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Knowledge, Skills, and Abilities: Minimum of 3 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents. Previous experience in Medical Writing in clinical drug development, preferably some experience in oncology. Working knowledge of Medical Writing requirements and document components. Experience with templates and template development, and document management systems. Excellent writing skills. Good interpersonal skills that involve working well in a team environment and the ability to lead others. Good organizational and planning skills; drive for results. Ability to read, analyze and interpret scientific and technical information. Effective analytical/problem solving skills. Ability to write procedures. Ability to follow instructions and synthesize information from multiple sources. Strong PC skills including intermediate/advanced proficiency with MS Word, and basic proficiency with other MS Office products. Adept in learning additional software utilized at Taiho. The pay range for this position at commencement of employment is expected to be between $116,450 - $137,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. #LI-Remote

The Senior Science Writer in the Communications and Public Relations Department will assist the director of science communications in translating scientific data and information related to cancer research into content that helps educate the public, policymakers, media and the health care industry about cancer research advances, the AACR's mission, and the importance of biomedical science and funding. In this capacity, the senior science writer will assist the director in implementing the AACR's communications and public relations plans that facilitate the accurate communication and reporting of the latest advances in cancer research from the AACR's meetings, journals, partnerships, and other scientific activities. Responsibilities The Senior Science Writer writes and edits content that helps promote awareness of AACR's scientific activities among the public, policymakers, the media, and others interested in cancer research. Responsibilities include: Writing and editing scientific press releases, blog posts, and features about cancer research advances from the AACR's conferences, journal articles, and other scientific sources. Developing scientific content for the AACR websites and social media platforms. Staying abreast of the latest developments in various areas of cancer research, including basic and translational research, population research, and preclinical and clinical research. Researching and gathering information on scientific topics of interest and participating in the SciComm Journal Club. Assisting with the development of scientific video content for blogs and websites. Assisting with writing scripts and letters for leadership, newsletter, Annual Report, and other content. Collaborating with SciComm members and media relations staff to help identify important cancer research advances from AACR's journals, scientific conferences, programs, and other initiatives to communicate to the scientific/medical press, national press, policymakers, cancer research community, and the public. Occasionally traveling to AACR conferences and other scientific programs to cover important scientific advances on the blog and websites as required. Collaborating with other members of the AACR about science communications projects that support the AACR's mission and goals. Qualifications Ability to translate complex scientific concepts into lay language for press releases and other written materials, including science backgrounders, blog posts, development activities, and reports. Ability to write compelling science content for lay audiences. Skill to develop scientific video content, including interviews and editing. Possesses outstanding editing skills and knowledge of AP style guide. Excellent interpersonal skills, including being a team player capable of working effectively with AACR colleagues, membership, and leadership. Good understanding of biomedical terminology. Proficiency in social media. EDUCATION AND TRAINING: PhD in biomedical science; cancer research experience preferred. Minimum of seven years of experience writing science content for a variety of target audiences, including scientists, media, and lay readers. How to Apply: Please upload your resume and cover letter (required). Equal Opportunity Employer

Senior Technical WriterEmployment Type: Full-Time, ExperiencedDepartment: Technology Support CGS is seeking an experienced Senior Technical Writer to provide consultative, analytical, and documentation support for a large Federal agency initiative. CGS brings motivated, highly skilled, and creative people together to solve the government's most dynamic problems with cutting-edge technology. To carry out our mission, we are seeking candidates who are excited to contribute to government innovation, appreciate collaboration, and can anticipate the needs of others. Here at CGS, we offer an environment in which our employees feel supported, and we encourage professional growth through various learning opportunities. Skills and attributes for success:- Drafting and development of technical documentation related to a variety of projects in the IT space.- Work closely with project stakeholders to establish technical processes and procedures.- Document projects through the SDLC.- Provide status reports for multiple ongoing projects and related documentation efforts.- Assist with both user and admin level documentation. Qualifications:- Excellent writing and Communication skills.- 5+ years experience with development of technical documentation.- 3+ years experience with development of user documentation.- Fluency with industry standard technical summary and reporting techniques including Agile project management methodology.- Ability to produce quality work independently or in a group setting.- Experience with MS Office Suite including Visio.- Willingness and ability to pass background check/security screening. Ideally, you will also have:- Familiarity with Business Intelligence/Analysis applications.- Experience with Government software development policies and procedures.- Client facing communication experience.- Federal Agency issued security clearance. Our Commitment:Contact Government Services (CGS) strives to simplify and enhance government bureaucracy through the optimization of human, technical, and financial resources. We combine cutting-edge technology with world-class personnel to deliver customized solutions that fit our client's specific needs. We are committed to solving the most challenging and dynamic problems. For the past seven years, we've been growing our government-contracting portfolio, and along the way, we've created valuable partnerships by demonstrating a commitment to honesty, professionalism, and quality work. Here at CGS we value honesty through hard work and self-awareness, professionalism in all we do, and to deliver the best quality to our consumers mending those relations for years to come. We care about our employees. Therefore, we offer a comprehensive benefits package.- Health, Dental, and Vision- Life Insurance- 401k- Flexible Spending Account (Health, Dependent Care, and Commuter)- Paid Time Off and Observance of State/Federal Holidays Contact Government Services, LLC is an Equal Opportunity Employer. Applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Join our team and become part of government innovation! Explore additional job opportunities with CGS on our Job Board:**************************************** more information about CGS please visit: ************************** or contact: Email: ******************* #CJ

Job Description Business Development/Proposal Writer BFW Construction Project Managers **************** is a regional construction project management agency that works with building owners, institutions and construction management partners to build amazing structures that positively impact the community. BFW is seeking a Business Development Manager to join our team. In this role, you will be responsible for overseeing the RFP and RFQ processes, writing proposals, and developing new Client relationships. The ideal candidate should have a proven track record in business development and/or proposal writing within the construction/architecture/engineering or real estate industries. Key Responsibilities: Conduct research on RFPs and RFQs, and develop or leverage research platforms including AI. Successfully respond to RFPs and RFQs, ensuring all requirements and deadlines are met. Draft Successful responses to RFPs and RFQs. Assist Operations Manager with Newsletter and managing social media posts. Assist with maintaining BFWs mailing list of 15,000+ contacts. Attend pre-proposal meetings and network with other Teams and potential bidders. Actively participate in industry organizations such as WTS, CREW, ULI, BIA, GBCA, URA, PDC, BOMA, COAA, PA Housing Alliance, MD Affordable Housing Coalition and NAOIP. Lead BFW into State and Federal Government contracting. Qualifications: Minimum of 3 years of experience in Business Development/Proposal Writing Strong writing and communication skills. Excellent time and project management skills. Must adhere to our core values of Honesty, Integrity, Teamwork, and Commitment. Benefits: Competitive salary, PTO, health care, 401K, life /disability insurance, education/training assistance Contact: To apply please send resume to ***************. No phone calls please. Powered by JazzHR fFZGLQRjPs

The Proposal Writer be responsible for overseeing the RFP and RFQ processes, writing proposals, and developing new Client relationships. The ideal candidate should have a proven track record in business development and/or proposal writing within the construction/architecture/engineering or real estate industries. Requirements: Bachelor's Degree Minimum of 2 years of experience in Business Development/Proposal Writing Strong writing and communication skills Excellent time and project management skills Must adhere to our core values of Honesty, Integrity, Teamwork, and Commitment Job Duties: Conduct research on RFPs and RFQs, and develop or leverage research platforms including AI. Successfully respond to RFPs and RFQs, ensuring all requirements and deadlines are met. Draft Successful responses to RFPs and RFQs. Assist Operations Manager with Newsletter and managing social media posts. Assist with maintaining company's mailing list of 15,000+ contacts. Attend pre-proposal meetings and network with other Teams and potential bidders. Actively participate in industry organizations such as WTS, CREW, ULI, BIA, GBCA, URA, PDC, BOMA, COAA, PA Housing Alliance, MD Affordable Housing Coalition and NAOIP. Lead the company into State and Federal Government contracting. Benefits: Competitive compensation package Health Care 401(k) 4 Days in office 15 PTO days and 8 paid holidays Disability Insurance Yearly training budget

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

Senior Medical Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of in Nvative treatments and therapies. What you will be doing * Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards. * Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form. * Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives. * Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community. * Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team. Your profile * Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotech Nlogy, or contract research organization (CRO) industry. * Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences. * Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process. * Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables. * Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes. Nous recherchons actuellement un(e) Rédacteur(trice) Médical(e) Senior pour rejoindre notre équipe diversifiée et dynamique. En tant que Rédacteur(trice) Médical(e) Senior chez ICON, vous jouerez un rôle clé dans la définition, la coordination et la mise en œuvre des stratégies de rédaction médicale pour des projets de recherche clinique. Vous contribuerez activement à l'avancement de traitements et de thérapies innovants, tout en garantissant une communication scientifique claire, précise et conforme aux exigences réglementaires. Vos missions principales * Diriger la préparation, la révision et l'édition des documents d'études cliniques, notamment les protocoles d'essais cliniques, les rapports d'études cliniques (Clinical Study Reports - CSR), les brochures de l'investigateur (Investigator Brochures - IB) ainsi que les dossiers de soumission réglementaire, en veillant à leur exactitude scientifique, leur clarté rédactionnelle et leur conformité aux lignes directrices réglementaires et aux standards de l'industrie. * Collaborer étroitement avec des équipes pluridisciplinaires, incluant la recherche clinique, la biostatistique, les affaires réglementaires et les affaires médicales, afin d'interpréter et d'analyser les données issues des essais cliniques, de synthétiser les résultats scientifiques et de communiquer les messages clés de manière structurée et compréhensible par écrit. * Participer à la planification et à l'exécution des programmes de développement clinique, en apportant une contribution stratégique et une expertise scientifique pour soutenir la conception, la conduite et l'interprétation des études cliniques et des initiatives de recherche. * Contribuer à l'élaboration des plans de publication, ainsi qu'à la rédaction de résumés, posters scientifiques et manuscrits destinés à des revues à comité de lecture et à des congrès scientifiques, afin de diffuser les résultats des études et les connaissances scientifiques auprès de la communauté scientifique internationale. * Encadrer, former et accompagner les rédacteurs médicaux plus juniors, en partageant les bonnes pratiques, les techniques de rédaction et les principes scientifiques, tout en favorisant une culture d'excellence, de collaboration et d'apprentissage continu au sein de l'équipe de rédaction médicale. Votre profil * Diplôme de niveau supérieur (Master, Doctorat, PharmD ou MD) en sciences de la vie, pharmacie, médecine ou domaine connexe, avec au moins 3 à 5 ans d'expérience en rédaction médicale dans l'industrie pharmaceutique, biotechnologique ou au sein d'une organisation de recherche sous contrat (CRO). * Excellente capacité à interpréter et synthétiser des données complexes d'essais cliniques, des résultats de recherche scientifique et des analyses statistiques, avec de solides compétences en rédaction, relecture et édition, ainsi qu'une aptitude à communiquer des concepts scientifiques à des publics variés. * Très bonne connaissance des exigences réglementaires (notamment ICH-GCP, FDA, EMA) relatives à la préparation et à la soumission des documents cliniques et des publications, ainsi qu'une expérience des interactions avec les autorités réglementaires lors des processus d'évaluation et d'approbation. * Capacité démontrée à travailler efficacement dans un environnement dynamique, avec des délais serrés, en gérant simultanément plusieurs projets et en priorisant les tâches en fonction des échéances et des livrables. * Excellentes compétences relationnelles et de communication, avec la capacité de collaborer efficacement avec des équipes transverses, d'établir des relations solides avec les parties prenantes clés et d'influencer les processus de prise de décision. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply