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  • Medical Writer

    Allstem Connections

    Medical writer job in Upper Gwynedd, PA

    Job Title: Medical Writer Duration: 12+ Months Hybrid-2-3days/week Required Qualifications: Bachelor's degree/Master's degree with minimum 2 years of relevant experience in life sciences and process- and systems-related coordination PharmD or PhD preferred. Prior experience in Medical Affairs and/or medical content development preferred. Required Skills & Experience Experience partnering with business stakeholders across geographies, therapy areas, and functions to meet business needs in a timely and compliant manner Experience working independently to design and produce slide decks within an easy-to-navigate framework that supports stakeholder use with external customers Attention to detail, excellent communication skills, and the ability to work independently, escalating risks and issues as appropriate Demonstrated success in a fast-paced environment, with the ability to learn on the fly while understanding and solving new problems that require a high level of independent judgement and initiative Ability to identify the most efficient and effective way to implement new solution Proven ability to innovate and think non-traditionally Strong business acumen and ability to judge whether ideas can lead to compliant and value-adding customer solutions Excellent verbal and written communication to technical and non-technical audiences of various levels within the organization Outstanding presentation and facilitation skills Strong leadership skills and proven ability to influence without authority Good interpersonal and networking skills Curiosity and willingness to constantly challenge the status quo Preferred: Experience working at an affiliate, regional, and/or global level. Our team is responsible for creating external tools and resources for scientific exchange and in response to medical information inquiries. Software: MS PowerPoint, MS Excel, MS Word, Veeva Vault MedComms (Nice to have). Key skills: Medical Content writing experience. Medical affair or medical writing background. TA-Oncology Responsibilities Medical Writer Contractor, Global Scientific and Value Content reports to the GSVC Team Lead and focuses on several key functions within the GSVC Team. This role directly supports the GSVC Team in developing resources (e.g., slide decks, Medical Information Letters [MILs], Verbal Response Documents [VRDs]) for use by the Field Medical Organization and Global Medical Information Staff, among other responsibilities. This role participates in transformational initiatives in the fast-paced and dynamic environment of Value & Implementation Global Medical and Value Capabilities (V&I GMVC). The Medical Writer Contractor is responsible for the following functions and activities: GSVC Creation and maintenance: With guidance from senior GSVC colleagues, develops and maintains GSVC resources in alignment with the GSVC Annual plans for GMSA Field Medical and Global Medical Information staff. Reviews GSVC materials to ensure they are relevant, scientifically accurate, and consistent with cited appropriate scientific literature, internal scientific information, and Company values and standards. Quality/Compliance: Critically analyzes and evaluates the rendering, display, and presentation of scientific and therapeutic data for use by internal stakeholders to respond to Medical Information Requests (MIRs). Innovative GSVC Practices and Procedures: Supports creative solutions for communicating GSC in multiple formats based on internal and external customer needs. Supports innovative design, consultation, and development for infographics or other digital media used for in the development of GSVC content based on internal and external customer needs. Serves as an advocate for changing customer needs for GSVC, particularly for GMSA Field Medical and Global Medical Information (GMI) staff. Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work. Influences, partners and collaborates with other colleagues within the GSVC team. Collaborates effectively with peers and stakeholders to offer a new perspective on existing solutions while offering new innovations for the organization and communication of scientific content for GMSA Field Medical and GMI staff. Evaluates new technologies to best support GSVC organization needs.
    $69k-104k yearly est. 2d ago
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  • Technical Writer

    Rajant Corporation 4.4company rating

    Medical writer job in Malvern, PA

    Technical Writer - Wireless Networking Products RAJANT CORPORATION, the 20+-year leader in industrial wireless patented Kinetic Mesh networking solutions, providing full mobility and autonomous products, is seeking a Technical Writer. Are you passionate about turning complex technical ideas into clear, useful content? We are looking for a Technical Writer to craft exceptional user manuals, data sheets, and documentation for our cutting-edge communication technologies. Join our small, collaborative team to drive real-world results in industries like mining, military, and telecom to support our global customers. About the Role: As a Technical Writer for Rajant, you will work within a group of writers to deliver content for new product releases and updates. You create and curate content that helps our diverse, global audience understand and use our software and hardware products. You also help define internal processes, maintain overall content standards, and drive the evolution of our technical content for customer audiences and end users. To succeed in this role, you must be naturally curious and collaborative, and enjoy clearly explaining complex technologies across a large product suite. You are able to deliver consistently with management supervision and guidance as part of a collegial and supportive team. 🔧 Responsibilities Assist in preparing and maintaining user guides, product manuals, specification sheets, and technical publications Gather technical information and prepare written text Interview subject matter experts and create content appropriate for the target audience Work with desktop publishing tools, image editing software, and document design applications Participate in agile activities (daily standup, sprint planning, and sprint review) to track and share project status Review and copyedit fellow writers' content to promote consistency and quality, and ensure documentation meets standards and guidelines Collaborate with other departments and stakeholders to ensure proper documentation approval prior to release Contribute to and support multistage documentation projects with assistance from managers and peer writers ✅ Requirements: Bachelor's degree and minimum two years' experience as a Technical Writer (or related course work) Excellent written and verbal communication skills Proficiency in English grammar and writing principles Proven track record of contributing to documentation projects from inception through delivery Assist with managing writing projects through multiple milestones, and manage more than one project at a time Proactive mindset, taking initiative to root out and assimilate information and formulate next steps toward delivery Strong curiosity and desire to learn about technology Ability to install and operate software products with assistance High attention to detail with a strong focus on content accuracy and quality Ability to build relationships that provide ongoing access to information Ability to understand basic editing concepts and write technical copies for various types of documents for a program/project of similar complexity 🌟 Desirable Skills and Experience: A problem-solving and continuous improvement mindset Writing content for software and hardware products Exposure to working within an agile development methodology Ability to perform Git operations including branching, repository management, pull requests, and resolving merge conflicts Familiarity with writing in Markdown Experience using desktop publishing tools, such as Adobe InDesign Experience using image editing software, such as Adobe Photoshop 💡 Why Rajant? You'll be documenting real-world technologies that empower defense, mining, energy, and critical infrastructure sectors. You'll join a forward-thinking company where your writing will make a real impact on global industries. Professional growth: Opportunity to work with cutting-edge Kinetic Mesh networking technology. We invest in our team's development through on-the-job training and chances to take on new responsibilities as you grow. Collaborative culture: Be part of an award-winning workplace with a tight-knit team of engineers and innovators. We pride ourselves on a fun, inclusive environment where your contributions matter. (Rajant has been recognized as a Best Place to Work in Pennsylvania & Kentucky.) Rajant's Company Profile: ************** We are the biggest name in dynamic wireless mesh networking you may not have heard of yet. No other mesh solution even comes close to the performance of our patented InstaMesh Kinetic Mesh technology in dynamic environments. We drive massive mines all over the globe, enabling autonomous haul trucks, shovels, and other equipment. Our networks are in factories and warehouses automating repetitive and dangerous tasks. We're in 'Spot' the Robot Dog and in a variety of aerial drones. We link Oil and Gas sites, and automate Maritime Ports worldwide. The U.S. Army trusts our resilient mesh technologies to keep America and our Global partners safe. Who We Are: We're a tight-knit group of technology experts that demand excellence of ourselves and in all we do. We need like-minded professionals to identify tech problems and solve them, enabling our development teams to efficiently push ever more hardware and software solutions to market, faster and more reliably. 📬 Ready to Apply? Do you have what it takes to be a part of the Rajant Team? Impress us with your resume today. If you make the team, this will be the most challenging and rewarding place you'll ever work. Send us your resume and a portfolio of writing samples to **********************. We're excited to see how you can help shape the voice of Rajant's innovative solutions. Job Details: Full-Time, annual salary with Full Benefits. Location: Rajant Corporate Office in Malvern, PA. Job Details: Full-Time, annual salary with Full Benefits. Location: Rajant Corporate Office in Malvern, PA. Apply: EASY APPLY or introduce yourself w/ cover letter & resume to: **********************. Rajant Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, national origin, age, physical or mental impairment, sexual orientation or any other category protected under federal, state or local law. Rajant is a USG Contractor and complies with all US laws, regulations and Executive Orders.
    $45k-60k yearly est. 1d ago
  • Bilingual Technical Writer

    Insight Global

    Medical writer job in Raritan, NJ

    Insight Global is looking for a technical writer for one of our pharmaceutical clients to sit in Raritan, NJ. This candidate will revise and approve protocols, SOPs, and other equipment focused documentation. They will partner with the engineers, metrology, maintenance, calibration, and other facilities resources to determine the clearest and most logical way to present information to users. Our client has current templates within their Veeva Vault, Trackwise and Comet systems which contains content and workflows for candidates to pull protocols. REQUIRED SKILLS AND EXPERIENCE -5 years of experience in pharma -5 years experience with technical writing -Engineering knowledge -cGMP Manufacturing experience NICE TO HAVE SKILLS AND EXPERIENCE -Maximo CMMS experience -Veeva Vault, Comet, or Track wise
    $56k-76k yearly est. 3d ago
  • IT Technical Writer I

    Teksystems 4.4company rating

    Medical writer job in Philadelphia, PA

    *Hybrid - Philadelphia, PA* *Contract - Long Term* *Summary: *The department is focused on app onboarding and development. This helps external developers create apps using the SDK for the platform. This tech writer will craft high quality technical documentation. It will need to be clean and public facing materials. This position will handle a mix of content and technical content *Job Description* * Responsible for creation and maintenance of IT documentation. * Translates technical and/or complicated information into clear concise documents appropriate for various target audiences. * Works with Development Quality Assurance and Technical Support to produce a wide variety of technical publications including instructional materials technical manuals product documentation and the like for use by both the IT and business community. * Interviews subject matter experts and technical staff to collect information prepare written text and coordinate layout and material organization. * Researches information such as drawings design reports equipment and test specifications to fill any gaps. * Reviews critiques and edits documentation including design documents programmer notes and system overviews. * Requires knowledge of company product lines and document structure. Depending on the industry/work environment such documents may include various media including written and video. * Responsibilities include maintenance of internal documentation library providing and/or coordinating special documentation services as required and oversight of special projects. * Must have strong organizational and project management skills and excellent writing and editing skills. *Additional Skills & Qualifications* * Bachelor's Degree in Journalism, Technical Writing, Business Administration or Other Related Field - OR equivalent work experience. * 1+ year of technical writing experience and working knowledge of multiple software and graphics packages. * Seeking candidates who have some coding knowledge as they will be working with developers. *Job Type & Location*This is a Contract position based out of Philadelphia, PA. *Pay and Benefits*The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) *Workplace Type*This is a hybrid position in Philadelphia,PA. *Application Deadline*This position is anticipated to close on Jan 22, 2026. h4>About TEKsystems: We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. About TEKsystems and TEKsystems Global Services We're a leading provider of business and technology services. We accelerate business transformation for our customers. Our expertise in strategy, design, execution and operations unlocks business value through a range of solutions. We're a team of 80,000 strong, working with over 6,000 customers, including 80% of the Fortune 500 across North America, Europe and Asia, who partner with us for our scale, full-stack capabilities and speed. We're strategic thinkers, hands-on collaborators, helping customers capitalize on change and master the momentum of technology. We're building tomorrow by delivering business outcomes and making positive impacts in our global communities. TEKsystems and TEKsystems Global Services are Allegis Group companies. Learn more at TEKsystems.com. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
    $25-30 hourly 1d ago
  • Lead Medical Writer

    Fishawack Health

    Medical writer job in Philadelphia, PA

    Job Title: Lead Medical Writer Department: Medical Writing JOB PURPOSE Lead the medical writing team for accounts that require multiple writers to meet the content demands of customized medical communications initiatives, and/or lead multiple accounts. JOB RESPONSIBILITIES With minimal direction or supervision, responsible for assigned-client service: provide high-quality editorial oversight for all content including planning through review; maintain knowledge of project status (content development and review) to ensure editorial quality and successful completion of all client content projects; identify and develop new opportunities for projects (working with the account manager) and publications (working with the publications manager); interact with account manager, publications managers, and project managers to ensure adherence to timelines and deliverables. RESPONSIBILITY/PERFORMANCE MEASUREMENT Content Development-Work closely with assigned project management team to ensure high-quality editorial implementation of all assigned-client programs. Effectively provides the information people need to know to do their jobs and to feel good about being a member of the assigned-client project team Provides medical writers information and direction so that they can draft accurate, high-quality editorial content; serves as a resource for questions Assesses potential projects to provide an estimate of writing time required for completion Reviews content for the assigned-client projects and ensures that content reflects clients' objectives and preferences while staying on time and on budget Cultivates and shares expertise in assigned therapeutic areas Delegates tasks and decisions in a professional manner, sets clear objectives, and trusts people to perform Shares responsibility and accountability for assigned-client projects Consistently complies with Fishawack standard editorial procedures, including ethical standards Communication-Effectively and proactively communicate with team members (editorial, project, client), authors/faculty, and vendors in areas related to project completion. Ensures that information is communicated effectively within and across internal teams in a timely manner Keeps project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (eg, changes in scope, delays in receiving comments) to ensure project completion on time and on budget Proactively provides input to team members to enhance project outcomes Prioritizes workload for medical writers on team Offers to assist others in times of slow workloads and asks for assistance during times of heavy workloads Business Development-Investigate, conceptualize, and strategize new medical communications projects and publications to support the assigned-client's needs and opportunities. Supports account manager's efforts to identify and secure new business for assigned client in a timely manner Understands scope of Fishawack's capabilities and how to tailor Fishawack's services to assigned-client's needs Effectively identifies opportunities for content development for assigned client Company Representation-Represent the company at client meetings (e.g, advisory boards, speaker-training meetings, business development initiatives) in a professional manner. Serves as onsite editorial resource and content expert in a professional manner Reviews and revises program content, as needed in an accurate and timely manner Prepares speakers for their presentations in a professional manner Anticipates additional onsite needs and proactively prepares for these needs Proactively assists project team; acts as a collaborative team member Is prepared to discuss top-line information pertaining to content of business development meetings; educates internal, non-medical team members about content-related issues CORE COMPETENCIES FOR THIS POSITION (The behaviors, skills and practices required to accomplish the objectives of this position and in the daily conduct of business.) Written Communications-Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect Timely Decision Making-Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision Informing-Provides the information people need to know to do their jobs and to feel good about being a member of the project team; provides medical writers information and direction so that they can draft accurate, high-quality editorial content; is timely with information Delegation-Clearly and comfortably delegates both routine and important tasks and decisions; broadly shares both responsibility and accountability; tends to trust people to perform; lets team members finish their own work Composure-Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress CORE COMPETENCIES FOR ALL FISHAWACK POSITIONS Client Focus-Is dedicated to meeting and exceeding the expectations and requirements of clients; gets first-hand client information and uses it for improvements in services; acts with clients in mind; establishes and maintains effective relationships with clients and gains their trust and respect Functional/Technical Skills-Has the functional and technical knowledge, skills, and creativity to do the job at an extremely high level of accomplishment Ethics/Values/Integrity/Trust-Adheres to an appropriate and effective set of core values and beliefs during both good and bad times; acts in line with those values; acts in a direct and truthful way; can present the unvarnished truth in an appropriate and helpful manner; admits mistakes; doesn't misrepresent him/herself for personal gain INTERACTIONS (EXTERNAL & INTERNAL DEPARTMENTS) Clients Authors/Thought Leaders/Experts Vendors Contract or Freelance Employees All Employees REQUIRED KNOWLEDGE, SKILLS, & ABILITIES (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and ability required.) Education Required: 4 year post secondary education, or equivalent experience; Bachelor's degree in the life sciences; PharmD or PhD highly preferred Experience 5+ years of medical writing experience 5+ years of editorial process experience 2+ years of experience with assigned-client's projects Special Knowledge/Skills Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel Proficiency in Internet and PubMed searches Ability to work independently with minimal supervision, and as part of a team
    $70k-104k yearly est. 60d+ ago
  • Medical Writer Position

    Integrated Resources 4.5company rating

    Medical writer job in Collegeville, PA

    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 RESPONSIBILITIES: • Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products. • High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. • Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management. • Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders. • Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents. • Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents. • Manage contract writers, as well as internal writers. • Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses TECHNICAL KNOWLEDGE: • Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy. • Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents. • Able to complete and turn around high quality outputs with only minimal guidance from management. Qualifications QUALIFICATIONS AND SKILLS NEEDED: • Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent. • Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance. • Experience with oncology and eCTD filing preferred. Additional Information Tel: 732-429-1921 http://www.irionline.com
    $72k-103k yearly est. 1d ago
  • Principal Medical Writer

    Icon Clinical Research

    Medical writer job in Blue Bell, PA

    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
    $69k-104k yearly est. 40d ago
  • Medical Writer

    Artech Information System 4.8company rating

    Medical writer job in Pennington, NJ

    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.
    $79k-111k yearly est. 1d ago
  • Principal Medical Writer

    Icon Plc 4.8company rating

    Medical writer job in Blue Bell, PA

    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
    $67k-93k yearly est. 41d ago
  • Medical Writer I

    Lancesoft 4.5company rating

    Medical writer job in Raritan, NJ

    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
    $82k-112k yearly est. 1d ago
  • Senior Medical Writer - FSP

    Parexel 4.5company rating

    Medical writer job in Trenton, NJ

    The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $95k-139k yearly est. 2d ago
  • Senior Science Writer

    News Writer/Reporter, Cancer Discovery In Boston, Massachusetts

    Medical writer job in Philadelphia, PA

    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
    $63k-101k yearly est. Auto-Apply 60d+ ago
  • Senior Technical Writer

    Contact Government Services, LLC

    Medical writer job in Philadelphia, PA

    Job DescriptionSenior 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 We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
    $58k-78k yearly est. Easy Apply 5d ago
  • Business Development/Proposal Writer

    BFW Group

    Medical writer job in Philadelphia, PA

    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
    $56k-86k yearly est. Easy Apply 3d ago
  • Associate Proposal Writer

    Angeion Group 3.4company rating

    Medical writer job in Philadelphia, PA

    Angeion Group is a fast-growing, international leader in progressive settlement administration-specializing in Class Action, Mass Tort, and Bankruptcy cases. We're on a mission to redefine the future of legal administration, and we're looking for passionate, purpose-driven individuals who are ready to make an impact. At Angeion, you'll join a dynamic, global team united by a commitment to excellence. With colleagues across continents and a collaborative, forward-thinking culture, we offer more than just a job-we offer a career with purpose, growth, and community. Whether you're just starting out or bringing deep expertise, you'll find opportunities to learn, lead, and shape the future with us. Angeion Group is seeking a motivated Associate Proposal Writer to join our team. This position plays a key role in developing, organizing, and producing high-quality proposals and other client correspondences. You will collaborate directly with the Project Development Manager and Senior Management to create strategic, compliant, and compelling proposal materials that reflect our company's operational excellence and commitment to client success. The ideal candidate is a proactive professional who thrives in a fast-paced environment, demonstrates exceptional attention to detail, and is eager to contribute to a high-performing, nationally recognized organization. Key Responsibilities Develop, write, and edit proposals including executive summaries, methodologies, budgets, and supporting materials. Coordinate proposal activities, gather project information, obtain quotes from vendors/partners, and ensure consistency in messaging and compliance across submissions. Research and respond to RFPs, amendments, legal documents, and class action settlement agreements. Collect, organize, and manage data from internal and external databases, CRM systems, and vendors. Ensure timely completion and submission of proposals by managing schedules, tracking progress, and coordinating input from contributors. Collaborate with Business Development and Operations Teams to ensure seamless project handoffs and accurate cost estimates. Maintain proposal templates, databases, and content libraries to support efficiency and quality in future submissions. Continuously improve proposal processes and documentation practices to enhance accuracy and impact. Communicate professionally with clients, vendors, and internal stakeholders across multiple departments and time zones. Exhibit strong organizational skills and meticulous attention to detail while meeting multiple deadlines. Perform additional duties and special projects as assigned by management. Qualifications Education & Experience Bachelor's degree in a related field or discipline. 3-5 years of proven experience in proposal writing, project coordination, or a related function. Demonstrated success in developing business proposals and cost estimates. Skills & Competencies Strong writing, editing, and research skills with the ability to translate technical information into clear, persuasive language. Proven ability to manage multiple projects simultaneously in a deadline-driven environment. Proficiency in MS Office 365 (Word, Excel, PowerPoint, Outlook, Teams, OneDrive). Strong analytical, organizational, and problem-solving skills. Excellent communication and collaboration skills with a professional demeanor. Ability to adapt quickly to shifting priorities and respond effectively under pressure. Familiarity with accounting principles and proposal management systems preferred. Experience in financial, insurance, or legal industries is a plus. Other Requirements Must be authorized to work in the U.S. without company sponsorship, now or in the future. Commitment to maintaining confidentiality and upholding company standards of professionalism. Why You'll Love Working at Angeion We care deeply about our people and offer a comprehensive benefits package, including: Medical & Dental Insurance Employer-Paid Vision Employer-Paid Short & Long-Term Disability Group Life Insurance 401(k) Offerings Employee Assistance Program (EAP) Time Off & Holidays: 120 Hours of Paid Time Off (PTO) 48 Hours of Sick Time (state dependent) 3 Floating Holidays 10 Paid Company Holidays: Ready to make your mark in a company that values growth, innovation, and people? Join us at Angeion Group-where your work truly matters.
    $51k-71k yearly est. Auto-Apply 60d+ ago
  • Grants Specialist, RACE - Jefferson Center City

    Kennedy Medical Group, Practice, PC

    Medical writer job in Philadelphia, PA

    Job Details The position of Research Administration Center of Excellence (RACE) Grants Specialist will be responsible for working with assigned departments as well as their Associate Director on post-award research activities while delivering excellent customer service. The position will perform support functions for TJU Principal Investigators (PIs), with a focus on ensuring that PIs have accurate and timely information to make decisions. The Grants Specialist will be provided an individualized opportunity to further their career path while receiving exposure to and training in more complex aspects of research administration. Portfolio assignments will be determined based on their experience, job level, and portfolio complexity (grant type/sponsors/PIs). Individuals within this role will communicate extensively and directly with faculty regarding their grant finances, progress reports, day-to-day needs, etc. The Grants Specialist will take on an increasingly complex research portfolio including but not limited to programmatic grants (Cooperative Agreements, Program Project Grants, and Training Grants). Research is a vital component of the TJU's mission and support of research administration is a key component of success for RACE. The Grants Specialist positions within RACE are mid-level research administration staff positions requiring the incumbent to ensure proper stewardship of grants financial management. The Grants Specialist is a full-time position that will strive to meet the research needs of Principal Investigators in basic, applied, or clinical research. The Grants Specialist will report to the the Associate Director of their assigned team. The Grants Specialist models and fosters behavior that establishes a culture that values the staff/faculty partnership and is consistent with the values, goals, and objectives of the enterprise/department to create an atmosphere of trust, cooperation, accountability, empowerment, and dedication to the research mission of the enterprise. Job Description Examines awards for suitability of terms and conditions and reviews budgets with PI; coordinates establishment of project accounts for the grant and sub-awards (as applicable) Working with Associate Director, administers grant by monitoring award and sub-awards for compliance, analyzing monthly financial reports, communicating with PI regarding financial progress and coordinating activities at the end of the budget period Maintains accounting records for all awards within their assigned portfolio Reconciles all assigned accounts against the General Ledger on a monthly basis Coordinates personnel and purchasing activities with the PI and applicable TJU offices; review and act as a signatory (if designated by the PI) for budget summaries, budget adjustment forms, JVs, Travel Authorizations and Reimbursements, Invoices, Check Requests, Expense Reimbursements and Purchase Requisitions as necessary Ensures payroll distribution is correct for faculty, graduate students, fellows and support staff on a bi-weekly basis and processes changes as needed Meets with PIs at least monthly to provide updates on the financial status of their accounts Acts as a liaison between PIs and ORA/SPAO to communicate and resolve any issues that arise concerning expenditures Assists PIs with effort reports to ensure accuracy and timely submission Assists PIs with budget development for progress reports Assists with submission of progress reports, program reviews and other activities related to the grant Working with ORA as appropriate, assists with providing just in time information or other agency requests such as budget revisions, compliance issues, etc. Serves as a resource to department staff and faculty to ensure compliance with policy Attends regular meetings, training sessions, and professional development workshops/seminars to keep current on policies and procedures relevant to position responsibilities, as requested and approved by the RACE Associate Director(s) (supervisor) or Director, Post-Award (RACE). Education and Experience: Associate's degree in General Studies, Business, Finance or Healthcare Administration, or related field required. Bachelor's degree preferred. 1.3+ years experience in research administration-related work. Computer skills in a PC/Windows environment, including MS Word, Excel, and PowerPoint, demonstrated by application materials and previous experience. Excellent written communication skills and attention to detail as demonstrated by application materials. Work Shift Workday Day (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson University Primary Location Address 1025 Walnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here
    $50k-73k yearly est. Auto-Apply 60d+ ago
  • Grant Writer

    Chestnut Hill College 4.4company rating

    Medical writer job in Philadelphia, PA

    The Grant Writer is responsible for researching, developing, writing, and managing grant proposals to secure funding from private foundations, corporations, and government agencies in support of the College's strategic priorities. The Grant Writer works collaboratively across departments to identify funding opportunities, ensure timely and accurate submissions, and maintain strong relationships with funders. The Grant Writer contributes to both pre- and post-award activities, including proposal development, budget coordination, grant reporting, and donor stewardship. About Chestnut Hill College: Chestnut Hill College, founded by the Sisters of Saint Joseph in 1924, is an independent, Catholic institution that strives to foster equality through holistic education within a strong liberal arts tradition. The mission of the College is dedicated to promoting the spiritual, academic, social, ethical, and moral development of the whole person. The College, situated in Chestnut Hill, a charming neighborhood in Northwest Philadelphia, serves a culturally diverse student body. Key Responsibilities: Research and identify grant opportunities aligned with institutional priorities. Write, edit, and submit high-quality letters of inquiry, concept papers, and full proposals. Develop and manage grant budgets in coordination with the Finance Office. Ensure all proposals comply with institutional policies and funder guidelines. Track proposal and reporting deadlines and ensure timely submissions. Maintain accurate records of grant activity and funder communications. Prepare required documentation and reporting for awarded grants. Support stewardship of corporate and foundation donors. Collaborate with faculty and staff to develop competitive proposals and stay informed about institutional programs and goals. Provide data analysis and reporting support as needed for institutional and foundation reporting. Participate in donor engagement activities, including occasional evening or weekend events. Contribute to strategic planning and fundraising initiatives led by the Office of Institutional Advancement. Q ualifications: Bachelor's degree required. 3-7 years of experience in grant writing and development, preferably in a higher education or nonprofit setting. Proven success in securing funding from private, corporate, and/or public sources. Exceptional writing, editing, and research skills. Strong interpersonal, organizational, and time-management abilities. Proficiency in Microsoft Office, fundraising databases (e.g., Raiser's Edge), and online funding research tools (e.g., Foundation Directory). Ability to work on-site, with occasional evening or weekend hours. Preferred: Master's degree. Experience in budget development and grant management. Familiarity with grants manual procedures. Knowledge of higher education fundraising and appreciation for the mission of a private liberal arts institution. Interested candidates should submit a cover letter and resume via ADP Workforce Now HERE . No phone calls, please. Chestnut Hill College is committed to a culture of diversity, equity, and inclusion as a core value. To foster an inclusive community and support our diverse student body, we embrace equal access. We welcome applications from candidates of all backgrounds, experiences, and perspectives, and encourage applications from groups historically underrepresented in higher education. We are committed to increasing the diversity of the college community and the curriculum
    $41k-48k yearly est. Auto-Apply 60d+ ago
  • Medical Writers

    Integrated Resources 4.5company rating

    Medical writer job in Spring House, PA

    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
    $72k-103k yearly est. 60d+ ago
  • Medical Writer

    Artech Information System 4.8company rating

    Medical writer job in Pennington, NJ

    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.
    $79k-111k yearly est. 60d+ ago
  • Senior Medical Writer

    Fishawack Health

    Medical writer job in Philadelphia, PA

    Job Title: Senior Medical Writer Department: Medical Writing (MW) JOB PURPOSE Provide research, writing, and substantive editing expertise for customized medical communications initiatives with minimal direction or supervision. JOB RESPONSIBILITIES Responsible for developing and delivering original, accurate, high-quality content (manuscripts, slides, and other editorial assignments) within the project specifications, timeline, and budget. Provide high‑quality editorial oversight for both project work and business development efforts. Strive to function as scientific and therapeutic expert (within limitations of budget and timelines) for assigned project teams, and function as primary writer for assigned accounts. RESPONSIBILITY Content Development-Research, write, and revise high-quality, original editorial content. Develops clear, concise outlines, on-target first drafts, and proactively incorporates data/revisions Cultivates expertise in assigned therapeutic areas Maintains focus and completes projects in timely manner, meeting project timeline, and staying within budget (assuming project scope does not change) Assesses each project to proactively identify areas that will require assistance from others (ie, graphic design, editorial support); elicits help as needed Assesses potential projects to provide an estimate of writing time required for completion Demonstrates ability to balance multiple projects for multiple clients Assists new/junior employees with content development activities and serves as a resource for questions Continuously complies with JK standard editorial procedures, including ethical standards Content Editing and Referencing-Edit and appropriately reference content written by others. Improves clarity in others' writing Ensures flow, content, and grammar are appropriate Enhances clarity and grammatical accuracy of the writing while maintaining the voice/tone/thoughts of external authors Ensures scientific accuracy while editing and referencing Company Representation-Represent the company at client meetings (eg, advisory boards, speaker-training meetings, business development initiatives) in a professional manner. Serves as onsite editorial resource and content expert in a professional manner Reviews and revises program content as needed in an accurate and timely manner Prepares speakers for their presentations in a professional manner Anticipates additional onsite needs and proactively prepares for these needs Proactively assists project team; acts as a collaborative team member Is prepared to discuss topline information pertaining to content of business development meetings; educates internal, nonmedical team members about content-related issues Communication-Effectively and proactively communicate with team members (editorial, editorial support, project, client), authors/faculty, and vendors in areas related to project completion. Ensures that information is communicated effectively within internal project teams Keeps project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (eg, changes in scope, delays in receiving comments) Functions as primary client and/or external author contact, as needed Prioritizes work, as appropriate and with help of project team and manager Proactively provides input to team members to enhance project outcomes Offers to assist others in times of slow workloads and requests assistance during times of heavy workloads CORE COMPETENCIES FOR THIS POSITION (The behaviors, skills and practices required to accomplish the objectives of this position and in the daily conduct of business.) Written Communications-Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect Intellectual Horsepower-Is bright and intelligent; deals with concepts and complexity comfortably; described as intellectually sharp, capable, and agile Independently Responsible-Doesn't shirk personal responsibility; functions well independently; can be counted on when times are tough; is comfortable working alone on a tough assignment Composure-Is cool under pressure; does not become defensive or irritated when times are tough; is considered mature; can be counted on to hold things together during tough times; can handle stress Organization/Time Management/Timely Decision Making-Can orchestrate multiple activities at once to accomplish a goal; uses resources effectively and efficiently; can juggle multiple projects and deadlines; arranges information and files in a useful manner. Uses time effectively and efficiently; concentrates efforts on more important priorities; able to make a quick decision, sometimes with incomplete information and under tight deadlines and pressure CORE COMPETENCIES FOR ALL FISHAWACK POSITIONS Client Focus-Is dedicated to meeting and exceeding the expectations and requirements of clients; gets first-hand client information and uses it for improvements in services; acts with clients in mind; establishes and maintains effective relationships with clients and gains their trust and respect Functional/Technical Skills-Has the functional and technical knowledge, skills, and creativity to do the job at an extremely high level of accomplishment Ethics/Values/Integrity/Trust-Adheres to an appropriate and effective set of core values and beliefs during both good and bad times; acts in line with those values; acts in a direct and truthful way; can present the unvarnished truth in an appropriate and helpful manner; admits mistakes; doesn't misrepresent him/herself for personal gain REQUIRED KNOWLEDGE, SKILLS, & ABILITIES (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and ability required.) Education-4 year post secondary education, or equivalent experience. Bachelor's degree in the life sciences; PharmD or PhD highly preferred Experience-3+ years of medical writing experience; 3+ years of experience in the editorial process Special Knowledge/Skills Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel Proficiency in Internet and PubMed searches Ability to work independently with minimal supervision, and as part of a team
    $80k-124k yearly est. 60d+ ago

Learn more about medical writer jobs

How much does a medical writer earn in Horsham, PA?

The average medical writer in Horsham, PA earns between $58,000 and $124,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.

Average medical writer salary in Horsham, PA

$85,000

What are the biggest employers of Medical Writers in Horsham, PA?

The biggest employers of Medical Writers in Horsham, PA are:
  1. icon Mechanical
  2. Integrated Resources
  3. Allstem Connections
  4. Icon Clinical Research
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