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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

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

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

Freddie Mac logo
Freddie MacMclean, VA

$85,000 - $127,000 / year

At Freddie Mac, our mission of Making Home Possible is what motivates us, and it's at the core of everything we do. Since our charter in 1970, we have made home possible for more than 90 million families across the country. Join an organization where your work contributes to a greater purpose. Position Overview: Freddie Mac's Quality Control Department is seeking an accomplished professional with technical proficiency and a keen attention to detail to join us as a Quality Control Credit Risk Policy Professional. The ideal candidate will infuse energy and innovative thinking to overcome challenges in a fast-paced, dynamic environment. If you are eager to explore business value through collaborative tools, we encourage you to apply and become part of a team committed to ensuring quality. As a member of the QC Policy team in the Credit Risk Policy Professional role, you will engage in a variety of tasks, such as supporting the review of policies and procedures to ensure their appropriateness and adequacy, assisting in process mapping initiatives, and contributing to the creation of visuals and job aids to simplify complex activities. The preferred candidate should possess a strong aptitude for analyzing data and summarizing intricate information, collaborating effectively with diverse teams, producing clear and user-friendly documentation, and customizing SharePoint pages to optimize user experience. Our Impact: The QC Policy team is responsible for producing policies and procedures, job aids and other resources to teams within Quality Control, such as Underwriting Operations which conducts quality control reviews of loans purchased by Freddie Mac to ensure that the loans purchased by Freddie Mac meet the terms of business under which they were delivered. Your Impact: As part of the QC Policy team, you will create job aids and other written documentation utilized by the QC Underwriting team to ensure resources are accurate, clear, and equip our underwriters to deliver a consistent experience in alignment with the Freddie Mac Selling Guide. You will also develop or update resources for various teams within QC which support the Underwriting team, providing cross-functional direction where roles and responsibilities connect. Your daily responsibilities will include: Participate in the creation and updating of Quality Control documentation, including job aids, tools, and procedures. Efficiently manage and maintain SharePoint sites for various teams within Quality Control. Work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Facilitate knowledge sharing sessions with subject matter experts and stakeholders across Single Family Quality Control by scheduling sessions, creating agendas, scribing meeting minutes and outlining action items and next steps, and following up to ensure next steps are executed. Qualifications: Typically has minimum of 2 - 4 years related experience in professional technical writing. Experience in the mortgage industry, including exposure or understanding of managing credit risk and familiarity with Freddie Mac Selling Guide. Ability to manage multiple projects within minimal supervision. Moderate to strong technical proficiency with MS Office, specifically Word and Excel, Adobe Acrobat and other databases. Intermediate knowledge of SharePoint is preferred, including familiarity with SharePoint architecture, experience creating lists and document/form libraries, and utilizing web parts. College Degree or equivalent work experience. Keys to Success in this Role: An extraordinary attention to detail. Quick to learn new technologies and tools, with the ability to provide technical guidance to the team. Strong written communication skills, capable of explaining concepts or new/updated processes clearly in writing. Ability to logically organize content. Exceptional reading comprehension with the ability to identify inconsistencies or gaps in documentation. Robust analytical and quantitative skills are essential. Capability to emulate the team's communication style to ensure consistency in terminology, tone, composition, and formatting across documentation. Comfortable interacting with internal management and partners within Freddie Mac. Strong problem-solving and critical thinking skills. Highly organized, with the ability to manage multiple assignments simultaneously and meet timelines, working independently without the need for significant guidance. Current Freddie Mac employees please apply through the internal career site. We consider all applicants for all positions without regard to gender, race, color, religion, national origin, age, marital status, veteran status, sexual orientation, gender identity/expression, physical and mental disability, pregnancy, ethnicity, genetic information or any other protected categories under applicable federal, state or local laws. We will ensure that individuals are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. A safe and secure environment is critical to Freddie Mac's business. This includes employee commitment to our acceptable use policy, applying a vigilance-first approach to work, supporting regulatory mandates, and using best practices to protect Freddie Mac from potential threats and risk. Employees exercise this responsibility by executing against policies and procedures and adhering to privacy & security obligations as required via training programs. CA Applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Notice to External Search Firms: Freddie Mac partners with BountyJobs for contingency search business through outside firms. Resumes received outside the BountyJobs system will be considered unsolicited and Freddie Mac will not be obligated to pay a placement fee. If interested in learning more, please visit www.BountyJobs.com and register with our referral code: MAC. Time-type:Full time FLSA Status:Non-Exempt Freddie Mac offers a comprehensive total rewards package to include competitive compensation and market-leading benefit programs. Information on these benefit programs is available on our Careers site. This position has an annualized market-based salary range of $85,000 - $127,000 and is eligible to participate in the annual incentive program. The final salary offered will generally fall within this range and is dependent on various factors including but not limited to the responsibilities of the position, experience, skill set, internal pay equity and other relevant qualifications of the applicant.

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

C logo
Collin County Community CollegeFrisco, TX

$23+ / hour

Primary Location: 9700 Wade Boulevard, Frisco, Texas, 75035 We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities. Job Summary: Provide tutoring support services to Collin College students. Help students understand the writing process, how to write thesis statements, how to organize and develop ideas and how to correct papers for sentence fluency, grammar, punctuation and diction. Required Qualifications: Essential Duties and Responsibilities Support students' writing efforts through tutoring. Maintain record of each tutoring session with student. Report promptly to student's professor on the material covered in the tutoring session (writing problems addressed) if applicable. Attend staff meetings or professional development as directed. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA).Ensure offices and files are adequately secured on a daily basis. Supplemental Functions Perform other duties as assigned. Perform all duties and maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of college-level composition Knowledge of of the English language Knowledge of MS Word, Excel and Publisher Knowledge of MLA style and format Knowledge of presentation software Organization and time management skills Document design skills Creative thinking skills Presentation skills Computer and applicable software skills Interpersonal skills Ability to create a positive tutoring and learning environment in the writing center Ability to communicate effectively, both orally and in writing Ability to establish and maintain effective working relationships Physical Demands, Working Conditions and Physical Effort Sedentary Work - Exerting up to 10 pounds of force occasionally, a negligible amount of force frequently, and/or constantly having to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Positions in this class typically require talking, hearing, seeing, grasping, standing, walking and repetitive motions. Relatively free from unpleasant environmental conditions or hazards. Office environment. Little physical effort required. Requirements Tutor Instructional, Level IV - Bachelor's degree with relevant courses and/or skills connected to the tutoring subject required. Tutor Instructional, Level V - Master's degree with relevant courses and/or skills connected to the tutoring subject required. Preferred One (1) year of tutoring/teaching experience. Experience with ESL and/or Developmental Level Tutoring. Licenses and Certifications Official transcript(s) required. International transcripts require an English translation and a course-by-course evaluation from an approved agency. This position is generally limited to working a maximum of 19.5 hours per week. (Maximum hours for employees with more than one part-time position at Collin College may vary.) This position is Security Sensitive, therefore, candidates will be subject to a criminal background check. The above description is an overview of the job. It is not intended to be an all-inclusive list of duties and responsibilities of the job as duties and responsibilities may change with business needs. Collin College reserves the right to add, change, amend, or delete portions of this job description at any time, with or without notice. Reasonable accommodations may be made by Collin College in its discretion to enable individuals with disabilities to perform the essential functions. Required & Preferred Qualifications (if applicable): To be considered for this position, candidates must upload a copy of their transcript(s) confirming the completion of the required education or higher. Unofficial transcripts are acceptable. The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Fair Labor Standards Act (exempt/non-exempt) is designated by position. The employer actively supports Americans with Disabilities Act and will consider reasonable accommodations. This is a Security Sensitive position. Therefore candidates will be subject to a criminal background check.* Compensation Type: Hourly Employment Type: Part time Compensation: $23.00 Hourly For any employment questions, please contact HR at (972) 985-3783 or send an email to: employment@collin.edu. Collin College is an Equal Opportunity Employer and does not discriminate on the basis of any characteristic protected by applicable law.

Posted 1 week 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 3 days ago

C logo
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

ShipHawk logo
ShipHawkSanta Barbara, CA
Technical Writing Internship This is an IN PERSON Internship in Santa Barbara, CA. Position Requirements: Part of the UCSB Professional Writing Program Senior at UCSB Live in the Santa Barbara area with the ability to work in the downtown office About ShipHawk ShipHawk is the premier warehousing and shipping software for ERP connected companies. We work with high volume retail, wholesale and eCommerce companies that have outgrown basic warehousing and shipping software. Come join us as we transform one of the last massive old-school industries into a transparent, efficient market, benefiting both retailers and consumers. Join a startup where you can make an impact, grow your career, and have a voice. About the Opportunity: Location: In Person at our Santa Barbara Headquarters Department: Product - Technical Writing Team Reports to: Senior Technical Writing Manager Technical Writers excel at clearly and accurately communicating complex information. As a Technical Writer Intern at ShipHawk, you will gain experience in creating and editing outstanding content while working with Technical Writers, Product Owners, and UX Designers. During your internship, you will support the Technical Writing team’s objectives and projects that drive the business forward. Expect to use Google Suite (Docs, Slides, Sheets), Confluence, LucidChart, and other tools to write, edit, and illustrate content for technical and non-technical audiences. We are looking for outstanding writers who love to learn and want to learn more about working in the software industry as a technical writer. This opportunity will include working on a variety of projects, including writing blog articles. 5 Reasons Why You Want to Work with Us: You want to work with a team that is competent, confident, passionate, and focused on achieving big goals. You want to work on a product with the potential to grow into a billion dollar business, become a household name, and help millions of people. You want to have a voice. You want to be part of a fun and healthy culture. You want to work at a company that will provide an opportunity to get to the next level of your career. What We’re Looking For In You: We are looking for an all-star skill set: efficient, organized and follows through on commitments. You're intelligent, have great analytical skills and pay attention to detail. In addition, you're calm under pressure, have a great work ethic and communicate well. And, more than the usual skills, we want you to push and not accept the mundane. Push for a higher standard. Be proactive. Be open to new ideas and personal feedback. Try stuff, fail and learn from it. 5% of business leaders are 20 times more efficient than 95% of business leaders. We want you to be the 5%. We would very much like to see any writing samples you may have. This internship is a great opportunity for upper level college students with a minor in professional writing. Some of the skills you will want for this internship: Strong writing, illustration, and multimedia content development skills Experience with online writing and publishing, including blogs, articles, newsletters, and wikis Interest in business, science, or technical writing as a career To get the most out of this internship, you will need to: Be available to work 10-15 hours per week Have an interest in pursuing a career in business and technical writing Have familiarity with technology and software as a service (SaaS) Be a self-starter Be organized and methodical Be coachable and able to acknowledge, digest and adapt to constructive criticism and feedback What we offer: Approximately five month long internship program February 3, 2026 - June 12th, 2026 $500 per month stipend 10-15 hours per week with flexibility to work with your schedule Work downtown in Santa Barbara Hands-on experience and opportunity to lead your own projects Ability to work in fun tech startup environment Be a part of a bigger internship cohort Work with renowned local SaaS tech company Being part of a driven, dynamic team Onboarding and final project Team building event with your fellow interns Network and build relationships within the community and make professional connections You will not make coffee, you will make an impact as part of the team! ShipHawk 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 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpRaleigh, NC

$106,000 - $149,000 / year

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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science What else we look for (preferred): Preferred Hybrid On Site in Irvine, Ca Advanced degree (Master's, PHD, Pharm D) Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. 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 (CA), the base pay range for this position is $106,000 to $149,000 (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. #LI-Remote 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

Mercer University logo
Mercer UniversityAtlanta, GA
Application Instructions: External Applicants: Please upload your resume on the Apply screen. Your application will automatically populate your resume details, and you may verify and update data on the My Information page. IMPORTANT: Please review the job posting and load ALL documents required in the job posting to the Resume/CV document upload section at the bottom of the My Experience application page. Use the Select Files button to add multiple documents including your Resume/CV, references, cover letter, and any other supporting documents required in the job posting. The "My Experience" page is the only opportunity to add your required supporting document attachments. You will not be able to modify your application after you submit it. Current Mercer University Employees: Apply from your existing Workday account. Do not apply from the external careers website. Log in to Workday and type Jobs Hub in the search bar. Locate the position and click Apply. Job Title: Assistant/Associate Professor of Writing and Interdisciplinary Studies Department: Liberal Studies College/Division: College Of Professional Advancement Primary Job Posting Location: Macon, GA 31207 Additional Job Posting Locations: (Other locations that this position could be based) Atlanta, GA 30341, Lithia Springs, GA 30122, McDonough, GA 30253 Job Details: Mercer University's College of Professional Advancement invites applications for an interdisciplinary Assistant or Associate Professor of Writing and Interdisciplinary Studies to join the Department of Liberal Studies. This is a full-time tenure-track position beginning August 1, 2026. Responsibilities: With twelve colleges and schools, Mercer University has a Carnegie Research II classification and offers a vibrant academic community committed to student success and academic excellence. This position will be based at one of Mercer's metro-Atlanta pr Macon campuses and includes a seven-course teaching load spread across four accelerated 8-week sessions in addition to research expectations and service responsibilities. Additional responsibilities include advising students, participating in faculty committees, attending faculty meetings, engaging in scholarly activity, maintaining on-site office hours, and working collaboratively with colleagues. The appointment is for the traditional nine-month academic year. Qualifications: The successful candidate must hold a Ph.D. in a discipline or field of the humanities or social sciences from an accredited institution at the time of appointment and sufficient education or experience to teach college writing. Demonstrated potential for exemplary teaching and the ability to translate that excellence into a fully online, accelerated format is expected. The successful candidate must be able teach general education courses in our Liberal Studies 100-level academic writing sequence, as well as interdisciplinary core courses for the B.A. in Liberal Studies. The successful candidate will be an outstanding teacher with an active scholarly agenda and a desire to contribute the life of the Department, College, and University by serving a post-traditional student population. Area of study is open, with a preference for candidates whose research apply methods of humanistic inquiry to engage contemporary concerns. The successful candidate must demonstrate the potential for teaching excellence and the ability to translate teaching excellence into a fully online, accelerated format for adult learners. Additional Information: The College of Professional Advancement's Department of Liberal Studies is an interdisciplinary department that serves the College's post-traditional student population by offering in-person, hybrid, and fully online B.A. degrees in Liberal Studies (a self-designed interdisciplinary major), World Humanities, and Communication. The Department also supports the University's General Education program. The department prioritizes high-impact teaching practices in service of student research and experiential learning. Ongoing departmental endeavors include the Coastal Georgia Research Initiative, a certificate in Globalization and Engagement, student e-portfolios, and study abroad experiences for working adults. Apply to join a collaborative group of teacher-scholars committed to educational equity through interdisciplinary inquiry. Required Documents: Interested candidates will complete a brief online application and attach required documentation including a letter of interest, curriculum vitae, teaching philosophy, and names and contact information of three references. Finalists for the position will be asked to have two current letters of recommendation sent directly to: Office of the Dean Writing & Interdisciplinary Studies Faculty Search College of Professional Advancement Mercer University 3001 Mercer University Drive Atlanta, GA 30341-4115 Unofficial transcripts may be requested from finalists as part of the recruitment process for this faculty position; finalists will need to redact any personal or private information including, but not limited to, social security number, birthdate, race, or gender, before submitting the unofficial transcripts. The successful candidate must submit official transcripts prior to employment. Deadline: Applications received by January 12, 2026 will receive priority consideration. Review of applications will continue until the position is filled. Background Check Contingency: Selection of the final candidate is contingent upon a successful background check. About Mercer University Founded in 1833, Mercer University is a distinguished private institution recognized for its commitment to academic excellence, leadership development, and community engagement. With campuses across Georgia, Mercer's twelve schools and colleges offer a wide range of undergraduate, graduate, and professional programs. The university cultivates a close-knit, student-centered environment where innovation, service, and personal growth are deeply valued. Mercer's employees are at the heart of its mission, dedicated to advancing innovation, supporting student success, and strengthening both our local and global communities through service. At Mercer, we believe in the power of relationships and the importance of in-person collaboration. Accordingly, our employees are expected to serve in-person as it fosters real-time problem solving, mentoring, and the meaningful connections that strengthen both our work and service to our students and the broader university community. Why Work at Mercer University Mercer University offers a variety of benefits for eligible employees including comprehensive health insurance (for self and dependents), generous retirement contributions, tuition waivers, paid vacation and sick leave, technology discounts, schedules that allow for work-life balance, and so much more! At Mercer University, a Bear is more than a mascot: it's a frame of mind that begins with a strong desire to make the most out of your career. Mercer Bears do not settle for mediocrity or the status quo. If you're seeking an environment where your passion and determination are embraced, then you want to work at Mercer University. For more information, please visit: https://hr.mercer.edu/prospective/ Scheduled Weekly Hours: 40 Job Family: Faculty Social Sciences EEO Statement: EEO/Veteran/Disability

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 1 week 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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Tutor Me EducationPacifica, CA
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 Pacifica, 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 Pacifica, CA, Details: In-Person Tutoring in Pacifica, CA, Schedule: 16 hours, 2 sessions a week for 2 hours Pay range is between $25 and $35 Ideal Candidate: Experience working with students on the autism spectrum and/or other learning differences. Strong understanding of executive functioning, reading comprehension, and writing instruction. Knowledgeable in Science and Math at a high school level. Skilled at implementing structured, visual, and engaging instruction. Patient, calm, and able to manage challenging behaviors with consistency and positive reinforcement. Creative and adaptable, capable of incorporating student interests into lessons to boost motivation. Background in Special Education, ABA, or related experience preferred. Key Responsibilities: Provide structured support for homework, projects, and retention of key information from texts. Reinforce reading fluency, comprehension, writing organization, and language skills. Support executive functioning skills, including planning, task initiation, and organization. Incorporate social-emotional learning strategies to foster self-regulation and engagement. Utilize movement breaks, relaxation strategies, and student interests to maintain focus and motivation. Support basic academic concepts in Math and Science as needed. Maintain a calm, patient, and positive environment, adapting strategies to the student’s needs. Collaborate with caregivers and other service providers as appropriate. Optional: Conduct assessments to identify skill levels and inform instruction. 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 2 weeks ago

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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 2 weeks ago

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Tutor Me EducationNorwalk, 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 Norwalk, 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 Norwalk, CA Details: In-Person Tutoring in Norwalk, CA Schedule: 6 hours, 1 session a week for 1.5 hours Pay range is between $25 and $35 Ideal Candidate: Experienced tutor with a strong background in supporting students with Autism Spectrum Disorder (Level 2). Skilled in foundational math, writing, and social-emotional learning (SEL). Comfortable providing structured guidance, homework support, and individualized instruction. Patient, engaging, and able to maintain motivation while supporting focus and task completion. Knowledgeable in strategies for improving writing mechanics, reading comprehension, and executive functioning. Able to adapt lessons to the student’s interests (e.g., video games, pretend play) to increase engagement. Key Responsibilities: Provide targeted support in math concepts, fractions, division, and writing paragraphs. Help improve reading comprehension and writing mechanics, including handwriting size and structure. Incorporate social-emotional learning strategies to support emotional regulation, focus, and task completion. Offer structured homework assistance to reinforce learning and academic confidence. Use engaging, hands-on, and interest-based activities to maintain motivation. Administer an assessment to determine current academic levels and guide individualized instruction. 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 4 days 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 4 weeks 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 1 day ago

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RyanDallas, Texas
Why Ryan? Hybrid Work Options Award-Winning Culture Generous Personal Time Off (PTO) Benefits 14-Weeks of 100% Paid Leave for New Parents (Adoption Included) Monthly Gym Membership Reimbursement OR Gym Equipment Reimbursement Benefits Eligibility Effective Day One 401K with Employer Match Tuition Reimbursement After One Year of Service Fertility Assistance Program Four-Week Company-Paid Sabbatical Eligibility After Five Years of Service The Senior Consultant provides advice and guidance to identify tax recovery opportunities through research of tax issues, analysis of data, reconciliations, and completion of complicated calculations. This includes delivering review and audit services for clients, preparing relevant documents, reports and/or client presentations, and gaining an understanding of clients methodology and business activities. A successful Senior Consultant should be able to demonstrate analytical and problem-solving skills, strong tax research skills, and effectively communicate with clients or taxing jurisdictions. This role may also requires certain supervisory tasks such as assigning work, training employees, and checking work for technical accuracy and completeness. They may also assists Managers in developing project workplans and scheduling associated project deliverables and be responsible for maintaining a positive team environment. Education and Experience: Four-year college degree from an accredited institution in practice-relevant area with 3+ years practice-relevant experience. Must have legal research and writing experience. JD with 0 to 3 years of experience in tax research and writing. Experienced paralegal with 5+ years of experience in tax research and writing. Excellent organization and time management skills, strong communication skills, and willingness to learn and be a team player. Computer Skills: To perform this job successfully, an individual must have beginner’s knowledge of Microsoft® Word, Access, Excel, PowerPoint, Outlook, and Internet navigation and research. Certificates and Licenses: Valid driver’s license required. Supervisory Responsibilities: Requires limited supervisory responsibilities, including training peers and checking work for accuracy and completeness. Work Environment: Standard indoor working environment. Occasional long periods of sitting while working at computer. Occasional long periods of standing while copying. Position requires regular interaction with employees and clients both in person and via e-mail and telephone. Equal Opportunity Employer: disability/veteran

Posted 30+ days ago

Edwards Lifesciences Corp logo

Senior Specialist, Medical Writing

Edwards Lifesciences CorpPhoenix, AZ

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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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