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Edwards Lifesciences Corp logo
Edwards Lifesciences CorpTexas, AL
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpMonterey, CA
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpPhoenix, AZ
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpCalifornia, MD
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

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Lexipol LLCFrisco, TX

$35 - $50 / hour

Grant Writing Consultant—Law Enforcement This is a remote role. Candidates must already live in the United States. #LI-Remote >>>>> This is direct with the Grant Consultant. NO outside firms will be considered. No visa sponsorship. We are unable to sponsor or take over sponsorship of any type of Visa (H1-B, Student visa, or OPT visa) at this time. Applicants must be authorized to work for ANY employer in the U.S. At Lexipol, our mission is to create safer communities and empower the individuals on the front lines with market-leading content and technology. Our top-notch team works closely with law enforcement, fire, EMS, corrections, and local government professionals to tailor our solutions to better address today’s challenges and keep first responders coming home safely at the end of each shift. Working at Lexipol means making a difference – day in and day out. The Work Lexipol’s pre-award Grant Services Team provides customized solutions enabling applicants to tap into federal, state, and private grants. More than $600 billion in nationwide grants is available to public safety agencies and local government each year. Few organizations have grants experts on staff, or the time to research opportunities and develop grant applications. We offer three unique grant solutions: GrantFinder , our grant search tool Grant Writing Services for stand-alone projects and programs Grant Assistance Platform program for applicants in need of support for multiple projects and programs on an annual basis The Law Enforcement Grants Consultant plays a key role on the Grants Team. The overall goal for this role is to assist the Grants Team in the fulfillment of grant writing services contracts, grant consulting, grant research and reviews for local police departments and sheriff’s departments in the US.. This role will be responsible for narrative writing, research, and consulting with agencies and communities one-on-one regarding grant programs. This position reports to the Grant Services Manager. The primary objective is to successfully submit complete and comprehensive, professional grant applications for our law enforcement clients. Working in partnership with a Grants Team Project Manager, this position will assist in the fulfillment and successful completion of contracted grant projects. The Lexipol Grants team will fulfill Law Enforcement grant writing applications; research; review and consulting for public safety agencies; state police; county, national and state Law Enforcement member associations. The team submits applications to major grant makers including FEMA, DHS, BJA, COPS, and OVW. This is a remote Contract role: candidates must live in the United States. This is done through working in these areas of focus: Narrative Writing and Development (40%) Example activities: Provide support and guidance to the project manager and agencies by developing comprehensive narratives. Narratives will be delivered professionally, timely, and free of grammar errors. Consult with agency point of contacts on items needed for narratives and make recommendations on project eligibility. Consulting (60%) Example activities: Advise, consult, problem solve, and research potential grant programs for the departments, agencies and governments we serve via phone calls, video conferencing, and email. Meet with agencies one-on-one to discuss project and recommend potential grant opportunities. Requirements: To be considered for this role, you will have this experience: 2 or more years of professional grant writing and consulting experience within local law enforcement agencies: police departments, sheriff’s departments, and corrections departments. A knowledge of federal, state, foundation, and corporate grant processes, in particular grants that benefit law enforcement agencies. Experience with writing grants or grant narratives for programs like the Bureau of Justice Assistance, the COPS Office, State and Local Law Enforcement grant programs, or programs focused on capital projects and equipment/technology improvement requests. Experience consulting with Law Enforcement agencies regarding grant writing processes and identifying grant opportunities. Ability to work under pressure and multitask in a fast-paced environment taking on multiple grant writing projects at a time. Familiarity with Law Enforcement grant administrative best practices Experience working with various CRM databases Target Outcomes/ Target Results 20-25% Success Rate in having Law Enforcement grants awarded 95% Narrative completion rate: fulfilling accepted projects in timelines assigned by project manager Employee Value Proposition Onboarding process that successfully trains you on our Grants Database, grant writing processes, and our project management system. The goal of this team is to support public servants through the successful guidance and submission of grant applications to achieve funding for their organization. The organization is growing, committed to staff growth, product improvement and looking to scale the impact of our work nationally. Mentoring by Grant Services Manager Career pathing opportunities in custom content creation, speaking opportunities Grant Writer and consultant roundtables: engage in activities designed to provide exchange of information and ongoing training The Environment Report to the Grant Services Manager who has 10+year experience as a first responder and in grants. Fun, engaging and talented teammates who are passionate about social good and contributing to communities Team oriented environment: collaborate with project managers who are the point of contact with agencies. The project manager collects information from our client agencies. This allows the grant writer to focus on narrative development. Working closely with fortune 500 Companies Marketing and sales organizations who have limited to no understanding of funding for state and local organizations. Multiple stakeholders and team members in immediate and ancillary teams Duties listed are not intended to be exhaustive or exclusive; other duties may be assigned. Management retains the discretion to add to or change the duties of the position at any time. Compensation and Benefits This is a contract-based, remote, seasonal hourly position that pays $35 to $50 per hour based on experience. About Lexipol Lexipol empowers first responders and public servants to best meet the needs of their residents safely and responsibly. We are the experts in policy, training and wellness support, committed to improving the quality of life for all community members. Our solutions include state-specific policies, online learning, behavioral health resources, grant assistance, and industry news and information offered through the websites Police1, FireRescue1, EMS1, Corrections1 and Gov1. Lexipol serves more than 2 million public safety and government professionals in over 12,000 agencies and municipalities. For additional information, visit www.lexipol.com . Lexipol Is an Equal Opportunity Employer (EOE) Lexipol, LLC provides equal employment opportunities (EEO) to all team members and applicants for employment without regard to race, color, religion, gender, national origin, age, sex, pregnancy, disability, sexual orientation, gender identity or expression, veteran status, genetic information, or any other non-job-related characteristic. Lexipol complies with applicable federal, state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leave of absence, compensation, and training. #LI-RC1 Powered by JazzHR

Posted 2 weeks ago

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Clark Creative SolutionsAlbuquerque, NM

$90,000 - $105,000 / year

Job Summary We are seeking a detail-oriented and experienced Senior Technical Writing/ Editing Specialist to join our dynamic team. The ideal candidate will possess exceptional editing and proofreading skills, with a strong background in technical writing. This role is crucial in ensuring that all technical documents are clear, concise, and accurate, meeting the highest standards of quality. The Senior Technical Editor will collaborate closely with writers, subject matter experts, and project managers to produce high-quality documentation that effectively communicates complex information. Location: Kirtland AFB, Albuquerque, NM Security Clearance: Secret (S) Classification: Technical Writer (SOC 27-3041) Experience Level: Senior Position Summary: The Senior Technical Writer will support the Joint Nuclear Weapons Publications System (JNWPS) Team by drafting, editing, and managing technical publications. This includes ensuring compliance with style guides and coordinating with internal and external stakeholders. Key Responsibilities:  - Draft and edit JNWPS publications and supporting documentation.  - Manage review cycles and consolidate feedback.  - Maintain publication tracking systems and logs.  - Upload documents to DIAMONDS and manage distribution.  - Provide editorial support for meetings and correspondence. Qualifications:  - Minimum 8 years of relevant experience with a BA/BS, or 6 years with a high school diploma.  - Proficiency in Adobe FrameMaker, Illustrator, Photoshop, and Acrobat.  - Strong attention to detail and ability to manage multiple projects. Join us as we strive for excellence in our documentation processes while fostering an environment of continuous learning and improvement. Job Type: Full-time Pay: $90,000.00 - $105,000.00 per year Benefits: 401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule: Monday to Friday Work Location: In person Powered by JazzHR

Posted 30+ days ago

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GD ResourcesBoston, MA
Job Title: Business Writing Training Consultant Duration: Long Term Contract Location: Boston, MA – Hybrid (Remote delivery with potential onsite sessions as needed) Position Overview We are seeking an experienced Business Writing Training Consultant to design and deliver a customized training program for our client. The consultant will build and lead targeted writing trainings for executive-level, technical, and general business audiences, helping staff improve clarity, consistency, and impact in all written communications. This role requires strong experience in corporate or government business writing training, curriculum design, and adult learning, as well as comfort working with complex financial, housing, or technical subject matter. The ideal consultant has a proven track record delivering interactive workshops (virtual and/or onsite), developing assessments, and coaching professionals on real-world documents to elevate overall writing quality and efficiency. Responsibilities Design and deliver tailored business writing trainings for three core groups: executive-level writers, technical writers, and staff with general writing responsibilities (emails, reports, project plans, etc.). Lead discovery session(s) with agency leadership and key stakeholders to understand current writing practices, pain points, and training goals, and use those insights to shape a customized training program. Develop a structured training curriculum totaling approximately 6 hours of instructor-led content per cohort, delivered across 2 to 6 sessions (for example, two 3-hour workshops, three 2-hour workshops, or six 1-hour sessions). Recommend optimal class sizes and manage enrollment to keep groups at an effective learning size (e.g., 15–18 participants) to maximize participation, feedback, and practice time. Deliver engaging training sessions virtually (via Zoom, Teams, etc.), onsite at the Boston office, or through a hybrid format, using interactive exercises, real examples, and practical writing frameworks. Create materials, templates, and job aids that support executive-level writing (memos, summaries for senior leadership, external communications), technical writing (templates, narrative + analysis of complex topics), and general writing (emails, meeting notes, status reports, project plans). Develop and administer pre-training and post-training writing assessments for each participant to measure skill improvements and training effectiveness. Provide structured, written and/or verbal feedback and 1:1 or small-group coaching on real writing samples submitted by participants, with options for deeper feedback for select staff as requested by the client. Analyze assessment results and observed writing samples to identify key strengths, recurring issues, and skill gaps across departments and staff levels. Prepare and present a comprehensive final assessment report to Multifamily leadership summarizing key challenges, trends, and opportunities in staff writing, along with clear recommendations and next steps for continued development. Coordinate schedules, logistics, and communications with internal points of contact to ensure smooth delivery, participant attendance, and timely follow-up. Maintain high standards of professionalism, confidentiality, and alignment with the agency’s mission, values, and commitment to diversity, equity, and inclusion in all training interactions. Qualifications Proven experience (typically 5+ years) designing and delivering business writing, technical writing, or executive communication training for corporate, financial services, government, or nonprofit clients. Demonstrated ability to tailor training content for multiple audiences, including senior/executive leaders, technical staff, and general business staff with varied writing responsibilities. Strong background in business writing, technical writing, communications, English, education, instructional design, organizational development, or a related field; Bachelor’s degree required, advanced degree or relevant certification (e.g., CPTD, ATD, ICF, etc.) preferred. Hands-on experience creating curricula, slide decks, handouts, templates, and practical exercises that help adult learners apply new writing skills to real work products. Experience designing and using pre- and post-training assessments, rubrics, or evaluation tools to measure writing quality and learning outcomes. Comfort providing constructive, actionable feedback on writing samples, including executive summaries, technical reports, emails, memos, and other business documents. Excellent facilitation skills with the ability to lead interactive workshops both virtually and in person, keep participants engaged, and manage group dynamics. Strong understanding of plain language principles, audience-focused writing, clarity and conciseness, structure and flow, tone, and editing best practices. Prior work with public agencies, housing finance, affordable housing, or financial services organizations is highly desirable. Ability to work as an independent consultant, manage timelines, meet milestones, and coordinate with client stakeholders over a one-year engagement with potential extension. Powered by JazzHR

Posted 30+ days ago

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Fort Worth STEAM AcademyFort Worth, TX
Who We Are Fort Worth STEAM Academy (FWSA) is launching a tuition-free public charter middle school in East Fort Worth, opening August 2026. Our mission is to prepare every student for success in high school, college, and career through a rigorous STEAM-focused education, a joyful culture of high expectations, and strong community partnerships. As a founding team member, you won't just take a job—you'll help build a safe, structured, joyful school where curiosity and excellence thrive. Summary Middle School Teachers deliver TEKS-aligned instruction, build a safe, structured, joyful classroom, and use data to drive learning—so every student grows. You plan engaging lessons, analyze instructional data, provide accommodations with fidelity (IEP/504/EB), and partner with families and colleagues to ensure students meet ambitious goals. Reports to: Dean of Instruction Directly Manages: None Location: Fort Worth, TX (on-site) Compensation: 61K Schedule: Full-time, school calendar Anticipated Start Date: July, 2026 Who We're Looking For: Values-Driven and Mission-Focused This is a rare opportunity to help build a safe, structured, joyful public charter middle school where rigorous STEAM learning thrives. We're seeking teammates who live our values daily and turn them into student results. Achievement: Set bold, measurable goals, use data relentlessly, own outcomes, and prioritize high-impact work. Teamwork: Collaborate across roles, communicate directly with empathy, uphold high standards, and put the team above ego. Continuous Improvement: Seek feedback fast, find root causes, iterate on systems, and treat setbacks as learning data. Innovation: Spot problems early, test bold ideas quickly, share learnings, and scale what works to advance the mission. Key Responsibilities Professional Learning & Team Contribution Engage in weekly coaching and bi-weekly professional development sessions; implement bite-size action steps and reflect on results. Collaborate in Professional Learning Communities to align pacing, assessments, and student work analysis; share resources and model lessons. Support campus duties (arrival, transitions, lunch, dismissal) and take accurate attendance. Family Partnership & Communication Communicate regularly with families about progress, behavior, attendance, and upcoming learning (in plain language). Respond to family messages within school-day norms; participate in conferences, data nights, and school events. Assessment, Data & Acceleration Administer and analyze assessments; maintain an up-to-date gradebook. Plan targeted reteach, small groups, and accelerated instruction; progress monitor and adjust quickly. Ensure accommodations/designated supports are delivered with fidelity (IEP/504/EB) and reflected in lesson artifacts. Classroom Culture Teach and reinforce clear routines, procedures, and norms; utilize our school-wide behavior system with fidelity. Contribute to a campus culture where students feel known, safe, and motivated to do their best. Instruction & Planning Design/internalize daily lessons and unit plans aligned to TEKS , integrating literacy, writing, and STEAM practices. Differentiate for diverse learners (readiness, language, and IEP/504 needs); embed academic discourse and practice. Maintain an orderly classroom that maximizes learning and eliminates distractions. Minimum & Preferred Qualifications Minimum Qualifications Bachelor's degree. Valid Texas teaching certificate (core content required for Reading, Writing, Math, Science, Social Studies). Demonstrated success raising student achievement and maintaining a strong classroom culture. Skilled at using data (CFAs/interims) to plan instruction and intervention. Clear, compassionate communicator; organized; growth-minded; mission-aligned. Preferred Qualifications ESL certification (strongly encouraged for core content teachers). For Special Education roles: valid Texas Special Education certification (required). Experience with co-teaching, inclusive practices, and accommodations; familiarity with T-TESS, PLCs, and interim assessment platforms. Certifications/Licensure Required (Core Teachers): Valid Texas teaching certificate in assigned content/grade. Required (Special Education Teachers): Valid Texas Special Education certification. Encouraged: ESL certification. All Staff: DPS fingerprint clearance per Texas Education Code §22.0835.

Posted 30+ days ago

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Starburst DataBoston, MA

$125,000 - $150,000 / year

About Starburst Starburst is the data platform for analytics, applications, and AI, unifying data across clouds and on-premises to accelerate AI innovation. Organizations—from startups to Fortune 500 enterprises in 60+ countries—rely on Starburst for fast data access, seamless collaboration, and enterprise-grade governance on an open hybrid data lakehouse. Wherever data lives, Starburst unlocks its full potential, powering data and AI from development to deployment. By future-proofing data architecture, Starburst helps businesses fuel innovation with AI. About the role: We are seeking an experienced Technical Writing Manager to lead and grow our technical documentation team. This role is crucial for establishing strong processes, developing managerial capability within the team, and driving the strategic direction of our customer-facing and internal documentation. The ideal candidate will possess a strong background in technical writing and management within the data, infrastructure, or SaaS product space. As a Technical Writing Manager at Starburst you will be responsible for: People Leadership & Development: Coach, mentor, and lead a team of Technical Writers. Documentation Strategy & Process: Define, implement, and govern the technical writing tools, standards, and processes used by the team. Technical Content Deep Dive: Oversee the creation and quality of technical documentation, ensuring deep, accurate coverage of the product. Cross-Functional Collaboration: Act as the primary interface for the documentation team, partnering closely with Product and Engineering teams to ensure content is integrated into the product lifecycle and aligned with releases. Values & Culture: Champion company values within the team and foster a collaborative, high-performing culture. Some of the things we look for: 5-10 years of experience in technical writing management or documentation leadership. Proven managerial capability, including mentoring, coaching, and strong problem-solving skills. Demonstrated experience prioritizing documentation projects with a focus on data, infrastructure, or SaaS product offerings. Expertise with modern technical writing tools and processes, and the ability to conduct a deep dive into documentation architecture. Ability to Travel : This role will require occasional in-person travel for purposes including but not limited to new hire onboarding, team and department offsites, customer engagements, and other company events. Actual travel expectations may vary by role and business needs. Where could this role be based? Remote, based in the US in the Eastern Time Zone Starburst is dedicated to maintaining fair and equitable compensation practices. The salary range provided for this role reflects the minimum and maximum targets for candidates across all U.S. locations and could be inclusive of variable compensation, such as commission or bonus. All employees receive equity packages (ISOs) and have access to a comprehensive benefits offering. Actual compensation packages are determined based on relevant skills, experience, education and training, and specific work location. For more information, connect with the recruiting team or Hiring Manager during the process as they can provide more detailed information about the salary range. Pay Range $125,000 — $150,000 USD Build your career at Starburst All-Stars have the opportunity and freedom to realize their true potential. By building alongside top talent, we’re empowered to take ownership of our careers and drive meaningful change. Anchored in industry-proven technology and unprecedented success, All-Stars are taking on the challenge everyday to disrupt our industry – and the future. Our global workforce is supported by a competitive Total Rewards program that reflects our commitment to a rewarding and supportive work environment. This includes a variety of benefits like competitive pay, attractive stock grants, flexible paid time off, and more. We are committed to fostering an intentional, inclusive, and diverse culture that drives deep engagement, authentic belonging, and an exceptional All-Star experience. We believe that diversity of thought, perspective, background and experience will enable us to own what we do, drive our success and empower our All-Stars to show up authentically. Starburst provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Posted 4 weeks ago

Vertex Pharmaceuticals logo
Vertex PharmaceuticalsBoston, Massachusetts

$137,600 - $206,400 / year

Job Description General Summary: The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners. The Business Engagement & Technology Principal Analyst will partner with business leadership to deliver capabilities and execute on a roadmap that align to support business strategy in Clinical Operations and Medical Writing . Additionally, the Business Engagement & Technology Principal Analyst will maintain reliable, scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations. Key Duties and Responsibilities: Become a trusted partner of the business leaders within their remit Understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives. Help refine and execute the technology strategy by leading the evaluation, selection, implementation, and ongoing maintenance of technology solutions. Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems. Manage relationships with our strategic software vendors and service providers Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements Serve as a liaison between GMDA and Data, Technology & Engineering (DTE) to ensure strategic alignment. Apply Agile, Lean, and design thinking methodologies to optimize solution delivery. Translate complex data into actionable insights and compelling business narratives. Monitor emerging technologies and trends to inform GMDA’s digital strategy. Drive change enablement and foster a culture of agility and continuous improvement. Knowledge and Skills: In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, and testing Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution Strong understanding of the business (Clinical Operations/Medical Writing), processes, and any appropriate regulatory environments Expertise in data analytics tools (e.g., Tableau, Power BI, SQL) and enterprise platforms in the Clinical Operations space (e.g., Veeva, Suvoda, Salesforce). Deep understanding of GMDA functions including clinical development, regulatory affairs, and medical affairs. Results oriented contributor with a proven track record of on-time project delivery for large, complex projects with global stakeholders Able to manage own workload with minimal direction Very strong written and verbal communication skills and strong ability to present complex or sensitive information in a clear and concise manner to various technical and non-technical audiences Exceptional analytical, quantitative, problem-solving, and prioritization skills Strong system life cycle expertise Good knowledge of running IT managed services or outsourced/ offshore teams Exceptional communication and stakeholder engagement skills. Very strong MS Office skills, including MS Project & Visio, Excel and PowerPoint experience Experience in Agile methodology Ability to influence strategic decisions and drive alignment across diverse teams. Education and Experience: Bachelor’s degree in Information Technology, Business Administration, Life Sciences, or related field; advanced degree preferred. Minimum of 8 years of experience in business engagement, technology strategy, or data analytics within the pharmaceutical or biotechnology industry. PMP or equivalent project management certification preferred. Experience with AI/ML applications and digital transformation initiatives is a plus. Pay Range: $137,600 - $206,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 5 days ago

DexCom logo
DexComSan Diego, California

$95,900 - $159,900 / year

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Dexcom Medical Affairs is looking for candidates for the role Senior Medical Affairs Specialist – Scientific Communications and Regulatory Writing. In this role you will own the Medical Affairs planning, authorship, and lifecycle maintenance of Clinical Evaluation Reports (CERs) and related documentation, as well as design and management of compliant literature search strategies that support these deliverables and align with corporate objectives. Additionally, you will develop abstracts, posters, and manuscripts that communicate Dexcom evidence to external audiences – aligned with GPP/ICMJE guidance and internal publication processes. This is a great opportunity to help shape the function and work with some outstanding colleagues! Where you come in: You will lead the authoring and updates of CERs and supporting documents You will define and execute literature search strategies in support of regulatory filings including management of vendor You will partner with Regulatory Affairs to ensure alignment of all documentation with corporate objectives You will manage project scope, schedule, risk/issue tracking, and stakeholder communication You will write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP) You will ensure timely feedback, review cycles, and adherence to deadlines for deliverables You will assist with tracking for scientific communication-related activities What makes you successful: You have an advanced degree in relevant scientific field You have a minimum of 3-5 years of experience in regulatory/clinical/medical writing within medical devices, biotech, or pharma You have strong knowledge of EU MDR/MEDDEV expectations for clinical evaluation report Previous experience in diabetes preferred You bring In-depth knowledge of industry regulations and guidelines governing publications and medical communications You bring strong project management skills with the ability to manage multiple high-priority projects simultaneously You have excellent written and verbal communication skills. What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community . A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a Bachelor’s degree and a minimum of 5 – 8 years of related experience. Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $95,900.00 - $159,900.00

Posted 4 days ago

Starburst logo
StarburstBoston, Massachusetts

$140,000 - $160,000 / year

About Starburst Starburst is the data platform for analytics, applications, and AI, unifying data across clouds and on-premises to accelerate AI innovation. Organizations—from startups to Fortune 500 enterprises in 60+ countries—rely on Starburst for fast data access, seamless collaboration, and enterprise-grade governance on an open hybrid data lakehouse. Wherever data lives, Starburst unlocks its full potential, powering data and AI from development to deployment. By future-proofing data architecture, Starburst helps businesses fuel innovation with AI. About the role: We are seeking an experienced Technical Writing Manager to lead and grow our technical documentation team. This role is crucial for establishing strong processes, developing managerial capability within the team, and driving the strategic direction of our customer-facing and internal documentation. The ideal candidate will possess a strong background in technical writing and management within the data, infrastructure, or SaaS product space. As a Technical Writing Manager at Starburst you will be responsible for: People Leadership & Development: Coach, mentor, and lead a team of Technical Writers. Documentation Strategy & Process: Define, implement, and govern the technical writing tools, standards, and processes used by the team. Technical Content Deep Dive: Oversee the creation and quality of technical documentation, ensuring deep, accurate coverage of the product. Cross-Functional Collaboration: Act as the primary interface for the documentation team, partnering closely with Product and Engineering teams to ensure content is integrated into the product lifecycle and aligned with releases. Values & Culture: Champion company values within the team and foster a collaborative, high-performing culture. Some of the things we look for: 5-10 years of experience in technical writing management or documentation leadership. Proven managerial capability, including mentoring, coaching, and strong problem-solving skills. Demonstrated experience prioritizing documentation projects with a focus on data, infrastructure, or SaaS product offerings. Expertise with modern technical writing tools and processes, and the ability to conduct a deep dive into documentation architecture. Ability to Travel : This role will require occasional in-person travel for purposes including but not limited to new hire onboarding, team and department offsites, customer engagements, and other company events. Actual travel expectations may vary by role and business needs. Where could this role be based? Remote, based in the US in the Eastern Time Zone Starburst is dedicated to maintaining fair and equitable compensation practices. The salary range provided for this role reflects the minimum and maximum targets for candidates across all U.S. locations and could be inclusive of variable compensation, such as commission or bonus. All employees receive equity packages (ISOs) and have access to a comprehensive benefits offering. Actual compensation packages are determined based on relevant skills, experience, education and training, and specific work location. For more information, connect with the recruiting team or Hiring Manager during the process as they can provide more detailed information about the salary range. Pay Range $140,000 - $160,000 USD Build your career at Starburst All-Stars have the opportunity and freedom to realize their true potential. By building alongside top talent, we’re empowered to take ownership of our careers and drive meaningful change. Anchored in industry-proven technology and unprecedented success, All-Stars are taking on the challenge everyday to disrupt our industry – and the future. Our global workforce is supported by a competitive Total Rewards program that reflects our commitment to a rewarding and supportive work environment. This includes a variety of benefits like competitive pay, attractive stock grants, flexible paid time off, and more. We are committed to fostering an intentional, inclusive, and diverse culture that drives deep engagement, authentic belonging, and an exceptional All-Star experience. We believe that diversity of thought, perspective, background and experience will enable us to own what we do, drive our success and empower our All-Stars to show up authentically. Starburst provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Posted 3 days ago

A logo
AlignerrSan Francisco, California

$25 - $100 / hour

Generalist Writer- English (Contract) Labelbox Remote (United States preferred) Shape the data that powers frontier AI Quick facts - Engagement- Hourly, at‑will contractor - Schedule- Fully remote & asynchronous (min. 15 hrs/week) - Pay Range (US) - \$25 – \$100 per hour - Start Date- Rolling — staffed as projects launch What you’ll do - Educate AI: Review AI-generated written content across multiple genres and formats, providing feedback on clarity, organization, and effectiveness of communication - Problem Solving: Use your expertise to help AI reason through writing challenges, including argumentation, structure, tone, and audience engagement in diverse disciplines - Red Teaming: Identify biases, inaccuracies, or unclear passages in AI-generated outputs, and develop tests to ensure the AI produces high-quality, accurate, and well-communicated written work You’re a great fit if - Enrolled in or have completed a Bachelor's degree or higher from an accredited institution - Experience in professional, academic, or technical writing, editing, or related fields (required) - Strong ability to communicate ideas clearly, effectively, and with attention to detail across a variety of formats and subjects - Excellent command of English grammar, style, and tone, with a keen eye for accuracy and coherence - Comfortable providing constructive feedback and evaluating writing for clarity, organization, and impact - Bonus : Experience with data labeling, RLHF, or other AI training projects About the role - Flexible workload — work from anywhere, on your own schedule - High impact — your craft directly improves models used by top AI labs & Fortune 500 teams - Clear ownership — know exactly what success looks like and have autonomy to deliver - Growth potential — consistent high performers spearhead new programs and mentor incoming SMEs Interview process - Complete a screening with Zara , our AI interviewer in English, to learn more about your background and experience. - About Labelbox Labelbox builds the data engine that accelerates breakthrough AI. Our platform, expert services, and marketplace let teams iterate on data as nimbly as they iterate on code, enabling safer, smarter models in production. We’re backed by SoftBank, Andreessen Horowitz, B Capital, Gradient Ventures, Databricks Ventures, and Kleiner Perkins, and trusted by leading research labs and enterprises worldwide. Ready to Apply? Click “Apply” above! We review candidates on a rolling basis and will contact you if your background matches an active project. $20 - $40 an hour

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpHouston, TX
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpCalifornia, MD
Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. How you'll make an impact: Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams Review and interpret study data analyses Contribute to the generation of product life cycle plans (e.g., post-market surveillance). What you'll need (Required): Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria Medical writing or regulatory certification or equivalent work experience based on Edwards criteria Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria Certification in related fields Strong leadership in project and team management, including coaching and performance oversight. Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. Familiarity with coronary interventional and structural heart environments. Proven ability to develop metrics demonstrating medical writing value to the business. Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

I logo
Ironwood Pharmaceuticals, Inc.Boston, MA

$239,000 - $278,565 / year

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence. The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines. The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. Responsibilities: Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization. Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents. Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials. Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices. Represent Medical Writing and provide medical writing expertise on cross-functional teams. Develop detailed timelines for document development in line with company goals and SOPs. Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers. Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables). Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable. Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards. Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates. Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations. Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable. Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC). Qualifications: BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred Success in managing resources (internal, external, or hybrid) Prior direct experience leading medical writing teams responsible for global marketing authorization applications Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology Excellent technical writing and editorial skills; excellent attention to detail Strong ability to understand and interpret medical and scientific data Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote Excellent communication, interpersonal, and organizational skills Experience working on cross-functional teams Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule. #LI-Hybrid

Posted 30+ days ago

Corcept Therapeutics logo
Corcept TherapeuticsRedwood City, CA

$144,800 - $212,900 / year

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is a hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs) Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package Lead document review and comment resolution processes with cross-functional teams Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports Coordinate the review and approval of documents Develop templates, style guidelines, and SOPs for regulatory documentation Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements Preferred Education and Experience: JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD) Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences Able to compile, analyze, and present data clearly, concisely, and effectively Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA) Strong understanding of drug development and regulations (US, EU and ICH) Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements Proficiency with Electronic Common Technical Document (eCTD) templates Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Posted 30+ days ago

University of Maryland Global Campus logo
University of Maryland Global CampusRockville, Maryland

$16+ / hour

Peer Tutor, Writing (On-Site) First Term Experience and Tutoring Services Student Affairs Non-Exempt, Contingent 1, Part-Time, Pay Grade Stateside Contingent 1 Location: The Universities at Shady Grove, MD University of Maryland Global Campus (UMGC) seeks accomplished UMGC students to work on-site as part-time peer tutors for UMGC undergraduate students at the Universities at Shady Grove. Tutoring will be offered on-site at Shady Grove via scheduled appointment and drop-in availability. Successful candidates will demonstrate high-level skills in both academic and technical writing and be able to support students in a variety of courses and programs. SPECIFIC RESPONSIBILITIES OF THE UMGC PEER TUTOR INCLUDE: Provide support as a UMGC student peer tutor to other undergraduate students enrolled in UMGC courses Respond to undergraduate students’ questions and concerns related to their UMGC assigned courses Respond to questions about course concepts related to assigned readings, projects, or written assignments Provide clarifications, examples, and tutorials that support the student in developing a writing process and authentic learning Promote a professional, respectful, and safe learning environment Work more closely with English language learners REQUIRED EDUCATION AND EXPERIENCE: In-depth knowledge in undergraduate writing skills, both academic and technical Excellent organizational, interpersonal, and verbal and written communication skills in English Ability to work closely with students to ensure student success Ability to work with diverse student populations PREFERRED EDUCATION AND EXPERIENCE: Letter of recommendation or referral from a faculty member in a WRTG course or another course in which writing assignments constituted the majority of graded assignments Background in teaching, tutoring, and/or other type of learning support experience initiatives in a face-to-face environment WHO WE ARE AND WHO WE SERVE UMGC—one of 11 degree-granting institutions in the University System of Maryland (USM)—is a mission-driven institution with seven core values that guide us in all we do. At the top of the list is "Students First," and we strive to do just that for our 90,000 students at home and abroad. From its start in 1947, UMGC has demonstrated its commitment to adult learners. We recognize that adult students need flexibility and options. UMGC is proud to be a global, 24-hour, institution of higher learning. The typical UMGC student is an adult learner juggling a career, family, and other priorities. Roughly 80% work full time, half are parents, and half are minority students. They are continuing their education to better themselves, their families, and their professional opportunities. UMGC is also a leading higher education provider to the U.S. military, enrolling 55,000 active-duty service members, reservists, National Guard members, veterans, and family members annually. We are proud of our military heritage and are committed to this service. POSITION AVAILABLE AND WILL REMAIN OPEN UNTIL FILLED All submissions should include a cover letter and a résumé University of Maryland Global Campus (UMGC) is an equal opportunity employer and complies with all applicable federal and state laws regarding nondiscrimination. UMGC is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, ancestry, political affiliation or veteran status in employment, educational programs and activities, and admissions. All submissions should include a cover letter and resume . The University of Maryland Global Campus (UMGC) is an equal opportunity employer and complies with all applicable federal and state laws regarding nondiscrimination. UMGC is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, ancestry, political affiliation or veteran status in employment, educational programs and activities, and admissions. Workplace Accommodations: The University of Maryland Global Campus Global Campus (UMGC) is committed to creating and maintaining a welcoming and inclusive working environment for people of all abilities. UMGC is dedicated to the principle that no qualified individual with a disability shall, based on disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of the University, or be subjected to discrimination. For information about UMGC’s Reasonable Workplace Accommodation Policy or to request an accommodation, applicants/candidates can contact Employee Accommodations via email at employee-accommodations@umgc.edu . Benefits Package Highlights: Time Off: C1s that regularly work over 12 hours per week are eligible for limited sick and safe leave at the rate of 1 hour for every 30 hours worked, up to a maximum accrual of 40 hours in a calendar year. Health Coverage: Access to health care, medical with vision, dental, and prescription plans for both individuals and families, effective from the 1st of the month following your hire date. NOTE: CI employees are not eligible for the State of Maryland subsidized rates. CIs would be responsible for the total cost if enrolled. Insurance Options: Term Life Insurance, Accidental Death and Dismemberment Insurance. Supplemental Retirement Plans : include 401(k), 403(b), 457(b), and various Roth options. The university does not provide matching funds. Hiring Rate: $16.00

Posted 30+ days ago

Prime Medicine logo
Prime MedicineWatertown, MA

$153,096 - $188,095 / year

Company Overview: Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit www.primemedicine.com . Position Summary Prime Medicine is seeking a Senior Manager, Medical Writing to support the development of high-quality clinical, regulatory, and scientific documents across our gene-editing pipeline. This role will be both hands-on and strategic, contributing directly to authorship while helping to build scalable medical writing processes in a rapidly growing organization. Reporting to the Head of Medical Writing, this individual will partner closely with Clinical Development, Regulatory Affairs, Research, and other cross-functional teams to ensure accurate, consistent, and timely documentation supporting global clinical trials and regulatory submissions. This is an excellent opportunity for an experienced medical writer who thrives in a collaborative, fast-paced biotech environment and wants to grow into increasing leadership responsibility. Key Responsibilities Medical Writing & Content Development Serve as primary author and/or lead writer for key clinical and regulatory documents, including: Clinical Study Protocols and Amendments Investigator’s Brochures (IBs) Clinical Study Reports (CSRs) IND/CTA submission documents and briefing packages Critically analyze and interpret nonclinical, clinical, and external literature data to develop clear scientific narratives, conclusions, and messaging. Ensure consistency of content, data interpretation, and scientific positioning across documents and programs. Cross-Functional Collaboration Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Quality teams to: Drive document timelines Resolve data and messaging questions Ensure regulatory and scientific alignment Lead and participate in cross-functional document review meetings and support responses to health authority questions as needed. Process, Quality & Infrastructure Support the development and maintenance of: Medical writing templates, style guides, and standards Document workflows, timelines, and best practices SOPs and quality control processes Perform or oversee document QC, ensuring accuracy, clarity, formatting consistency, and compliance with internal standards and regulatory expectations. Evaluate and incorporate new writing support tools, including AI tools, to streamline processes and improve writing quality. Contribute to inspection readiness and submission quality initiatives. Leadership & Development (scope dependent on level) May mentor junior writers, contractors, or co-ops as the team grows. Provide guidance on best practices in medical writing, document planning, and scientific storytelling. Required Qualifications Advanced degree or bachelor’s/master’s degree in life sciences, health sciences, or a related field. ~5+ years of medical writing experience in biotech/pharma OR ~7+ years of writing experience in biotech/pharma or other scientific or academic setting. Includes document ownership and cross-functional leadership Strong experience authoring clinical and regulatory documents (protocols, IBs, CSRs, IND/CTA content). Solid understanding of clinical development and regulatory frameworks (FDA, EMA, ICH). Excellent written, verbal, and organizational skills with strong attention to detail. Proficiency with document authoring tools (e.g., Microsoft Word, Office suite, SharePoint, Adobe). Preferred Qualifications Experience supporting gene editing/therapy or biologics programs. Familiarity with rare disease clinical development. Experience contributing to submissions across multiple development stages. Comfort working in a hands-on, fast-moving biotech environment. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together. U.S. Pay Range $153,096 — $188,095 USD Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

Posted 6 days ago

T logo
Tutor Me EducationChino Hills, CA

$25 - $35 / hour

At Tutor Me Education, we are revolutionizing the way students learn, and we're seeking passionate teachers and tutors with special education experience to provide 1:1 in-home tutoring in Chino Hills, CA ! If you're committed to making a difference in the lives of students with special needs and helping them achieve academic success, we want to hear from you! About the Role: As an Tutor at Tutor Me Education, you’ll provide personalized, one-on-one tutoring to students with special needs in their homes. You will be responsible for helping students with daily activities, offering moral support, and delivering tailored instruction based on their Individualized Education Plan (IEP). We are currently hiring for multiple positions across all cities in Chino Hills, CA Details: In-Person Tutoring in Chino Hills, CA Schedule: 75 hours, 5 sessions for 2 hours Pay range is between $25 and $35 Ideal Candidate: Bilingual in Mandarin and English to support both the student and family communication. Experience working with students with Autism and/or other learning differences. Strong ability to support high school–level reading, writing, and comprehension . Skilled in providing clear, structured, and engaging academic instruction. Excellent communication, organization, and motivational skills. Preferred: Experience supporting neurodiverse learners or students transitioning from SPED to general education. Key Responsibilities: Provide in-person homework support across core subjects, with emphasis on English reading, writing, and comprehension. Reinforce classroom learning through structured practice and targeted academic interventions. Support the student in staying focused, completing assignments, and improving comprehension skills. Use the TME curriculum for additional instruction when homework is completed. Implement strategies that promote task completion, academic engagement, and sustained attention. Maintain open communication with the family in Mandarin regarding progress, needs, and session updates. Create a supportive, patient, and structured learning environment that fosters confidence and independence. Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.

Posted 30+ days ago

Edwards Lifesciences Corp logo

Senior Specialist, Medical Writing

Edwards Lifesciences CorpTexas, AL

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Job Description

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you'll make an impact:

  • Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines.
  • Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment.
  • Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders
  • Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports.
  • Act as representative in core team meetings in the development of regulatory submissions for EU
  • Provide leadership, training, and guidance and act as a mentor to less experienced medical writers.
  • Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing
  • Other incidental duties assigned by Leadership

What you'll need (Required):

Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required

What else we look for (Preferred):

  • Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel
  • Experienced with literature reviews and various publication databases including PubMed and Embase
  • Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
  • Excellent written and verbal communication skills including customer negotiating and relationship management skills
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content
  • Full knowledge of medical writing
  • Good leadership skills and ability to influence change
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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