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

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

    DeVine is a leading provider of Educational and Scientific solutions for Federal, State and commercial clients.   Our company is looking for an PhD Advanced G raduate Writing Instructor  to join our team in Monterey, CA. This position will be supporting a government customer, hence only US Citizens may apply.  Our client’s primary mission is to support the development of graduate and certificate-program students’ writing, critical thinking, and academic skills.  These services enhance students’ discipline-based learning, improve the quality of their academic work and help them complete their educational goals. The successful PhD Advanced Graduate Writing Instructor  will join a team of Writing Instructors, and Thesis Processors, to provide one-to-one instruction focused on developing students’ writing, critical thinking, and other academic skills. Other services offered by the team include workshops, academic department-based courses, online guides and learning tools, and support with non-academic and multimodal writing. If you have the relevant experience & attributes, and would enjoy working in the Monterey, CA, area, then we want you on our team! Responsibilities: Provide one-to-one writing instruction support to graduate students Occasionally conduct research related to writing, critical thinking, program effectiveness, and special topics such as generative artificial intelligence’s (AI) impact on teaching and learning Edit faculty papers, faculty executive summaries and technical reports per year Analyze student papers for plagiarism, and create & maintained online learning and communication materials Develop and deliver 60- to 90-minute hands-on workshops and general presentations for students and faculty Support students in understanding academic norms and graduate-level standards with respect to writing, organizing thoughts, writing to conform to advanced presentation of arguments and evidence, brainstorming, outlining, revising, citing/attribution, ethical use and disclosure of generative AI, and interpreting and presenting data effectively Accommodate varying student needs and required support Review student papers 2 to 24 hours before appointments to: prioritize issues based on student requests and needs, review reports on students’ past appointments, develop consultation strategies Complete student client reports, short summaries of issues covered and progress made Experience:   PhD in English, literature, journalism, communication, rhetoric, international or public policy, or related writing-intensive field from an accredited university Minimum master's (or PhD) degree GPA of 3.50 10+ years’ working one-to-one with university students to improve their writing, critical-thinking, or research skills 3+ years’ teaching experience in writing and critical thinking at the graduate-level - Preference is given to those with teaching awards At least one thesis, dissertation, or single-author final-project report of an academic standard, academic conference paper accepted by and presented at an academic conference, or publication in an academic journal or by an academic press Evidence of strong teamwork and collaboration to reach mutual goals. Production of original written work Verifiable experience with the following: Microsoft Office suite; classroom presentation software; classroom management software, such as Blackboard or Sakai; videoconference software, such as Zoom or MS Teams; and originality-check software, such as Turnitin or iThenticate Possess and demonstrate strong knowledge of:   English-language, academic-writing fundamentals, including organization, structure, grammar, writing conventions and styles, prewriting strategies, punctuation, word choice, paraphrasing, quoting, and citing Critical thinking, argumentation, and reasoning. Teaching pedagogy Research methods Academic norms and standards, such as citation styles and methods for avoiding plagiarism, and for producing original work, evidenced-based research, literature reviews, abstracts, and executive summarizes High academic standards, such as the importance of honor codes Strong computer skills for word processing, spreadsheets, presentations, videoconferencing, file sharing, and project management and reporting About the position:   Position Type: Full-time Hourly, Must be U.S. Citizen  Location: Monterey, CA  Benefits: Medical, Dental, Vision, 401K, Life Insurance, Paid Holidays, Paid Sick Leave and Paid Vacation  Compensation: $26.92 - $48.08 per hour compensation range, DOE and skills Equal Opportunity Employer  We are committed to a policy of assuring that all applicants for employment are recruited, hired and assigned on the basis of qualifications and merit without discrimination based on any protected classification, including, but not limited to, race, color, religion, sex, sexual orientation, national origin, veteran status, age, disability, handicap, marital status, or any other characteristic protected by applicable laws.      Powered by JazzHR

About Open Road Integrated Media Open Road Integrated Media is a prestige content brand delivering digital experiences that entertain and inform readers around the world. Laser-focused on revenue, reach, and repeat customers, the Open Road network of digital properties produces compelling stories that keep audiences engaged — across devices, content verticals, and global territories. Essential Functions The editors of ORIM’s content sites are searching for a full-time, paid Content Writing Intern. The intern would work across the network of sites, including The Portalist, The Lineup, A Love So True, The Archive, Murder & Mayhem, and Early Bird Books. Intern responsibilities include researching story ideas, writing pitches and stories for the websites, search engine optimization research, and sourcing photos. The intern will receive bylines, learn about working in a content management system, best practices for SEO, honing editorial judgment, and writing for a variety of audiences. This position pays $16.50 per hour. For consideration, the intern must be able to work on-site in our Manhattan office two days per week. Requirements Available 40 hours per week for the fall semester Must be able to work in a hybrid environment (two days working on-site, three days working remotely) Must be an organized, detail-oriented self-starter Excellent written and verbal communication skills Able to work independently and on a team Previous experience in editing, writing, and/or digital media a plus   Powered by JazzHR

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

Undergraduate writing coaches are primarily responsible for one-on-one coaching of undergraduate student visitors to the Writing Center during the Fall and Spring semesters. Coaches are expected to possess excellent writing and grammar skills, as well as maintain current knowledge in all formats of undergraduate academic writing (MLA, APA, etc.). Other duties as assigned. Required Materials Please attach (or email to writing@liberty.edu ): 1. A sample of your academic writing (3-8 pages) 2. Your class schedule for the semester you are applying to work 3. Your anticipated graduation date 4. Of the following, which writing format(s) you are most familiar with: APA, MLA, Turabian 5. A description of the attributes that will make you a strong candidate for this position Essential Functions and Responsibilities 1. Meet with students at the Residential Writing Center to help them develop better writing skills that can translate to better paper writing. 2. Work 12-16 hours a week, receive thorough training, and provide valuable resources to residential student writers. 3. May present in classrooms, work on special projects, and complete other tasks as deemed necessary. 4. Maintain accurate records of coaching sessions and attendees. 5. Attend mandatory orientation, training sessions, and scheduled meetings as required by the Assistant Director of Residential Writing Services. Qualifications, Credentials, and Competencies Minimum Qualifications: 1. Current Residential student at Liberty University. 2. Cumulative LU GPA of at least 3.0. 3. Strong written and spoken communication skills. Preferred Qualifications: 1. Flexible schedule. 2. Eligibility for Federal Work Study (a dditional information may be found here ). 3. Previous tutoring experience. Target Hire Date 2025-08-30 Time Type Part time Location Lynchburg - In Office The University is an Equal Opportunity Employer. We believe it is our moral and legal obligation to meet the responsibility of ensuring that all management practices regarding employees are conducted in a nondiscriminatory manner. In compliance with Title VII of the 1964 Civil Rights Act, and other applicable federal and state statutes, all recruiting, hiring, training, and promoting for all job classifications will be administered without regard to race, color, ancestry, age, sex, national origin, pregnancy or childbirth, disability, military veteran status or other applicable status protected by law, including state of employment protected classes. It is, therefore, our policy and intention to evaluate all employees and prospective employees strictly according to the requirements of the job. All personnel related activities such as compensation, benefits, transfers, job classification, assignments, working conditions, educational assistance, terminations, layoffs, and return from layoffs, and all other terms, conditions and privileges of employment will be administered without regard to race, color, ancestry, age, sex, national origin, pregnancy or childbirth, disability, military veteran status or other applicable status protected by law, including all applicable state of employment protected classes. The University is a Christian religious-affiliated organization; and as such, is not subject to religious discrimination requirements. The University’s hiring practices and EEO discrimination practices are in full compliance with both federal and state law. Federal law creates an exception to the “religion” component of the employment discrimination laws for religious organizations (including educational institutions), and permits them to give employment practice preference to members of their own religious beliefs.

Job Title Director Medical Writing & Clinical Development Job Description The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert, mentor, and strategic guide that integrates multiple data and evidence streams (published literature, society guidelines, Philips' clinical studies, Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification, evidence generation, and surveillance/safety). Your role: Leads the medical writing team in planning and delivering high-quality, compliant documents through effective resources, budget, and timeline management. Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). Author and maintain clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports, Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities. Drives collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research & Development, and Regulatory Affairs. Develops clinical evidence strategies for New Product Introductions, including performance claims and coordination on usability and non-clinical evidence. Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy. Optimizes medical writing processes by identifying and implementing automation, standardization, and workflow efficiencies. Translates complex scientific data into clear, impactful narratives for regulatory bodies, clinicians, and stakeholders to support product development and commercialization You're the right fit if: You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development of clinical evidence/documents (manuscripts, scientific abstracts, conference presentations/posters, reports based on clinical studies, and data/analytics). You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products. You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile), mentoring, training, performance management and development of team members. You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, compliance, and reduce time to market. You have a minimum of a Master's degree in life sciences or equivalent discipline (REQUIRED). Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology, Health Services Research, Health Economics or Medicine) and healthcare quality improvement. Project management background and familiarity with agile tools (Azure Dev Ops/Jira), information management (Confluence, Distiller, Endnote) or dashboarding/visualization (Tableau, PowerBI). You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Cambridge, MA and Bothell, WA is $184,800 to $295,680. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA or Cambridge, MA. This role may require travel up to 10%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a key member of the Clinical Science team, the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have strong scientific acumen and a commitment to putting patients first. This position is an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. How you will make an impact: Perform and maintain systematic literature searches, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports Prepare moderately complex medical writing documents/deliverables for assigned project(s) Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience. What else we look for (preferred): Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area including, but not limited to, structural heart interventions, coronary interventions, heart failure, current mitral and tricuspid treatment landscape, and relevant clinical research/trials. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational knowledge. Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Company Overview: Dyne Therapeutics is discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that deliver to muscle and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/ , and follow us on X , LinkedIn and Facebook .  Role Summary: The Associate Director, Medical Writing is responsible for the timely preparation of high quality, compliant clinical and regulatory documents. This position is responsible for the medical writing activities for one or more clinical programs and will interact with other functions (eg, clinical development, clinical operations, clinical pharmacology, research, preclinical, biomarkers, program management, and medical affairs) as necessary. This position will function with limited supervision as required and ensures deliverables are of high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. Previous experience in authoring and reviewing clinical, nonclinical, and regulatory documents is desired. The ability to lead strategic discussions to ensure aligned messaging throughout regulatory documentation is critical. Outstanding communication skills are a must. This role is based in Waltham, MA without the possibility of being  fully remote. Primary Responsibilities Include: Writes, edits, and collaborates with program team members on a variety of regulatory documents including protocols, investigator brochures, clinical study reports, CTDs, and briefing books Reviews, edits, and ensures quality of documents or sections of documents prepared by functional area representatives as required and ensures adherence to standards Oversees document review comment resolution meetings Contributes to overall project management and to cross-functional working groups as needed to facilitate efficient development and finalization of clinical and regulatory documents for submissions Supports the development of best practices for authoring and reviewing, with a focus on continuous process improvement Education and Skills Requirements: Minimum of a Bachelor’s degree (advanced degree preferred) in Life Sciences, or related discipline, with a solid understanding of the basic principles of biochemistry and molecular biology Minimum 5 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company Competence in writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents per company and other guidelines Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs) Proficiency with typical office applications (eg, Microsoft Office, Adobe Acrobat) and in shared document systems (eg, SharePoint, Veeva) Ability to work independently: prioritize tasks, problem solve, and complete high-quality documents under aggressive timelines Aptitude for compilation, analysis, and presentation of data Ability to work with multiple contributors to produce a final unified document Commitment to accuracy and detail-oriented work       The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements.  Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values. Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Job Title Director Medical Writing & Clinical Development Job Description The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert, mentor, and strategic guide that integrates multiple data and evidence streams (published literature, society guidelines, Philips' clinical studies, Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification, evidence generation, and surveillance/safety). Please apply in English. Applications submitted in any other language won't be considered. Your role: Leads the medical writing team in planning and delivering high-quality, compliant documents through effective resources, budget, and timeline management. Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). Author and maintain clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports, Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities. Drives collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research & Development, and Regulatory Affairs. Develops clinical evidence strategies for New Product Introductions, including performance claims and coordination on usability and non-clinical evidence. Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy. Optimizes medical writing processes by identifying and implementing automation, standardization, and workflow efficiencies. Translates complex scientific data into clear, impactful narratives for regulatory bodies, clinicians, and stakeholders to support product development and commercialization You're the right fit if: You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development of clinical evidence/documents (manuscripts, scientific abstracts, conference presentations/posters, reports based on clinical studies, and data/analytics). You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products. You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile), mentoring, training, performance management and development of team members. You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, compliance, and reduce time to market. You have a minimum of a Master's degree in life sciences or equivalent discipline (REQUIRED). Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology, Health Services Research, Health Economics or Medicine) and healthcare quality improvement. Project management background and familiarity with agile tools (Azure Dev Ops/Jira), information management (Confluence, Distiller, Endnote) or dashboarding/visualization (Tableau, PowerBI). Near-native level of English How we work together We believe that we are better together than apart. For this role it means working in-person at least 3 days per week. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. #LI-EU

Job Description Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. General Summary: The Medical Writing Science Manager is responsible for authoring & preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision. Key Duties and Responsibilities: Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders Serves as the lead Medical Writing Scientist for moderately complex clinical studies Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members Participates in developing key messages for moderately complex clinical regulatory documents Ensures medical and scientific consistency between related documents or studies in a clinical program Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans Participates in developing standard operating processes and related procedures Knowledge and Skills: Superior written and oral communication skills Experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize moderately complex data Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology Ability to manage project teams, form productive working relationships, and work through conflicts Excellent project management and organizational skills Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools Education and Experience: Typically requires an MS, Ph.D. (or equivalent degree) Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience) #LI-AR1 #LI-Hybrid Pay Range: $120,200 - $180,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Mission Graduates increases the number of K-12 students in San Francisco's Mission District who are prepared for and complete a college education. We work towards fulfilling our mission through a wide range of after-school support services that serve over 1,500 children, youth and families each year. Our vision is to transform the culture of our neighborhood so that college becomes the expectation for Mission families, rather than the exception. We would like to invite you to volunteer as High School Mentors to work with our incoming High School seniors as they prepare for their college applications. Every summer, Mission Graduates pair Writing Partners with high school students to work one-on-one on writing their personal insight questions (PIQ) for college applications and scholarships, meeting weekly throughout the academic year. Writing Partners are able to cultivate meaningful relationships with youth and provide them with much-needed support in such an important chapter of their lives. If you are looking to give back to your community, develop meaningful relationships, and impact the lives of our San Francisco youth, you are encourage you to apply for this volunteer opportunity. Ask: 11-12 month commitment 1 hr per week, at our College Connect Office June 2024 - May 2025: Personal Statement Workshops, June 2024 followed by weekly 1:1 mentorship

Established Restoration and reconstruction company in the Dallas/Ft Worth metroplex in search of independent contractor to write estimates in Xactimate. Must be proficient in Xactimate and have knowledge of job scope in water mitigation and reconstruction of residential properties. Set your own schedule. Requirements include site visit, working with insurance adjusters to establish proper scope and writing estimates in Xactimate. I can accompany this person on all initial visits. This is a remote position. Compensation: $20.00 - $80.00 per hour Restoration Support to Help You Get Your Normal Back At Restoration 1, we help people get their property and life back to normal when they're dealing with water, mold, or fire damage. We understand that our customers are going through a taxing and emotionally trying time. This is why our restoration specialists strive to be attentive, offer upfront communication, and valuable services to our customers. Most people struggle to clean up the mess after a disaster such as a flood or fire. We've created a straightforward process to guide our customers through their property restoration. With one phone call, your life can get back to normal. What We Do Our reputation for fast response, exceptional quality, and commitment has contributed to our growth as a company throughout the United States. Our restoration specialists understand that a disaster and the need for property restoration services can come without warning, and that is why we are always at hand to assist you 24/7! Restoration 1 aims to go the extra mile for our customers and make sure their property is back the way they remember it. This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to Restoration 1 Corporate.

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

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

Job Description Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. General Summary: The Medical Writing Science Manager is responsible for authoring & preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision. Key Duties and Responsibilities: Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator’s brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders Serves as the lead Medical Writing Scientist for moderately complex clinical studies Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members Participates in developing key messages for moderately complex clinical regulatory documents Ensures medical and scientific consistency between related documents or studies in a clinical program Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans Participates in developing standard operating processes and related procedures Knowledge and Skills: Superior written and oral communication skills Experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize moderately complex data Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology Ability to manage project teams, form productive working relationships, and work through conflicts Excellent project management and organizational skills Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools Education and Experience: Typically requires an MS, Ph.D. (or equivalent degree) Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience) #LI-AR1 #LI-Hybrid Pay Range: $120,200 - $180,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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

Essential Duties and Responsibilities: Meet with students on a one-to-one or small-group basis to give learning assistance. Maintain a weekly schedule of available hours in the Student Education and Services Center and through the online tutoring services scheduling system for student appointments for tutoring in course content areas and/or learning strategies. Support and develop writing skills, strategies, and grammar 101 techniques Familiar with referencing styles (APA and MLA) Excellent understanding of academic writing such as research and thesis papers in one or more disciplines Keep regular and accurate records of tutoring sessions using the required software and/or relevant forms. Visit applicable classes at least once to make contact with faculty members and to obtain any necessary course syllabi or materials. Attend tutor-training sessions as required by the Learning Specialist or the Dean’s Office. Assist with additional duties as needed; for example, organizing materials, performing student data collection and data reporting, or other duties. Provide requested reports and/or updates on tutoring. EDUCATION: Regionally accredited bachelor’s degree or equivalent of combined education; master’s degree is preferred. Must be in good academic standing at a regionally accredited college or university. Must have completed at least 12-18 units in the assigned content areas. EXPERIENCE: Must have a recommendation from a faculty member. Completion of the applicable course or courses related to the subject matter with a grade of “B” or above. Good English-language communication skills. SKILLS: Good interpersonal communication skills and ease in relating to people from varying educational, cultural, and social backgrounds. Reliability and punctuality. Demonstrates and maintains appropriate and professional behavior. Demonstrated data base management skills. Ability to establish priorities, meet deadlines and attain growth-oriented goals. Must possess excellent computer skills and be proficient in MS Windows, Word, Excel, etc. COMPLEXITY: The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position. PHYSICAL DEMANDS: 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasional stooping. Frequent standing. Constant walking, sitting, climbing, reaching high/low levels, finger movement, feeling, speaking clearly, hearing conversationally, and seeing far and near. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasionally required to work in confined space. MENTAL DEMANDS: The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Frequent variety of unrelated tasks. Constant calculating, interrupted work, a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity. Special Requirements: Ability to work effectively with a diverse community. COVID-19 Vaccination : As a health professions institution of higher education, Charles R. Drew University of Medicine and Science seeks to protect the health and safety of the University community. Accordingly, CDU will require COVID-19 vaccinations for all University students, faculty, and staff subject to limited exceptions and exemptions. The University vaccine requirement has been implemented consistent with federal and state law related to medical exemptions for students, faculty, and staff. Requests for disability and religious accommodations from faculty and staff will be evaluated consistent with the law and University policies and procedures. Hourly Rate Range: $17 for undergraduate students; $20 for graduate students Part Time EEO Statement: Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability or covered veteran status. Fair Chance Statement: Charles R. Drew University of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: Reporting to the VP, Regulatory Affairs, the Executive Director, Medical Writing will establish the function and oversee internal and external medical writing resourcing to support authoring needs. The Executive Director will lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders to help drive our mission to set a new standard of care for brain disorders. Responsibilities : Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables, including the identification, selection, and oversight of qualified full- or part-time medical writers, vendors, consultants, or contractors Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders. Collaborate with subject matter experts on document development and review Independently author or manage others in the preparation of clear and concise clinical, nonclinical and regulatory documents and ensure consistency of messaging/content across all documents supporting regulatory submissions Responsible for ensuring the accuracy and quality of submission-ready documents using established and effective writing processes Coach, develop, and support employees in function Oversight of team members to perform weekly literature searches Responsible for clinical trial transparency and disclosures, including clinical trials results posting on clinicaltrials.gov, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs Develop and implement document templates, style standards, reference library, reviewer guidelines, and quality control checklists, to ensure consistent and high-quality deliverables Ensures development and maintenance of relevant SOPs and internal best practices Has flexibility to react rapidly to changing situations/environment. Will plan strategically, anticipate problems, and recommend process improvements to address current and future needs Willing to travel for occasional in-person team meetings Qualifications: Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience. A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing. Minimum of 10 years of relevant medical/regulatory writing experience in the pharmaceutical industry required, or in a related area such as regulatory, clinical research, or product support/R&D. Minimum of 5 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams. Extensive knowledge of English grammar and American Medical Association (AMA) style guide. Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers/vendors. Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology. Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations. Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology. Location: This is a hybrid role with three days per week onsite in either our Burlington, MA or Redwood City, CA offices. Please refer to the city listed on the top of this post for this role's location. MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.