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CytokineticsRadnor, Pennsylvania
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator’s brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals. The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed. Responsibilities Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed. If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy. May oversee additional writing and QC work performed by the vendors. For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval. Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively (e.g. comments and questions arising from the writing/review process). Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment. Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents. Develop and drive timelines, and communicate writing process and timelines to team members. Provide status/updates of Regulatory Writing deliverables to management. Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams. May contribute content to safety documents (e.g., DSURs, RMPs). May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices. Comply with established company policies and procedures, and industry and regulatory guidelines. Other duties as assigned. Qualifications BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation. Excellent communication skills both orally and in writing. Ability to work both independently and in cross-functional team environments with minimal supervision. Demonstrated ability to lead development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents. Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. Strong attention to detail with the ability to effectively write/summarize science-and data-driven content into clear, concise, and complete documents. Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively. Ability to work effectively in a fast-paced environment with multiple high-priority projects. Ability to oversee consultants/contractors and serve as a liaison for project purposes. Excellent Project management skills. Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP). #LI-HYBRID Pay Range: Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer
Posted 1 week ago
Hartwick CollegeOneonta, NY
College Writing Program - Adjunct (Pool) Hartwick College is accepting applications on a continuing basis for instructors who are qualified to teach ENGL 110 College Writing. Qualifications include a master's degree (or higher) in English, rhetoric, composition, or related fields and demonstrated experience teaching first-year writing. This pool will be utilized on an as-needed basis, should an opportunity arise, and applications submitted will remain active for up to two years. An independent, residential liberal arts college enrolling approximately 1,100 full-time undergraduates, Hartwick embraces the teacher-scholar model, with teaching excellence as the first priority, and seeks to recruit, retain and promote a diverse workforce. Hartwick operates as a community of learners where there is a very real sense of belonging and connection. By joining Hartwick, you become part of a group of people who work together, share in our successes, and celebrate our accomplishments. All positions at Hartwick contribute to the education and development of students with the opportunity to see the impact on future leaders - what you do at Hartwick really matters. Hartwick College is an Equal Opportunity Employer, committed to broadening "the understanding, awareness, and appreciation of diversity among all members of the Hartwick community." Women, minorities, and other underrepresented groups are especially encouraged to apply. Interested applicants are invited to submit a current curriculum vitae and introductory cover letter via the following link: https://hartwickcollege.applytojob.com/apply/6kQuMKHH3y/College-Writing-Program-Adjunct-Pool Salary Range: $830-1,100 per credit
Posted 30+ days ago
American UniversityWashington, DC
American University is a student-centered research institution located in Washington, DC, with highly-ranked schools and colleges, internationally-renowned faculty, and a reputation for creating meaningful change in the world. Learn more about American University Department: College of Arts & Sciences Time Type: Part time Job Description: This is an open continuous vacancy announcement that will be used to fill adjunct vacancies as they occur. Until you hear from a representative of the Department of Literature, the Writing Studies Program, or the Office of HR Faculty, please continue to also apply directly to other positions posted on AU's website. The Department of Literature and the Writing Studies Program in the College of Arts and Sciences at American University invites applications for a number of adjunct faculty positions, including College Writing positions, for upcoming Academic Years. Rank will depend on an applicant's highest degree earned in Literature or Composition. The applications will be reviewed on a rolling basis. The Department of Literature offers both undergraduate and graduate degree programs. The Department is organized under the College of Arts and Sciences, which is where scholarship in the Arts, Humanities, and Sciences is pursued. Learn more about the College of Arts and Sciences at https://www.american.edu/cas/ and the Department of Literature at https://www.american.edu/cas/literature/ . The Department of Literature in the College of Arts and Sciences has the following adjunct salary ranges: Candidates Without a Terminal Degree In Course Subject Area 1-2 Credit Course: $2,865 3-4 Credit Course: $4,725 5-6 Credit Course: $4,938 Candidates With a Terminal Degree In Course Subject Area 1-2 Credit Course: $3,414 3-4 Credit Course: $5,400 5-6 Credit Course: $5,548 Benefits AU offers a competitive benefits package including a 200% matching retirement plan, tuition benefits for full-time staff and their families, several leadership development certificates, and has been recognized by the American Heart Association as a fit-friendly worksite. Click here to learn about American University's unique benefit options. Other Details Hiring offers for this position are contingent on successful completion of a background check. Employees in staff positions at American University must deliver their services to the university from either the District of Columbia, Maryland, or Virginia, or perform work on-site at the university. Please note this job announcement is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. American University is an E-Verify employer. Current American University Employees American University current employees must apply through their employee Workday account. If you are a current employee at American University, please log into Workday and select the Find Jobs report which will take you to our internal career listings. Contact Us For more information or assistance with the American University careers site, email theworkline@american.edu. American University is an equal opportunity, affirmative action institution that operates in compliance with applicable laws and regulations. The university does not discriminate on the basis of race, color, national origin, religion, sex (including pregnancy), age, sexual orientation, disability, marital status, personal appearance, gender identity and expression, family responsibilities, political affiliation, source of income, veteran status, an individual's genetic information or any other bases under federal or local laws (collectively "Protected Bases") in its programs and activities.
Posted 30+ days ago
Edwards Lifesciences CorpLos Angeles, CA
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a key member of the Clinical Science team, the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have strong scientific acumen and a commitment to putting patients first. This position is an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. How you will make an impact: Perform and maintain systematic literature searches, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports Prepare moderately complex medical writing documents/deliverables for assigned project(s) Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience. What else we look for (preferred): Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area including, but not limited to, structural heart interventions, coronary interventions, heart failure, current mitral and tricuspid treatment landscape, and relevant clinical research/trials. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational knowledge. Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Posted 30+ days ago
Loyola Marymount UniversityWestchester, CA
The Graduate Writing Specialist in the LMU Academic Resource Center (ARC) supports graduate students in enhancing their writing, critical thinking, and research skills to achieve academic and professional success. This role is integral to the ARC's mission of empowering students to thrive through personalized academic support and resources. The specialist will provide one-on-one tutoring, facilitate workshops, and collaborate with faculty and staff to develop tailored writing support for diverse graduate programs. This role reports to the Associate Director (Writing Center Lead). Position Specific Responsibilities/Accountabilities Provide personalized writing assistance to graduate students across campus. 40% Design and lead workshops on academic writing topics (e.g., thesis development, citation styles, voice, and revision strategies) specific to the needs of graduate students. 10% Design and lead events such as writing retreats, peer review sessions, and other writing spaces that facilitate collaboration, community building, and feedback. 10% Partner with faculty and various campus stakeholders to understand and address the writing needs of graduate students. Work in collaboration with Faculty Tutors and Graduate Writing Tutors to deliver high quality writing support to graduate student clients. 10% Co-manage all writing technologies and oversee the creation and curation of graduate writing resources. 10% Assess and generate reports regarding ARC graduate writing services. This may include gathering feedback from students, analyzing client data in WC Online, hosting focus groups, co-managing writing related technology etc. 5% Actively promote ARC services to the graduate student community via orientation events, departmental meetings, and other outreach activities. 5% Stay current on best practices and trends in writing pedagogy, graduate writing support, and higher education tutoring strategies. 8% Perform other duties as assigned or requested, contributing to the overall success of the Academic Resource Center. 2% Loyola Marymount University Expectations: Exhibit leadership behavior that supports the mission, vision, and values of the university. Demonstrate exemplary professional conduct, accountability, and commitment to ethical practices. Provide outstanding service to students, faculty, and staff, upholding the highest standards of customer service. Required Qualifications Typically a master's degree in a related field (e.g., English, Rhetoric or Composition, Education) or equivalent experience. Minimum of three years of experience in teaching or tutoring writing at the college level, preferably with graduate students. Experience working with multilingual or international students is a plus. A candidate who has completed or is currently in progress with a doctoral degree is preferred. Experience supporting the writing and research needs of doctoral students is preferred. Experience support ELL and multilingual writers is preferred. Strong understanding of academic writing conventions and research expectations across disciplines. Excellent interpersonal and communication skills, with the ability to work effectively with diverse student populations. Ability to develop and lead workshops and collaborate with faculty on writing-related initiatives. Proficiency with instructional technology and digital learning platforms. Strong organizational and project management skills. The above statements describe the general nature and level of work expected in this role. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required. #HERC# #HEJ# Staff Regular Salary range $66,600.00 - $86,600.00 Salary commensurate with education and experience. Loyola Marymount University, a Carnegie classified R2 institution in the mainstream of American Catholic higher education, seeks outstanding applicants who value its mission and share its commitment to inclusive excellence, the education of the whole person, and the building of a just society. LMU is an equal opportunity employer committed to providing an environment free from discrimination and harassment as defined by federal, state and local law. We invite all persons in the full diversity of their being, life experience, and beliefs to apply. (Visit www.lmu.edu for more information.)
Posted 30+ days ago
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Vir Biotechnology, Inc.San Francisco, CA
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is looking for a Regulatory Writing Director (Temporary Staff) who will support all aspects of regulatory submissions writing needs. They will collaborate with senior management and other leads to support consistent documents/messaging within and across programs. This Person will report to the SVP, Regulatory. This role is located in our San Francisco headquarters with an expectation of 4 days per week in office. WHAT YOU'LL DO Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA (European Medicines Write and edit a wide range of regulatory documents, including: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, regulatory submission dossiers (e.g., NDA, IND, MAA) and summary documents, such as summaries of safety and efficacy. Ensure all documentation adheres to relevant regulatory guidelines and standards, such as ICH E3 and ICH M4. Analyze complex scientific and medical information, including clinical trial data, and translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences. Work closely with cross-functional teams (e.g., clinical, biostatistics, regulatory affairs, pharmacology, safety) to gather data and ensure comprehensive and accurate documentation. Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress. WHO YOU ARE AND WHAT YOU BRING Preferred Bachelor's Degree in Science or Medical related field with 15+ years industry experience, Master's Degree with 13+ years industry experience, or PhD with 10+ years industry experience. Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules. Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs. Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities. At least 8 years of experience as a writer in biotechnology or equivalent. #LI-AS1 #LI-Onsite WHO WE ARE AND WHAT WE OFFER The expected hourly range for this position is $94.00 to $131.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors. Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment. Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees. For hires based in the United States, Vir Biotechnology, participates in E-Verify. Candidate Privacy Notice
Posted 2 weeks ago
The Culinary Institute Of AmericaSaint Helena, CA
The hiring rate for this position is as follows: Base Rate: $3,837, Rate with Master's Degree is $4,067 rate with Master's degree and two years of college-level teaching experience is $4,297. Hiring offers will be determined based on the final candidate's education and relevant experience. The recruiter can share more information about what the anticipated hiring salary would be based upon your specific qualifications during the selection process. Please apply to learn more about the benefits of working for the CIA. POSITION SUMMARY Culinary Institute of America adjunct faculty members are responsible for teaching students a high standard of professionalism. The responsibilities of Adjunct Faculty include but are not limited to teaching and evaluating students. Adjunct Faculty members also maintain office hours, assist students who are having difficulty with studies, and honor college policies. College Writing (LITC-100) 3.0 credits Students will write and revise essays that demonstrate their ability to read and think critically, to incorporate evidence into the development of their ideas, and to articulate their responses persuasively. Readings may include essays, articles, literature, or literary criticism. Basic concepts of information literacy will be introduced. Grammar, usage, and mechanics will be reviewed as necessary. ESSENTIAL RESPONSIBILITIES Prepare daily lesson plans for classes and teach classes as requested and scheduled, in a manner consistent with the philosophy, policies, and guidelines of the Institute. Work individually as an advisor for students who may need extra help, who have questions about course information, who want career guidance, or who need assistance in their studies. Provide regular and constructive feedback to students in an objective, consistent, and timely manner; evaluates and documents student performance using established methods and criteria; files course grades consistently and without prejudice. Evaluate and document student performance using established methods and criteria. File course grades promptly within the specific timeframe allowed. Compile and present instructional material at scheduled times and places in accordance with the College Catalog descriptions, course syllabi and outlines and class schedules as assigned. Utilize the established syllabus and textbook(s) for the course being taught. Maintain record of student attendance, student progress, and grade distributions. Maintain discipline and order during instructional activities. Communicate through appropriate channels. Enforce sanitation principles (appropriate to particular teaching assignment), attendance policies, Institute's Professionalism, Uniform, and Hygiene Policy, and other academic policies. Support the mission and policies of the Institute. Assume responsibility for equipment and facilities of the classroom. Any and all other duties as assigned. REQUIRED QUALIFICATIONS Education: Bachelor's Degree in a related field. Experience: Teaching experience required. Knowledge of general subject area required. PREFERRED QUALIFICATIONS Experience using Moodle. REQUIRED SKILLS Strong interpersonal skills; excellent verbal and written communication skills; ability to effectively work across the organization. Ability to use sound judgment and discretion in handling sensitive student issues with confidentiality and discretion. Excellent written, verbal communication, and presentation skills required. Strong computer experience, which must include abilities to work effectively with MS Office suite products, i.e. Word, PowerPoint. Moderate to strong organizational skills, detail oriented and thorough. Ability to work independently or in a team environment, and maintain collaborative relationships with all members of faculty and administration. Must have an excellent and welcoming presence in front of guests and employees. Moderate to strong presentation skills are required. WORKING CONDITIONS Work requires regular use of a computer. Must be able to work the assigned course schedule
Posted 30+ days ago
University Of PittsburghPittsburgh, PA
The Composition Program at the University of Pittsburgh welcomes applications for part-time, non-tenure stream teaching positions. Position appointments may be renewable based on need, funding, and performance. Our program has long cultivated interdisciplinary and innovative approaches to the field of composition. We believe in asking students to do real intellectual work and to engage with difficulty. Our program in Public and Professional Writing extends those commitments across the university and to workplaces, as well as to the broader public sphere. We value flexible teachers who can create engaging and responsible courses. Responsibilities: We are seeking outstanding faculty members who can teach in our First-Year Engineering Writing Program, in which Composition teachers work with students in their first-year Engineering class to support their professional writing. (This teaching experience requires that teachers respond in writing to students' work and may involve going into the Engineering classroom to teach writing. Assignments and rubrics are created by the team.) For information on our first-year composition courses, visit http://composition.pitt.edu/undergraduate/first-year-composition . MA or higher degree required; terminal degree (MFA, PhD, etc.) preferred. Preferred qualifications include a record of superior academic or professional performance; the ability to develop engaging courses that meet established learning goals; effective communication skills, both oral and written; and a demonstrated ability to interact efficiently with various people in a multidisciplinary environment. Required Documents: Current C.V Cover letter '396729
Posted 1 week ago
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Elanco Animal Health IncorporatedBangalore, IN
At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: The purpose of Associate Manager, Global CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drugs with global regulatory agencies. This role also executes CM&C regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions. Your Responsibilities: Design/develop CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco Lead CMC submission preparation to provide high quality submissions to multiple geographies Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams What You Need to Succeed (minimum qualifications): Degree in Science (MSc, B. Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,) 5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management Understanding of the cGMP requirements Experience working with Regulatory Information Management Tools and Systems What will give you a competitive edge (preferred qualifications): Strong knowledge of FDA/CVM and EMA guidelines Experience with CMC registrations in the US and/or Europe Strong communication skills, both written and oral Ability to make decisions when there is no clear right or wrong answer Self-starter, takes initiative Timeline driven Attention to detail Quality and customer focused mindset Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time Additional Information: Travel percentage up to 10%, annually. Location: IN, Bangalore - Hybrid Work Environment Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Posted 30+ days ago
Lesley UniversityCambridge, MA
The Opportunity Lesley University's Department of Liberal Arts & Business is seeking a qualified adjunct faculty member to teach: FA 25 CWRIT 1101 Writing as Thinking and Process. Mondays and Wednesdays 9:35-11:10. Course Description: This course is designed to develop writing skills for college writing assignments, professional communication, and personal expression. The focus of the course is on writing in a variety of forms. Assignments include reading essays or longer pieces, writing paragraphs, short essays, and a research paper. Attention is given to mechanics, syntax, and grammar. Qualifications and Capabilities A successful candidate will have: Master's degree (PhD preferred) in English/Writing/Linguistics or equivalent, with experience teaching in the first-year writing program. Successful teaching experience at the undergraduate level. Experience in constructivist, inquiry-based learning. Excellent verbal and written communication skills. Why Lesley Located in the heart of Cambridge, Massachusetts, Lesley University is highly regarded for its graduate and undergraduate programs in the human arts of education, the arts, and applied social sciences. Lesley fosters a highly creative environment in which innovative ideas thrive, theory is integrated with practice and its 6,400 students and 90,000 alumni are empowered to improve and enrich communities. Lesley is committed to the ongoing pursuit of strategic diversity initiatives that help to position diversity, equity, and inclusion as fundamental to institutional and academic excellence at Lesley. In doing so, Lesley strives for a campus culture and community that fosters a true sense of belonging for all, provides opportunity for everyone to participate equally and fully in the Lesley experience, and helps to develop each individual's capacity to confidently and competently engage within and across difference. Given an evolving national context and the rapid change in the demographic profile of our country, the University has made a significant commitment to addressing and enhancing its campus climate and diversity capabilities as an institution. Expressing Interest A letter of interest, CV/resume, and a statement addressing past and/or potential contributions to diversity, equity, and inclusion through teaching, professional activity, and/or service must be included for full consideration. At Lesley University we strive for a supportive and equitable environment where people -- regardless of race, ethnicity, color, sex, physical ability, religion, national origin or ancestry, age, neurodiversity, sexual orientation, gender identity or expression, genetic information, veteran or military status, membership in uniformed services, and all other categories protected by applicable state and federal laws -- can participate equally and fully as their true selves in all aspects of university life. Accordingly, the University prohibits discrimination based on these protected categories in any education program or activity that it operates, including in admission and in employment. We are committed to diversity, equity, and inclusion throughout the fabric of our institution. Individuals may submit concerns or questions related to discrimination to the University's Director of Equal Opportunity. Please visit the Office of Equal Opportunity's webpage for the University's entire notice of nondiscrimination and for additional information.
Posted 4 days ago
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Collin County Community CollegeCelina, TX
Primary Location: 2505 Kinship Pkwy, Celina, Texas, 75009 We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities. Job Summary: Provide tutoring support services to Collin College students. Help students understand the writing process, how to write thesis statements, how to organize and develop ideas and how to correct papers for sentence fluency, grammar, punctuation and diction. Required Qualifications: Essential Duties and Responsibilities Support students' writing efforts through tutoring. Maintain record of each tutoring session with student. Report promptly to student's professor on the material covered in the tutoring session (writing problems addressed) if applicable. Attend staff meetings or professional development as directed. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA).Ensure offices and files are adequately secured on a daily basis. Supplemental Functions Perform other duties as assigned. Perform all duties and maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of college-level composition Knowledge of of the English language Knowledge of MS Word, Excel and Publisher Knowledge of MLA style and format Knowledge of presentation software Organization and time management skills Document design skills Creative thinking skills Presentation skills Computer and applicable software skills Interpersonal skills Ability to create a positive tutoring and learning environment in the writing center Ability to communicate effectively, both orally and in writing Ability to establish and maintain effective working relationships Physical Demands, Working Conditions and Physical Effort Sedentary Work - Exerting up to 10 pounds of force occasionally, a negligible amount of force frequently, and/or constantly having to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Positions in this class typically require talking, hearing, seeing, grasping, standing, walking and repetitive motions. Relatively free from unpleasant environmental conditions or hazards. Office environment. Little physical effort required. Requirements WRITING CTR ASST Level I (204) $16.03 Associate degree in English or a closely related field from an accredited institution. Writing proficiency. Some tutoring experience. WRITING CTR ASST Level II (208) $20.24 Bachelor's degree in English and one year teaching and/or tutoring experience OR Master's degree with 18 graduate hours in English or related field, writing proficiency, and some teaching and /or tutoring experience at the college level. WRITING CTR ASST Level III (209) $21.45 Master's degree or higher in English or a closely related field from a regionally accredited institution. Proven proficiency in writing. Some teaching/tutoring experience at the college level. This position is generally limited to working a maximum of 19.5 hours per week. (Maximum hours for employees with more than one part-time position at Collin College may vary.) This position is Security Sensitive, therefore, candidates will be subject to a criminal background check. The above description is an overview of the job. It is not intended to be an all-inclusive list of duties and responsibilities of the job as duties and responsibilities may change with business needs. Collin College reserves the right to add, change, amend, or delete portions of this job description at any time, with or without notice. Reasonable accommodations may be made by Collin College in its discretion to enable individuals with disabilities to perform the essential functions. Required & Preferred Qualifications (if applicable): The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Fair Labor Standards Act (exempt/non-exempt) is designated by position. The employer actively supports Americans with Disabilities Act and will consider reasonable accommodations. This is a Security Sensitive position. Therefore candidates will be subject to a criminal background check.* Compensation Type: Hourly Employment Type: Part time Compensation: $16.03 Hourly For any employment questions, please contact HR at (972) 985-3783 or send an email to: employment@collin.edu. Collin College is an Equal Opportunity Employer and does not discriminate on the basis of any characteristic protected by applicable law.
Posted 30+ days ago
T
Tutor Me EducationIndio, CA
At Tutor Me Education, we are revolutionizing the way students learn, and we're seeking passionate teachers and tutors with special education experience to provide 1:1 in-home tutoring in Indio, CA ! If you're committed to making a difference in the lives of students with special needs and helping them achieve academic success, we want to hear from you! About the Role: As an Tutor at Tutor Me Education, you’ll provide personalized, one-on-one tutoring to students with special needs in their homes. You will be responsible for helping students with daily activities, offering moral support, and delivering tailored instruction based on their Individualized Education Plan (IEP). We are currently hiring for multiple positions across all cities in Indio, CA Details: In-Person Tutoring in Indio, CA Schedule: Flexible, 4-5 sessions per week Competitive hourly rate based on experience Focus Area: Math, Writing, 7th Grade Science Ideal Candidate: Experience tutoring or teaching middle school students , particularly those with autism, ADHD, or learning differences Strong knowledge of middle school math, writing, and science curriculum Skilled in breaking down complex tasks and concepts into manageable steps Understanding of executive functioning and how to support learners with focus and planning challenges Patient, structured, and engaging approach to instruction Familiarity with special education supports such as educational therapy, OT, or speech therapy is a plus Must be reliable and able to provide in-home sessions in Indio, CA Key Responsibilities: Provide targeted instruction in math , focusing on topics such as fractions, factors, place value, multi-step word problems, composite numbers , and general number sense. Support the development of writing skills , including paragraph structure, essay writing, grammar, and organization. Offer science tutoring aligned with 7th grade curriculum , assisting with homework, project support, and concept mastery. Reinforce strategies for task initiation, goal setting, and independent work , building on prior educational therapy. Adapt instruction to accommodate learning needs related to processing speed, attention, and executive functioning. Create a consistent, positive, and motivating learning environment. Collaborate with the family to align tutoring with academic goals and school expectations. Why Tutor Me Education? At Tutor Me Education, we are dedicated to providing a nurturing, supportive environment where students can thrive. We pride ourselves on offering meaningful tutoring opportunities that make a lasting impact in the communities we serve. Whether you're looking for consistent hours or just want to make a difference, we have a place for you. Benefits: Performance-Based Pay Incentives Voluntary retirement program Referral program Flexible schedule Help students with special needs reach their full academic potential Equal Opportunity Employer: Tutor Me Education is proud to be an Equal Opportunity Employer, committed to diversity and inclusion. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status. We encourage candidates from all backgrounds to apply. Diversity, Equity, and Inclusion: We are committed to fostering an inclusive workplace where every team member feels valued, respected, and empowered. Diversity drives innovation, and we believe it is essential for success.
Posted 4 days ago
Kubicki DraperMiami, FL
Role Overview: The Miami office of Kubicki Draper is seeking an Associate Attorney with 2+ years of experience in legal research & writing and providing litigation support on insurance coverage matters. Must be an active member of the Florida Bar. Your Day-to-Day: Complex Research and Analysis Assist with Drafting Appellate Briefs Draft/review substantive complex pleadings and motions Insurance Coverage Analysis Communicate in a highly effective manner with team members and clients Ability to work in a fast-paced, evolving environment Requirements What You Bring: An active member of the Florida Bar in good standing, Required Strong skills in legal research, writing, and persuasive oral advocacy Judicial Clerkship Preferred Prior Appellate or Insurance Coverage Experience Preferred, But Not Required Drive for Success: Possess an unyielding drive to climb the hierarchical ladder, aspiring to leadership roles and leaving a mark. Client-Centric Approach: Our clients are our compass—your unwavering commitment to exceptional client service. Organizational Mastery: An organized mind paired with the ability to communicate succinctly and effectively is crucial Licensed member of the Florida Bar and in good standing Benefits We offer competitive pay, top-tier medical insurance, 401(k) with matching, and much more. Why Join Us? Opportunity to Grow: We’re expanding fast and offer hands-on experience, mentorship, and real career advancement. Work-Life Balance: We value you - not just as an employee but as an individual. Enjoy hybrid flexibility, PTO, and wellness-forward programs. Long-Term Value: Over 20% of our team has been with us for 10+ years. We invest in your future – at every stage. Inclusive Culture: We’re not just a law firm—we’re a team. One that values collaboration, supports innovation, and champions diverse perspectives. In fact, over 70% of our attorneys come from diverse backgrounds, reflecting the communities we serve. At Kubicki Draper, we combine over 60 years of legal excellence with a modern, inclusive, and growth-oriented culture. With more than 250 attorneys across 12 offices, we are a trusted leader in trial, appellate, insurance defense, commercial, and real estate litigation. No matter where you are in your legal journey—from your first case to your hundredth—you’ll find the support, challenge, and opportunity to succeed. Kindly note: Direct applicants only. No phone calls or recruiters, please.
Posted 30+ days ago
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DeVine Consulting, Inc.Monterey, CA
DeVine is a leading provider of Educational and Scientific solutions for Federal, State and commercial clients. Our company is looking for an Advanced G raduate Writing Instructor to join our team in Monterey, CA. This position will be supporting a government customer, hence only US Citizens may apply. Our client’s primary mission is to support the development of graduate and certificate-program students’ writing, critical thinking, and academic skills. These services enhance students’ discipline-based learning, improve the quality of their academic work and help them complete their educational goals. The successful Advanced Graduate Writing Instructor will join a team of Writing Instructors, and Thesis Processors, to provide one-to-one instruction focused on developing students’ writing, critical thinking, and other academic skills. Other services offered by the team include workshops, academic department-based courses, online guides and learning tools, and support with non-academic and multimodal writing. If you have the relevant experience & attributes, and would enjoy working in the Monterey, CA, area, then we want you on our team! Responsibilities: Provide one-to-one writing instruction support to graduate students Occasionally conduct research related to writing, critical thinking, program effectiveness, and special topics such as generative artificial intelligence’s (AI) impact on teaching and learning Edit faculty papers, faculty executive summaries and technical reports per year Analyze student papers for plagiarism, and create & maintained online learning and communication materials Develop and deliver 60- to 90-minute hands-on workshops and general presentations for students and faculty Support students in understanding academic norms and graduate-level standards with respect to writing, organizing thoughts, writing to conform to advanced presentation of arguments and evidence, brainstorming, outlining, revising, citing/attribution, ethical use and disclosure of generative AI, and interpreting and presenting data effectively Accommodate varying student needs and required support Review student papers 2 to 24 hours before appointments to: prioritize issues based on student requests and needs, review reports on students’ past appointments, develop consultation strategies Complete student client reports, short summaries of issues covered and progress made Experience: Master’s degree or higher in English, literature, journalism, communication, rhetoric, international or public policy, or related writing-intensive field from an accredited university Minimum master's degree GPA of 3.50 10+ years’ working one-to-one with university students to improve their writing, critical-thinking, or research skills 3+ years’ teaching experience in writing and critical thinking at the graduate-level - Preference is given to those with teaching awards At least one thesis, dissertation, or single-author final-project report of an academic standard, academic conference paper accepted by and presented at an academic conference, or publication in an academic journal or by an academic press Evidence of strong teamwork and collaboration to reach mutual goals. Production of original written work Verifiable experience with the following: Microsoft Office suite; classroom presentation software; classroom management software, such as Blackboard or Sakai; videoconference software, such as Zoom or MS Teams; and originality-check software, such as Turnitin or iThenticate Possess and demonstrate strong knowledge of: English-language, academic-writing fundamentals, including organization, structure, grammar, writing conventions and styles, prewriting strategies, punctuation, word choice, paraphrasing, quoting, and citing Critical thinking, argumentation, and reasoning. Teaching pedagogy Research methods Academic norms and standards, such as citation styles and methods for avoiding plagiarism, and for producing original work, evidenced-based research, literature reviews, abstracts, and executive summarizes High academic standards, such as the importance of honor codes Strong computer skills for word processing, spreadsheets, presentations, videoconferencing, file sharing, and project management and reporting About the position: Position Type: Full-time Hourly, Must be U.S. Citizen Location: Monterey, CA Benefits: Medical, Dental, Vision, 401K, Life Insurance, Paid Holidays, Paid Sick Leave and Paid Vacation Compensation: $25.24 - $45.67 per hour compensation range, DOE and skills Equal Opportunity Employer We are committed to a policy of assuring that all applicants for employment are recruited, hired and assigned on the basis of qualifications and merit without discrimination based on any protected classification, including, but not limited to, race, color, religion, sex, sexual orientation, national origin, veteran status, age, disability, handicap, marital status, or any other characteristic protected by applicable laws. Powered by JazzHR
Posted 30+ days ago
Hartwick CollegeOneonta, NY
College Writing Program - Adjunct (Pool) Hartwick College is accepting applications on a continuing basis for instructors who are qualified to teach ENGL 110 College Writing. Qualifications include a master’s degree (or higher) in English, rhetoric, composition, or related fields and demonstrated experience teaching first-year writing. This pool will be utilized on an as-needed basis, should an opportunity arise, and applications submitted will remain active for up to two years. An independent, residential liberal arts college enrolling approximately 1,100 full-time undergraduates, Hartwick embraces the teacher-scholar model, with teaching excellence as the first priority, and seeks to recruit, retain and promote a diverse workforce. Hartwick operates as a community of learners where there is a very real sense of belonging and connection. By joining Hartwick, you become part of a group of people who work together, share in our successes, and celebrate our accomplishments. All positions at Hartwick contribute to the education and development of students with the opportunity to see the impact on future leaders – what you do at Hartwick really matters. Hartwick College is an Equal Opportunity Employer, committed to broadening “the understanding, awareness, and appreciation of diversity among all members of the Hartwick community.” Women, minorities, and other underrepresented groups are especially encouraged to apply. Interested applicants are invited to submit a current curriculum vitae and introductory cover letter via the following link: https://hartwickcollege.applytojob.com/apply/6kQuMKHH3y/College-Writing-Program-Adjunct-Pool Salary Range: $830-1,100 per credit Powered by JazzHR
Posted 30+ days ago
AdyenChicago, IL
This is Adyen Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition. For our teams, we create an environment with opportunities for our people to succeed, backed by the culture and support to ensure they are enabled to truly own their careers. We are motivated individuals who tackle unique technical challenges at scale and solve them as a team. Together, we deliver innovative and ethical solutions that help businesses achieve their ambitions faster. Technical Writing Manager Technical writers at Adyen play a key role in connecting our external users, developers, product teams, developer advocates, and support teams. As our product and development teams expand globally, we're searching for a Technical Writing Manager to partner with the Global Documentation Manager. Together, you will guide a talented group of writers who are instrumental in documenting our high-impact solutions for a developer audience including: API documentation, SDKs, Release Notes, and integration guides. In this role, you will work closely with the Global Documentation Manager, contributing to strategic initiatives and directly managing a team focused on creating exceptional documentation for our developer community. What you'll do Lead a high-performing team of writers Support the projects and professional growth of writers as they document complex product capabilities Help your team deliver a docs experience that developers will love Help strategize solutions to automate and optimize our docs and tooling Partner on driving strategic initiatives Set your team’s priorities in alignment with broader business goals Collaborate with the Global Manager on strategic initiatives for the Developer Experience and Docs teams Co-lead and execute Adyen’s AI developer experience strategy Help build and drive collaborative engagement Engage with stakeholders and collaborators in Product, Engineering, UX, Support, and other functions to understand their business needs, identify opportunities for partnership, advance business goals, and socialize your team's value and impact Remove blockers and improve ways of working across teams Who you are Minimum 2-3 years experience managing documentation teams, preferably in API docs Experience in leading documentation projects and initiatives (for example, scaling or automation solutions, or migration to new tooling or workflows) Able to work on multiple projects simultaneously in a fast-paced, dynamic environment Experience working with cross-functional leads and stakeholders, gathering support and buy-in for key initiatives Ability to effectively inspire, influence, and communicate across all levels of management Partner effectively with developers, product managers, and technical writers to deliver quality documentation Experience writing documentation for UI components, SDKs, and APIs a strong plus Proficiency in using Git and working with a docs-as-code workflow is helpful Open to some domestic and international travel The annual base salary range for this role is $150,000 - $200,000; to learn more about our compensation philosophy, please click here . Our Diversity, Equity and Inclusion commitments Our unique approach is a product of our diverse perspectives. This diversity of backgrounds and cultures is essential in helping us maintain our momentum. Our business and technical challenges are unique, and we need as many different voices as possible to join us in solving them - voices like yours. No matter who you are or where you’re from, we welcome you to be your true self at Adyen. Studies show that women and members of underrepresented communities apply for jobs only if they meet 100% of the qualifications. Does this sound like you? If so, Adyen encourages you to reconsider and apply. We look forward to your application! What’s next? Ensuring a smooth and enjoyable candidate experience is critical for us. We aim to get back to you regarding your application within 5 business days. Our interview process tends to take about 4 weeks to complete, but may fluctuate depending on the role. Learn more about our hiring process here . Don’t be afraid to let us know if you need more flexibility. Adyen is an equal opportunity employer. We do not discriminate based on race, color, ethnicity, ancestry, national origin, religion, sex, gender, gender identity, gender expression, sexual orientation, age, disability, veteran status, genetic information, marital status or any legally protected status. All your information will be kept confidential according to EEO guidelines. This role is based out of our Chicago office. We are an office-first company and value in-person collaboration; we do not offer remote-only roles. This role is hybrid, with 3 days per week in the Chicago office.
Posted 30+ days ago
PhilipsParis, TX
Job Title Director Medical Writing & Clinical Development Job Description The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert, mentor, and strategic guide that integrates multiple data and evidence streams (published literature, society guidelines, Philips' clinical studies, Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification, evidence generation, and surveillance/safety). Please apply in English. Applications submitted in any other language won't be considered. Your role: Leads the medical writing team in planning and delivering high-quality, compliant documents through effective resources, budget, and timeline management. Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). Author and maintain clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports, Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities. Drives collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research & Development, and Regulatory Affairs. Develops clinical evidence strategies for New Product Introductions, including performance claims and coordination on usability and non-clinical evidence. Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy. Optimizes medical writing processes by identifying and implementing automation, standardization, and workflow efficiencies. Translates complex scientific data into clear, impactful narratives for regulatory bodies, clinicians, and stakeholders to support product development and commercialization You're the right fit if: You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development of clinical evidence/documents (manuscripts, scientific abstracts, conference presentations/posters, reports based on clinical studies, and data/analytics). You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products. You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile), mentoring, training, performance management and development of team members. You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, compliance, and reduce time to market. You have a minimum of a Master's degree in life sciences or equivalent discipline (REQUIRED). Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology, Health Services Research, Health Economics or Medicine) and healthcare quality improvement. Project management background and familiarity with agile tools (Azure Dev Ops/Jira), information management (Confluence, Distiller, Endnote) or dashboarding/visualization (Tableau, PowerBI). Near-native level of English How we work together We believe that we are better together than apart. For this role it means working in-person at least 3 days per week. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. #LI-EU
Posted 3 weeks ago
PhilipsBothell, WA
Job Title Director Medical Writing & Clinical Development Job Description The Director Medical Writing & Clinical Development is a key member of the Ultrasound Medical and Clinical Affairs team and serves as a subject matter expert, mentor, and strategic guide that integrates multiple data and evidence streams (published literature, society guidelines, Philips' clinical studies, Real-World Data) to support all aspects of Clinical Development (clinical opportunity identification, evidence generation, and surveillance/safety). Your role: Leads the medical writing team in planning and delivering high-quality, compliant documents through effective resources, budget, and timeline management. Compiles and analyzes clinical and safety data to support medical device performance in alignment with EU regulatory standards (MEDDEV 2.7.1 Rev. 4, EU Medical Device Regulation). Author and maintain clinical documentation, including Clinical Evaluation Plans and Clinical Evaluation Reports, Post-market Clinical Follow-up Plans/Reports, and Investigator Brochures, contributing to Risk Management and Post-Market Surveillance activities. Drives collaboration and knowledge-sharing across medical, clinical, and regulatory teams, including Medical Affairs, Clinical Development, Research & Development, and Regulatory Affairs. Develops clinical evidence strategies for New Product Introductions, including performance claims and coordination on usability and non-clinical evidence. Collaborates with cross-functional teams to ensure regulatory compliance and to define medical writing scope and clinical evidence strategy. Optimizes medical writing processes by identifying and implementing automation, standardization, and workflow efficiencies. Translates complex scientific data into clear, impactful narratives for regulatory bodies, clinicians, and stakeholders to support product development and commercialization You're the right fit if: You've acquired a minimum of 10+ years combined experience working within FDA regulated medical device and clinical environments, with a focus on the development of clinical evidence/documents (manuscripts, scientific abstracts, conference presentations/posters, reports based on clinical studies, and data/analytics). You have detailed knowledge of medical device regulations, requirements, and standards for FDA and EU especially for medium risk devices (Class II/Class IIA) focused on AI/software and information products. You have proven strategic/functional management experience in building and developing highly organized and capable teams. Experience in project management (a plus if you have experience in agile), mentoring, training, performance management and development of team members. You have a demonstrated track record of learning agility and comfort in taking on /shaping complex/uncertain business problems and creating creative/pragmatic solutions. You have a passion for simplification and optimizing processes and workflows, identifying opportunities for automation and software tools that improve productivity, compliance, and reduce time to market. You have a minimum of a Master's degree in life sciences or equivalent discipline (REQUIRED). Preferred experience: Background in Real-World Data/Analytics (such as Epidemiology, Health Services Research, Health Economics or Medicine) and healthcare quality improvement. Project management background and familiarity with agile tools (Azure Dev Ops/Jira), information management (Confluence, Distiller, Endnote) or dashboarding/visualization (Tableau, PowerBI). You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. How we work together: We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. This is an Office role. About Philips: We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody, everywhere, has access to the quality of healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details: The pay range for this position in Cambridge, MA and Bothell, WA is $184,800 to $295,680. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. Additional Information: US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Bothell, WA or Cambridge, MA. This role may require travel up to 10%. #LI-PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Posted 3 weeks ago
Edwards Lifesciences CorpRiverside, CA
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a key member of the Clinical Science team, the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have strong scientific acumen and a commitment to putting patients first. This position is an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. How you will make an impact: Perform and maintain systematic literature searches, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports Prepare moderately complex medical writing documents/deliverables for assigned project(s) Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience. What else we look for (preferred): Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area including, but not limited to, structural heart interventions, coronary interventions, heart failure, current mitral and tricuspid treatment landscape, and relevant clinical research/trials. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational knowledge. Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Posted 30+ days ago
Edwards Lifesciences CorpIrvine, CA
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a key member of the Clinical Science team, the Specialist, Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. The Specialist should have strong scientific acumen and a commitment to putting patients first. This position is an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California. How you will make an impact: Perform and maintain systematic literature searches, contribute to the development of search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the clinical evaluation and clinical study reports Prepare moderately complex medical writing documents/deliverables for assigned project(s) Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders Assist in the implementation of continuous process improvements as it relates to medical writing Other incidental duties What you'll need (required): Bachelor's Degree in a related field with 3 years of experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Master's degree in a related field with 1 year experience working in medical writing, medical affairs, clinical affairs and/or clinical science; OR Doctorate degree (PhD, MD, PharmD) with relevant postdoctoral fellowship or graduate research experience. What else we look for (preferred): Experienced with literature reviews and various publication databases including PubMed and Embase. Familiarity with the cardiovascular therapeutic area including, but not limited to, structural heart interventions, coronary interventions, heart failure, current mitral and tricuspid treatment landscape, and relevant clinical research/trials. Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. Familiarity with FDA PMA applications. Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. Additional skills and general expectations: Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously Excellent oral and written communication skills Experienced in keeping up-to-date with product developments, clinical literature, and therapeutic knowledge, and operational knowledge. Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat Strong analytical, problem-solving, and scientific writing skills Strict attention to detail Ability to interact professionally with all organizational levels Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects Ability to build productive internal/external working relationships Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $85,000 to $120,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Posted 30+ days ago
Senior Manager, Regulatory Writing
CytokineticsRadnor, Pennsylvania
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Job Description
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator’s brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals.
The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed.
Responsibilities
- Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed.
- If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy. May oversee additional writing and QC work performed by the vendors.
- For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval.
- Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively (e.g. comments and questions arising from the writing/review process).
- Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment.
- Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents.
- Develop and drive timelines, and communicate writing process and timelines to team members.
- Provide status/updates of Regulatory Writing deliverables to management.
- Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams.
- May contribute content to safety documents (e.g., DSURs, RMPs).
- May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices.
- Comply with established company policies and procedures, and industry and regulatory guidelines.
- Other duties as assigned.
Qualifications
- BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation.
- Excellent communication skills both orally and in writing.
- Ability to work both independently and in cross-functional team environments with minimal supervision.
- Demonstrated ability to lead development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents.
- Ability to engage and disseminate information among appropriate stakeholders for effective document preparation.
- Strong attention to detail with the ability to effectively write/summarize science-and data-driven content into clear, concise, and complete documents.
- Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively.
- Ability to work effectively in a fast-paced environment with multiple high-priority projects.
- Ability to oversee consultants/contractors and serve as a liaison for project purposes.
- Excellent Project management skills.
- Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP).
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Pay Range:
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.
Here are some ways to check for authenticity:
We do not conduct job interviews through non-standard text messaging applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
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