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Clinical Regulatory Medical Writing Manager (Hybrid)-logo
Vertex Pharmaceuticals, IncBoston, MA
Job Description Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. General Summary: The Medical Writing Science Manager is responsible for authoring & preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision. Key Duties and Responsibilities: Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders Serves as the lead Medical Writing Scientist for moderately complex clinical studies Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members Participates in developing key messages for moderately complex clinical regulatory documents Ensures medical and scientific consistency between related documents or studies in a clinical program Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans Participates in developing standard operating processes and related procedures Knowledge and Skills: Superior written and oral communication skills Experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize moderately complex data Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology Ability to manage project teams, form productive working relationships, and work through conflicts Excellent project management and organizational skills Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools Education and Experience: Typically requires an MS, Ph.D. (or equivalent degree) Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience) #LI-AR1 #LI-Hybrid Pay Range: $120,200 - $180,400 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: Hybrid: work remotely up to two days per week; or select 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. 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 3 weeks ago

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DeVine Consulting, Inc.Monterey, CA
    DeVine is a leading provider of Educational and Scientific solutions for Federal, State and commercial clients.   Our company is looking for a Thesis Processor  to join our team in Monterey, CA. This position will be supporting a government customer, hence only US Citizens may apply.  Our client’s primary mission is to support the development of graduate and certificate-program students’ writing, critical thinking, and academic skills.  These services enhance students’ discipline-based learning, improve the quality of their academic work and help them complete their educational goals. The successful Thesis Processor  will join a team of Writing Instructors, and Thesis Processors, to provide one-to-one instruction focused on developing students’ writing, critical thinking, and other academic skills. Other services offered by the team include workshops, academic department-based courses, online guides and learning tools, and support with non-academic and multimodal writing. If you have the relevant experience & attributes, and would enjoy working in the Monterey, CA, area, then we want you on our team! Responsibilities: Manage approximately 35–80 student theses per quarter Provide final approvals needed for theses and publish final theses For each thesis provide: 1) an initial proofing and formatting review of at least 3 of 5 chapters, approximately 6 weeks prior to graduation; 2) a final copy, formatting, and compliance review conducted after thesis advisors and department chairs have approved the document’s content, approximately 2 weeks prior to graduation; and 3) a reconciliation compliance check prior to publication Conduct plagiarism reviews Provide students light copyediting advice, citation guidance, generative AI disclosure and formatting guidance Provide guidance on due dates, deadlines, use of the student information system’s thesis dashboard module, compliance issues, processes, filesharing, distribution statement placement, and classified thesis reviews Provide editing-advice quality control before documents are returned to the students, and clarify intent with students as needed Provide multiple mandatory 50-minute thesis processing briefs for each student Experience:   Bachelor’s degree or higher in English, journalism, communication, rhetoric, international or public policy, or writing-intensive field from an accredited university Minimum bachelor’s degree GPA of 3.25 3+ years’ experience in formatting and editing academic or professional publications using advanced features of MS Word and Adobe Acrobat Pro 3+ years’ experience communicating editing, formatting, grammar, punctuation, and proper attribution practices to others Evidence of strong teamwork and collaboration to reach mutual goals. Produce example/s of original work involving editing or writing Experience creating PowerPoint presentations, educational materials, or webpages that meet professional standards Evidence of strong recordkeeping and time-management skills. Possess and demonstrate strong knowledge of the following:   English-language, academic-writing fundamentals, including organization, structure, grammar, writing conventions and styles, punctuation, word choice, paraphrasing, quoting, and citing Document formatting standards for academic or professional publications Diverse academic norms, such as multiple citation styles and methods for avoiding plagiarism, as well as producing original work, data presentation, formatting of publications, and components of publications High academic standards, such as the importance of academic honor codes Exceptional computer skills for word processing, spreadsheets, presentations, and file sharing Data-management systems for tracking projects, including writing SOPs About the position:   Position Type: Full-time Hourly, Must be U.S. Citizen  Location: Monterey, CA  Benefits: Medical, Dental, Vision, 401K, Life Insurance, Paid Holidays, Paid Sick Leave and Paid Vacation  Compensation: $23.56 - $38.46 per hour compensation range, DOE and skills  Equal Opportunity Employer  We are committed to a policy of assuring that all applicants for employment are recruited, hired and assigned on the basis of qualifications and merit without discrimination based on any protected classification, including, but not limited to, race, color, religion, sex, sexual orientation, national origin, veteran status, age, disability, handicap, marital status, or any other characteristic protected by applicable laws.      Powered by JazzHR

Posted 4 weeks ago

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Impact KidsWauconda, IL
About Us: Impact Kids has been providing safe, fun, and meaningful enrichment programs for over 5 years, and today we serve students at public and private schools across the country. Students have a safe space to develop, learn, play, and most importantly, just be kids in our before, during, and after school programs! Who We Are Looking For: Looking for experienced individuals for teaching and instruction of writing for kids. Candidate must possess a high energy, positive approach with a genuine desire to impact young children’s lives through writing. The ideal candidate would be knowledgeable about writing and be passionate about teaching kids. This individual must provide constructive criticism, implement curriculum, and be a team player.  Also demonstrate outstanding communication skills with children and their parents, which include the ability to use clear, concise, and grammatically correct written and oral language in all aspects of professional interaction with students, their families, peers, the leadership team and the larger community. A Child abuse clearance and criminal checks are required. Experience Requirements: A Minimum of 2 years of previous experience working with children; examples include but are not limited to:  academic/athletic tutoring, camp counselor, and youth volunteer. Writing instructor/teaching experience (1 – 5 years minimum) required. Education Requirements: Bachelor’s degree (preferred but not required) Essential Job Responsibilities: The Writing Tutor is responsible for the supervision of students, giving writing instruction, providing a safe and fun learning environment, and serving as a positive role model for students. Implementing daily writing tutoring to students between the ages of 4 and 18 with different ability levels. 1 on 1 Tutoring to connect with individual students for a highly personalized learning experience while managing the group of students. Teach fundamental writing to promote skill development and proficiency. Group supervision of students with attention to: behavior and group management, health and safety, security, and personal and skill development. Ensure the safety of students and team members Organize and prepare daily plans in a fun and creative manner. Use effective classroom management skills to lead the activity and effectively create a fun environment where everyone feels included. Work effectively with fellow Activity Specialists and collaborate on daily responsibilities. Serve as a positive role model to students. Follow the Impact Kids Code of Conduct and maintain the Impact Kids look at all times. Exhibit Impact Kids Core Values at all times and adhere to all company policies. Have fun! Working Conditions and Physical Requirements: Be willing to travel. Ability to respond to emergency situations that may require running and climbing stairs. Good physical condition which enables candidate to execute all responsibilities associated with this position Powered by JazzHR

Posted 2 weeks ago

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TPAPTChicago, IL
The Association of Test Preparation, Admissions, and Private Tutoring is searching for SAT Tutors for remote tutoring assignments with students in grades 9-12. Position: SAT Tutor Location: Remote Requirement: Bachelor's degree and at least 2 years of SAT RW experience or TPAPT Tutor Certification Job Classification: Contract Time Zone: US all time zones Summary of the Position: This is remote tutoring position. Hours are generally after school during weekdays (Eastern time). Our team is small and the assignment load can vary from 3-20 hours per week. Requirements Exceptionally strong communication skills. Strong past SAT section scores. Bachelor's degree from a reputable university. A track record of having tutored either the verbal sections of SAT or ACT. Experience with US students in grades 9-12. Strong academic background. A true passion for helping others succeed academically. Benefits No marketing required Tutoring rate: $40-50hr Work for an established company Help students achieve their college goals Enjoy a flexible schedule with reliable demand

Posted 3 weeks ago

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Red Hat Inc.Raleigh, NC
The Red Hat Customer Content Services (CCS) team is looking for an Associate Technical Writing Manager to join our organization. The Associate Technical Writing Manager plays a critical role in making Red Hat's product documentation a competitive differentiator. As part of a global team, you will work with your peers around the world to drive our strategic initiatives to develop customer-centric content that supports Red Hat's product documentation needs. The ideal candidate will have experience growing and leading highly performant writing teams in a high tech, fast-paced environment. What you will do: Partner with your peers across teams to ensure that project needs are met to satisfaction and that each individual has appropriate, challenging assignments that contribute to team goals Build an agile, engaged, and flexible team of writers equipped with the ability to make strong contributions to team and departmental goals Provide direction, coaching, and assessments of work that increase your team's capabilities and effectiveness Develop an understanding of customer and partner needs and company goals to organize and coach the team Assess team performance and capacity against strategic business goals Drive collaboration efforts between technical writers and customer-facing technical staff, such as Global Support Services and other stakeholders across the business What you will bring: Experience coaching, mentoring, or leading people in a collaborative environment Demonstrated understanding of how to build highly performant teams Demonstrated track record of improving customer experiences Excellent written and verbal communication skills Experience with and passion for creating and evolving technical content The salary range for this position is $94,550.00 - $151,170.00. Actual offer will be based on your qualifications. Pay Transparency Red Hat determines compensation based on several factors including but not limited to job location, experience, applicable skills and training, external market value, and internal pay equity. Annual salary is one component of Red Hat's compensation package. This position may also be eligible for bonus, commission, and/or equity. For positions with Remote-US locations, the actual salary range for the position may differ based on location but will be commensurate with job duties and relevant work experience. About Red Hat Red Hat is the world's leading provider of enterprise open source software solutions, using a community-powered approach to deliver high-performing Linux, cloud, container, and Kubernetes technologies. Spread across 40+ countries, our associates work flexibly across work environments, from in-office, to office-flex, to fully remote, depending on the requirements of their role. Red Hatters are encouraged to bring their best ideas, no matter their title or tenure. We're a leader in open source because of our open and inclusive environment. We hire creative, passionate people ready to contribute their ideas, help solve complex problems, and make an impact. Benefits ● Comprehensive medical, dental, and vision coverage ● Flexible Spending Account - healthcare and dependent care ● Health Savings Account - high deductible medical plan ● Retirement 401(k) with employer match ● Paid time off and holidays ● Paid parental leave plans for all new parents ● Leave benefits including disability, paid family medical leave, and paid military leave ● Additional benefits including employee stock purchase plan, family planning reimbursement, tuition reimbursement, transportation expense account, employee assistance program, and more! Note: These benefits are only applicable to full time, permanent associates at Red Hat located in the United States. Inclusion at Red Hat Red Hat's culture is built on the open source principles of transparency, collaboration, and inclusion, where the best ideas can come from anywhere and anyone. When this is realized, it empowers people from different backgrounds, perspectives, and experiences to come together to share ideas, challenge the status quo, and drive innovation. Our aspiration is that everyone experiences this culture with equal opportunity and access, and that all voices are not only heard but also celebrated. We hope you will join our celebration, and we welcome and encourage applicants from all the beautiful dimensions that compose our global village. Equal Opportunity Policy (EEO) Red Hat is proud to be an equal opportunity workplace and an affirmative action employer. We review applications for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, age, veteran status, genetic information, physical or mental disability, medical condition, marital status, or any other basis prohibited by law. Red Hat does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for, and will not pay, any fees, commissions, or any other payment related to unsolicited resumes or CVs except as required in a written contract between Red Hat and the recruitment agency or party requesting payment of a fee. Red Hat supports individuals with disabilities and provides reasonable accommodations to job applicants. If you need assistance completing our online job application, email application-assistance@redhat.com. General inquiries, such as those regarding the status of a job application, will not receive a reply.

Posted 2 weeks ago

Specialist, Medical Writing-logo
Edwards Lifesciences CorpIrvine, CA
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. 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. As a key member of the Clinical Science team, the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have strong scientific acumen and a commitment to putting patients first. This position is an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. How you will make an impact: Perform and maintain systematic literature searches, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports Prepare moderately complex medical writing documents/deliverables for assigned project(s) 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 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience. What else we look for (preferred): 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, current mitral and tricuspid treatment landscape, and relevant clinical research/trials. 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. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational 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 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. 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. 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 $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

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Sylvan Learning Center- PearlandPearland, Texas
GENERAL SUMMARY The Sylvan Teacher is responsible for creating a positive personal learning experience for students by teaching students using Sylvan program materials. Using the program materials, the teacher creates balanced and robust learning experiences for students. The Sylvan Teacher evaluates student progress on each assignment, communicates this progress, and works with Center staff to ensure learning is personal for each student. ESSENTIAL JOB FUNCTIONS Prepares for each instructional session; Gathers and prepares materials as appropriate Greets students and initiates instruction to personally engage each student Instructs students according to the design of the Sylvan programs Manages students, tasks and time to create a balanced and robust instructional session Evaluates and records the progress of each student on their program assignment Uses praise and encouragement to ensure students are engaged and inspired to learn Motivates students with Sylvan tokens given for specific achievements according to the Sylvan instructional management standards Records and tracks tokens earned by students Manages the conclusion of each instructional session and manages the completion of learning log and transition activities; Supports procedures to ensure student safety and well-being Communicates specific student needs to Center staff Attends periodic staff meetings and completes ongoing training as needed Completes certification training on each Sylvan program taught to students KNOWLEDGE REQUIRED Language Arts and Study Skills Program Teachers: Four year degree or equivalent required State or provincial teaching credentials (current or expired) Minimum of one or two years of teaching experience preferred Knowledge of phonics and reading comprehension preferred for reading teachers Math Program Teachers: Four year degree required in a discipline requiring 3 or more years of college level math SAT/ACT, Test Prep, and Advanced Reading Skills Teachers: Four year degree or equivalent preferred Knowledge of general office equipment such as copiers, printers, and office phones Knowledge of tablet computers preferred SKILLS AND ABILITIES REQUIRED Proven ability to engage, motivate, and inspire students to learn Strong interpersonal and communication skills Proven ability to manage multiple tasks and be flexible Strong problem solving and customer service skills Strong team player The above statements are intended to describe the general nature and level of work being performed. They are not intended to be a complete list of all job responsibilities or skills, knowledge and abilities required.

Posted 30+ days ago

Clinical Regulatory Medical Writing Manager (Hybrid)-logo
Vertex PharmaceuticalsBoston, Massachusetts
Job Description Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. General Summary: The Medical Writing Science Manager is responsible for authoring & preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision. Key Duties and Responsibilities: Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders Serves as the lead Medical Writing Scientist for moderately complex clinical studies Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members Participates in developing key messages for moderately complex clinical regulatory documents Ensures medical and scientific consistency between related documents or studies in a clinical program Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans Participates in developing standard operating processes and related procedures Knowledge and Skills: Superior written and oral communication skills Experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize moderately complex data Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology Ability to manage project teams, form productive working relationships, and work through conflicts Excellent project management and organizational skills Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools Education and Experience: Typically requires an MS, Ph.D. (or equivalent degree) Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience) #LI-AR1 #LI-Hybrid Pay Range: $120,200 - $180,400 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. 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 2 weeks ago

Learning Support Specialist II - Reading and Writing Lab-logo
Columbus State Community CollegeColumbus, Ohio
Compensation Type: Hourly Compensation: $18.00 Job Summary The Learning Support Specialist II (LSS II), Reading & Writing Lab performs the duties of a professional tutor. The LSS II tutors in-person and is expected to work with students, faculty, staff, and community members, either one-on-one or in small groups, to help them attain a deeper and more substantial command of the assigned subject matter. This role must be able to work with multiple writers and with other tutors present, in a shared tutoring space. The LSS II communicates with the department regarding individual progress and needs for students. This position is responsible for generating reports from tutoring software and sending them to his/her supervisor. The LSS II must have a strong command of the subject matter and be able to communicate it effectively to writers using a variety of methods and teaching tools. Tutoring Supplements learners’ understanding and command of the material for which they are seeking assistance, according to the learning outcomes and best practices outlined by the Developmental Program in the English Department. Assists learners in the completion of course requirements, as well as providing basic instruction in the use of digital resources. Administrative/Clerical Functions Maintains order in course-related documents and binders, duplicating items when necessary. Files student submissions. Submits accurate timecard information on a timely basis. Communicates student issues to relevant instructors and/or lead instructors. Reports technology issues to lead instructors and/or appropriate departments. Uses the College’s tutoring software as necessary. Continuous Learning & Mentoring Maintains a thorough knowledge of the material, as well as multiple instructional methodologies, to accommodate various learning styles. Attends tutor training sessions. Provides support to lead instructors and colleagues. Culture of Respect Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community. Minimum Qualifications: Bachelor's Degree in English or a related field One (1) or more years of reading, writing, and grammar instruction and/or tutoring experience in a secondary or adult education environment. Additional License Requirement: State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s). Full Time/Part Time: Part time Union (If Applicable): Scheduled Hours: 20 Additional Information In order to ensure your application is complete, you must complete the following: Please ensure you have all the necessary documents available when starting the application process. For all faculty positions (Instructor, Annually Contracted Faculty, and Adjunct), you will need to upload an unofficial copy of your transcript when completing your aplication. Prior to submitting your application, please review and update (if necessary) the information in your candidate profile as it will transfer to your application. If you are a current employee of Columbus State Community College, please l og in to Workday to use the internal application process. Thank you for your interest in positions at Columbus State Community College. Once you have applied, the most updated information on the status of your application can be found by visiting your Candidate Home. Please view your submitted applications by logging in and reviewing your status.

Posted 30+ days ago

M
Midas GEORGETOWN 3642Georgetown, Kentucky
Benefits: 401(k) Bonus based on performance Opportunity for advancement Paid time off Training & development At Midas we are dedicated to providing quality services to customer vehicles in the areas of inspection, diagnosis and repair utilizing the expertise attained through ASE Certifications and/or years of automotive repair experience. We are looking for automotive service managers to manage and direct all service department activities of a retail store engaged in selling tires and related automotive parts and mechanical services. This position is a Store Manager developmental role. Midas is committed to training our associates and promoting from within the organization. Responsibilities As a Midas automotive customer service writer, you will quote customers and direct all automotive and general service technicians in the operation of the shop, including: Deliver exceptional customer service while listening and consulting customers Following up with customers, services requested, estimated completion times etc. Oversee complete vehicle inspections and then make comprehensive recommendations—building computerized repair orders and sourcing parts Deliver and discuss pricing estimates with customers as well as promoting shop service specials Work with the team while keeping in tune with our companies’ vision, purpose, core values, and employee creed Oversee technicians’ inspections, diagnosing and repairing of domestic, European and Asian cars and light trucks Overall cleanliness and organization of the facility Other duties as assigned Qualifications A minimum of 2 years of store or service manager experience General automotive knowledge Excellent customer service disposition Good communication skills Team building skills Ability to work a flexible retail schedule including weekends, evenings and holidays Valid driver’s license Compensation: $18.00 per hour Join Our Team As one of the largest destinations for automotive services, Midas is dominating the industry in developing career paths and building relationships within the communities they serve. At Midas, we take care of everything… tires, brakes, oil… so the opportunities to grow and develop expertise with Midas are endless. www.midas.com

Posted 30+ days ago

In-Person Baccalaureate Adjunct Faculty In Writing For Environmental Professionals-logo
Unity CollegeNew Gloucester, ME
Job Details Job Location: Pineland Campus - New Gloucester, ME Salary Range: Undisclosed Description About Unity: At Unity Environmental University we are on a mission to make environmental education accessible and affordable to all. Our unique model combines a functional hierarchy and project-based structure through our four Sustainable Education Business Units (SEBUs) to promote collaboration and innovation (Unity Environmental University at Pineland, Distance Education, Hybrid Learning, and the Technical Institute for Environmental Professions). We prioritize our students' needs above all else, offering a variety of modalities, including in-person, hybrid, HyFlex, and online. Our innovative and inclusive culture prepares students to tackle real-world challenges and cultivate the next generation of environmental professionals and leaders who can make a positive impact on our world. Our Mission: We are dedicated to delivering quality education and experiences that produce outstanding environmentally competent professionals and inspire individuals from all walks of life to steward sustainable ecosystems. About Unity Environmental University at Pineland: Unity Environmental University at Pineland provides in-person, experiential learning that adapts to the unique circumstances of each student. Unity offers fully accredited bachelor's and master's degree programs, as well as non-degree credits, empowering learners to shape their own educational journey and become the changemakers our world needs. With 8 five-week terms for undergraduates, our model offers unparalleled flexibility. Courses at Pineland are taught in our state-of-the-art facilities, including HyFlex classrooms and laboratories, allowing students to immediately apply what they learn in their careers and lives. With a mixture of course offerings during the week, in the evenings, and on Saturdays, Unity's in-person education is ideal for busy professionals who seek to advance their careers while still honoring commitments. Students learn hands-on, integrating practical skills in and outside the classroom. The Opportunity: Unity Environmental University at Pineland is seeking enthusiastic individuals to teach Writing for Environmental Professionals courses for our in-person baccalaureate degree programs. Courses are taught on the Pineland Farms campus in New Gloucester, Maine and run for five weeks in eight terms during the year. Day to day responsibilities: This position is responsible for facilitating engagement in 5-week baccalaureate-level courses in Writing for Environmental Professionals focusing on refining and reflecting on the writing process to become more effective professional communicators and developing strategies to improve writing to become more persuasive and impactful environmental professionals. Courses are taught in-person with an average of 20 students per course. Instructors must meet expectations for timely feedback, classroom engagement, and responsiveness to students. Qualifications Do you have the skills? The ideal candidate will possess a terminal degree in a related discipline or a master's degree with ample professional experience. Ability to efficiently operate a personal computer and associated software (Outlook, Word, Excel, etc.). Must have strong organizational and time management skills. Ability to communicate effectively and appropriately using e-mail and digital conferencing tools. Personal commitment to the environmental focus and mission of Unity Environmental University. Desired skills: Experience teaching in-person at the postsecondary level. Experience using Canvas or other Learning Management System to facilitate learning. The Location: Unity Environmental University at Pineland's curriculum is in person at our Pineland Farms campus in New Gloucester, Maine. Benefits: This is a temporary part time position and is not eligible for benefits. To Apply: Interested and qualified candidates should click on the Apply Now button and submit a CV, cover letter, unofficial copies of all University/College transcripts, and points of contact for three references Do you have the skills? The ideal candidate will possess a terminal degree in a related discipline or a master's degree with ample professional experience. Ability to efficiently operate a personal computer and associated software (Outlook, Word, Excel, etc.). Must have strong organizational and time management skills. Ability to communicate effectively and appropriately using e-mail and digital conferencing tools. Personal commitment to the environmental focus and mission of Unity Environmental University. Desired skills: Experience teaching in-person at the postsecondary level. Experience using Canvas or other Learning Management System to facilitate learning. The Location: Unity Environmental University at Pineland's curriculum is in person at our Pineland Farms campus in New Gloucester, Maine. Benefits: This is a temporary part time position and is not eligible for benefits. To Apply: Interested and qualified candidates should click on the Apply Now button and submit a CV, cover letter, unofficial copies of all University/College transcripts, and points of contact for three references

Posted 30+ days ago

Writing Center Consultant - Student Worker-logo
Asbury Theological SeminaryWilmore, KY
Job Details Job Location: Kentucky Campus - Wilmore, KY Position Type: Student Salary R ange: Undisclosed Job Shift: 15 hours Description Position Summary Work with Writing Center clients on a day-to-day basis, providing writing assistance at different stages in the writing process. Consultants may work with individuals or groups, and consulting sessions may take place in either face-to-face or online formats. MUST BE A CURRENT STUDENT AT ASBURY THEOLOGICAL SEMINARY (see Job Qualifications section below). Application Deadline: September 1, 2023 Essential Functions Provide writing assistance to Writing Center clients. Maintain records of Writing Center activities. Develop and lead Writing Center workshops on a variety of topics. Develop and maintain Writing Center resources, written and digital. Participate in ongoing training programs as assigned. Other Responsibilities Assist the Writing Center Director in maintaining and updating the Writing Center handbook. Other duties as assigned by the Director Tools and Equipment Basic computer applications (Word, Excel, etc) Familiarity with both PC and Mac as well as other audio/visual tools Qualifications Education/Training/Experience Minimum of 18 graduate-level hours completed; candidates with fewer graduate hours, but with a strong undergraduate background in English, Education, or related field will be considered Strong oral and written communication skills Proficiency in English grammar and stylistic conventions Prefer experience in a teaching or tutoring context Strong interpersonal skills and the ability to work both independently and collaboratively Ability to manage time well and meet deadlines as needed Must be detailed-oriented Must be familiar with Word, Excel, Google drive Must have an ethic of service and care An ability/willingness to learn is essential Ability to maintain confidentiality Education/Training/Experience Minimum of 18 graduate-level hours completed; candidates with fewer graduate hours, but with a strong undergraduate background in English, Education, or related field will be considered Strong oral and written communication skills Proficiency in English grammar and stylistic conventions Prefer experience in a teaching or tutoring context Strong interpersonal skills and the ability to work both independently and collaboratively Ability to manage time well and meet deadlines as needed Must be detailed-oriented Must be familiar with Word, Excel, Google drive Must have an ethic of service and care An ability/willingness to learn is essential Ability to maintain confidentiality

Posted 30+ days ago

College Writing Adjunct-logo
The Culinary Institute of AmericaHyde Park, NY
The hiring rate for this position is as follows: Rate with Master's Degree is $3,281; rate with Master's degree and two years of college-level teaching experience is $3,467. Hiring offers will be determined based on the final candidate's education and relevant experience. The recruiter can share more information about what the anticipated hiring salary would be based upon your specific qualifications during the selection process. Please apply to learn more about the benefits of working for the CIA. POSITION SUMMARY Culinary Institute of America Adjunct Faculty members are responsible for teaching students a high standard of professionalism. The primary responsibility of the Adjunct Faculty in Liberal Arts is teaching and evaluating students. Adjunct Faculty members also maintain office hours, assist students who are having difficulty with studies, and honor college policies. College Writing (LITC-100) 3.0 credits Students will write and revise essays that demonstrate their ability to read and think critically, to incorporate evidence into the development of their ideas, and to articulate their responses persuasively. Readings may include essays, articles, literature, or literary criticism. Basic concepts of information literacy will be introduced. Grammar, usage, and mechanics will be reviewed as necessary. ESSENTIAL RESPONSIBILITIES Prepares daily lesson plans for classes and teaches classes as requested and scheduled, in a manner consistent with the philosophy, policies, and guidelines of the Institute. Works individually as an advisor for students who may need extra help, who have questions about course information, who want career guidance, or who need assistance in their studies. Provides regular and constructive feedback to students in an objective, consistent, and timely manner; evaluates and documents student performance using established methods and criteria; files course grades consistently and without prejudice. Evaluates and documents student performance using established methods and criteria. Files course grades promptly within the specific timeframe allowed. Compiles and presents instructional material at scheduled times and places in accordance with the College Catalog descriptions, course syllabi and outlines and class schedules as assigned. Utilizes the established syllabus and textbook(s) for the course being taught. Maintains record of student attendance, student progress, and grade distributions. Maintains discipline and order during instructional activities. Communicates through appropriate channels. Enforces sanitation principles (appropriate to particular teaching assignment), attendance policies, Institute's Professionalism, Uniform, and Hygiene Policy, and other academic policies. Supports the mission and policies of the Institute as well as the overall strategic direction of the Department of Continuing Education. Assume responsibility for equipment and facilities of the classroom. Any and all other duties as assigned. REQUIRED QUALIFICATIONS Education: Master's Degree in a related field. Experience: A minimum of one (1) year of teaching experience. PREFERRED QUALIFICATIONS PhD in a related field. A minimum of one (1) year college level teaching experience. Previous experience with Moodle. REQUIRED SKILLS Strong teamwork and interpersonal skills; ability to be adaptable, dependable and handle multiple priorities simultaneously. Ability to use sound judgment and discretion in handling sensitive student issues with confidentiality and discretion. Excellent written, verbal communication, and presentation skills required. Strong computer experience, which must include abilities to work effectively with MS Office suite products, i.e. Word, Excel, PowerPoint. Strong customer service skills. Exceptional organizational skills. Ability to work independently or in a team environment, and maintain collaborative relationships with all members of faculty and administration. Must have an excellent and welcoming presence in front of guests and employees. WORKING CONDITIONS Must be available to work nights and weekends as required due to business needs. Regular work requires a great deal of sitting and standing for extended periods.

Posted 30+ days ago

C
Collin County Community CollegeFrisco, TX
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: As directed, provide discipline-specific academic assistance to learners and support the operation and promotion of services. Required Qualifications: Essential Duties and Responsibilities Support learners through individual and/or group tutoring in a variety of modalities. Assist students with course-related equipment and supplies. Create, maintain and assure accuracy of records of students tutored as required under department guidelines. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA). Prepare and present workshops as needed. Assist with daily operations and promotion of services. Be available to work a flexible schedule as needed. Supplemental Functions Perform other duties as assigned. Perform all duties to maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of content within the specified subject field Knowledge of department guidelines and record-keeping Knowledge of related instructional equipment Organization and time management skills Presentation skills Computer and applicable software skills Interpersonal and customer service skills Ability to create a positive and safe tutoring and learning environment Ability to communicate effectively in the English language, both orally and in writing Ability to establish and maintain effective working relationships Ability to assist students in using technology Ability to work independently and collaboratively Physical Demands, Working Conditions and Physical Effort Light Work - Exerting up to 20 pounds of force occasionally, up to 10 pounds of force frequently, and/or a negligible amount of force constantly having to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for the Sedentary Work category and the worker sits most of the time, the job is rated Light Work. Positions in this class typically include talking, hearing, seeing, grasping, standing, walking and repetitive motions, plus stooping, kneeling, crouching, and reaching. Relatively free from unpleasant environmental conditions or hazards. Office environment. Occasional physical effort required. Required 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. Tutor Instructional, Level IV (208PT) - $20.24 Tutor Instructional, Level V (209PT) - $21.45 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: $20.24 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 3 weeks ago

Vertex Pharmaceuticals, Inc logo

Clinical Regulatory Medical Writing Manager (Hybrid)

Vertex Pharmaceuticals, IncBoston, MA

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Job Description

Job Description

Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.

This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available.

General Summary:

The Medical Writing Science Manager is responsible for authoring & preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision.

Key Duties and Responsibilities:

  • Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders
  • Serves as the lead Medical Writing Scientist for moderately complex clinical studies
  • Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members
  • Participates in developing key messages for moderately complex clinical regulatory documents
  • Ensures medical and scientific consistency between related documents or studies in a clinical program
  • Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document
  • Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans
  • Participates in developing standard operating processes and related procedures

Knowledge and Skills:

  • Superior written and oral communication skills
  • Experience writing and editing clinical regulatory documents
  • Ability to analyze, interpret, and summarize moderately complex data
  • Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
  • Ability to manage project teams, form productive working relationships, and work through conflicts
  • Excellent project management and organizational skills
  • Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues
  • Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process
  • Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools

Education and Experience:

  • Typically requires an MS, Ph.D. (or equivalent degree)
  • Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience)

#LI-AR1

#LI-Hybrid

Pay Range:

$120,200 - $180,400

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.

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

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