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Summary: The Department of Writing at Grand Valley State University invites applications for two Affiliate Faculty of Writing positions to begin Fall 2026. Applicants are expected to have an M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing or a closely related field. Candidates should have expertise and experience in teaching college composition to students from diverse backgrounds. Individuals from all backgrounds, including from underrepresented groups, are encouraged to apply. Successful candidates must be able to effectively engage with students, colleagues, and community members with a broad range of backgrounds and experiences. Required Qualifications and Education: M.A., M.S., M.F.A., or PhD in English, Rhetoric/Composition, Writing, or a closely related field. Experience and expertise in teaching college composition. Strong communication and interpersonal skills, such as the ability to interact with others with respect and cultural humility. Preferred Qualifications and Education: Graduate coursework in rhetoric and composition or its professional equivalent. Experience in or demonstrated commitment to inclusive pedagogical practices. Experience teaching with a range of technological tools to foster students’ digital literacy skills. Responsibilities: The ideal candidate will focus their career on teaching general education first-year writing courses and on continuously developing their professional expertise as a writing instructor. Affiliate Faculty are full-time, teaching faculty with a typical full-time (9-month) teaching load of 12 credit hours per semester, drawn from GVSU's general education writing courses. The position is not tenure track, and there are no scholarship expectations or service obligations. Individuals will be appointed for one academic year on a full-time basis. This may be renewed once for an additional academic year. Thereafter, such individuals may be appointed for three (3) consecutive academic years . Minimum Starting Salary: $51,000; commensurate with experience. Benefits: Affiliate Faculty at GVSU are offered a comprehensive benefits package including medical, vision, dental, life insurance, generous employer retirement contributions, wellness resources and tuition waiver effective on date of hire. Department: The Department of Writing emphasizes teaching excellence using inclusive writing pedagogies. Full-time faculty uphold the values of a liberal arts education while providing a collaborative, experiential learning environment within writing studies. In addition to offering general education courses in first-year writing, creative writing, and professional communication, the department provides a unique 42-credit modular curriculum for students seeking a B.A. or B.S. in writing. College: The College of Liberal Arts and Sciences (CLAS) is the largest college at Grand Valley, offering over 50 bachelor’s degrees and a growing number of advanced degrees in the natural and mathematical sciences, the fine arts and humanities, and the social sciences. CLAS is a student-centered learning community that welcomes individuals from various backgrounds and engages in critical inquiry, extending knowledge to enrich and enliven individual and public life. Our faculty are active teacher-scholars committed to offering students an accessible and community-engaged liberal arts and sciences education that prepares them for meaningful careers. There are many opportunities for collaboration within CLAS and across a broad group of partners on and off campus. We are interested in attracting a cohort of new faculty committed to these core values as we seek to foster a community where members from all backgrounds can live, learn, and thrive together. University: Grand Valley State University (GVSU) is a public comprehensive institution located in West Michigan with campuses in Allendale, downtown Grand Rapids, and Holland, plus centers in Detroit, Muskegon and Traverse City. The University attracts more than 22,000 undergraduate and graduate students with high quality programs and state-of-the-art facilities and has been nationally recognized for innovativeness and its contribution to students’ social mobility. The greater Grand Rapids metropolitan area has a population of around one million people, is affordable, and offers rich cultural amenities. Grand Valley is located within easy driving distance of Chicago, Detroit, Lake Michigan beaches, and many other superb summer and winter recreational venues. Information can be found at the Community Resources page on Grand Valley State University Human Resources website . How To Apply: Apply online at GVSU Careers . To be considered for the position, applicants must upload the following items to the online application: A cover letter addressing qualifications and your motivation to teach at GVSU Curriculum vitae Teaching philosophy statement Graduate transcripts (unofficial transcripts issued to students are acceptable) The online application will allow you to attach these documents electronically, in the same file location . Applicants selected for interviews will be required to submit official transcripts prior to the interview. If you need technical assistance, email Human Resources (hro@gvsu.edu) . Questions about the position may be directed to Department of Writing Chair, Amy Ferdinandt Stolley, at stolleam@gvsu.edu. Application Deadline: Consideration of applicants will begin on Monday, November 10, 2025. The posting may be closed at any time at the discretion of the University thereafter. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Must have the physical stamina to work long hours and/or more than 5 days per week. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The information contained in this job description is for compliance with the Americans with Disabilities Act as amended by the ADA Amendment Act (2008), Section 504 of the Rehabilitation Act of 1973, and other applicable federal and state laws that prohibit discrimination on the basis of disability. GVSU will provide reasonable accommodations to qualified individuals with disabilities upon request. See www.gvsu.edu/equalopportunity/ . TDD Callers: Call Michigan Relay Center at 711 (in State) or 1-800-833-7833 (out of State). Grand Valley State University is an Antidiscrimination/Equal Opportunity Employer, which includes providing equal opportunity for protected veterans and individuals with disabilities. University policy extends protections to additional identities.

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

Job Description Kickstart Your Career at Vertex! Are you ready to make a real impact? At Vertex, our mission is to tackle serious diseases and to change lives, for the better, for the future. Our aim is to give you the skills, insights, and career guidance to be an important part of that future; to turn your potential into progression. As a Vertex intern or co-op, you’ll work on meaningful projects, collaborate with talented teams, and learn from industry leaders. We’re passionate about innovation, inclusion, and supporting your growth—inside and outside the lab. Why Vertex? Real Projects: You’ll work on assignments that make a real impact, not just busy work. Mentorship & Networking: Connect with leaders and peers who want to see you succeed through professional networks, connections, and collaborations that will shape your longer-term career. Flexible & Supportive: We offer flexible work options with Flex @ Vertex and prioritize your wellbeing. Inclusive Culture: Collaboration and inclusion are embedded in everything we do. Career Launchpad: Build skills, explore career paths, and get guidance for your future career. Ready to apply? Submit your application and let’s turn possibilities into reality! Your Impact The Vertex Corporate Communications Scientific Writing Co-Op program is a 6-month experiential training program for students currently working towards undergraduate or advanced degree in Journalism, Communications, Marketing, or other related fields. If you are passionate, collaborative, and growth-minded, a co-op at Vertex will help you gain meaningful experience in our communications functional areas and serve as a launchpad for your career. Please note that Vertex reviews applications on a rolling basis and reserves the right to close this job posting prior to the listed deadline. Important Notice Regarding Internship and Co-op Inquiries At Vertex Pharmaceuticals, we are committed to providing a fair and structured recruitment process for all students interested in internship and co-op opportunities. To ensure consistency and equity, all student applications must go through our Early Talent Acquisition Team. Due to the high volume of interest, we are unable to respond to individual solicitation. Direct solicitation to Vertex employees- including senior leaders via email will result in removal from the recruiting process. We appreciate your enthusiasm and interest in Vertex. To be considered for internship or co-op roles, please apply directly through our official application channels. ( https://www.vrtx.com/careers/career-growth-and-opportunities/co-ops/ ) Thank you for respecting our process and helping us maintain a fair experience for all candidates. What you will be doing: The Co-op Corporate Communications - Scientific Writing and Disease Area Communications will gain valuable experience through supporting, and in some cases leading, several important communications projects across the disease areas in our research pipeline at Vertex. In pipeline communications, we work across the company to create both internal and external content about our disease and program areas, program announcements and research at Vertex. The selected candidate will work closely with project leads and other cross-functional team members on several defined projects, as well as provide general day-to-day support as needed. Potential duties will include: Writing and production of pipeline-related content for our employee intranet by researching, writing and packaging articles, patient and employee stories and multimedia content. Supporting disease affinity recognition throughout the year by writing internal and external content to educate our audiences and raise awareness for a given disease area Supporting the team and business partners by helping create and execute on communications plans for pipeline announcements and content campaigns (such as launching a video series) Supporting pipeline social media content channels with copy for disease recognition and pipeline-related conferences Compile metrics from communications campaigns and provide insight to help guide creation of strategy and planning for future initiatives. Provide support for ongoing communications initiatives and ad hoc projects, as needed What you will need to succeed: Enrolled in an undergraduate or graduate program in a Scientific Field, Journalism, Communications, Marketing, or another related field Outstanding written and verbal communication skills with excellent attention to detail Ability to succeed in a fast-paced environment with multiple, competing priorities Understanding of the scientific method and scientific concepts Prior internship experience in the medical/pharmaceutical/biotechnology industry, or in communications Ability to deliver results with limited direction and guidance on tight deadlines -- a self-starter Highly motivated and energetic Strong work ethic and tenacity Legal authorization to work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization. You must be enrolled in an advanced degree program if graduating before June 2026 You must be available to work full-time, 40 hours per week from January – June 2026 Program Details: Full-time, paid co-op $20.00 – 35.00 USD/hour Program Dates: January – June 2026 At Vertex, we believe that when you feel your best, you can perform at your best. That’s why our US benefits and global well-being resources are designed to support you. Free 24/7 onsite gym access and free access to group exercise classes Subsidized commuter benefits- transit and parking Provided meals—free breakfast daily! Career development opportunities and events, including C Suite engagement Social events—both intern-only and company-wide Location-specific perks and extras! Recognition of National Intern Day Our Ways of Working 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. Equal Opportunities 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. Vertex is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accessibility & Accommodations We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Vertex is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role, Vertex is unable to sponsor non-U.S. persons to apply for an export control license. This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. Pay Range: $0 - $0 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. 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

Join ourcommunityand experienceEmerson College! The Department of Writing, Literature, and Publishing is a vibrant and engaged community of writers, scholars, publishers, and designers. The department has over 120 full- and part-time faculty members, nearly 500 undergraduate majors, and over 330 graduate students in the Creative Writing MFA program, the online MFA program in Popular Writing and Publishing, and the Publishing MA program. Responsibilities: Teach assigned courses and/or duties as specified in the schedule and contract Select texts and instructional materials; prepare course materials and lesson plans Provide students an approved syllabus that includes course description, learning objectives, course calendar, course requirements, texts, and other materials, grading policy and the required accessibility and plagiarism statements Be available for student consultation through office hours or scheduled appointments or by phone or email Maintain records of enrollment and attendance, assessments and grades, submit class rosters and grades online by the deadlines established by the College Upload your CV.

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 the discipline area of expertise. Duties include assisting students with coursework, 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 environments. 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 discipline to Tutor Writing: Business Communication Language Arts English Composition 1 &2 Fundamentals of Speech Communication (SPC1017) Reading & Writing for all disciplines All Levels of EAP (English for Academic Purposes) -TESOL Studies Skills (SLS1501) C ollege 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 Knowledge of: Microsoft Office Professional or similar application Content within the tutoring discipline Skilled in: Delivering a high level of customer service Ability to: Ability to convey knowledge of the 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 Licenses, Registration, Certifications, or Special Requirements: Regular physical attendance required Preferred Qualifications : Knowledge of: 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 Identify and distinguish colors and shades of color Communicate information orally and in writing Receive and understand information through oral and written communication Proofread and check documents for accuracy Operate a motor vehicle 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

We are a growing information technology company that offers its employees a culture of success, the chance to work on revolutionary federal IT infrastructure, and the opportunity to grow alongside cutting-edge technology that is reshaping the industry. We are seeking forward thinking candidates that have strong experience in operational support and can help take to the next level in a pro-active stance. Chameleon Integrated Services has expertise in operations management, quality systems, data operations and cybersecurity. We secure some of the most sensitive data for the Department of Defense and for other U. S. federal government agencies. We are known for the great care we take with clients and employees, and we believe in promoting from within. We offer a Full Benefits package including: Competitive Employee Health Insurance options including dental 100% company paid vision plan 401K plan with generous company match and no vesting period 100% company paid Life insurance 100% company paid long and short-term disability insurance Training allowance PTO and more The Position : Chameleon Integrated Services is currently looking for a Military Writing Specialist to support one of our clients in St. Louis, MO. Overview: As a Military Writing Specialist or Expert, you will be responsible for producing and grading written content that will train AI models for government use-cases.This is an exciting opportunity to help shape the future of AI-powered writing for the U.S. government! Responsibilities: Train AI models by crafting and answering questions related to intelligence, operations, logistics, or other similar military disciplines and domains Leverage your domain expertise to evaluate and critique corpuses of text produced and written by AI systems Attend regular training sessions for upskilling and quality alignment on writing projects Integrate feedback from expert instructors into your written work Education & Experience 5 years’ minimum experience in military occupation specialties related to planning, logistics, orintelligence Experience writing professionally using military and formal Department of Defense writing styles The Location: St. Louis, MO 63103 “ " We are an equal opportunity employer and all Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status” “We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status” Texting Privacy Policy Message type: Informational; you will receive text messages regarding your application and potentially regarding interview scheduling. No mobile information will be shared with third parties/affiliates for marketing/promotional purposes. Message frequency will vary depending on the application process.Msg & data rates may apply. OPT out at any time by texting "Stop". Powered by JazzHR

Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation. Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs. Description of Role We are seeking an experienced and strategic professional to lead the operational medical writing initiatives across our research and development portfolio. Reporting to the Senior Vice President of Regulatory and Medical Writing, this role combines hands-on medical writing expertise with project management leadership. The Director, Medical Writing Operations will serve as the central point of contact for internal teams and external vendors to ensure consistency, quality, and timely delivery of medical writing outputs while helping to shape the future of our medical writing function. This position is ideal for a strategic, hands-on professional ready to drive quality, consistency, and operational excellence in a fast-paced environment. Key Responsibilities Project Management and Vendor oversight (75%) Serve as the primary point of contact for external medical writing vendors ensuring alignment with company standards, timelines, and expectations, and supporting effective collaboration among writers and reviewers. Lead and coordinate medical writing activities across internal SMEs, programs, and external partners, ensuring deliverables are linked to program strategy and remain on track. Manage resource planning, including estimating costs and timelines for document preparation. Partner with internal stakeholders to ensure deliverables are on track. Ensure medical writing deliverables are scientifically sound, well-organized, and compliant with regulatory and company standards by managing SME contributions and maintaining consistency, accuracy, and quality in a fast-paced, deadline-driven environment. Attend clinical study teams, providing strategic input and resolving resource or timeline issues as needed. Develop, manage, and continuously improve medical writing procedures, SOPs, and quality frameworks; proactively lead process and system improvements to enhance efficiency and effectiveness within the Centessa medical writing model. Authorship (15%) Review, edit, and ensure the quality, accuracy, and consistency of documents authored by other writers (functional area representatives, or agency or contractors) as required, maintaining compliance with GCP, ICH, eCTD, and company guidelines. Provide hands-on support to internal teams by assisting with protocol amendments, clinician responses, and ensuring clarity, consistency, and proper formatting of documents. Drive continuous improvement by leveraging industry knowledge to implement new templates, technologies, and processes that enhance medical writing efficiency and effectiveness. Author medical writing content, ensuring alignment with company standards, SOPs, style guides, templates, and lexicons. Strategic Planning (5%) Building consistent processes to optimize utilization of resources aligned with company priorities. Contribute to long-term planning for potentially transitioning medical writing in-house. Qualifications PhD or advanced degree in a scientific or clinical discipline. 10+ years of medical writing or relevant pharmaceutical industry experience, including at least 5 years in sponsor-level clinical/regulatory medical writing. Previous neuroscience experience is strongly preferred. Experience developing and managing project/program teams; demonstrated ability to lead and motivate cross-functional teams. Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines. Solid understanding of drug development, biostatistics, pharmacokinetics, and medical terminology; basic understanding of scientific methodology as applied to drug development. Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations. Proficiency in Microsoft Word (advanced features) and familiarity with document management and collaborative authoring platforms (e.g., Veeva Vault, Please Review). Experience managing external medical writing vendors and resolving conflicting editorial feedback. Able to work independently and collaboratively in a dynamic, fast paced, cross-functional environment. Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges. Compensation The annual base salary range for this position is $190,000 to $250,000. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, and job knowledge. In addition to base pay, this role is eligible for a discretionary annual bonus and participation in our equity program, allowing you to share in Centessa's long-term success. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program. Work Location The Director, Medical Writing Operations role is a remote role based in the US, with occasional travel. POSITION: Full-Time, Exempt EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.

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

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: Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Copy Editing, Cross-Functional Collaboration, Developing Others, Inclusive Leadership, Industry Analysis, Leadership, Medical Affairs, Medical Communications, Performance Measurement, Quality Validation, Standard Operating Procedure (SOP), Succession Planning, Tactical Planning 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

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.

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Director, Medical Writing will collaborate with colleagues to write and/or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management Mentor and support direct reports in the development of their skills and careers Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, and other regulatory submissions as needed Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables Maintain subject area expertise related to the company's investigational products, disease indications, and regulatory and publication guidelines Perform miscellaneous job-related duties and additional duties and responsibilities as needed Preferred Skills, Qualifications and Technical Proficiencies: Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas Excellent attention to detail, multitasking, prioritization, and flexibility Excellent communication skills with proven ability to interact in a cross-functional environment Understanding of the drug-development process, including research and development processes and objectives and the required documents Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint) Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision Ability to think strategically, be resourceful, and lead without formal authority Preferred Education and Experience: BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $172,300 - $253,300; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: https://www.corcept.com/ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

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.

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: 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

Medica is a nonprofit health plan with more than a million members that serves communities in Minnesota, Nebraska, Wisconsin, Missouri, and beyond. We deliver personalized health care experiences and partner closely with providers to ensure members are genuinely cared for. We're a team that owns our work with accountability, makes data-driven decisions, embraces continuous learning, and celebrates collaboration - because success is a team sport. It's our mission to be there in the moments that matter most for our members and employees. Join us in creating a community of connected care, where coordinated, quality service is the norm and every member feels valued. The Manager, Proposal Development and Management is responsible for leading the creation of high-quality, persuasive, and professional proposal materials that support Medica's business growth, client retention, and brand credibility. This role oversees a team of communication professionals and plays a key part in shaping proposal strategy, content development, and execution to align with Medica's product and service offerings. Perform other duties as assigned. Key Accountabilities Lead the strategy and execution of RFP communications that enhance Medica's reputation as a trusted health plan Ensure the team responds accurately and timely to RFPs/RFIs/Questionnaires. Collaborate and build strong relationships with internal stakeholders and subject matter experts to write compelling and thorough proposal content Forecast RFP volume and develop resourcing plans to support team capacity. Manage the RFP content library including annual review and consolidation of content and management of technology vendor. Maintain the proposal database to provide weekly dashboard reporting on RFP tracking and status to stakeholders. Lead and develop a team of 12-18 The successful candidate will demonstrate strong leadership in managing a high-performing RFP response team, while exhibiting exceptional writing and editing skills with a focus on clarity, accuracy, and brand alignment. They will proactively develop and maintain proposal content and tools, effectively manage multiple projects and shifting priorities in a fast-paced environment and communicate confidently with executives and cross-functional teams. Required Qualifications Bachelor's degree in business, Communications, English, Marketing, Journalism or equivalent experience in related field 4 years of related experience beyond degree in the health insurance, HMO, or health care industry Writing portfolio for review Strongly Preferred Qualifications Experience managing proposal teams and developing strategic communications Familiarity with proposal automation tools such as RFP360 and RFPIO Proven ability to build and maintain relationships with internal stakeholders Experience in developing sales and business presentations for executive audiences Skills and Abilities Strong business leadership combined with proposal writing expertise Excellent written and verbal communication with attention to grammar and detail Advanced proficiency in MS Word, Excel, PowerPoint, and proposal automation tools Strong project management skills and ability to manage multiple priorities Exceptional interpersonal and relationship-building skills Ability to align content with brand standards and corporate identity This position is an Office role, which requires an employee to work onsite, on average, 3 days per week. We are open to candidates located near one of the following office locations: Minnetonka, MN, Madison, WI, Omaha, NE, or St. Louis, MO. The full salary grade for this position is $87,100 - $149,300. While the full salary grade is provided, the typical hiring salary range for this role is expected to be between $87,100 - $130,620. Annual salary range placement will depend on a variety of factors including, but not limited to, education, work experience, applicable certifications and/or licensure, the position's scope and responsibility, internal pay equity and external market salary data. In addition to base compensation, this position may be eligible for incentive plan compensation in addition to base salary. Medica offers a generous total rewards package that includes competitive medical, dental, vision, PTO, Holidays, paid volunteer time off, 401K contributions, caregiver services and many other benefits to support our employees. The compensation and benefits information is provided as of the date of this posting. Medica's compensation and benefits are subject to change at any time, with or without notice, subject to applicable law. Eligibility to work in the US: Medica does not offer work visa sponsorship for this role. All candidates must be legally authorized to work in the United States at the time of application. Employment is contingent on verification of identity and eligibility to work in the United States. We are an Equal Opportunity employer, where all qualified candidates receive consideration for employment indiscriminate of race, religion, ethnicity, national origin, citizenship, gender, gender identity, sexual orientation, age, veteran status, disability, genetic information, or any other protected characteristic.

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 Privacy Policy

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.

The Suffolk University McNair Scholars Program invites applications for a Verbal Reasoning and Analytical Writing for Spring 2026. This position is designed to strengthen scholars' academic skills for success in graduate-level study. In accordance with 34 CFR § 647.30(a), this time-limited role constitutes "activities of an academic or scholarly nature … which have as their purpose the encouragement and preparation of project participants for doctoral studies." The McNair Scholars program supports first-generation and income-eligible college students who have demonstrated a commitment to preparing for and pursuing research doctorates. Appointment: February - March/April 2026 (8 weeks) Schedule: ~2-hour, in-person, class session per week; evenings, class time to be determined in conjunction with McNair program director; no classes week of March 9th due to Spring Break Type: Time-limited, seasonal instructor Pay: $3,000, flat-rate, per course, paid bi-weekly in accordance with the University pay schedule This position is grant funded by the U.S. Department of Education's McNair Scholars Program Award # P217A220037 at Suffolk University Responsibilities The Verbal Reasoning and Analytical Writing instructor will lead an eight-week, in-person, academic class series that strengthens advanced reading comprehension, critical reasoning, and written argumentation for graduate study. Core Topics may include: Reading comprehension and evidence-based analysis of complex texts Vocabulary in context and verbal inference Logical reasoning and argument evaluation Analytical writing: structure, argumentation, and clarity The Verbal Reasoning and Analytical Writing Instructor will be expected to: Design and facilitate weekly two-hour classes emphasizing conceptual understanding and applied reasoning. Integrate analytical exercises that mirror graduate-level expectations without functioning as commercial test-preparation instruction. Connect quantitative reasoning to research design, data analysis, and doctoral-level inquiry. Provide brief formative assessments and individualized feedback to track progress. Offer limited individual or small-group tutoring sessions, by appointment, to reinforce class material and address specific learning needs. Coordinate with McNair staff on instructional planning, attendance documentation, and content summaries for grant reporting. Combined Appointment Option The McNair Program is looking for instructors in both quantitative reasoning and verbal and analytical-writing instruction. Applicants with demonstrated expertise in both quantitative reasoning and verbal or analytical-writing instruction may be considered for appointment to both instructional tracks during the same spring term. If you are interested in being considered for both, you may submit all materials to the one job posting that would be your preferred subject, but please make your interest and qualifications for both positions explicit in your cover letter. Qualifications Bachelor's degree required; master's degree or higher preferred in a relevant discipline Demonstrated experience teaching or tutoring college-level students in the relevant content area. Proven ability to design engaging, scaffolded instruction that develops academic and analytical skills necessary for graduate study. Commitment to equity-minded pedagogy and mentorship of first-generation and low-income scholars. Familiarity with graduate-level academic expectations preferred. Familiarity with and/or working with federal TRIO program populations preferred a complete submission includes the following components: (1) CV/Resume; (2) Cover Letter detailing the rationale for applying to the role and relevant qualifications; (3) Recent Teaching Evaluations (if available). Applications without cover letters will NOT be considered. If candidate is a finalist, three professional references will be required before a final offer is made. Review of applications will begin immediately. Salary: $3,000.00 per course

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

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.