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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

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpTucson, 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

Columbus State Community College logo
Columbus State Community CollegeColumbus, Ohio

$56+ / hour

Job Description: The Adjunct—English, Developmental Reading and Writing position provides quality instruction and maintains a positive learning environment in the classroom, with major emphasis placed on teaching, supporting, and evaluating students. The adjunct role provides instruction and monitors teaching/learning effectiveness in courses assigned by the Department Chair or other leadership members. The incumbent must exhibit strong organizational skills and the ability to multitask while engaging large groups of people with complicated material. Adjuncts teach pre-college reading or writing courses according to the learning outcomes and best practices in student success outlined by the English Department. Instruction & Student Learning Teaches assigned courses as scheduled. Designs curriculum to foster talent in all students, utilizing effective teaching strategies, with an understanding of traditionally underserved students who may not currently possess college-level skills.. Considers individual differences of students in order to design and support a range of appropriate learning activities. Participates in the identification of students with academic or other needs and responds by utilizing an appropriate resource. Uses technology in a manner appropriate to the nature and objectives of courses and programs and communicates clearly to students the expectations concerning the use of such technology. Keeps accurate and appropriate records in accordance with departmental policies. Maintains attendance records, determines and submits grades timely manner, and in accordance with established policies and procedures of the College, and communicates progress feedback as well as other relevant information to students throughout the semester. Distributes and maintains accurate syllabi that incorporate departmental, college, cross-college, and instructor requirements. Conducts classes punctually and in accordance with the prescribed meeting schedule. Employs appropriate assessment techniques to measure students’ performance in achieving course goals and objectives. Engages in periodic meetings with the department, Lead Instructor, and Chairperson relative to teaching duties and professional development. Student Engagement & Advisement Creates a positive classroom atmosphere that encourages active and collaborative learning, student effort, academic challenge, student and faculty interaction, and support for learners. Uses technology to assist in communication with students. Encourages a sense of community among students for learning both inside and outside the classroom. Refers students to appropriate student and academic support services available at the College or in the community. Culture of Respect Fosters and maintains a safe environment of respect and inclusion for faculty, staff, students, and members of the community. Minimum Qualifications Master's degree in English, English Education, or a closely related field. Two (2) years of experience teaching reading and/or writing to adults or students in grades 6-12. Additional Information State Motor Vehicle Operator's License or demonstrable ability to gain access to work site(s). Compensation Details: Compensation: $55.88 per contact hour Contact Hour: Two hours equals one contact hour Hours: Maximum of 12 contact hours per week Full Time/Part Time: Part time

Posted 30+ days ago

University of Tampa logo
University of TampaTampa, Florida
If you are a current University of Tampa student, please search for and apply to student jobs here via Workday. Job applications for current students will not be considered if submitted through the external career center. Position Details The Department of English and Writing within the College of Arts and Letters at the University of Tampa is pleased to invite applications for a full-time and continuing position as Assistant Teaching Professor of English and Writing, to begin in August 2026. The University of Tampa is a medium-sized, comprehensive, residentially-based private institution of more than 11,000 undergraduate and graduate students. The University is ideally situated on a beautiful 110-acre campus next to the Hillsborough River, adjacent to Tampa's dynamic central business district, which is a growing, vibrant, diverse metropolitan area. UTampa reflects this vibrancy; with 30 consecutive years of enrollment growth UTampa boasts 260 student organizations, a multicultural student body from 50 states and more than 100 countries, and "Top Tier" ranking in U.S. News and World Report. Our vibrant and growing Academic Writing (AWR) Program welcomes applicants with experience and enthusiasm for teaching academic writing to students with diverse backgrounds. The ideal candidate will be a dedicated teacher with a demonstrable commitment to academic writing and writing pedagogy. The on-campus, in-person teaching load consists of seven four-hour courses in academic writing per year. In addition to teaching duties, successful candidates will contribute to the Academic Writing Program by participating in curricular initiatives and taking part in committee work. Candidates may also have the opportunity to serve as Assistant Director of the Academic Writing Program. Successful candidates will have a terminal degree in English or related field, college- or university-level experience teaching academic writing and demonstrated scholarly/professional activity. Required Attachments:All required documents listed below should be uploaded the attachment box at the bottom of the "My Experience" page of the application before continuing through the application. 1. Cover letter detailing teaching experience and scholarly interests2. A current curriculum vitae3. A scholarly writing sample Review of applications will begin October 27th. The University delivers challenging and high-quality educational experiences to a diverse group of learners. The University has a strong core curriculum rooted in the liberal arts, an enduring commitment to internationalization that has garnered the Senator Paul Simon Award, and a practical, experiential approach to learning. The University offers more than 200 areas of study, including majors in our colleges of Arts and Letters, Business, Natural and Health Sciences and Social Sciences, Math and Education, 18 master's programs, and 3 professional doctoral programs. The College of Arts and Letters (CAL) is a place where theory meets practice and expression meets experience. Guided by faculty who are talented artists and distinguished scholars, students come to CAL to study everything from fleeting snaps to enduring works of classic literature. The College is home to eight collaborative and innovative academic departments: Art and Design, Communication, English and Writing, Film, Animation and New Media, Languages and Linguistics, Music, Philosophy and Religion, and Theatre and Dance. As a community of scholars and artists, the College of Arts and Letters engages in cutting-edge creative work, technological innovation, critical scholarly practice, and dialogue with diverse communities. Faculty and students across CAL work with emerging technologies in cutting-edge facilities including the stunning new Ferman Center for the Arts, the Bailey Art Studios and FabLAB, the historic Falk Theatre, the Sykes Chapel and Center for Faith and Values, and the Cass media production facilities. The University of Tampa is an equal opportunity employer dedicated to excellence through diversity and does not discriminate on the basis of age, race, sex, disability, sexual orientation, national origin, religion, marital status, gender identity, veteran status, or any other non-job related criteria. The University of Tampa recognizes the importance of a multicultural community of students, faculty, and staff who seek to advance our commitment to diversity. The University invites applications from underrepresented groups and those who have academic experiences with diverse populations. Submission Guidelines To receive full consideration for a faculty appointment with The University of Tampa, please be sure to upload documents as required for this position at time of application submission. Once your application has been submitted, no changes may be made. Required documents should be submitted in the attachment box at the bottom of the "My Experience" page of the application before continuing through the application. Note: A maximum of five (5) documents may be attached to your application. If more than five (5) documents are required, please combine the additional documents into a single attachment so that you may continue through the application process. Background Check Requirements Finalists may be required to submit to a criminal background check.

Posted 1 week ago

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Cambri VenturesFayetteville, Georgia

$30,000 - $40,000 / year

Responsive recruiter Benefits: Bonus based on performance Flexible schedule Opportunity for advancement Training & development Looking for a little extra money? Our Sales position is one that will ask that you talk to people. There is no hard selling, just writing estimates and talking to people in person. This is a part time or full time job that is perfect for the person that is busy with family, school or other responsibilities and just wants to earn some money. The schedule is flexible and there is no pressure. No Nights, No Weekends and No Holidays!!! Come join the fun working culture!! Are you motivated to make sales? Do you want to get out of the office? Job Responsibilities: Meet people and ask who cleans their windows. Acquire new commercial customers through follow-up phone calls for written estimates given on site. Weekly, monthly, quarterly, or annual sales/marketing goals to meet for bonus Job Requirements: Friendly, outgoing personality, make weekly follow up calls Good organizational skills and ability to follow-through on contacts made. Excellent communication skills in person and on the telephone. Ability to calculate and prepare job estimates on site. Goal-oriented and results-driven. Demonstrated self-confidence and trustworthiness Driver’s license and reliable transportation. FISH offers: On-the-job training No nights, no weekends, no holidays Flexible hours Commission and bonus opportunities Uniforms furnished Compensation: $30,000.00 - $40,000.00 per year Fish Window Cleaning has grown to be the world's largest window cleaning company with more than 250 franchise territories in 43 states, yet we still maintain the traditional values we were founded on. We will always treat every customer as though they are our only customer. Since its inception over three decades ago, Fish Window Cleaning has been dedicated to being a considerate and respectable neighbor in the communities where we work and live. FISH partners with nonprofit organizations on an ongoing basis to support causes across the United States. Through volunteering, leadership, and charitable giving, FISH lives its mission to be the best and most respected window cleaning company in the world. We are looking for courteous, self- motivated and friendly individuals that pay attention to detail. We clean glass at commercial and residential locations; including retail locations, office buildings, and malls from 1 to 3 stories. Some ladder work, travel between jobs, and minimal paperwork are required. You need reliable transportation, proof of insurance, and a valid driver’s license to be considered for employment. Thank you for your interest in Fish Window Cleaning ®. Fish Window Cleaning is a franchise. All Fish Window Cleaning locations are independently owned and operated. By clicking the apply button you understand that you are not applying to Fish Window Cleaning but rather an independent company that does business as Fish Window Cleaning.

Posted 3 weeks ago

CSL Plasma logo
CSL PlasmaWaltham, Massachusetts
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Your role The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regualtory documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Your responsibilities will include Oversight of Individuals Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches Ensuring delivery of high-quality clinical development content including: Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals Regulatory submissions and meetings Stage-gate and benefit –risk evaluations and assessments Presentations at scientific and technical review committees Implementation of clinical recommendations from all advisory and governance committees Internal interfaces and collaboration Member of the Clinical Development Leadership Team Will be responsible for managing a team of approximately 50 Scientists . Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries Participate and/or lead enterprise initiatives Maintaining effective oversight of quality in conjunction with appropriate Quality functions External-scientific Enhancing the reputation of the Company through a culture of scientific integration of the department with the scientific community and other partners through visible publication record, KOL interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts Ensures that the patient and health-care provider voice is integrated into CSL’s development mindset Building a culture of risk taking, innovation and peer review across the clinical function Providing clinical scientific and medical writing leadership throughout CSL Providing support and insight into business development opportunities as required Your skills & experience Graduate level degree (M.Sc, PhD, MD etc) preferred. 10 years+ of Pharma experience in clinical development Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management. Medical writing experience. Strong track record of leadership skills. Enhanced organizational awareness and the ability to interact and influence from the team level to senior management Extensive experience of leading teams and/or line managing a group(s) #LI-Hybrid About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ . Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL . You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

Posted 1 week ago

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916 InkSacramento, CA

$20+ / hour

Job title AT PROMISE YOUTH WORDSLINGER Reports to AT-PROMISE YOUTH PROGRAM COORDINATOR Classification Hourly Nonexempt. Regular Part Time. Pay $20.00/hr Job purpose The At-Promise Youth Wordslinger provides high-quality literary arts education through facilitating 916 Ink’s At Promise youth "Find Your Voice" Creative Writing Workshop curriculum in at-promise classrooms, afterschool and field trip settings for students in grades 3-12. Duties and responsibilities Workshop Facilitation · Arrive on time and prepared with all materials necessary to conduct workshop at site · Ensure that classroom set up is complete before students arrive · Direct and communicate with all volunteers on program needs and deadlines · Report any volunteer issues to Programming staff · Adhering to the workshop timelines and curricula so that all necessary activities take place in each workshop. · Modeling workshop method and observance of workshop guidelines as an active participant, writing and sharing alongside students · Presenting reading samples, encouraging discussion and active listening to ensure workshop participants receive quality instruction · Providing appropriate feedback within workshop method, while facilitating student introduction to literary devices, vocabulary, writing genres, poetry forms and new reading material · Model, lead, and maintain a respectful class environment using kindness and consistent boundaries, following 916 Ink’s classroom management guidelines · Interacting professionally with teachers, administrative staff, parents and 916 Ink Volunteers fostering positive ongoing relationships with school site staff and parents · Upon completion of program, Wordslingers are responsible to facilitate and emcee Book Release Parties · Workshop Administrative Duties · Track student attendance · Manage student record collection (includes all enrollment and evaluation documents) and ensure Programming staff receive all paper records · Manage digital program manuscript and ensure all student edits, revisions and corrections are made in document throughout program · Ensure students receive information about book release party dates and locations, and any upcoming writing opportunities · Meet all production deadlines set by Production Coordinator · Participate in monthly staff meetings · Attend required training and professional development sessions as needed · Train new At-Promise Youth Wordslingers and volunteers as needed · Other job-related duties as assigned · REQUIRED AVAILABILITY: Must be available between 9:00 AM - 5:30 PM four or more days out of the work week. Direct reports Program Coordinator AcknowledgementPlease note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Employee signature below constitutes employee's understanding of the requirements, essential functions and duties of the position. HOW TO APPLY Please send a resume and a cover letter describing your interest and qualifications to Brooke Noble, Find Your Voice At-Promise Youth Coordinator, at Brooke@916ink.org . This position is open until filled. Requirements Qualifications Must be at least 18 years of age Minimum of two years of administrative work experience in a fast-paced organization Minimum of two years of experience working with youth Minimum of two years of experience working in at-promise environments Excellent verbal and written communication skills Demonstrated ability to use critical thinking skills in order to analyze data and solve problems Must be able to demonstrate a commitment to 916 Ink’s mission, vision and core values Demonstrated ability to perform all tasks with strong attention to detail Must be able to take direction and carry out assigned tasks with minimal supervision Must be able to respond quickly and effectively to changing worksite conditions Demonstrated ability or track record for establishing strong internal and external working/professional relationships Must be able to work in a collaborative team-driven environment Must have ability to work a flexible, yet demanding schedule including nights and weekends Must be able to travel frequently Must possess a valid driver’s license with reliable transportation. If you drive your own automobile on company related business, must show evidence of current automobile insurance Upon conditional offer of employment, must be able to: Provide evidence of ability to live/work in the United States Provide evidence that you’re 18 years of age or older Must satisfactorily pass criminal background and professional employment background checks Working conditions PHYSICAL REQUIREMENTS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this Job, the employee is regularly required to sit; use hands to handle or feel and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. INTERPERSONAL SKILLS Alternative or combined skills in understanding, counseling, and/or influencing people are important in achieving job objectives, causing action, understanding others, or changing behavior; and, skills of persuasiveness or assertiveness, as well as sensitivity to the point of view of others. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate. We acknowledge that the education field industry is historically white and disproportionately hurts the most marginalized people in society — including BIPOC, people from working class backgrounds or immigrant communities, and LGBTQ+ people. We believe that these communities must be centered in the work we do. Hence, we strongly encourage applications from people with these identities or who are members of other marginalized communities.

Posted 3 weeks ago

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Tutor Me EducationIndio, 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 Indio, 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 Indio, CA Details: In-Person Tutoring in Indio, CA Schedule: 18 hours, 2 sessions a week for 2 hours Pay range is between $25 and $35 Ideal Candidate: Fluent in both Spanish and English, with the ability to deliver clear, bilingual instruction. Experienced in working with students with special education needs, including those with speech delays. Skilled in reading comprehension, writing support, retention strategies, and SEL instruction. Patient, creative, and adaptable, able to maintain engagement and structure during sessions. Background in Special Education, ABA, or related fields preferred but not required. Key Responsibilities: Provide individualized instruction in reading comprehension, writing, and retention strategies. Incorporate social-emotional learning (SEL) into lessons to support emotional regulation and interpersonal skills. Use structured, engaging activities to help the student organize and clearly express ideas in writing. Integrate Spanish instruction into sessions to enhance bilingual learning and communication. Bring supplemental curriculum materials to support lessons and reinforce learning. Use positive reinforcement, visual supports, and hands-on activities to maintain focus and motivation. Communicate progress and strategies with caregivers as appropriate. Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.

Posted 30+ days ago

Beam Therapeutics logo
Beam TherapeuticsCambridge, MA
Company Overview: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: Beam is seeking a highly talented and motivated AD/Director to join our growing Medical Writing team. The AD/Director will be responsible for creating, authoring, and leading the management of key documents for regulatory filings and clinical studies, such as clinical protocols and amendments, clinical study reports, investigator’s brochures, safety and efficacy summaries, and other documents required for regulatory submissions. Working across functions such as clinical operations, regulatory affairs, medical, biostatistics, and pharmacovigilance, this role will represent Medical Writing on study teams and will report to the VP of Medical Writing. Responsibilities: Act as lead writer for clinical regulatory documents for the hematology program. Plan and lead the development of clinical study documents, working with cross-functional colleagues. Work closely with the regulatory team and other writers on regulatory document submissions. Assist with developing and maintaining medical writing process documents. Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor. Contribute to statistical output plans concerning organization and table layout for specific documents. Project management, strategic design, planning, team input, and reviews. Opportunities for management/mentorship of other writers. Qualifications: Bachelor’s degree required; MS, PharmD, or PhD preferred in a life science or health discipline. 12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry. A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements. Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents. Gene therapy experience is preferred but not required. Excellent communication skills, both oral and written. Ability to build strong relationships and work collaboratively across functions. Effective organizational and meeting skills and attention to detail. Experience with workflow management within standard document management systems. Ability to come onsite when needed such as for important meetings and team/company functions. The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data. Beam Pay Range $180,000 — $260,000 USD

Posted 4 weeks ago

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Tutor Me EducationHawthorne, 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 Hawthorne, 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 Hawthorne, CA Details: In-Person Tutoring in Hawthorne, CA Schedule: 4pm onwards, 2x a week Competitive hourly rate based on experience Ideal Candidate: Fluent in English and Spanish (bilingual required) Experience working with students with ADHD, sensory processing needs, or fine motor delays Strong understanding of early literacy and handwriting instruction Familiarity with IEPs, RSP support, and occupational therapy goals Patient, creative, and skilled at engaging students who struggle with motivation Ability to implement positive reinforcement and multisensory learning strategies Reliable transportation for in-home sessions in Hawthorne, CA Key Responsibilities: Provide targeted support in handwriting , focusing on letter formation, spacing, pencil grip, and writing endurance Use multisensory and adaptive techniques to help reduce sensory-related avoidance of writing tasks Support reading comprehension to reinforce academic growth alongside writing development Incorporate strategies aligned with IEP goals and occupational therapy recommendations Create a supportive, engaging environment that builds the student’s confidence and independence Collaborate with the family to maintain consistency and track progress over time Respect and build upon the student’s strengths, interests, and learning style Use bilingual (English/Spanish) communication to support both the student and family Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.

Posted 30+ days ago

Thermo Fisher Scientific logo
Thermo Fisher ScientificMorrisville, North Carolina
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to expand our Medical Writing FSP Team and appoint a Program Manager (FSP Document Review Lead) to provide oversight to our DR team and DR client-specific leads. We are seeking a Program Manager who will be responsible for implementing document review processes within FSP to ensure efficient and accurate review of regulatory MW documents. This role involves acting as the primary point of contact for clients, addressing their needs and concerns, and ensuring a high-level of client satisfaction. Additionally, the role will include managing and allocating resources effectively, including staffing and technology, to meet project requirements and deadlines across clients with support from client-aligned leads. Key skills for this position include strong organizational and planning abilities, excellent communication and client management skills, and experience in resource management and team leadership. The ideal candidate will have relevant experience in document review, medical writing or a related field, a proven track record in managing complex projects and teams, and the ability to work under pressure and meet tight deadlines. Essential Functions: Supports development, monitoring and adapting project plans, timelines, and forecasts for complex review activities. Serves as the point of contact for client aligned DR leads for risk escalation, evaluating and resolving or escalating risks related to project quality, budget, or timeline. Ensures compliance with quality processes and requirements for assigned programs, maintaining consistency within and between project documents. Develops, reviews, and manages performance metrics for assigned projects. Provides senior-level review of FSP document review materials. Trains new reviewers on processes and technical aspects of document review. May serve as primary reviewer for regulatory documents. Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in document review or medical writing required. Experience in allocating resources preferred. Experience working in the pharmaceutical/CRO industry preferred. Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. Knowledge, Skills, and Abilities: Solid project management skills to include resource management and timeline development Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills Extensive knowledge of global, regional, national and other document development guidelines Excellent oral and written communication skills with strong presentation skills Excellent negotiation skills Self-motivated and adaptable Excellent judgment; high degree of independence in decision making and problem solving Ability to mentor and lead entry-level staff What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme , ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Posted 1 week ago

Madrigal Pharmaceuticals logo
Madrigal PharmaceuticalsBoston, Massachusetts

$155,000 - $189,000 / year

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Overview Madrigal Pharmaceuticals is seeking an Senior Manager of Medical Writing. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical documents . This role is critical in supporting the company’s mission to develop transformative therapies for patients with liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH). Responsibilities Write documents supporting Phase 1 though IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures) Collaborate closely with cross-functional teams to create documents that support program goals and timelines Ensure that documents are of the highest quality and compliant with global regulatory requirements and industry best practices. This role may also include contributing to updates to standard operating procedures to reflect evolving requirements. Contribute to the development and implementation of processes and systems to optimize Madrigal’s efficiency and productivity in document development Stay current with regulatory guidelines, industry trends, and best practices in medical writing Qualifications 6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development Ab le to: Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences Ensure accuracy and consistency in the quality control of documents with precise attention to detail Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP) Preferred : Familiarity with designing and operationalizing clinical studies Advanced degree in scientific area Experience in liver, cardiovascular or metabolic diseases Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate’s qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $155,000 to $189,000 per year. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact HR@madrigalpharma.com. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to HR@madrigalpharma.com .

Posted 30+ days ago

Thermo Fisher Scientific logo
Thermo Fisher ScientificChapel Hill, North Carolina
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Medical Writing Manager (FSP) At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to announce that we are looking for an FSP Medical Writing Manager in the United States! Are you an experienced Medical Writer ready to take the next step in your career? Do you thrive leading teams and driving excellence in clinical documentation? If so, we want to hear from you. As a Medical Writing Manager, you will lead a team of talented Medical Writers, and blend scientific expertise, operational leadership, and strategic insight to guide high-visibility projects and shape best-in-class medical writing practices. This role is perfect for a seasoned writer with leadership experience who’s ready to elevate both people and process. What You’ll Do Lead & Develop a High-Performing Team · Manage, mentor, and develop Medical Writers to ensure exceptional performance and continuous growth. · Oversee workload distribution, resource planning, and project assignments. · Conduct regular 1:1s, performance reviews, and coaching conversations. Drive Quality & Delivery Excellence Supervise and review the preparation of a wide range of medical writing deliverables. · Ensure projects are completed on time and to the highest scientific and regulatory standards. · Serve as a senior reviewer and departmental expert for study design, adverse event reporting, and interpretation of statistical data. · Stay current with ICH, FDA, and global regulatory guidance. Represent the Department Externally · Deliver compelling capabilities presentations to prospective clients. · Collaborate with Business Development and Contracts teams to support bids, budgets, and proposals. Shape Medical Writing Strategy & Processes · Contribute to the development, evaluation, and improvement of SOPs and work practices. · Lead or support internal training programs to ensure new and existing staff are well-equipped for success. What You Bring · Bachelor’s degree in a life science field (advanced degree—PharmD, PhD, MSc—preferred). · 5+ years of relevant regulatory writing experience, including at least 2 years in medical writing within pharma/CRO and 1+ year of leadership responsibility. · Exceptional writing, editorial, and data interpretation skills. · Strong project management ability—forecasting, timelines, resource allocation. · Excellent communication and presentation skills, especially in client-facing setting. · Ability to manage complexity, multitask, and work in a fast-paced environment. What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programmer, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain five reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. .

Posted 5 days ago

J logo
6084-Janssen Research & Development Legal EntityTitusville, New Jersey

$160,000 - $276,000 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States- Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. Participate in industry standards working groups to represent MW and ensure alignment with best practices. Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) Head and in line with R&D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio(s). Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. Can step in for DU Head in case of absence. Is a major contributor to multiple deliverables for the function, TA, or DU. Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables. Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: o Cross-functional, cross-TA, cross-J&J initiative/collaboration. o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. Supervises/manages and is accountable for direct reports. Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. Ensures direct report’s adherence to established policies, procedural documents, and templates. Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. Minimum of 14 years of relevant pharmaceutical/scientific experience is required. Minimum of 12 years of relevant clinical/medical writing experience is required. Minimum of 5 years of people management experience is required. Expertise in project management and process improvement is required. Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: Excellent oral and written communication skills. Attention to detail. Expert time management for self, direct reports (if applicable), and teams. Ability to delegate responsibility to other medical writers. Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. Expert ability to motivate and develop best in class talent pipeline. Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. Creates a positive Credo-based work environment for staff members. Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Posted today

C logo
CbDenver, Colorado

$55,000 - $65,000 / year

Owner with 20+ years of publishing, real estate, design, legal, and business experience seeks an excellent writer and legal/business assistant.Minimum Requirements: Exceptional analytical, writing, and verbal communication skills; Excellent memory--must recall past notes, documents and research and locate information quickly in notebooks, files, computer; Able to participate in negotiations in an informed and professional manner; Able to attend formal meetings with attorneys/business experts/architects, and display excellent client-relationship skills; Professional presence and wardrobe required for meetings (otherwise, casual is acceptable); Able to execute assigned tasks with meticulous detail; work under pressure and meet deadlines; Review and assimilate voluminous notes from owner, attorneys, and design professionals; Assist owner to document and assess risks based on facts and relevant law; Demonstrate proficiency in drafting clear, concise, and accurate memoranda; Typing on computer/tablet must be at a high enough speed to be efficient; Assist owner to research the law regarding formation and operation of various business entities (e.g. corporations, LLCs, partnerships, trusts, etc.); Motivated, organized, hard-worker who is ready to take responsibility for challenging issues with an intellectual curiosity and desire to grow and develop enhanced skillsets;Applicant Background and Job Information: Recent college graduates may be okay, subject to proof of excellent capabilities; Ex or current attorneys with great writing ability are welcome to investigate this position; Must provide resume, cover letter, professional and/or academic references, and a writing sample (5-9 pages; May be part time or full time, additional overtime hours available; owner may afford some flexibility with scheduling; Position offers substantial advancement to include other duties (e.g., management of projects, accounting and finance); Compensation: commensurate with competence and experience;Please apply if you can be truly committed to the opportunities and requirements embedded in this posting.Thank you. Compensation: $55,000.00 - $65,000.00 per year

Posted 5 days ago

Johnson & Johnson logo
Johnson & JohnsonTitusville, New Jersey

$160,000 - $276,000 / year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States- Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. Participate in industry standards working groups to represent MW and ensure alignment with best practices. Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) Head and in line with R&D priorities and TA objectives. Recognized expert medical writer for any document within and across TAs. Accountable for MW resource management and allocation within their portfolio(s). Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. Can step in for DU Head in case of absence. Is a major contributor to multiple deliverables for the function, TA, or DU. Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. Responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables. Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: o Cross-functional, cross-TA, cross-J&J initiative/collaboration. o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. Supervises/manages and is accountable for direct reports. Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. Ensures direct report’s adherence to established policies, procedural documents, and templates. Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. Minimum of 14 years of relevant pharmaceutical/scientific experience is required. Minimum of 12 years of relevant clinical/medical writing experience is required. Minimum of 5 years of people management experience is required. Expertise in project management and process improvement is required. Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: Excellent oral and written communication skills. Attention to detail. Expert time management for self, direct reports (if applicable), and teams. Ability to delegate responsibility to other medical writers. Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. Expert ability to motivate and develop best in class talent pipeline. Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. Creates a positive Credo-based work environment for staff members. Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time- 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Posted today

Worcester Polytechnic Institute logo
Worcester Polytechnic InstituteWorcester, MA

$6,000+ / project

JOB TITLE Adjunct Faculty- Literature and Creative Writing LOCATION Worcester DEPARTMENT NAME Humanities & Arts- JM DIVISION NAME Worcester Polytechnic Institute- WPI JOB DESCRIPTION SUMMARY Part-time adjunct faculty pool in Literature and Creative Writing to fill opportunities on a course-by-course basis as need arises. JOB DESCRIPTION The Humanities and Arts Department at Worcester Polytechnic Institute is regularly seeking part-time adjunct faculty to teach Literature and Creative Writing courses. The Literature faculty teach introductory courses, intermediate thematic surveys, and advanced topic seminars and have particular interests in American (including African American and Chicana/o), English, and World literatures; poetry; and American and Global cinema. The Creative Writing Program offers introduction, intermediate, and advanced seminars in fiction, creative non-fiction, and poetry. We are looking for outstanding scholars, but successful candidates must also demonstrate teaching excellence and versatility as well as an ability to jump into an existing curriculum with creative and critical pedagogical approaches. A successful candidate should hold a PhD in English, Comparative Literature, or Modern Languages and Literatures or an MFA in creative writing. Submitting an application through this part-time posting will place you in an applicant pool to fill Literature and Creative Writing adjunct faculty positions on an as needed basis. Specific topics and start dates will vary over the academic year. Qualified applicants from this applicant pool will be contacted as opportunities arise. Your application will remain in the pool until the posting closes. If you wish to be considered for positions beyond that date, then you must reapply. Applicants should submit the following: -cover letter that addresses relevant expertise and experience -current c.v. that includes the names and contact information for three references -evidence of teaching experience (syllabi, teaching portfolio, etc.) Compensation: $6,000 per course FLSA STATUS United States of America (Exempt) WPI is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. It seeks individuals from all backgrounds and experiences who will contribute to a culture of creativity, collaboration, inclusion, problem solving, innovation, high performance, and change making. It is committed to maintaining a campus environment free of harassment and discrimination.

Posted 30+ days ago

C logo
Cedar Park/Round RockRound Rock, Texas

$20 - $22 / hour

Do you have a passion for literacy and helping students find their confidence? Our Round Rock center is looking for patient, encouraging tutors to help students ranging from kindergarten to 12th grade improve their reading and writing abilities. Whether it is helping a younger student master phonics or guiding a high schooler through a research paper, your support makes a difference. Why this is better than private tutoring: Curriculum Provided: You don't need to spend hours creating lesson plans. We provide the lesson plan and all necessary materials. Safe & Professional: All tutoring happens in our secure center—no driving to strangers' homes. Team Environment: You are supported by full-time directors who handle the parent communication and scheduling. Responsibilities: Teach reading comprehension, vocabulary, phonics, and writing skills using Huntington’s proprietary curriculum. Assist students with general study skills and organization. Create a positive and encouraging learning environment for students who may be struggling. Requirements: 4-Year College Degree is required. (Any major is accepted if you have strong English proficiency). Patience and a genuine desire to work with school-aged children. Must be local to Round Rock/North Austin. Availability for at least 2 shifts per week (Evenings and/or Saturdays). Pay: Starting at $20.00-$22.00 per hour.

Posted 1 week ago

University of Maryland Global Campus logo
University of Maryland Global CampusPearl City, Hawaii

$16+ / hour

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

Posted 5 days ago

S logo
Southern CARedlands, California
Sylvan Learning - Redlands Sylvan Learning is the industry leader in providing supplemental education to children in pre-kindergarten through 12th grade. Our talented employees experience daily the impact they make. We're an organization that prides itself in instilling knowledge and confidence in each customer we benefit! Join us, and be inspired! Why did you first decide to become a Teacher? At Sylvan, we remember why. As an Instructor at Sylvan, your primary responsibilities are: Just Teaching. No Lesson Plans. No Preparation. We are currently looking for writing teachers. As a part-time Sylvan Instructor, you will be trained on the Sylvan curriculum and given the tools to teach in a small group, 4:1 setting for students building their English language arts and writing skills. Evening and weekend hours available. If you aspire to inspire, then we want you on our team. As a successful teacher you will:-Teach using Sylvan based programs-Supervise, interact with and motivate students during instruction hour while they work with equipment and materials-Reward students for completed assignments-Evaluate and document student progress-Communicate student needs to the center director-Inspire Students-Develop rapport with students and establish a fun learning environment-Maintain a positive attitude and demonstrate enthusiasm for teaching and Sylvan Requirements:- Hold a bachelor's degree and teaching certificate -or- are a college junior/senior working towards your degree in English or education- Advanced knowledge and familiarity with teaching or tutoring in the area of writing - Strong communication skills and the ability to multi-task -Availability 2-4 afternoons/week and/or Saturday mornings Preferrred:- 2 years teaching or tutoring experience preferred-availability starting at 3pm Monday-Thursday preferred

Posted 2 days ago

Edwards Lifesciences Corp logo

Senior Specialist, Medical Writing

Edwards Lifesciences CorpCalifornia, MD

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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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