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Stoke Therapeutics, Inc.Bedford, MA

$262,000 - $299,000 / year

About Stoke: Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights STK-002 is Stoke's proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals. Stoke's initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach. Position Purpose: The Senior Director, Regulatory Writing and Operations oversees the strategic direction and management for both the Regulatory Writing and Regulatory Operations functions within Stoke. This position is responsible for the preparation, collaborative authoring, and completion of ICH-compliant regulatory documents, including those for clinical. Additionally, this position oversees submission and document management, publishing, and the Regulatory Information Management System (RIM). Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. This position will report into the Chief Regulatory Officer. Key Responsibilities: Partners with stakeholders to author complex regulatory documents including but not limited to; clinical study protocols, clinical study reports, investigator's brochures, regulatory briefing packages, regulatory responses, and sections of marketing authorization applications. Develop and manage SOPs, editorial standards, internal templates, and style guides. Partner with peers to increase visibility of upcoming submissions and deliverables across the regions. Work directly with team members to communicate and drive timelines, lead document review and roundtable discussions. Provide expert review of study-level and program-level documents for consistency in messaging and formatting. Effectively manage workloads and product quality of internal and contract medical writers. Direct the development and implementation of standards (SOPs and work processes) for dossier development, management, publishing, archiving, metrics, and submission process. Accountable for QC and validation of submissions to ensure they are error-free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements. Oversee maintenance, validation, implementation and training on operations systems. Drive continuous process improvement and increased communications across regulatory through leadership of initiatives to capture learnings, integration of new tools and technologies, and identify opportunities for change. Lead or participate in process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable. Required Skills & Experience: In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents (e.g., GCP, ICH). Sound working knowledge of writing, publishing and RIM computer applications Excellent written and oral communication skills. Ability to manage teams and individuals. A BS/BA degree or equivalent, and a minimum of 10 years' experience in Medical or Regulatory Writing. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Proven ability to lead complex projects, with flexibility and adaptability. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects Location(s): Stoke is located in Bedford, MA. This position is a hybrid position with an office setting based in Bedford, MA location. Travel: This position will require approximately 5% travel. Compensation & Benefits: At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $262,000 - $299,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation. Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP). Culture & Values: At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation. Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do. Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center: https://www.stoketherapeutics.com/careers/ For more information, visit https://www.stoketherapeutics.com/ . All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status. Stoke participates in E-Verify.

Posted 2 weeks ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpPortland, OR
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 2 weeks ago

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Charles R. Drew UniversityLos Angeles, California

$17 - $20 / hour

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.

Posted 30+ days ago

Ivy Tech Community College logo
Ivy Tech Community CollegeIndianapolis, Indiana

$18+ / hour

Job Title: Part-Time ESOL Writing TutorLocation: Downtown Indy CampusJob Type: Part-TimeSchedule / Hours: 18-20 hours per week, including evenings and weekends as neededClassification: Part- TimeSalary Range: $18.00/hourlyReports To: Writing Center Assistant DirectorWho We Are:We are an open-access college that fuels Indiana’s economy through excellence in teaching and proactive engagement with industry and community partners, embedded in a culture of innovation that empowers all students to learn and succeed. We are “higher education at the speed of life!”Our Values:•* Empathy: We stand with our students, partners, and communities.•* Integrity: We treat all with dignity and respect.•* Accountability: We deliver on our commitments.•* Agility: We innovate, iterate, and transform.•* Connectivity: We connect with partners to strengthen communities and ensure student success for all. About the Role:We are seeking a highly skilled ESOL Writing Tutor to join our team. In this role, you will leverage your technical and functional abilities to support the Ivy Tech Indianapolis Library & Tutoring team by conducting one-on-one tutoring in-person and virtually with Ivy Tech students and assisting leadership with additional tasks. The ideal candidate will display strong communication, patience, and cultural competencies; show creativity and adaptability while supporting learners; and have a proven track record of scaffolding and modeling the language-learning and writing processes, coaching reader and writer development; championing customer service experiences; and a passion for delivering outstanding results in a dynamic environment. Required Skills & Competencies: Technical Skills: Proficiency in composing rhetorically-savvy texts, with hands-on experience tutoring, teaching, or coaching others through learning and skill development processes. Proficiency with computer and web applications on various devices, including Windows PCs, MacBooks, and Google Chromebooks. Proficiency with Microsoft and Google Suites, Zoom, and email and chat applications. Communication Skills: Strong verbal and written communication skills, with the ability to articulate ideas clearly to diverse audiences, provide non-judgmental feedback, and build positive rapport with others. Problem-Solving: Ability to think critically, make decisions independently, and solve complex problems in a timely manner. Teamwork: Proven experience in collaborating effectively with diverse teams to achieve common goals. Preferred Additional Skills: Experience teaching/tutoring English Language Learners in their development with speaking, listening, reading, and/or writing English. Familiarity with writing center or rhetoric/composition pedagogies, academic writing genres, and tutoring best practices. Experience in teaching or tutoring writing at the college level, customer service, or similar environments. Ability to demonstrate a positive attitude of approachability and adaptability Key Responsibilities: The following is not to be construed as an exhaustive list. Other duties logically associated with this position may be assigned. All responsibilities will be conducted within the parameters of the Family Educational Rights and Privacy Act (FERPA), other applicable regulatory requirements, and professional standards. Use established Writing Center pedagogy and protocols to tutor students one-on-one at various points of the writing process, working on written documents that span a range of subjects and genres. Thoroughly document tutoring data. Sustain high quality customer service while facilitating back-to-back tutoring sessions Apply advanced problem-solving skills to troubleshoot and resolve student questions and inquiries. Collaborate effectively with cross-functional teams—including faculty—utilizing transparent and empathetic communication to help elevate departmental services and contribute to team initiatives. Recommend and share professional development resources focused on teaching or tutoring English Language Learners, contributing to the Writing Center’s growing professional development archive. Maintain an understanding of pedagogical trends and apply relevant skills in support of student success. Education & Experience: We need candidates who can demonstrate the practical skills and experience necessary to excel in this role. As such, candidates must possess an earned baccalaureate or higher degree in English for Speakers of Other Languages, applied linguistics, English, reading, or a related field; and/or have an ESOL teaching endorsementor certification. Must demonstrate ability to promote an environment that reflects the broad backgrounds represented by our students and employees and which every individual feels respected and valued. Major Responsibilities: Tutoring Tutor students with writing assignments following the established protocol in the Writing Center. Facilitate one-on-one support and student learning throughout the entire writing process. Complete a written report for each student upon the conclusion of each session. Collaborate with faculty and staff when necessary to ensure best possible outcomes for students. Professional Development Participate in the Writing Center’s training and professional development throughout the semester. Utilize observation feedback to promote ongoing growth and tutor development. Customer Service Demonstrate strong customer service and/or student advocacy through a positive attitude of approachability, adaptability, strong problem-solving, collaboration, and desire to identify and support student success. Engage in behaviors that create an inclusive environment in which all people are valued, supported, and empowered to succeed. Take initiative to go beyond the easiest or surface answer for a student or stakeholder, and get to the root cause of the problem, question, or issue to solve it as quickly and professionally as possible. Other duties logically associated with the position may be assigned. All duties are to be carried out under the guidelines of FERPA. Must demonstrate ability to promote an environment that reflects the broad backgrounds represented by our students and employees and which every individual feels respected and valued. Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College’s Title IX Coordinator or to the US Department of Education Office of Civil Rights.

Posted 6 days ago

Restoration 1 logo
Restoration 1Dallas, Texas

$20 - $80 / hour

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.

Posted 30+ days ago

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

Posted 2 weeks ago

Chatham University logo
Chatham UniversityPittsburgh, Pennsylvania
Chatham University welcomes your interest in employment opportunities and encourages you to review open positions. Please note that Chatham does not accept unsolicited applications. Chatham University seeks to fill Adjunct Instructor opportunities in their First Year Writing program. Individuals with professional experience and training in the areas of rhetoric and composition, literary studies, and/or academic research and writing are encouraged to apply. The First Year Writing curriculum aligns with the University’s core values of sustainability, community engagement, and inclusion. All First Year Writing sections share a common syllabus and schedule of assignments. However, instructors may customize the readings, discussions, and assignment prompts of this course around the topic of their choice and utilize a variety of teaching methods to promote student engagement such as experiential learning, group discussion, project work, multimedia, or other techniques. Chatham University strives to promote a campus environment that understands and embraces multiculturalism while increasing individuals' intercultural competence. We actively work to build a nd sustain a diverse and culturally vibrant campus, which promotes employee and student success and retention. Review of applications is ongoing. Position Summary: Adjunct positions will be filled as needed in First Year Writing. We welcome adjunct faculty who bring creativity, enthusiasm and a collaborative approach to their teaching and course development. Primary Responsibilities: Teaching sections of First Year Writing using a predesigned syllabus template. Consulting and collaborating with other faculty to align course content with departmental teaching goals and objectives. Holding office hours and being available to first-year students for additional support and mentorship. Participating in adjunct instructor training sessions. Required Qualifications: Completion of a master’s degree in English/Literature, Creative/Professional Writing, Rhetoric and Composition or relevant field. Preferred Qualifications: Completion of a doctoral degree in English/Literature, Rhetoric and Composition, or relevant field. Candidates with college teaching and mentoring experience. Candidates with professional and/or lived experiences that advance the university’s commitment to diversity, equity, and inclusion. How to Apply: Interested candidates should visit www.chatham.edu/careers and follow the instructions to complete the application process. Cover letter addressing how your experience and training aligns with the qualifications of the position. Please indicate in your cover letter if you are available for in-person or online teaching or both. Curriculum vitae or resume Contact information for three professional references Chatham University is an Equal Opportunity Employer with a strong commitment to diversity, inclusion, and equity. Persons of color, women, veterans, individuals with disabilities, and members of other underrepresented groups are highly encouraged to apply. Chatham University does not discriminate on the basis of race, color, religion, gender, gender identity, gender expression, sexual orientation, age, or national origin. Chatham University strives to promote a campus environment that understands and embraces multiculturalism while increasing individuals' intercultural competence. We actively work to build and sustain a diverse and culturally vibrant campus, which promotes employee and student success and retention. Chatham University is an Equal Opportunity Employer with a strong commitment to diversity, inclusion, and equity. Chatham University does not discriminate on the basis of race, creed, color, religion, gender, gender identity, gender expression, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, age, national origin, age, disability, genetic information, veteran status, marital or family status, political affiliation, or any other characteristic protected by applicable law.

Posted 30+ days ago

IQVIA logo
IQVIADurham, North Carolina
The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development. As a strategic partner to senior clinical leadership, the incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions This role reports to the Director of Medical Writing Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities: Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinial Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed. Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission) The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines Forecasting, budgeting, resource planning and resource allocation. Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with intial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan). Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinial Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process. Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents. Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents. Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards. Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables. Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks. Responsible for continual improvement of in-house medical writing. Provides expert medical writing support to other CR&D and CSL groups where required In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance. Participant in bid defense, contract development, work alignment and / or operation meetings. Post-graduate qualifications (PhD or MD preferred) Experience A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization. A minimum of 3 years in a supervisory role A comprehensive understanding of the clinical development process, including the documents that are required at each stage. A comprehensive understanding of medical writing processes, standards and issues. Demonstrated track record in cross-functional, multicultural and international clinical trial teams Excellent verbal, written and presentation skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation Prior experience with submissions in Common Technical Document (CTD) format. Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Posted 2 days ago

Trimble logo
TrimbleDayton, Ohio

$18 - $23 / hour

Your Title: Technical Writing Intern Job Location: Dayton, OH Our Department: IS Duration: Summer 2026 About Trimble’s Internship Program As a Trimble intern, you will not only gain valuable hands-on experience, but you will also be given challenging, meaningful tasks that will give you insight into what it's like working full-time as a valued member of a team. Our internships are designed to prepare you for your career journey, while growing as a professional through lunch and learns, professional development courses, team building activities, and social networking events with other interns, whether you are in person or remote. Over the course of your internship, we want you to feel like you belong, innovate, and grow personally and professionally. Join Trimble’s community to have a global impact where we value you, your experience, and your skills to propel your career forward. Job Summary Are you passionate about the power of words to inform, engage, and inspire? Do you excel at crafting clear, concise, and compelling content across a diverse range of formats to meet audience needs? The Google Workspace Platform Team at Trimble is seeking a full-time Technical Writing Intern to join our team in Dayton, OH. You'll have the opportunity to utilize your skills in the dynamic world of technical communication, where you'll have the chance to fully utilize and further develop your creative skills while contributing to real-world projects. If you're eager to learn, grow, and make a tangible impact within a supportive and forward-thinking environment, we encourage you to apply. Job Responsibilities You will work closely with the team to ensure all internal documentation for Google Workspace products is clear, current, and accessible. Key tasks include: Write, edit, and proofread articles, user guides, and internal announcements for the Google Workspace Training Hub that adhere to company guidelines and standards used by Trimble staff worldwide. Test product features and review existing documentation to confirm accuracy and completeness. Collaborate on content for AI systems, including updating and managing documentation pertaining to AI technology. Participate in and contribute to the team's processes for content review, documentation standards, and content calendar management. Bring a creative mindset to identify new ideas and opportunities for projects, tasks and processes to help improve business function and overall team effectiveness. Recommended Skills & Experience Rising Junior or Senior at an accredited college or university studying English, Communications, Creative Writing, Technical Writing, Marketing or a related field . Strong command of grammar, punctuation, and style, with a talent for writing clear, concise, and compelling content. Must have a general understanding and working knowledge of Google Docs, Sheets, and Slides. Strong ability to manage time, meet deadlines, and balance multiple priorities. Ability to quickly learn new technical concepts and work collaboratively in a team environment. Additional Skills & Experience Prior coursework or experience in technical writing or content development is a plus. Familiarity with AI concepts and an interest in documenting emerging technologies, not required, but a plus. Application Requirement Applicants must submit 3–5 professional or academic writing samples to demonstrate their technical communication abilities. Visa sponsorship is not available for this position. Candidates must already possess authorization to work in the United States of America without the need for employer sponsorship. Compensation: Trimble provides the following compensation range and general description of other compensation and benefits that it in good faith believes it might pay and/or offer for this position. This compensation range is based on a full time schedule. Trimble reserves the right to ultimately pay more or less than the posted range and offer additional benefits and other compensation, depending on circumstances not related to an applicant’s sex or other status protected by local, state, or federal law. Hiring Range $18.32–$22.88 Pay Rate Type Hourly Bonus Eligible? No Commission Eligible? No Benefits: Trimble offers comprehensive core benefits that include Medical, Dental, Vision, Life, Disability, Time off plans and retirement plans. Most of our businesses also offer tax savings plans for health, dependent care and commuter expenses as well as Paid Parental Leave and Employee Stock Purchase Plan. If this position is identified above as commission- or bonus-eligible, the terms of the commission plan or discretionary bonus plan for which you are eligible will be provided following the employee start date. How to Apply: Please submit an online application for this position by clicking on the ‘Apply Now’ button located in this posting. Application Deadline: Applications could be accepted until at least 30 days from the posting date. At Trimble, we are committed to fostering a diverse, inclusive, and equitable workplace where everyone can thrive. Guided by our core values—Belong, Innovate, and Grow—we embrace and celebrate differences, knowing they make us stronger and more innovative. We are proud to be an equal opportunity employer, welcoming individuals of all backgrounds and advancing opportunities while embracing race, color, gender identity, sexual orientation, religion, disability, veteran status, or any other protected and diverse characteristic. We are committed to offering our candidates and employees with disabilities or sincerely held religious beliefs the ability to seek reasonable accommodations in accordance with applicable law and/or where it would not constitute undue hardship for Trimble. For more, please see Trimble's Code of Business Conduct and Ethics at https://investor.trimble.com , under “Corporate Governance.” Our mission to transform the way the world works starts with transforming how we work together. By actively listening, asking questions, and taking intentional actions, we cultivate a culture that provides equitable opportunities for everyone to contribute and grow. Trimble’s Privacy Policy If you need assistance or would like to request an accommodation in connection with the application process, please contact AskPX@px.trimble.com.

Posted 1 week ago

The New York Times Company logo
The New York Times CompanyNew York, NY

$200,000 - $225,000 / year

The mission of The New York Times is to seek the truth and help people understand the world. That means independent journalism is at the heart of all we do as a company. It's why we have a world-renowned newsroom that sends journalists to report on the ground from nearly 160 countries. It's why we focus deeply on how our readers will experience our journalism, from print to audio to a world-class digital and app destination. And it's why our business strategy centers on making journalism so good that it's worth paying for. About the role: The Managing Director of Writing is a critical leader on our in-house marketing team and central to that effort. You will set the creative vision and drive conceptual thinking for a team of 10+ writers and managers, defining a consistent, distinctive New York Times tone of voice that brings our brand to life across marketing, product, and emerging platforms. You will lead the team through its next chapter, shaping our product writing practice, and continuing experiments with new technologies like Generative A.I. to enhance our creative capabilities. This is a leadership role for someone excited to manage an exceptional team, including three direct reports (two of whom are people managers). You will champion the importance of writing and voice across the organization, working collaboratively to design processes that deliver benchmark-quality, creativity, and impact at scale. We will look to you to bring unexpected, yet deeply resonant, thinking about how to communicate that our journalism is worth doing and worth supporting. This is a hybrid role based in our New York City headquarters and requires regular in-office attendance each week, per your departmental guidance. You will report to the VP, Creative Marketing. Responsibilities: Establish a clear creative vision for the entire marketing writing team, elevating its output from excellent copy to campaign-defining creative concepts and inspiring and guiding writers toward achieving organizational goals and maximizing the team's impact across all business lines. Set the strategic direction and empower team execution by providing clear context, objectives, business metrics, and rationale. Foster a culture where results, accountability, and creative thinking are valued. Consistently develop talent by proactively coaching, delivering direct feedback, and setting clear expectations. Identify team members' potential and shape development plans to support the team's and the business's future needs. Lead the strategy for the team's flexible workforce, building and maintaining a high-quality talent pipeline of part-time and temporary writers to ensure the team can scale effectively for key initiatives.Transform the functional vision into actionable roadmaps that align cross-functional teams. Lead high-visibility programs, ensuring consistent quality while navigating competing priorities. Define and lead the writing team's strategy for Generative A.I., establishing ethical guidelines and best practices while guiding writers on the application of tools to enhance creativity, productivity, and impact. Lead the development and implementation of comprehensive content strategies across marketing, brand, and product (UX), acting as the primary steward for our brand voice to ensure its cohesive and consistent application across all internal teams and third-party partners. Establish trusted relationships with senior leaders across marketing, product, the newsroom, brand messaging and strategy teams. Create compelling narratives that convince decision-makers and advance critical organizational priorities. Act as a key enterprise influencer and an ambassador for the marketing creative team, clearly articulating the team's strategic role and impact across the organization. Demonstrate support and understanding of our value of journalistic independence and a strong commitment to our mission to seek the truth and help people understand the world. Basic Qualifications: 12+ years of copywriting experience 8+ years managing writing teams, including experience managing managers. A Bachelor's degree Experience establishing strategic direction, driving enterprise-level impact, and leading teams through strategic shifts in a dynamic environment. Exceptional conceptual thinking and editorial judgment, with impeccable writing and editing skills that can shape a brand's voice across a range of surfaces, including brand marketing, growth marketing, and user experience (UX) writing. Preferred Qualifications: Deep understanding of trends in advertising and media, coupled with thought leadership on the intersection of AI and creativity. You bring a strategic perspective on how to apply new technologies responsibly and effectively in a creative process. A passion for building and coaching teams, with proven success in developing talent and identifying future leaders. A track record of informing and influencing senior stakeholders, building strong partnerships, and navigating a complex organization to drive results. A core belief in the value of journalism to people and society. We hope you enjoy reading, watching, and listening to journalism, and that you have a deep curiosity about our work and company. REQ-019137 The annual base pay range for this role is between: $200,000-$225,000 USD The New York Times Company is committed to being the world's best source of independent, reliable and quality journalism. To do so, we embrace a diverse workforce that has a broad range of backgrounds and experiences across our ranks, at all levels of the organization. We encourage people from all backgrounds to apply. We are an Equal Opportunity Employer and do not discriminate on the basis of an individual's sex, age, race, color, creed, national origin, alienage, religion, marital status, pregnancy, sexual orientation or affectional preference, gender identity and expression, disability, genetic trait or predisposition, carrier status, citizenship, veteran or military status and other personal characteristics protected by law. All applications will receive consideration for employment without regard to legally protected characteristics. The U.S. Equal Employment Opportunity Commission (EEOC)'s Know Your Rights Poster is available here. The New York Times Company will provide reasonable accommodations as required by applicable federal, state, and/or local laws. Individuals seeking an accommodation for the application or interview process should email reasonable.accommodations@nytimes.com. Emails sent for unrelated issues, such as following up on an application, will not receive a response. The Company encourages those with criminal histories to apply, and will consider their applications in a manner consistent with applicable "Fair Chance" laws, including but not limited to the NYC Fair Chance Act, the Los Angeles Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance for Employers, and the California Fair Chance Act. For information about The New York Times' privacy practices for job applicants click here. Please beware of fraudulent job postings. Scammers may post fraudulent job opportunities, and they may even make fraudulent employment offers. This is done by bad actors to collect personal information and money from victims. All legitimate job opportunities from The New York Times will be accessible through The New York Times careers site. The New York Times will not ask job applicants for financial information or for payment, and will not refer you to a third party to do so. You should never send money to anyone who suggests they can provide employment with The New York Times. If you see a fake or fraudulent job posting, or if you suspect you have received a fraudulent offer, you can report it to The New York Times at NYTapplicants@nytimes.com. You can also file a report with the Federal Trade Commission or your state attorney general.

Posted 3 days ago

BETA Technologies logo
BETA TechnologiesSouth Burlington, VT
At BETA Technologies, we apply our intellectual curiosity, passion for aviation, and commitment to sustainability toward a shared mission of revolutionizing electric aviation. Regardless of the position one holds, each team member brings their talent and desire to positively impact the environment and lives of others in a refreshing, vibrant, and inclusive culture. We’re seeking talented technical illustrators with aerospace industry experience to produce technical illustrations for use in maintenance, flight, and other manuals. An ideal candidate will have great communication skills and a collaborative attitude. This role involves working closely with other team members, ranging from technical writers to various subject matter experts, including airframe & powerplant mechanics, pilots, engineers in various disciplines, and commercial and government operations personnel. We are looking for a creative, dedicated person who is passionate about technical illustration. How you will contribute to revolutionizing electric aviation: Creating technical illustrations to support manuals, training material, manufacturing work instructions, sales sheets, etc. Leveraging engineering CAD data to generate clear, simple technical illustrations for use in structured authoring applications Collaborating with technical writers and subject matter experts (SMEs) on the definition of technical illustration needs Coordinating with technical writers on incorporation of technical illustrations within a structured authoring software application Supporting document reviews, comments and questions Tracking technical illustration and document workflows using collaboration tools Meeting project deadlines Minimum Qualifications: Bachelor’s degree (engineering or aerospace-related field is a plus) Technical illustration experience Catia V5 experience (V6 a plus) Catia Composer experience Strong communication and collaboration skills Passion for detail A customer-centric understanding of end-item configuration Driven to continually learn, develop, and adapt Ability to identify roadblocks and find solutions A team player capable of working independently Above and Beyond Qualifications that will distinguish you: Catia V6 experience PTC IsoDraw S1000D experience Experience on projects subject to approval by aviation regulatory authorities (FAA, EASA, Transport Canada, etc.) DoD or military aviation technical illustration experience Experience with collaboration tools such as Confluence/Jira, Slack, Google Suite Startup experience Adobe Creative Suite experience The wage listed here reflects our best faith estimate for this role. We pay competitively and base compensation on a variety of factors including skills, experience, industry background, and the evolving needs of the role. We remain committed to fair and equitable pay and we're happy to discuss during the interview process. Build electric airplanes with us! We encourage all driven candidates to apply, even if they do not meet every listed qualification. We are an equal opportunity employer. Employment decisions are based on merit, competence and qualifications and will not be influenced in any manner on race, color, religion, age, sex, sexual orientation, gender identity, national origin, ancestry, citizenship, disability, veteran or military status, genetic information, pregnancy, or any other protected characteristic under federal, state, or local law. BETA complies with all applicable federal, state and local non-discrimination laws and does not tolerate discrimination of any kind in our workplace. Employment offers are contingent upon the successful completion of a background check. BETA Technologies participates in E-Verify.

Posted 30+ days ago

Edwards Lifesciences logo
Edwards LifesciencesIrvine, California
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 E dwards 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 1 day ago

Immunome logo
ImmunomeBothell, Washington

$168,934 - $202,671 / year

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. Position Overview The Senior Manager, Medical Writing will be responsible for directly authoring and/or leading the creation of high-quality medical and scientific documents that support the development, regulatory approval, and commercialization for one or more of our products. The role will require close collaboration with internal groups, such Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders, to ensure high-quality and on-time deliverables that meet regulatory standards. Candidates should possess strong medical writing and scientific communications experience, with a strong understanding of early and late-stage drug development processes. This position reports to the Head of Medical Writing. Responsibilities Regulatory and Clinical Documents Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents. Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements). Ensure timely and successful responses to health authority questions and/or requests. Authoring of ICF and other patient facing materials In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR. Publications Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals. Collaborate with subject matter experts and external authors to develop high-quality publications. Ensure publications align with strategic communication plans and company objectives. Process Development In collaboration with internal partners, develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables. Ensure the development and maintenance of relevant SOPs and internal best practices. Innovation and Digital Solutions In collaboration with the Head of Medical Writing, evaluate and drive adoption of innovative approaches medical writing and communication strategies that may assist in document development, review, and/or QC. Qualifications Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered. A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus. Knowledge and Skills Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide). Excellent writing, editing, and verbal communication skills. Strong project management skills with the ability to manage multiple projects simultaneously. Proficiency with medical writing software and tools. Exceptional attention to detail and a commitment to excellence. Strong business acumen and a deep knowledge and understanding of the drug development process. Experience managing vendors and contractors a plus. Strategic thinker with strong analytical skills and ability to work in a fast-paced environment. Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators. Strong ethical standards and integrity. Washington State Pay Range $168,934 - $202,671 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish) .

Posted 2 weeks ago

Columbus State Community College logo
Columbus State Community CollegeColumbus, Ohio

$18+ / hour

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

Posted 30+ days ago

Mission Graduates logo
Mission GraduatesSan Francisco, CA
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

Posted 30+ days ago

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

Posted 30+ days ago

Revolution Medicines logo
Revolution MedicinesRedwood City, California

$204,000 - $255,000 / year

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director of Medical Writing will be responsible for helping to develop strategic leadership and management of the medical writing function and involves both a people and project-orientated focus. This position reports to the Executive Director, Medical Writing. Required Skills, Experience and Education: Driving for success in terms of people, projects, and productivity of medical writing, including all deliverables in alignment with corporate goals. Assuring the successful completion of high quality, timely and compliant document deliverables. Developing and implementing remediation plans/actions as needed. Providing medical writing leadership and guidance to full-time and contract medical writers. Assisting the Executive Director, Medical Writing, in developing budget and resource requirements for contract medical writers across multiple programs for each fiscal year. Demonstrating current and applied knowledge and understanding of regulatory requirements and standards to ensure consistent application, adherence, and timely achievement of compliant deliverables. Serving as a primary subject matter expert for the planning, design, and preparation of clinical and regulatory documents. Authoring and reviewing clinical regulatory documents as needed, including assisting teams in responding to regulatory requests. Attracting, hiring, and retaining qualified contract medical writing professionals Providing an atmosphere of training, mentorship, and coaching to align with a strategic view of the role of medical writing in clinical development. Working within the medical writing function and cross-functionally to test and develop policies regarding the use of structure content management and/or generative AI as part of clinical regulatory document processes. Structuring resourcing to ensure an effective and cost-efficient approach to covering portfolio workload and goals while ensuring sustainability and alignment with corporate goals. Providing leadership across the medical writing department through strategic input, continual process improvement, and innovation in the development and implementation of a strategic view of regulatory documents. Collaborating and partnering with cross functional leaders and other staff across project management, regulatory affairs, clinical operations, clinical development, biostatistics, and other functions. Representing the medical writing department externally with academic institutions, industry groups/peers, vendors and other entities to develop expertise and drive industry standards and best practice. Doctoral degree and 5 years of regulatory medical writing experience. Master’s degree and 7 years of regulatory medical writing experience. Bachelor’s degree and 8 years of regulatory medical writing experience. At least 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Preferred Skills: Academic preparation in life sciences or pharmacy with at least 8 years of related experience in the pharmaceutical/biotechnology industry. Experience in oncology. Strong understanding of drug development process. Experience with authoring major clinical regulatory documents, including protocols and amendments, study reports, and marketing application summaries. Experience with structured content management and/or generative AI use in the medical writing space preferred but not required. #LI-Hybrid #LI-JC1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and . For additional information, please contact privacy@revmed.com . Base Pay Salary Range $204,000 — $255,000 USD

Posted 1 week ago

Valor Collegiate Academies logo
Valor Collegiate AcademiesNashville, Tennessee

$44,520 - $55,000 / year

Description Location: Nashville, Tennessee Employment Type: Full-time, in-person lead teaching position for the current 2025-2026 school year. Salary: Starting at $55,000 for certified teachers based on years of K-12 teaching experience; $44,520 to begin for pre-licensure candidates without an active TN license. Course Details: 7th and 8th Grade Writing Why Choose Valor? Valor Collegiate Academies is a top-performing public charter school network in Nashville, Tennessee, serving 1,900 students in grades 5-12. Our mission is to empower our diverse community to live inspired and purposeful lives. This mission is made possible through an innovative school model that blends rigorous academics and whole-child education, within an intentionally diverse school environment. Our results include: A-Rated Charter Network in Tennessee: Scored as an A-rated charter network by the Tennessee Department of Education, earning perfect scores in Academic Achievement, Academic Growth, Growth of Highest Need Students, and College & Career Readiness. Top 1% for Student Growth: Our middle schools consistently rank in the 99th percentile in student growth statewide, based on TVAAS data from the past 5 years. National Leader in SEL: Over 50 partner schools nationwide have adopted and implemented Valor’s Compass model for social-emotional learning. At Valor, you'll join an academically excellent and supportive community that is dedicated to your growth as an educator. With personalized coaching and high-quality professional development, we invest in your development so you can make the greatest impact for students. Your Role as a Teacher: Planning & Instruction: Most teach 4 classes daily in one content area; all teachers have 2 planning periods daily Plan and lead 1 Intervention Block or Literature Seminar daily Plan and prepare daily lessons and materials in alignment with Valor’s curriculum and TN State Standards Utilize school-wide tracking and tech systems to collect, enter, and analyze students’ academic and behavioral data daily Ensure both academic and behavioral gradebooks are maintained with accurate information, in accordance with school-wide deadlines and policy Actively engage in and prepare for weekly 1:1 coaching and weekly intellectual preparation (IP) meetings School-Based Duties & Faculty Engagement Enforce, uphold, and exhibit school’s values, student management policies, and culture systems Own an arrival, recess or lunch, transition, or dismissal duty daily Participate in school events that occur outside of normal school hours, such as parent-teacher conferences, field trips, IEP meetings, report card conferences, and new student orientation. Estimated time commitment per school year is approximately 25 hours. Engage in ongoing professional development, which includes attending 3 weeks of faculty training in July 2025 and weekly PL sessions throughout the school year Participate in faculty Circle on Wednesdays after school, and complete and present 2 pieces of faculty Badge Work per school year Student Mentorship & Circle Facilitation Serve in the capacity of a “Pride Leader” and lead daily lessons and activities to support scholars’ social-emotional development Plan, prepare, and lead student Circles weekly; provide coaching of students regarding Badge Work and their Circle presentations Track and input student behavior feedback through Kickboard to share with families, school leaders, and culture team What We Offer: Competitive Salary: Starting at $55,000 for certified teachers, with Years of Service bonus Comprehensive Benefits: 75% coverage of health, dental, and vision benefits; retirement benefits including a hybrid pension and 401K with 5% employer matching. Paid Time Off: 8 PTO days annually and access to an org-wide PTO sharing program. Family Leave: 8 weeks of fully-paid parental leave Professional Growth: 100+ hours of PD annually, 1:1 coaching, and career advancement opportunities. Additional Perks: Access to an on-campus gym, unlimited classroom supplies, and a dedicated course budget for every teacher. Role Requirements: Must have an active Tennessee teaching license with an endorsement in Middle Grades 6-8 or Secondary ELA, or enrolled in an approved job-embedded educator preparation program Must have authorization to work in the United States without requiring employer sponsorship Key Mindsets: You believe all students can succeed and have a proven track record of promoting their growth and achievement. You enjoy cultivating meaningful relationships with students, families, and staff to support a positive learning environment. You crave feedback and are deeply committed to continuously developing your skills as an educator. You have a passion for serving a diverse community of students and families. You are willing to learn and adopt school-wide tech platforms (e.g., Kickboard, Infinite Campus, Google Suite). You model, live, and reinforce our school’s core values, commitments, and policies Interview Process: Resume Review Phone Interview Teacher Performance Task Virtual Sample Lesson & Leadership Interview Reference Checks Offer Extension Commitment to Diversity, Equity, and Inclusion: Valor believes in the importance of being a diverse, equitable, and inclusive organization that enables students and staff to thrive. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We actively seek applications from people of all backgrounds to strengthen our community and the perspectives needed to thrive in a diverse world.

Posted today

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Senior Director, Regulatory Writing And Operations

Stoke Therapeutics, Inc.Bedford, MA

$262,000 - $299,000 / year

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Job Description

About Stoke:

Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary approach, the company is developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights

STK-002 is Stoke's proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals.

Stoke's initial focus is on diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach.

Position Purpose:

The Senior Director, Regulatory Writing and Operations oversees the strategic direction and management for both the Regulatory Writing and Regulatory Operations functions within Stoke. This position is responsible for the preparation, collaborative authoring, and completion of ICH-compliant regulatory documents, including those for clinical. Additionally, this position oversees submission and document management, publishing, and the Regulatory Information Management System (RIM). Demonstrates excellent understanding of drug development and leadership behaviors consistent with level. This position will report into the Chief Regulatory Officer.

Key Responsibilities:

  • Partners with stakeholders to author complex regulatory documents including but not limited to; clinical study protocols, clinical study reports, investigator's brochures, regulatory briefing packages, regulatory responses, and sections of marketing authorization applications.
  • Develop and manage SOPs, editorial standards, internal templates, and style guides.
  • Partner with peers to increase visibility of upcoming submissions and deliverables across the regions.
  • Work directly with team members to communicate and drive timelines, lead document review and roundtable discussions.
  • Provide expert review of study-level and program-level documents for consistency in messaging and formatting.
  • Effectively manage workloads and product quality of internal and contract medical writers.
  • Direct the development and implementation of standards (SOPs and work processes) for dossier development, management, publishing, archiving, metrics, and submission process.
  • Accountable for QC and validation of submissions to ensure they are error-free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements.
  • Oversee maintenance, validation, implementation and training on operations systems.
  • Drive continuous process improvement and increased communications across regulatory through leadership of initiatives to capture learnings, integration of new tools and technologies, and identify opportunities for change.
  • Lead or participate in process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable.

Required Skills & Experience:

  • In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents (e.g., GCP, ICH).
  • Sound working knowledge of writing, publishing and RIM computer applications
  • Excellent written and oral communication skills.
  • Ability to manage teams and individuals.
  • A BS/BA degree or equivalent, and a minimum of 10 years' experience in Medical or Regulatory Writing.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Proven ability to lead complex projects, with flexibility and adaptability.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Location(s):

Stoke is located in Bedford, MA. This position is a hybrid position with an office setting based in Bedford, MA location.

Travel:

This position will require approximately 5% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $262,000 - $299,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Interested candidates: Please visit Stoke's website to learn more and apply directly to the position listed on our Career Center:

https://www.stoketherapeutics.com/careers/

For more information, visit https://www.stoketherapeutics.com/.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.

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