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Vertex Pharmaceuticals logo
Vertex PharmaceuticalsBoston, Massachusetts

$120,200 - $180,400 / year

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

Posted today

Zoox logo
ZooxFoster City, CA
We are seeking a Manager, Technical Writing to lead a team of Technical Writers within Manufacturing Operations, including responsibility for documentation supporting both production processes and diagnostic/maintenance workflows. This role will ensure that Zoox’s technical content—ranging from manufacturing and maintenance work instructions to fleet diagnostics procedures—is accurate, scalable, and technician-friendly. As the leader of the Technical Writing team, you will manage documentation priorities, mentor writers, and partner closely with engineering, quality, and operations teams. You will play a key role in developing frameworks, tools, and processes that improve the clarity, consistency, and efficiency of Zoox’s technical publications, enabling technicians and operators to execute their tasks safely, accurately, and on time. In this role, you will Lead and mentor Technical Writers by providing coaching, feedback, and guidance on best practices to drive performance and growth. Enhance standards, templates, and style guides while building a robust framework for document creation, review, storage, and maintenance across manufacturing, maintenance, and diagnostics. Partner with Engineering, Manufacturing, Tiger teams, Rework Review Board, Base Operations, and other cross functional stakeholders to gather inputs and ensure documentation supports production readiness, training, troubleshooting, and technician effectiveness. Oversee the review and approval process to ensure compliance with ISO, APQP, SAE, and other industry standards, while also supporting both hardware and software tools that affect documentation creation, alignment, or the development of new content, such as functional diagrams and guided diagnostics. Establish and manage dashboards, workflows, and platforms (e.g., Dozuki, Oxygen XML, Confluence, Jira) to streamline creation, tracking, and updates, and also explore external partnership and AI tools to optimize documentation effort. Provide clear weekly and monthly updates, proactively seek stakeholder feedback, and ensure team administration and logistics, enabling on-time delivery of critical documentation. Qualifications Bachelor’s degree in Technical Communication, Engineering, or a related field. 10+ years of experience in technical writing, with at least 3–5 years in a leadership or management role. Strong experience in building and maintaining documentation frameworks, including standards, templates, and workflows. Hands-on expertise with documentation tools such as Dozuki, Oxygen, FrameMaker, Confluence, and Jira, with proven ability to streamline documentation processes using dashboards and tracking systems. Demonstrated ability to lead cross-functional collaboration with engineering, manufacturing, and operations teams to ensure documentation supports production readiness and compliance (ISO, APQP, SAE, or similar frameworks). Excellent project management and organizational skills, with a track record of delivering complex documentation programs on time and reporting progress effectively to stakeholders. Bonus Qualifications Hands-on experience with diagnostic or automotive documentation, including familiarity with CAN, UDS, and SAE diagnostic standards. Experience with instructional design, training content creation, or technician enablement programs. Familiarity with CAD visualization tools (3DX, CATIA) or integration of multimedia (photos, video, animations) into technical documentation. Base Salary Range There are three major components to compensation for this position: salary, Amazon Restricted Stock Units (RSUs), and Zoox Stock Appreciation Rights. A sign-on bonus may be offered as part of the compensation package. The listed range applies only to the base salary. Compensation will vary based on geographic location and level. Leveling, as well as positioning within a level, is determined by a range of factors, including, but not limited to, a candidate's relevant years of experience, domain knowledge, and interview performance. The salary range listed in this posting is representative of the range of levels Zoox is considering for this position. Zoox also offers a comprehensive package of benefits, including paid time off (e.g. sick leave, vacation, bereavement), unpaid time off, Zoox Stock Appreciation Rights, Amazon RSUs, health insurance, long-term care insurance, long-term and short-term disability insurance, and life insurance. About Zoox Zoox is developing the first ground-up, fully autonomous vehicle fleet and the supporting ecosystem required to bring this technology to market. Sitting at the intersection of robotics, machine learning, and design, Zoox aims to provide the next generation of mobility-as-a-service in urban environments. We’re looking for top talent that shares our passion and wants to be part of a fast-moving and highly execution-oriented team. Follow us on LinkedIn Accommodations If you need an accommodation to participate in the application or interview process please reach out to accommodations@zoox.com or your assigned recruiter. A Final Note: You do not need to match every listed expectation to apply for this position. Here at Zoox, we know that diverse perspectives foster the innovation we need to be successful, and we are committed to building a team that encompasses a variety of backgrounds, experiences, and skills.

Posted 30+ days ago

Vertex Pharmaceuticals logo
Vertex PharmaceuticalsBoston, Massachusetts

$157,600 - $236,400 / year

Job Description General Summary: The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Science and manages a team Participates in developing and implementing goals and initiatives for Medical Writing Science Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues Proven track record of anticipating potential problems and preparing contingency plans as needed Understanding of scientific disciplines beyond own specialty area Experience managing direct reports and guiding staff development Experience with marketing authorization application regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote : work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select 2. Hybrid : work remotely up to two days per week; or select 3. On-Site : work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted today

Berklee College of Music logo
Berklee College of MusicBoston, Massachusetts
In order to participate in Berklee Student Employment, a student must fulfill the following requirements: Current student at Berklee College of Music or Boston Conservatory at Berklee. Enrolled at least half-time in a degree, diploma, or certificate-seeking undergraduate or graduate program. Summer is the only semester in which a student can maintain employment without being enrolled. In this case, the student must be pre-registered for the upcoming fall semester. This exception does not apply to fall or spring semesters. Have a valid United States Social Security Number (SSN). Remain in “valid” Visa status as applicable. A minimum 2.0 cumulative GPA. Students in their first semester can work, even though they do not have an official GPA until the completion of their first semester. Federal Work Study student may apply. In good disciplinary standing. Must be located in the U.S. For complete program details, please go to our website: www.berklee.edu/se . Seeking singing actors who learn music quickly, strong sight-reading skills, eager to take on new character work and be the first to try out new material written by students in the Musical Theater Writing minor. Seeking singing actors who learn music quickly, strong sight-reading skills, eager to take on new character work and be the first to try out new material written by students in the Musical Theater Writing minor. Strong connection delivering lyrics in character as well as dialogue. Rehearse outside of class with music director and writers, and present material during the class itself, while getting paid for it! When applying please specify which class(es) you’d be available for. Partial availability is a possibility, but you must list ALL potential conflicts. You must be available to present the songs you rehearse the night before. Also please include a link to one or more videos of yourself performing solo, ideally musical theater repertoire. If your link isn’t ready, feel free to apply first and prepare a video audition as soon as possible. See dates and times below: SW-445 MT Writing 2 - Reiffel Class: Wednesdays 11am-1pm, 135 Mass. Ave, 3rd floor (the conference room) Rehearsals: Tuesday evenings, 6pm-11pm. Note that this is a small class. It’s likely that there will only be 2 or 3 projects, so the Tuesday rehearsals will probably only run 2 or 3 hours. 9/16 - Rehearse Group Anthems 9/17 - Present Group Anthems 10/7 - Rehearse I Want solos 10/8 - Present I Want solos 10/21 - Rehearse AABA terse solos 10/22 - Present AABA terse solos 11/4 - Rehearse Crisis/Climax scenes and songs 11/5 - Present Crisis/Climax scenes and songs 11/18 - Rehearse pitches 11/19 - In-class rehearsal / draft presentation 12/2 - Rehearse revised pitches 12/3 - In-class first “dress rehearsal” of pitches 12/9 - Final rehearsals of pitches ADDED REHEARSAL 12/10 - In-class Live pitches on Zoom SW-345-001 MT Writing 1 - Reiffel Class: Thursdays 9am, 921-511 Rehearsals: 4 Wednesday evenings, 6-11 PM. This class is very full—we will likely have 8 projects for each rehearsal. 9/24 - Rehearse every lyric is a lie - solos 9/25 - Present every lyric is a lie - solos 10/15 - Rehearse action/activity - solos 10/16 - Present action/activity - solos 11/12 - Rehearse duets from PROOF 11/13 - Present duets from PROOF 12/10 - Rehearse PROOF threaded scenes 12/11 - PROOF threaded scenes recital Pay Rate: Student Worker 3 Hiring Manager: David Reiffel

Posted today

Palm Beach State College logo
Palm Beach State CollegeBelle Glade, Florida

$16+ / hour

Join our team! What We Offer At Palm Beach State College, you will discover a place where ideas come to life and the heartbeat of a county begins. By joining us, you will be exposed to professionals from across the U.S. and abroad who are the strivers, reinventors, explorers, and influencers dedicated to developing talent that fills the most needed workforce roles. As the Panthers, we embrace a community of belonging, caring, and connection for our students and employees. We seek creative individuals to help PBSC fulfill its mission of inspiring hope, advancing skills, and transforming lives. About this role Palm Beach State College Job Description* * * * * |Human ResourcesJob Summary:Responsible for providing tutoring assistance for students within discipline area of expertise. Duties include assisting students with course work, learning strategies, and overall academic skills development.Varies Base Pay: $16.06. Offer amount based on College's Salary Schedule guidelines. Duties and Responsibilities: (This list is not exhaustive and may be supplemented as necessary) Conducts tutoring sessions with individual or multiple students in person and virtual environment. Provides constructive feedback and suggestions on student assignments. Creates an engaging learning environment and enhances student confidence and interest in learning. Maintains an awareness of current College and department policies and guidelines. Performs other job-related duties as assigned. We are seeking individuals with the following areas of disciplines to tutor Writing: Communication Language Arts Business English Composition 1 & 2 Fundamentals of Speech Communication (SPC1017) All Levels of EAP (English for Academic Purposes) -TESOL Studies Skills (SLS1501) Writing /Reading For All Disciplines College Readiness ( ENC0017 & ENC0052) What to Expect: As part of our recruiting process, we require candidates to complete an assessment test. Required Minimum Qualifications : Education and Experience: High school diploma or GED Some related experience Knowledge of: Microsoft Office Professional or similar application Skilled in: Delivering a high level of customer service Ability to: Ability to convey knowledge of tutorial discipline to others in a practical and comprehensive manner Effectively communicate verbally and in writing on a regular basis with internal and external customers, build relationships, manage customer expectations, and take responsibility for a high level of service Interact in a positive manner with diverse populations and varying education levels of students, faculty, staff, and the public Preferred Qualifications : Education and Experience: In-person and remote tutoring experience Work Environment and Physical Demand: Reach and grasp objects Use of video display terminal Use of manual dexterity and fine motor skills Communicate information orally and in writing Receive and understand information through oral and written communication Proofread and check documents for accuracy Work a fluctuating work schedule This job description is intended to be generic in nature and describe the essential functions of the job. It is not an exhaustive list of all duties and responsibilities. The essential duties, functions and responsibilities, and overtime eligibility may vary based on the specific tasks assigned to the position. READY TO APPLY? Here's your application preparation! Please review the following information to apply for a position at Palm Beach State College: Carefully review the minimum qualifications advertised for the available position, as only applicants meeting the minimum requirements will be considered. Background Check/ Drug Screen may be required based on the specific requirements of the position for which the application is being submitted. Employment is contingent upon passing a drug test and completing a criminal background investigation. An essential goal of the Office of Human Resources is to respond to all applicants once a selection is made. Please take notice of the position closing date advertised. Whenever positions are filled, the Office of Human Resources responds to all applicants who have submitted applications. The College conducts its employment activity within the State of Florida except for occasional brief and temporary pre-approved periods related to college travel. Application Deadline This position is open until filled

Posted 3 weeks ago

M logo
Midas GEORGETOWN 3642Georgetown, Kentucky

$18+ / hour

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

Posted 3 weeks ago

Allegion logo
AllegionTempe, Arizona

$55,000 - $65,000 / year

Creating Peace of Mind by Pioneering Safety and Security At Allegion, we help keep the people you know and love safe and secure where they live, work and visit. With more than 30 brands, 12,000+ employees globally and products sold in 130 countries, we specialize in security around the doorway and beyond. Additionally, in 2024 we were awarded the Gallup Exceptional Workplace Award, which recognizes the most engaged workplace cultures in the world. Specification Writer Apprenticeship Program; Phoenix/Tempe, AZ Specification Writer Apprentice We are looking for Specification Writers to join our Allegion team as part of our Specification Writing Apprenticeship Program! As a Specification Writer in the program, you will complete two rotations in the span of 9 months. This immersive program includes in depth training and development to prepare you for your role of providing access solutions by creating door hardware specifications. In the first six months of the training program, you will relocate to our training facility in Denver, Colorado. Here you will participate in classroom style training with others in your cohort. During this segment, you will learn about the industry, our products, and codes as well as how to read blueprints. In the last three months of the training program, you will transfer to your permanent location in your respective regional sales office. Here you will prepare for your full-time role by writing specifications with the help and supervision of your team so that you are prepared to hit your market ready for success! Hybrid: At Allegion, we are driven by a bold vision: redefining safety while empowering our employees to thrive. When you join our team, you become part of a culture that values innovation, purpose, and excellence. This role offers the benefits of our dynamic hybrid work model—combining in-person collaboration for meaningful moments with the flexibility of remote work. Since hybrid arrangements can vary based on the needs of the individual, team and business, your talent acquisition partner will provide specific hybrid details about this role. We are committed to fostering a healthy work-life balance and building meaningful connections, ensuring you have the tools, resources, and support needed to excel in any environment. Together, we’ll unlock your potential and create a lasting impact. While this is the current structure and we currently have no plans to change, we reserve the right to make changes to the hybrid schedule as needed at the Company’s discretion. Qualified candidates must be legally authorized to be employed in the United States. The company does not intend to provide sponsorship for employment visa status (e.g., H-1B, TN, etc.) for this employment position. What You Will Do: Rotational Training Key Elements: Complete immersive SWAP training program curriculum to increase knowledge about Allegion customers, products and processes. Participate and engage in various manufacturing trainings, product training and program events to deepen you understanding of Allegion systems, processes and customers. Immerse yourself in Allegion’s culture by attending networking and professional development events to gain valuable relationships throughout the organization. Learn and master Allegion’s state of the art tools, systems, and resources. Graduate from 9-month training program with in depth knowledge of role, best practices, policies, guidelines, and procedures to ensure best in class customer experiences. Full Time Role Responsibilities: Create technical hardware sets and specifications for the architectural community, including code compliance for new construction projects as well as aftermarket requests. Provide solutions to architects on product application requirements. Participate in pre and post installation meetings as needed and assist with revisions, access control coordination, and requests for information during all phases of the project. Exhibit a basic understanding of electro-mechanical products and solutions including access control and software. Communicate door hardware coordination requirements and/or conflicts, such as access control, electrical requirements, and specialty doors. Work in conjunction with Project Coordinator to provide a positive customer experience and deliver on project commitments. Maintain excellent industry/competitor product knowledge by reviewing and understanding market data of competitive activity. Adapt to changes in the marketplace. What You Need to Succeed: Associate’s or Bachelor’s degree in Construction, Architecture, or Technical field preferred Strong mechanical and electronics aptitude Excellent attention to detail with a high level of organization and time management skills Proficiency with MS Office tools Ability to learn industry specific software Exemplary verbal and written communication skills Ability to influence with actionable goals Why Work for Us? Allegion is a Great Place to Grow your Career if: You're seeking a rewarding opportunity that allows you to truly help others. With thousands of employees and customers around the world, there’s plenty of room to make an impact. As our values state, “this is your business, run with it”. You’re looking for a company that will invest in your professional development. As we grow, we want you to grow with us. You want a culture that promotes work-life balance. Our employees enjoy generous paid time off, because at Allegion we recognize that you have a full life outside of work! You want to work for an award-winning company that invests in its people. Allegion is proud to be a recipient of the Gallup Exceptional Workplace Award for the second year in a row, recognizing our commitment to employee engagement, strengths-based development, and unlocking human potential. What You’ll Get from Us: Health, dental and vision insurance coverage, helping you “be safe, be healthy” Unlimited Paid Time Off A commitment to your future with a 401K plan, which currently offers a 6% company match and no vesting period Health Savings Accounts – Tax-advantaged savings account used for healthcare expenses Flexible Spending Accounts – Tax-advantaged spending accounts for healthcare and/or dependent daycare expenses Disability Insurance –Short-Term and Long-Term coverage, paid for by Allegion, provides income replacement for illness or injury Life Insurance – Term life coverage with the option to purchase supplemental coverage Tuition Reimbursement Voluntary Wellness Program – Simply complete wellness activities and earn up to $2,000 in rewards Employee Discounts through Perks at Work Community involvement and opportunities to give back so you can “serve others, not yourself” Opportunities to leverage your unique strengths through CliftonStrengths assessment & coaching Compensation: This range is provided by Allegion. Your actual pay will be based on your skills and experience. The expected Total Compensation Range: $55,000-$65,000. The actual compensation will be determined based on experience and other factors permitted by law. Apply Today! Join our team of experts today and help us make tomorrow’s world a safer place! Not sure if your experience perfectly aligns with the role? Studies have shown that some people are less likely to apply to jobs unless they meet every single qualification and every single preferred qualification of a job posting. At Allegion, we are dedicated to building a diverse, inclusive, and authentic workplace. So, if you’re excited about this role but your past experience doesn’t align perfectly with every item in the job description, we encourage you to apply anyway. You may be just the right candidate for this role. #ALLEGION We Celebrate Who We Are! Allegion is committed to building and maintaining a diverse and inclusive workplace. Together, we embrace all differences and similarities among colleagues, as well as the differences and similarities within the relationships that we foster with customers, suppliers and the communities where we live and work. Whatever your background, experience, race, color, national origin, religion, age, gender, gender identity, disability status, sexual orientation, protected veteran status, or any other characteristic protected by law, we will make sure that you have every opportunity to impress us in your application and the opportunity to give your best at work, not because we’re required to, but because it’s the right thing to do. We are also committed to providing accommodations for persons with disabilities. If for any reason you cannot apply through our career site and require an accommodation or assistance, please contact our Talent Acquisition Team . © Allegion plc, 2023 | Block D, Iveagh Court, Harcourt Road, Dublin 2, Co. Dublin, Ireland REGISTERED IN IRELAND WITH LIMITED LIABILITY REGISTERED NUMBER 527370 Allegion is an equal opportunity and affirmative action employer

Posted today

Fulcrum Therapeutics logo
Fulcrum TherapeuticsCambridge, MA

$175,000 - $191,000 / year

Company Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is pociredir, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. The company’s proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. Description The Director, Head of Medical Writing, will report to the Head of Regulatory Affairs & Quality Assurance and collaborate cross-functionally with colleagues in Discovery, Clinical Development, Medical Affairs, and Regulatory. This individual will lead the development and delivery of a broad range of clinical and regulatory, documents to support the company’s drug development programs. Initially, this role will oversee an outsourced model for medical writing activities. Over time, the Director will be responsible for building and managing an internal medical writing team that is appropriately resourced to meet the evolving needs of the organization. The ideal candidate will combine hands-on writing expertise with strategic leadership to ensure timely delivery of high-quality documents. Responsibilities Strategic Leadership & Operational Execution Develop and implement a scalable, fit-for-purpose medical writing delivery model that balances internal and external resources Lead the planning, preparation, and review of high-quality clinical, regulatory, and publication documents in collaboration with cross-functional teams Ensure consistency, accuracy, and compliance with applicable regulatory and scientific guidelines and standards Serve as a subject matter expert in medical writing and provide direct writing support as needed Document Ownership Clinical Documents: Investigator Brochures Protocol Synopses, Protocols, and Amendments Informed Consent Forms Clinical Study Reports (CSRs), Safety Narratives Regulatory Documents: Annual Reports, Safety Updates Briefing Documents, Regulatory Correspondence Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs/sNDAs, MAAs Qualifications PhD in biological science is preferred Minimum of 10 years of medical writing experience in the biopharmaceutical industry or CRO setting Proven leadership experience managing teams of full-time employees and/or contractors Deep knowledge of GCP, ICH, and CFR regulatory requirements; familiarity with Health Canada, MHRA, PMDA, and EMA guidelines Proficiency in scientific literature research methods; familiarity with AMA, APA, CSE, and Chicago style guides Understanding of publication guidelines including GPP2, ICMJE, and CONSORT Strong technical proficiency with tools such as Adobe Acrobat Pro, Microsoft Office Suite (Word, Excel, PowerPoint, Teams, Project, SharePoint), and EndNote We offer a hybrid work model, with employees expected to be onsite at least 50% of the time. Base Salary Pay Range $175,000 — $191,000 USD

Posted 30+ days ago

Labelbox logo
LabelboxSan Francisco, California

$25 - $100 / hour

Generalist Writer- English (Contract) Labelbox Remote (United States preferred) Shape the data that powers frontier AI Quick facts - Engagement- Hourly, at‑will contractor - Schedule- Fully remote & asynchronous (min. 15 hrs/week) - Pay Range (US) - \$25 – \$100 per hour - Start Date- Rolling — staffed as projects launch What you’ll do - Educate AI: Review AI-generated written content across multiple genres and formats, providing feedback on clarity, organization, and effectiveness of communication - Problem Solving: Use your expertise to help AI reason through writing challenges, including argumentation, structure, tone, and audience engagement in diverse disciplines - Red Teaming: Identify biases, inaccuracies, or unclear passages in AI-generated outputs, and develop tests to ensure the AI produces high-quality, accurate, and well-communicated written work You’re a great fit if - Enrolled in or have completed a Bachelor's degree or higher from an accredited institution - Experience in professional, academic, or technical writing, editing, or related fields (required) - Strong ability to communicate ideas clearly, effectively, and with attention to detail across a variety of formats and subjects - Excellent command of English grammar, style, and tone, with a keen eye for accuracy and coherence - Comfortable providing constructive feedback and evaluating writing for clarity, organization, and impact - Bonus : Experience with data labeling, RLHF, or other AI training projects About the role - Flexible workload — work from anywhere, on your own schedule - High impact — your craft directly improves models used by top AI labs & Fortune 500 teams - Clear ownership — know exactly what success looks like and have autonomy to deliver - Growth potential — consistent high performers spearhead new programs and mentor incoming SMEs Interview process - Complete a screening with Zara , our AI interviewer in English, to learn more about your background and experience. - About Labelbox Labelbox builds the data engine that accelerates breakthrough AI. Our platform, expert services, and marketplace let teams iterate on data as nimbly as they iterate on code, enabling safer, smarter models in production. We’re backed by SoftBank, Andreessen Horowitz, B Capital, Gradient Ventures, Databricks Ventures, and Kleiner Perkins, and trusted by leading research labs and enterprises worldwide. Ready to Apply? Click “Apply” above! We review candidates on a rolling basis and will contact you if your background matches an active project. $20 - $40 an hour We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Posted 2 days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpAustin, TX
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 3 weeks ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpTexas, AL
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 3 weeks ago

Vertex Pharmaceuticals, Inc logo
Vertex Pharmaceuticals, IncBoston, MA

$137,600 - $206,400 / year

Job Description General Summary: The Business Engagement & Technology Principal Analyst will be a technical resource in ensuring delivery and support of commercial-off-the-shelf (COTS) and a wide range of custom solutions in support of their business partners. The Business Engagement & Technology Principal Analyst will partner with business leadership to deliver capabilities and execute on a roadmap that align to support business strategy in Clinical Operations and Medical Writing . Additionally, the Business Engagement & Technology Principal Analyst will maintain reliable, scalable and compliant systems that easily meet business needs by efficient delivery and enhancements that provides opportunities for developing and implementing innovative solutions and integrations. Key Duties and Responsibilities: Become a trusted partner of the business leaders within their remit Understand their needs and vision, and deliver technology solutions to support and enable their goals and objectives Provide insights on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives. Help refine and execute the technology strategy by leading the evaluation, selection, implementation, and ongoing maintenance of technology solutions. Develop and maintain a long term life cycle plan for the ongoing maintenance and management of systems. Manage relationships with our strategic software vendors and service providers Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements Serve as a liaison between GMDA and Data, Technology & Engineering (DTE) to ensure strategic alignment. Apply Agile, Lean, and design thinking methodologies to optimize solution delivery. Translate complex data into actionable insights and compelling business narratives. Monitor emerging technologies and trends to inform GMDA's digital strategy. Drive change enablement and foster a culture of agility and continuous improvement. Knowledge and Skills: In-depth knowledge in the core disciplines of project management, business analysis, solution design, delivery, and testing Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution Strong understanding of the business (Clinical Operations/Medical Writing), processes, and any appropriate regulatory environments Expertise in data analytics tools (e.g., Tableau, Power BI, SQL) and enterprise platforms in the Clinical Operations space (e.g., Veeva, Suvoda, Salesforce). Deep understanding of GMDA functions including clinical development, regulatory affairs, and medical affairs. Results oriented contributor with a proven track record of on-time project delivery for large, complex projects with global stakeholders Able to manage own workload with minimal direction Very strong written and verbal communication skills and strong ability to present complex or sensitive information in a clear and concise manner to various technical and non-technical audiences Exceptional analytical, quantitative, problem-solving, and prioritization skills Strong system life cycle expertise Good knowledge of running IT managed services or outsourced/ offshore teams Exceptional communication and stakeholder engagement skills. Very strong MS Office skills, including MS Project & Visio, Excel and PowerPoint experience Experience in Agile methodology Ability to influence strategic decisions and drive alignment across diverse teams. Education and Experience: Bachelor's degree in Information Technology, Business Administration, Life Sciences, or related field; advanced degree preferred. Minimum of 8 years of experience in business engagement, technology strategy, or data analytics within the pharmaceutical or biotechnology industry. PMP or equivalent project management certification preferred. Experience with AI/ML applications and digital transformation initiatives is a plus. Pay Range: $137,600 - $206,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 4 weeks ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpPhoenix, AZ

$106,000 - $149,000 / year

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science What else we look for (preferred): Preferred Hybrid On Site in Irvine, Ca Advanced degree (Master's, PHD, Pharm D) Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpTexas, AL
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 3 weeks ago

Ivy Tech Community College logo
Ivy Tech Community CollegeIndianapolis, IN

$18+ / hour

Job Title: Part-Time ESOL Writing Tutor Location: Downtown Indy Campus Job Type: Part-Time Schedule / Hours: 18-20 hours per week, including evenings and weekends as needed Classification: Part- Time Salary Range: $18.00/hourly Reports To: Writing Center Assistant Director Who 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 endorsement or 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 30+ days ago

American University logo
American UniversityWashington, DC
American University is a student-centered research institution located in Washington, DC, with highly-ranked schools and colleges, internationally-renowned faculty, and a reputation for creating meaningful change in the world. Learn more about American University Department: College of Arts & Sciences Time Type: Part time Job Description: This is an open continuous vacancy announcement that will be used to fill adjunct vacancies as they occur. Until you hear from a representative of the Department of Literature, the Writing Studies Program, or the Office of HR Faculty, please continue to also apply directly to other positions posted on AU's website. The Department of Literature and the Writing Studies Program in the College of Arts and Sciences at American University invites applications for a number of adjunct faculty positions, including College Writing positions, for upcoming Academic Years. Rank will depend on an applicant's highest degree earned in Literature or Composition. The applications will be reviewed on a rolling basis. The Department of Literature offers both undergraduate and graduate degree programs. The Department is organized under the College of Arts and Sciences, which is where scholarship in the Arts, Humanities, and Sciences is pursued. Learn more about the College of Arts and Sciences at https://www.american.edu/cas/ and the Department of Literature at https://www.american.edu/cas/literature/ . The Department of Literature in the College of Arts and Sciences has the following adjunct salary ranges: Candidates Without a Terminal Degree In Course Subject Area 1-2 Credit Course: $2,865 3-4 Credit Course: $4,725 5-6 Credit Course: $4,938 Candidates With a Terminal Degree In Course Subject Area 1-2 Credit Course: $3,414 3-4 Credit Course: $5,400 5-6 Credit Course: $5,548 Benefits AU offers a competitive benefits package including a 200% matching retirement plan, tuition benefits for full-time staff and their families, several leadership development certificates, and has been recognized by the American Heart Association as a fit-friendly worksite. Click here to learn about American University's unique benefit options. Other Details Hiring offers for this position are contingent on successful completion of a background check. Employees in staff positions at American University must deliver their services to the university from either the District of Columbia, Maryland, or Virginia, or perform work on-site at the university. Please note this job announcement is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. American University is an E-Verify employer. Current American University Employees American University current employees must apply through their employee Workday account. If you are a current employee at American University, please log into Workday and select the Find Jobs report which will take you to our internal career listings. Contact Us For more information or assistance with the American University careers site, email theworkline@american.edu. American University is an equal opportunity, affirmative action institution that operates in compliance with applicable laws and regulations. The university does not discriminate on the basis of race, color, national origin, religion, sex (including pregnancy), age, sexual orientation, disability, marital status, personal appearance, gender identity and expression, family responsibilities, political affiliation, source of income, veteran status, an individual's genetic information or any other bases under federal or local laws (collectively "Protected Bases") in its programs and activities.

Posted 30+ days ago

Edwards Lifesciences Corp logo
Edwards Lifesciences CorpRiverside, CA
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Act as primary contact for medical writing projects, working with other cross-functional Edwards departments and clients to set and meet internal and external deliverable timelines. Develop complex medical writing documents/deliverables such as clinical evaluation plans/report, post-market clinical follow-up plans/reports, and Summary of safety and clinical performance documents in a fast paced environment. Serve as the lead for negotiating deliverables, timelines, and resolving project-related issues in collaboration with cross-functional stakeholders Conduct literature searches and reviews, including developing search strategy, managing associated documentation, extracting relevant data, writing clear and concise summaries of the data to support the development of clinical evaluation reports. Act as representative in core team meetings in the development of regulatory submissions for EU Provide leadership, training, and guidance and act as a mentor to less experienced medical writers. Identify, recommend, and assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties assigned by Leadership What you'll need (Required): Bachelor's Degree in in related field, with 5 years experience of previous related experience in medical writing or equivalent work experience based on Edwards criteria Required What else we look for (Preferred): Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel Experienced with literature reviews and various publication databases including PubMed and Embase Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Excellent written and verbal communication skills including customer negotiating and relationship management skills Excellent problem-solving, organizational, analytical and critical thinking skills Full knowledge and understanding of policies, procedures and guidelines related to the development of scientific content Full knowledge of medical writing Good leadership skills and ability to influence change Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Posted 3 weeks ago

Johnson & Johnson logo
Johnson & JohnsonRaritan, NJ

$160,000 - $276,000 / year

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

Posted 3 weeks ago

Hartwick College logo
Hartwick CollegeOneonta, NY
College Writing Program - Adjunct (Pool) Hartwick College is accepting applications on a continuing basis for instructors who are qualified to teach ENGL 110 College Writing. Qualifications include a master’s degree (or higher) in English, rhetoric, composition, or related fields and demonstrated experience teaching first-year writing. This pool will be utilized on an as-needed basis, should an opportunity arise, and applications submitted will remain active for up to two years. An independent, residential liberal arts college enrolling approximately 1,100 full-time undergraduates, Hartwick embraces the teacher-scholar model, with teaching excellence as the first priority, and seeks to recruit, retain and promote a diverse workforce. Hartwick operates as a community of learners where there is a very real sense of belonging and connection.  By joining Hartwick, you become part of a group of people who work together, share in our successes, and celebrate our accomplishments.  All positions at Hartwick contribute to the education and development of students with the opportunity to see the impact on future leaders – what you do at Hartwick really matters.  Hartwick College is an Equal Opportunity Employer, committed to broadening “the understanding, awareness, and appreciation of diversity among all members of the Hartwick community.” Women, minorities, and other underrepresented groups are especially encouraged to apply. Interested applicants are invited to submit a current curriculum vitae and introductory cover letter via the following link:  https://hartwickcollege.applytojob.com/apply/6kQuMKHH3y/College-Writing-Program-Adjunct-Pool Salary Range: $830-1,100 per credit Powered by JazzHR

Posted 30+ days ago

A logo
accentedge, LLCChicago, IL
About accentedge At accentedge, we are committed to developing AI-driven solutions that empower businesses and transform industries. As we continue expanding, we are looking for a Generative AI Technical Writing/Training Specialist who can bridge the gap between complex AI technologies and their end users through clear, engaging, and accessible documentation and training resources. Role Overview The Generative AI Technical Writing/Training Specialist will be responsible for simplifying technical details about generative AI utilities, tools, and workflows into comprehensible documentation and training materials. This role requires exceptional communication skills, creativity, and technical understanding to educate internal teams and clients effectively. Key Responsibilities Convey complex technical processes of AI solutions in simple, clear terms to various audiences (technical and non-technical personnel). Develop comprehensive user guides, technical documentation, and training materials for generative AI systems and utilities. Leverage multiple media formats—visuals, audio, and text—to create engaging documentation and educational resources. Collaborate with developers, engineers, and subject matter experts to gather insights and ensure accuracy in documentation. Train internal teams and external stakeholders on the use, integration, and optimization of generative AI solutions. Create FAQs, troubleshooting guides, and other resources to support end users. Continuously update and refine documentation based on feedback, product updates, and evolving AI systems. Organize and facilitate workshops, webinars, and training sessions to enhance adoption and understanding of AI tools. Ensure all documentation aligns with company branding, tone, and accessibility standards. Requirements Proven experience in technical writing and developing documentation for AI, machine learning, or software systems. Ability to simplify complex technical information into easily digestible materials for a wide audience. Excellent verbal and written communication skills with a strong focus on clarity and accuracy. Proficiency in tools for content creation such as Markdown, Microsoft Office Suite, Adobe Creative Cloud, or similar platforms. Familiarity with AI/ML concepts, particularly generative AI models, utilities, and applications. Experience creating materials in multiple media formats: visual guides, audio content, videos, and written documentation. Strong organizational and project management skills. Ability to facilitate training sessions, workshops, and webinars effectively. Preferred Qualifications Bachelor’s degree in Technical Writing, Communications, Computer Science, AI, or a related field. Experience with AI tools like GPT, LLMs, or other generative AI utilities. Experience with LMS platforms for delivering training content. Knowledge of visual storytelling tools such as Figma, Canva, or Articulate for training design. Familiarity with Agile workflows and version control systems like Git. Benefits What accentedge Offers Competitive salary and a comprehensive benefits package. A dynamic and collaborative work environment in downtown Chicago. Hybrid work options to balance flexibility and productivity. Opportunities for career growth and professional development. The chance to work with innovative technologies and passionate AI experts. Ready to Make AI Accessible? If you have a passion for transforming complex AI concepts into clear and actionable resources, we invite you to apply and join accentedge. Apply now and help us empower teams to embrace AI solutions with confidence and clarity!

Posted 30+ days ago

Vertex Pharmaceuticals logo

Medical Writing Manager (Hybrid)

Vertex PharmaceuticalsBoston, Massachusetts

$120,200 - $180,400 / year

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Job Description

Job Description

General Summary:

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

Key Duties and Responsibilities:

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

Knowledge and Skills:

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

Education and Experience:

  • Ph.D. (or equivalent degree)
  • Typically requires 4 years of experience or the equivalent combination of education and experience

#LI-AR!

#LI-Hybrid

Pay Range:

$120,200 - $180,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as: 1.    Hybrid: work remotely up to two days per week; or select2.    On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. 

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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