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College Writing Adjunct-logo
College Writing Adjunct
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

Associate Director, Clinical Medical Writing-logo
Associate Director, Clinical Medical Writing
BioMarin PharmaceuticalSan Rafael, California
Description Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. Our Culture From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Summary The Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program and product development, and other resource or budgetary medical writing requirements for that/those program(s) Responsibilities Oversight responsibilities for Medical Writing staff Works with the Head of Medical Writing to ensure appropriate CMW deliverables planning for specified clinical development program(s), including resource forecasting and allocation, timelines, and budget Works with CMW line management to establish and maintain timelines for program planning. Acts as management-level author/reviewer for CMW and other Development Sciences deliverables, where such review/authoring is required by SOPs or other controlled process documentation Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met. For outsourced projects, performs vendor management tasks (including but not limited to reviewing contract proposals, conducting interviews, preparing and conducting onboarding sessions, and providing oversight for external writers) Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (e.g. PSURs, DSURs) Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents CMW at cross-functional team meetings (eg, study team, development team, other sub-teams). Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Oversees development and review of standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments Works effectively with cross-functional groups within BioMarin Other tasks as assigned. Education & Experience Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: At least 10-years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable, e.g. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. Relevant Experience Fulfills one of the following: At least 10 years of experience as a medical writer in the pharmaceutical industry Management Minimum of 3 years administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting. Demonstrated leadership abilities. Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities. Experience with budgeting documentation projects. Experience selecting vendors, establishing working relationships with vendors, and overseeing vendor deliverables. Experience establishing partnerships with cross-functional groups in a clinical development setting. Experience with delegating and overseeing projects and tasks. Experience with establishing departmental and company-level processes and procedures. Experience coaching or mentoring medical writers both in behavioral and technical areas. Clinical Studies - Able to mentor or train others in clinical study concepts, design, and documentation - Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets. - Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. - Advanced applied knowledge of: o documentation required for the conduct of clinical studies o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) o study results reporting o integrated results reporting - Direct experience with documentation in all phases of drug development. Medical Writing - Writing high-quality documents that support corporate goals and objectives. - Ability to mentor, train, or manage others in the following: o Routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. o Interpreting data from tables, graphs, and listings o Creating in-text data presentations (including complex tabular and graphical clinical data presentations) o Interpreting basic clinical laboratory tests o Researching literature o Understanding concepts of coding dictionaries (MedDRA, WHO Drug) o Preparing high-quality clinical and regulatory documents (protocols, IBs, clinical study reports, ICFs). Computer/office equipment Skills Proficiency and ability to train/mentor others in the use of Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, and PowerPoint. Proficiency with MS Project/Project Server Experience using document management software (e.g. SharePoint, Veeva) Experienced with scanners, printers, and copiers. Regulatory Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs: o ‘standalone’ regulatory documents (e.g. protocols, investigator brochures, clinical study reports, IND annual reports) o Clinical sections of pre-submission meeting packages (e.g. pre-IND or end-of-Phase 2 meetings), Orphan Drug Applications, CTAs, IMPDs, etc. o Targeted Product Profile, Package Inserts/Product Labels (using structured product labeling guidelines) o Responses to FDA queries and inspection findings Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US, EU and RoW submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances. Ability to provide leadership for presentations to regulatory authorities and regulatory inspections. Project Management Ability to plan, resource, assign, and keep executive management appraised of the status of multiple simultaneous document development projects (stand-alone and complex dossiers) with shifting priorities Ability to support staff in renegotiating timelines during development as necessary. Good conflict management skills. Communication Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Posted 30+ days ago

Academic Writing Part-time Instructor Pool 2025-2026-logo
Academic Writing Part-time Instructor Pool 2025-2026
University of TampaTampa, Florida
If you are a current University of Tampa student, please search for and apply to student jobs here via Workday. Job applications for current students will not be considered if submitted through the external career center. Position Details The Department of English and Writing in the College of Arts and Letters at The University of Tampa invites applications for part-time instructors of on-campus, in-person Academic Writing courses Responsibilities will include: 1. Teach one or two 4-hour courses per semester. 2. Create an individual syllabus with meeting times and specific reading and writing assignments for students within the departmental guidelines and program mission. 3. Manage online/paperwork grading system. The successful candidate will have: Experience teaching academic writing at the college level . A Ph.D. is preferred, but at a minimum all candidates must have a Master's Degree in English or TESOL, or an MFA in Writing. Required Attachments Please be sure to attach all required documents listed below in the attachment box at the bottom of the "My Experience" page of the application before continuing through the application. Cover Letter Curriculum Vitae Additional Information Applications for part-time positions are accepted on a continuous basis and reviewed by the department when openings become available. Future teaching assignments are on a term-by-term basis which may include fall, spring and summer. The University of Tampa is an equal opportunity/affirmative action employer dedicated to excellence through diversity and does not discriminate on the basis of age, race, sex, disability, sexual orientation, national origin, religion, marital status, gender identity, veteran status or any other non-job related criteria. The University of Tampa recognizes the importance of a multicultural community of students, faculty, and staff who seek to advance our commitment to diversity. The University invites applications from underrepresented groups and those who have academic experiences with diverse populations. Submission Guidelines To receive full consideration for a faculty appointment with The University of Tampa, please be sure to upload documents as required for this position at time of application submission. Once your application has been submitted, no changes may be made. Required documents should be submitted in the attachment box at the bottom of the "My Experience" page of the application before continuing through the application. Note: A maximum of five (5) documents may be attached to your application. If more than five (5) documents are required, please combine the additional documents into a single attachment so that you may continue through the application process. Background Check Requirements Finalists may be required to submit to a criminal background check.

Posted 30+ days ago

UNIV - Science Writing and Communications Program Coordinator - Department of SCTR-logo
UNIV - Science Writing and Communications Program Coordinator - Department of SCTR
MUSCCharleston, South Carolina
Job Description Summary The Science Writing and Communications Program Coordinator contributes science content that translates research originating from the South Carolina Clinical and Translational Research Institute (SCTR) into compelling language and formats appropriate for all stakeholders, including scientific and lay audiences, students, collaborators, and sponsors. SCTR is a statewide, NIH-funded institute that provides consultative expertise, resources, training, and funding to support research teams. Our goal is to accelerate scientific discoveries from the laboratory to clinical and public health practice to improve the health of patients and communities across SC and beyond. The Science Writing and Communications Program Coordinator reports to the SCTR Science Development Officer and is a member of the SCTR Communications Team, which is responsible for developing and implementing SCTR’s strategic communication priorities. The position is part of a fast-paced, engaged, and creative team that helps to support SCTR’s stakeholder relationships and reputation. We are especially interested in applicants who bring a blend of science communication experience and digital media skills. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type​ Research Grant Cost Center CC001064 COM SCTR Operations CC Pay Rate Type Salary Pay Grade University-06 Pay Range 46,655.00 - 66,488.00 - 86,321.000 Scheduled Weekly Hours 40 Work Shift Job Description Job Description: The Science Writing and Communications Program Coordinator contributes science content that translates research originating from the South Carolina Clinical and Translational Research Institute (SCTR) into compelling language and formats appropriate for all stakeholders, including scientific and lay audiences, students, collaborators, and sponsors. SCTR is a statewide, NIH-funded institute that provides consultative expertise, resources, training, and funding to support research teams. Our goal is to accelerate scientific discoveries from the laboratory to clinical and public health practice to improve the health of patients and communities across SC and beyond. The Science Writing and Communications Program Coordinator reports to the SCTR Science Development Officer and is a member of the SCTR Communications Team, which is responsible for developing and implementing SCTR’s strategic communication priorities. The position is part of a fast-paced, engaged, and creative team that helps to support SCTR’s stakeholder relationships and reputation. We are especially interested in applicants who bring a blend of science communication experience and digital media skills. This position is mostly remote with in-person attendance at meetings and events as required. Job Responsibilities: Content Creation (30%) Plans, researches, develops, and delivers written content – and potentially visual assets, such as photography and video – in a deadline-driven environment for communication channels including but not limited to SCTR’s website, print reports, electronic newsletters (internal and external), online magazine stories, news releases, blogs, brochures, and other marketing-related materials. Cultivates relationships with SCTR leaders, faculty, staff, and study teams for the purpose of understanding and communicating their research to external stakeholders. Collaborates with and interviews faculty, staff, and study teams to develop and produce compelling stories about their research. Advises SCTR leadership and staff on how to frame stories about innovative and important scientific advances and key SCTR research initiatives so that they resonate with target audiences. Develops and delivers strategic research communications in appropriate formats for the relevant audience(s) under the supervision and mentorship of the SCTR Sr Science Writer. Coordinates review and release of stories with institutional communication offices. Tracks and reports metrics on the effectiveness of science stories and releases Editing (20%) Assists with editing communications and marketing content developed by SCTR colleagues to ensure strategic messaging coherence, clarity and conciseness as well as technical and factual accuracy, readability, style, and adherence to brand and editorial guidelines. Provides sentence-level editorial guidance to other SCTR team members, including scholars and trainees, on academic writing such as manuscripts, reports, and grant proposals. Offers recommendations for streamlining content, use of tables and or visual elements to communicate information succinctly and for different audiences. Digital Media Development (20%) Uses digital tools to promote online content, amplify news coverage to key audiences. Contributes messaging to promote written and multi-media content. May initiate development of graphic elements in consultation with study team members and the SCTR Communications Manager. Assists Communications Manager with editorial review/updates of website. Assists Communications Manager with editorial review and news feature development for e-newsletter. Manuscript and Grant Development (20%) Works collaboratively with SCTR Science Officer to facilitate manuscript and grant development/reporting activities, which may include: providing editorial review of multi-collaborator grants/manuscript to create a consistent voice, contributing written content when needed. advising investigators on ways to effectively translate and communicate scientific concepts to enhance acceptance of peer-reviewed manuscripts and competitiveness of grant applications, and suggesting and creating relevant graphics, tables and appendices to support grant applications. Material and Report Preparation (5%) Assists in creating materials to disseminate information and promote SCTR resources, events, and accomplishments, including SCTR’s retreats, funding opportunities, symposia, webinars, and special events. Maintains yearly tracking for SCTR news coverage and science communication projects, Assists with report preparation using relevant data sources to inform ongoing program promotions strategy and development. Other Activities (5%) Contributes knowledge and project coordination expertise to special projects determined by SCTR leadership, particularly projects to promote effective written and visual science communications, such as with scientific presentations, posters, visual abstracts, research manuscripts and grant proposals. MUSC Minimum Training and Experience Requirements: A bachelor's degree and two years relevant program experience. Preferred skills Bachelor’s degree in journalism/communications/English or a science field with two (2) years of professional writing and editing experience. Demonstrated ability to comprehend scientific or technical information and complex ideas and turn them into clear and compelling stories that are appropriate for the target audience for the purpose of advancing the organization. Strong storytelling ability with the know-how to compose a narrative about discovery and write memorable stories that captivate and inspire the target audience. Demonstrated prior professional experience researching and writing news releases concisely, effectively, and persuasively in a variety of styles for specific audiences under significant time constraints. Advanced editorial skills, knowledge of current Associated Press style, attention to detail. Demonstrated skill in the use of visual modalities (videography/photography/graphic design/AI tools) in communications. Experience with design tools such as Canva, Adobe Creative Cloud. Ability to work independently and collaboratively, use sound judgment in making decisions, balance multiple priorities, and communicate proactively with stakeholders about project risks or uncertainties. Demonstrated organizational and project management skills. Demonstrated success in cultivating relationships with research faculty and/or key stakeholders. Demonstrated flexibility and adaptability, including a willingness to undertake both mundane and high-profile tasks. Application Materials Resume or CV Cover letter 2-3 writing samples preferably science related Additional Job Description Minimum Requirements: A bachelor's degree and two years relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

Posted 1 week ago

Director, Medical Writing -logo
Director, Medical Writing
TrialSparkNew York, NY
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.   Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.  You can read more at the following links: Our Vision for AI in Pharma Our Current Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently. About the Position The Director of Medical Writing will be responsible for developing and implementing medical writing strategies and operational plans to support Formation Bio Clinical Development activities. The Medical Writer will have responsibilities to write or facilitate the writing of key documents, with an emphasis on clinical development related documents within the Research & Development department. This team member will be the first member of a growing team and work across multiple teams to integrate the medical writing strategies and operational plans. Responsibilities Leads and manages the writing, review, and finalization of clinical development documents such as protocol synopses and protocols, Investigator’s brochures (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by serving as the document author or providing oversight to the assigned author. Partners with Formation Bio’s tech team members to innovate and streamline regulatory writing processes through a combination of programmed automation solutions and the use of generative AI tools Creates the timelines, in conjunction with the project team or relevant subteam, for completion of clinical development and pharmacovigilance related documents. Ensures that clinical, regulatory, and/or pharmacovigilance documents are developed in a format compliant with the governing regulatory agency (EMA, FDA, and ICH guidelines) and with electronic submission guidelines.  Acts as liaison between cross-functional department personnel to ensure that background materials are provided, timelines are communicated, and questions are answered for Medical Writing deliverables. Ensures that Medical Writing deliverables are complete, well organized, and scientifically accurate, and that messaging is consistent throughout all technical documentation to reflect the project and regulatory strategies and requirements. Reviews work of other functional expert writers for accuracy, quality, and appropriate messaging. Facilitates internal review of materials and documents and consolidates comments from internal and external reviewers (adjudication meetings).  Leads the development of style standards and guidelines for preparation of documents, including those submitted to health agencies, and ensures Medical Writing deliverables adhere to stylistic guidelines. Potentially supervises and manages external contracted medical writers to ensure quality and meeting of timelines for all clinical development  and select pharmacovigilance and/or regulatory documents as prioritized by the CMO. This could also include the coordination of working with CROs to assist in moving any of these documents to completion. Keeps management current on project status and provides ongoing risk assessments. Develops and implements continuous improvement processes for document writing processes. Accomplishes department objectives by managing and leading medical writing team members and contractors and deliverables. Potentially involved in the development of the medical writing team by effectively recruiting, selecting, orienting, and training employees. Ensures all tasks are carried out in accordance with applicable principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines. About You Bachelor of Science Degree, as a minimal requirement. A advanced degree (MS or PhD) is preferred. 7+ years of experience in the development of clinical and regulatory documents to support drug development programs.  Experience as lead writer for key clinical and regulatory documents required. Experience mentoring or managing other writers (internal or contract) preferred. Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (ie, eCTD). Excellent critical thinking, organizational, problem solving, negotiation, and time management skills. Able to effectively manage multiple assignments and adapt flexibly to changing priorities. Strong communication skills with the ability to simply summarize complex information verbally and in a written format. Able to work collaboratively on multi-disciplinary project teams and to proactively manage relationships with external medical writing vendors. Ability to lead and/or facilitate meetings. Formation Bio is headquartered in New York City, with plans to build a larger team and presence in Boston. We are prioritizing hiring in these areas, with an expectation for NYC-based employees to work in the office at least two days per week. While our primary focus is on candidates in NYC (including the Tri-state Area) and Boston, we may consider remote candidates from specific geographies based on qualifications, skills, and business needs. We believe that in-person collaboration is essential for breaking down silos, fostering cross-functional teamwork, and embedding our company values into daily work. All employees located outside of the NYC Metro Area will be expected to travel to the NYC office at least four times per year for company events and team-specific meetings or activities. Compensation: Salary ranges are informed in part by geographic location, in addition to other factors. The target salary ranges for this role are:  NYC Metro Area, Boston Metro Area, SF Bay Area : $250,000 - $300,000 All Other Eligible Remote Locations : $238,000 - $285,000 The ranges provided above include base salary only. In addition to base salary, we offer equity, generous perks, hybrid flexibility, and comprehensive benefits. If this range doesn’t match your expectations, please still apply because we may have something else for you. ** Eligible Remote Locations: Alabama (AL), Arizona (AZ), California (CA), Connecticut (CT), Florida (FL), Georgia (GA), Illinois (IL), Indiana (IN), Maryland (MD), Massachusetts (MA), New Hampshire (NH), New Jersey (NJ), North Carolina (NC), Ohio (OH), Pennsylvania (PA), South Carolina (SC), Texas (TX), Utah (UT), Virginia (VA), and Washington, D.C. (DC). You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. #LI-hybrid

Posted 30+ days ago

Senior Technical Writing/Editing Specialist-logo
Senior Technical Writing/Editing Specialist
CIYISAlbuquerque, NM
About the Role We are seeking a detail-oriented and experienced Senior Technical Writing/Editing Specialist to support the NE-NL Logistics & Maintenance Division (NLMJ), Joint Nuclear Weapons Publications System (JNWPS) Team. This role involves drafting, editing, and managing technical publications, ensuring compliance with established standards, and coordinating with internal and external stakeholders to maintain high-quality documentation. Key Responsibilities • Adhere to the Government Printing Office Style Manual, JNWPS Continuity Book, and Technical Publication 1-1. • Draft and edit publications for inclusion in JNWPS. • Provide draft publications for Comment and Review, Consolidating Comments, and Final Product Review processes. • Assist in resolving issues with JNWPS content. • Collaborate effectively with JNWPS management to complete assignments. • Support project officers during review and finalization processes. • Create and maintain in-house documentation such as checklists, logs (SIPR, DIAMONDS, Customer Conversation), and quality assurance checks. • Upload technical publications to DIAMONDS. • Prepare, reproduce, distribute, and track media products. • Coordinate with JNWPS counterparts across DTRA and external organizations. • Initiate and update reference and 'How to...' materials; document conversations as needed. • Submit trouble tickets as required. • Provide editorial support for meetings and correspondence. • Conduct CD burn and distribution via ARL Safe. • Maintain the Publication Requirement Table for all accounts. • Maintain the Technical Publication tracking system. Required Qualifications • Detail-oriented, highly organized, and task-driven. • Excellent time management skills and ability to work independently. • Proficiency in Adobe FrameMaker, Adobe Illustrator, Photoshop, Excel, and Adobe Acrobat. • Strong written and verbal communication skills. • Experience in technical writing and editing in a government or defense environment. • Ability to obtain a DOE L clearance. Preferred Skills • Experience with JNWPS or similar technical publication systems. • Familiarity with DIAMONDS and SIPR systems. • Ability to support and coordinate technical documentation processes across multiple teams. CIYIS is an Equal Opportunity Employer and all Qualified Applicants will receive consideration for employment without regard to Race, Color, Religion, Sex, National Origin, Disability Status, Protected Veteran Status or any other Characteristic Protected by Law.

Posted 1 week ago

Adjunct - English: Professional Writing-logo
Adjunct - English: Professional Writing
Saint Leo UniversitySaint Leo, FL
Job Description Summary Saint Leo University is current seeking qualified candidates to be cleared and added to our adjunct availability pool. Qualified applicants, transcripts, and materials will be reviewed and processed in preparation for assignment-based student enrollment needs for upcoming terms. Select adjuncts from the pool are contracted term-by-term based on course/section need and availability. Saint Leo University reserves the right to not schedule and/or cancel courses based on enrollment. Job Description Special Instructions Required Documents In addition to your curriculum vitae/resume, the following documents are required for consideration. Please be sure to check the email under which you applied for important instructions on completing remaining steps, including uploading documents in the second step of the application packet process as follows: Cover Letter Teaching Philosophy - (500 words or less), highlight how your teaching philosophy and practices fit the Mission and Values of Saint Leo University. Three (3) Names of References- Please list three names of recent professional references, including at least one recent supervisor. Be sure to include reference name, email and phone numbers. Transcripts Official transcripts are required for all adjuncts. All official transcripts must be requested from the universities and/or colleagues attended and/or certified transcript evaluations/translations from World Education Services (WES) to be sent to the attention of Veronica Mantegna by email to faculty.transcripts@saintleo.edu or hardcopy to the following address: ATTN: VERONICA MANTEGNA ACADEMIC AFFAIRS - MC 2006 SAINT LEO UNIVERSITY PO BOX 6665 SAINT LEO, FLORIDA 33574 Instructors will be responsible for teaching within the English: to teach Professional Writing: ENG-205: Introduction to Professional Writing ENG-310: Social Media ENG-421: Editing Adjuncts are required and agree to: Teach assigned courses as contracted. Provide all necessary information and teach materials as provided on the course syllabus. Submit final grades within three (3) days after the end of the term. Deliver in a professional manner course content for any assigned course(s) as specified by the master syllabus and/or as directed by the appropriate academic school dean, director, or chair. Meet all scheduled class meetings for the assigned period. Be available to students before and after class for individual consultation. Cooperate in the dissemination of information to students. Abide by and uphold University policies and core values. Carry out instructor duties and responsibilities as provided on the website, handbook(s), and policies. REPORTING: Adjuncts are assigned to specific teaching locations and report to their location administrator as it pertains to daily operations as defined in the term-by-term contractual agreement, but ultimately have responsibility to their discipline specific department chair or director and/or school dean. Required/Minimum Qualification(s): A master's degree and 18 graduate semester credit-hours in the either Professional Writing or Journalism from a regionally accredited institution. Why Work at Saint Leo? What it's Like to Work Here: Ask our employees and the one word they'd use to describe working at Saint Leo University is "Community." Our team members all share the Saint Leo core values, positive attitudes, and problem-solving abilities, enabling them to provide excellent student centered service. Our mission is educating and preparing students for life and leadership in a challenging world. Thank you for your interest in joining the Saint Leo PRIDE! We are committed to providing our employees with the support they need. At Saint Leo, we offer an array of medical, dental, and vision packages as well as several add-on perks to make your benefits package truly customizable to you and your family needs. Available benefits based on employment status (Full Time vs Part Time). Inclusive Group Health Plan (Medical, Dental, Vision) Group Health Plan features include Teledoc, Surgery Plus!, Wellness Incentive Program, Nationwide Pet Insurance, just to name a few! Health Reimbursement Account (University Paid!) and Flexible Spending Accounts (healthcare and dependent options) Tuition Remission (Employee, Spouse, and Dependents)* Tuition Exchange opportunity for dependent of employees* Paid Personal Leave (Sick, Vacation, Holidays) 403b- Annual match 3%-9% of pay based on employee's contribution. University match and fully vested within one month of hire date. Basic Life and AD&D Insurance valued at 30k (University Paid!) Income Protection Benefits after one year Additional options for supplemental insurance Eligibility based on meeting required service period

Posted 2 weeks ago

Online Academic Tutor - College English and Writing-logo
Online Academic Tutor - College English and Writing
The Princeton ReviewManhattan, NY
Are you looking to make an impact through a rewarding, flexible part-time gig that you can do from home? The Princeton Review is looking to bring on additional online Academic Tutors for rewarding work that can make a difference. Major Responsibilities: Tutor students in our online classroom in a dynamic and supportive manner Customize lesson plans to meet students’ needs and keep them engaged in material. Familiarize yourself with a student’s school curriculum Model professionalism and accountability at all times by showing up to tutoring sessions on time, replying to students and parents in a timely manner, and holding students accountable for assignments. Create an open, safe, and positive learning environment. Regularly documenting student progress and communicating this progress with student and parents. Education, Experience & Qualifications: Bachelor’s degree completed or in progress Confident and engaging discussion leader High school level expertise in academic subject matter evident through educational background or work-related experience. Excellent verbal and written communication skills Availability after school and/or weekends. Summer daytime availability a plus. Applicants must pass a qualifying exam Access to a reliable internet connection and computer in a reliably quiet location Experience with one-on-one tutoring required. Experience teaching online preferred. Why you want to teach for The Princeton Review: Competitive hourly teaching rates Flexible hours: work when you’re available to work Paid training Performance and merit-based raises and bonuses You can work remotely from most locations with a stable internet connection within the US Work for a company with a long-standing reputation in the education industry with opportunities for growth. English/Writing Subjects Needed: College English Writing Additional subjects needed: Algebra Pre-Calculus Chemistry Physics English (HS) Essay Writing Grades 9-12 Pre-Algebra Algebra II Geometry Calculus Biology Trigonometry Statistics French Spanish Compensation: Pay: $16-$26 per hour, based on credentials and geographic location The company does not provide benefits for this position. Applications accepted on an ongoing basis. Please note that the above-referenced position can be performed anywhere in the United States except in the following states: Arkansas, Hawaii, Idaho, Mississippi, New Mexico, North Dakota, Rhode Island, South Dakota and Wyoming. About The Princeton Review: The Princeton Review is a leading tutoring, test prep, and college admission services company. Every year, it helps millions of students bound for college and graduate school to achieve their education and career goals through online and in-person courses delivered by a network of more than 4,000 teachers and tutors, online resources, and its more than 150 print and digital books published by Penguin Random House. The company’s Tutor.com brand is one of the largest online tutoring services in the U.S. It comprises a community of thousands of tutors who have delivered more than 19 million one-to-one tutoring sessions. The Princeton Review is headquartered in New York, NY. Follow the company on LinkedIn , YouTube and Instagram . The Princeton Review is an equal employment opportunity employer. The Princeton Review’s policy is not to discriminate against any applicant or employee based on race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, marital status, disability, military status, genetic information, or any other basis protected by applicable law. The Princeton Review also prohibits harassment of applicants or employees based on any of these protected categories. It is also The Princeton Review’s policy to comply with all applicable laws respecting consideration of unemployment status in making hiring decisions. The Princeton Review is a drug-free workplace. Pursuant to, and consistent with, any applicable state or local laws, such as the Los Angeles Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance for Employers, New York City Fair Chance Act, Philadelphia’s Fair Chance Hiring Law, and San Francisco Fair Chance Ordinance, The Princeton Review will consider for employment qualified applicants with arrest and conviction records. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Review the Privacy Policy for California Employees, Job Applicants, and Independent Contractors

Posted 30+ days ago

Director, Medical Writing (Hybrid)-logo
Director, Medical Writing (Hybrid)
Vertex Pharmaceuticals, IncBoston, MA
Job Description Our Medical Writing team at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams, authoring and driving clinical & regulatory documents to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available. The Director, Medical Writing Science has responsibility for the management, oversight, operation, and direction of a group within the department. This role is held accountable for the results of the group and the work performance of line staff and is responsible for setting technical direction for the staff. This role is expected to optimize interdisciplinary understanding and teamwork and integrate activities with those of other groups in Medical Writing Science and with other functions. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Advises development teams on the content and optimal presentation of documents to facilitate achievement of submission objectives Provides strategic input into program-level and therapeutic area plans, including defining the direction of the clinical development program or regulatory strategies Sets goals and strategic vision for the group shares that vision within Medical Writing Science Optimizes interdisciplinary understanding and synergy within group(s) and integrate activities with those of other department and project teams Manages resource plans for projects within their oversight ensuring appropriate staff are available to meet program goals Provides coaching and performance management for staff, ensuring goal setting is effectively linked to program and corporate goals Plans strategically, anticipates problems, and recommends process improvements to address current and future needs Provides expert review of policies and procedures for the department innovates and leads process improvements with high cross-functional impact Knowledge and Skills: Highly advanced understanding of the clinical development process and authoring and preparation of the clinical sections of marketing applications and other regulatory submissions Proven track record of developing, communicating, and executing strategic direction for projects Strong leadership and influencing skills, ability to communicate and present ideas/solutions to senior management Ability to recognize business impact and identify networks to gain unified approach to solutions Demonstrated knowledge of field Ability to manage teams and individuals Experience with marketing applications for regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) highly preferred Typically requires 10 years of relevant medical writing experience in Pharma, Biotech or CRO industries and 3 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $0 - $0 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Posted 5 days ago

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

Posted 30+ days ago

Senior Manager, Medical Writing-logo
Senior Manager, Medical Writing
Gilead Sciences, Inc.Parsippany, NJ
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description POSITION OVERVIEW: Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world. We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Inflammation) to join our dynamic team. You will author a wide range of regulatory documents independently, including documents of high complexity. You will lead review and planning processes for multiple products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements, new standards, and updating document templates. You may coach, train, and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise contractors to ensure the highest quality of medical writing and adherence to Gilead documents standards. EXAMPLE RESPONSIBILITIES: Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator's brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses. May represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent. Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects. May serve as the filing lead for small to medium regulatory submissions. May serve as lead medical writer and department representative across development programs. Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities. May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives. Where applicable, oversees the work of external contractors supporting deliverables and other activities. May coach, train, and provide guidance to less experienced Medical Writing colleagues. Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements. REQUIREMENTS: We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. U.S. Education & Experience PharmD/PhD with 4+ years' relevant experience. MA/MS/MPH/MBA with 6+ years' relevant experience. BA/BS with 8+ years' relevant experience. Significant medical writing, regulatory, quality, clinical R&D, or related experience supporting medicinal products. Significant experience in the biopharma industry is strongly preferred. Experience authoring a broad range of regulatory, scientific, and/or medical documentation across multiple stages of drug development. Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred. Rest of World Education & Experience BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry. Knowledge & Other Requirements Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance. In-depth knowledge of relevant health authorities, including system, processes and requirements. In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation. Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives. Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles. Ability to lead and influence programs, projects and/or initiatives. Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly matrixed environment. When needed, ability to travel. The salary range for this position is: Other US Locations: $157,590.00 - $203,940.00. Bay Area: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 3 weeks ago

Writing Studio Student Worker-logo
Writing Studio Student Worker
Lipscomb UniversityNashville, TN
Tutoring university students one-on-one on all aspects of the writing process. Consultants will receive training and the opportunity to attend and present original work at professional conferences with the Writing Studio Director. Education: For those interested in the writing process, creative writing, teaching, or who expect to continue their English education at a graduate-level; and students who have passed LU 1203 and EN 1313 with a 'B' or above. Job Related Skills: Good oral and written communication skills. Proficiency in all stages of the writing process: drafting, outlining, research, revision and polishing. Computer skills, including a working knowledge of Word, Excel, and Publisher. Strict confidentiality. Web/online etiquette. Strong attention to detail. Decision-making skills. Description of Tasks Performed: Tutoring university students one-on-one Promoting the Writing Studio Leading workshops for faculty or student groups Participating in community writing events Leading community writing workshops Meeting regularly with the Director and/or Assistant Director May be eligble for Federal Work Study.

Posted 30+ days ago

Writing Lab Coordinator-logo
Writing Lab Coordinator
Hinds Community CollegeUtica, MS
Position Title: Writing Lab Coordinator Job Description: JOB TITLE: Writing Lab Coordinator REPORT TO: Director, Instruction and Intervention Equals Retention and Graduation (I2=RG) DEPARTMENT: Title III EXEMPT: Yes VICE PRESIDENT: Vice President of Career and Technical Education, Sponsored Grants, and HBCU Initiatives GENERAL STATEMENT OF THE FUNCTION All Hinds Community College employees must commit to the Caring Campus approach to student engagement and daily apply these general behavioral objectives: listen to student questions and concerns with a positive attitude and make meaningful connections with students. QUALIFICATIONS REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND/OR EXPERIENCE Bachelor's degree required, in Education, English, Technical Writing, or related field and or, two years of experience teaching, mentoring, advising, career counseling, and/or providing student services in a higher education setting. Experience working in a post-secondary writing center/ lab preferred. ESSENTIAL DUTIES AND RESPONSIBILITIES, include the following. Maintain knowledge of diversity-related issues, legislation, and best practices. Conduct one-on-one student writing consultations. Assist students at any stage of the writing process, from brainstorming and outlining to revising and editing. Create and implement subject area workshops for students. Submit Writing Lab updates and advertisement to be posted on social media accounts. Coordinate all clerical duties associated with writing lab work-study students. Assist with department initiatives that require supporting students with writing. Supervise the day-to-day operations and maintenance of the Reading/Writing Lab; assure the availability of necessary materials and maintain an appropriate learning environment. Establish and monitor lab schedules to optimize tutor availability and student participation. Host subject area off campus exposure opportunities. Meet and confer with English department faculty; establish and implement program standards, policies and procedures. Prepare and maintain records of student lab usage and document communication. Adhere to department objectives and monthly reporting processes. Participate in professional developments that support continuous development of the lab. Evaluate tutorial program on a periodic basis; solicit feedback, recommendations and evaluations from faculty members relevant to the program and tutors; propose and implement changes to the program as needed. Meet and confer with tutors and students to resolve specific problems; determine appropriate writing tutor and schedule tutoring time; orient new tutors concerning policies and procedures. Develop a list of classroom workshops or topics to disseminate to faculty. Schedule and conduct lab tours and travel to other locations to evaluate lab operations. Other duties may be assigned. SUPERVISORY RESPONSIBILITIES: None PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hand to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to stand, walk, sit, taste and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate, and the employee is occasionally required to perform job responsibilities in the outdoors and off site. We promote a culture of inclusion for all employees that respects individual strengths, ideas, and capabilities. We believe that our differences enable us to make better decisions, drive innovation, and deliver better results. MISSION Hinds Community College is committed to moving people and communities forward by helping develop their purpose, passion and profession. VISION Hinds Community College will be a catalyst to create a competitive economy and a compelling culture for Mississippi. VALUES Hinds Community College aspires to the following IDEALS: Integrity Diversity Excellence Accountability Leadership Stewardship In compliance with Title VI of the Civil Rights Act of 1964, Title IX, Education Amendments of 1972 of the Higher Education Act, Section 504 of the Rehabilitation Act of 1973, the Americans with Disabilities Act of 1990 and other applicable Federal and State Acts, Hinds Community College offers equal education and employment opportunities and does not discriminate on the basis of race, color, national origin, religion, sex, age, disability or veteran status in its educational programs and activities. We recognize our responsibility to provide an open and welcoming environment that fosters a culture of diversity, equity, and inclusion for employees and students to collaboratively learn, work and serve our communities. The following have been designated to handle inquiries regarding these policies: EEOC Compliance: Coordinator of Campus Culture and Diversity Box 1100 Raymond MS 39154; Phone: 601-857-3458 or Email: EEOC@hindscc.edu. Title IX: Associate Vice President Student Services, Title IX Coordinator Box 1100 Raymond MS 39154; Phone: 601-857-3353 or Email: TitleIX@hindscc.edu Full Time/Part Time: Full time Position Type: 9 Month 175 Days Job Classification: Title III Scheduled Hours: 35

Posted 3 weeks ago

Part Time Writing Center Tutor-logo
Part Time Writing Center Tutor
Ivy Tech Community CollegeFort Wayne, IN
Provide individual and group tutoring virtually and in-person in a manner that enhances student success. Primary focus will be on tutoring for Freshman Composition courses. Major Responsibilities: Will be working on-campus. Maintain a functional and productive tutoring environment. Interact with faculty as to student needs, course changes and writing strategies. Monitor student activity logs and internet sites accessed. Assist students with Canvas, MicroSoft Office, and other software programs. In addition to the above, other duties associated with working in the Writing Center may be assigned. Minimum Qualifications: Credentialed to teach ENGL 111: English Composition: "A qualified faculty member in English meets the discipline standard through one of two routes: Possesses an earned master's or higher degree from a regionally accredited institution in English, or Possesses an earned master's or higher degree from a regionally accredited institution in any field with 18 graduate semester credit hours in English, linguistics, or courses related to the writing process" (ASOM 07.01.00) Must provide cover letter and transcripts with application Preferred Qualifications: The Minimum Qualifications and Tutoring or teaching experience at the college level. Other Requirements: Selected candidate for employment will be subject to pre-employment background checks, including criminal history check, and any offer of employment will be contingent upon that outcome. Transcripts due at the time of hire. Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College's Title IX Coordinator or to the US Department of Education Office of Civil Rights.

Posted 30+ days ago

Kaplan Exam Services - Exam Development Specialist, Essay Writing-logo
Kaplan Exam Services - Exam Development Specialist, Essay Writing
Kaplan, Inc.Washington, DC
Job Title Kaplan Exam Services - Exam Development Specialist, Essay Writing Job Description CA Essay Question Writers will be instrumental in crafting California-specific bar exam essay questions that challenge examinees and reflect the intricacies of California law. Their contributions will support the organization's goal by providing top-notch, relevant materials. Incumbents are expected to use their extensive knowledge of California legal principles and commitment to precision to develop clear, accurate, and confidential essay questions. Primary/Key Responsibilities Develop California-Specific Bar Exam Essays: Write clear, precise, and legally accurate essay questions tailored to California bar exam standards to ensure rigorous and relevant exam content. Ensure Legal Accuracy: Conduct thorough legal research and verification for each essay question to maintain the integrity and accuracy of the exam materials. Review and Edit Questions: Collaborate with other writers and editors to review and refine essay questions, ensuring clarity and eliminating ambiguities. Adhere to Confidentiality Standards: Follow strict confidentiality protocols to protect the integrity of the exam content and prevent unauthorized disclosure. Apply California Legal Expertise: Utilize in-depth knowledge of California-specific subjects such as Community Property and California Civil Procedure to develop relevant and challenging questions. Integrate Feedback: Implement feedback from peer reviews and supervisors to improve the quality and accuracy of essay questions continuously. Update Content Regularly: Stay current with changes in California law and update essay questions accordingly to keep the exam content relevant and accurate. Meet Deadlines: Work efficiently to meet project deadlines, ensuring timely delivery of high-quality essay questions. Collaborate with Team Members: Engage in regular communication and collaboration with team members to align on project goals and share best practices. Minimum Qualifications J.D. (Juris Doctor Degree) 1+ years of experience in the legal industry, or education and/or curriculum design. Passed the bar exam Excellent verbal and written communication skills Proficiency in English grammar Ability to work in a collaborative team environment Demonstrated ability to meet deadlines while maintaining product quality and accuracy Preferred Qualifications Previously written essay questions for law school and/or bar exam content CA Bar Admission We offer a competitive benefits package including: Remote work provides a flexible work/life balance Our Gift of Knowledge Program provides tuition assistance and substantial discounts for our employees and close family members Access to health and wellness benefits new hire eligibility starts on day 1 of employment Access to 401K Savings Plan company match provided after eligibility is met Employee Discounts enjoy discounts, rewards, and perks on thousands of the brands you love in a variety of categories And so much more! #LI-Remote #LI-TK1 The hourly rate for this position is $70.00 per hour Location Remote/Nationwide, USA Additional Locations Employee Type Employee Job Functional Area Content/Material Creation Business Unit 00091 Kaplan Higher ED At Kaplan, we recognize the importance of attracting and retaining top talent to drive our success in a competitive market. Our salary structure and compensation philosophy reflect the value we place on the experience, education, and skills that our employees bring to the organization, taking into consideration labor market trends and total rewards. All positions with Kaplan are paid at least $15 per hour or $31,200 per year for full-time positions. Additionally, certain positions are bonus or commission-eligible. And we have a comprehensive benefits package, learn more about our benefits here. Diversity & Inclusion Statement: Kaplan is committed to cultivating an inclusive workplace that values diversity, promotes equity, and integrates inclusivity into all aspects of our operations. We are an equal opportunity employer and all qualified applicants will receive consideration for employment regardless of age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, veteran status, nationality, or sex. We believe that diversity strengthens our organization, fuels innovation, and improves our ability to serve our students, customers, and communities. Learn more about our culture here. Kaplan considers qualified applicants for employment even if applicants have an arrest or conviction in their background check records. Kaplan complies with related background check regulations, including but not limited to, the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. There are various positions where certain convictions may disqualify applicants, such as those positions requiring interaction with minors, financial records, or other sensitive and/or confidential information. Kaplan is a drug-free workplace and complies with applicable laws.

Posted today

Director, Proposal Writing-logo
Director, Proposal Writing
CCS FundraisingNew York, New York
Description TITLE: Director, Proposal Writing LOCATION: New York, New Jersey, Connecticut REPORTS TO: Senior Director, Proposal Writer TYPE: Full Time, Remote (with occasional one to two days in-office a week) Please submit a cover letter. This position is not eligible for employer visa sponsorship. WHO WE ARE CCS Fundraising is an international strategic fundraising firm that partners with nonprofits for transformational change. Since 1947, CCS has empowered many of the world’s greatest organizations across sectors to advance some of the most important causes in history. We plan, manage, and implement programs and initiatives that achieve fundraising goals and mission impact. CCS provides tailored support to more than 700 nonprofit organizations annually. Headquartered in New York, the firm has over 600 professionals and 18 offices throughout the United States and Europe. Our people are our greatest strength. At CCS, you will join a diverse team of smart, passionate, and resourceful professionals who are driven by purpose and committed to performance. UNDERSTANDING THE ROLE CCS is seeking a motivated, deadline-driven Director, Proposal Writing to work with a New York-based Executive team. The successful candidate will work closely with our Executive team, managing new leads from ideation to contract and ensuring that all team Executives have the materials and preparation they need to conduct successful business development and sales meetings. A critical component of this role is to produce compelling, consistent, creative, and professional proposals, RFPs, and presentations that differentiate CCS from our competitors. Please note that this is not a sales or lead generating position. Ideal candidates will possess excellent writing, communication, research, and design skills to contribute to the development of sales materials and resources. The candidate is also comfortable working with multiple Executives and other proposal writers and is capable of meeting set deadlines and prioritizing tasks in a fast-paced corporate environment. Prior experience with RFPs, proposals, and client relationship management databases are a plus. Experience with research, data visualization, and professional writing is key. This is an excellent opportunity to join a growing team in a role that has room to grow and evolve. RESPONSIBILITIES Write and design customized sales proposals, presentations, and supporting materials in close coordination with the Executive Team Participate in sales meetings as needed to understand client needs and inform proposal strategy Develop tailored content based on the specific needs, scope, and interests of each prospective client Partner with Team Executives to define key elements of each proposal, including scope of work, pricing, and service structure Establish and manage internal timelines to guide daily work and ensure on-time delivery of materials Collaborate with the Executive Team to identify strategic next steps for active leads in the sales pipeline Support final editing, formatting, and distribution of proposals and other materials Complete research on potential leads and complete other sales materials in advance of sales meetings to ensure Team Executives are prepared in a timely manner Maintain and update proposal templates; customize templates as needed for specific proposals, decks, one-pagers, etc. Assist other proposal writers in securing client case studies and references for proposals Draft thank-you and follow-up correspondence for Team Executives Work with team database coordinators to ensure our information is up-to-date Liaise with proposal writers across the firm to understand trends and continually enhance materials Additional tasks as needed to support the sales process QUALIFICATIONS Bachelor’s degree required 3+ years professional experience with proven writing and project management track record Exceptional ability to manage multiple projects and competing deadlines in a fast-paced environment Excellent writing and visualization skills, with a keen eye for detail Thorough proofreading skills Excellent time management and organizational abilities; capable of independently structuring time and tasks to meet deadlines Demonstrated resourcefulness and initiative in problem-solving and adapting to changing needs Advanced knowledge of Word, Excel, PowerPoint, and Outlook Creative presentation design experience - experience with InDesign, Photoshop, Publisher, Canva, and other graphic design programs a plus but not required Comfortable working both independently and collaboratively within a team setting CCS offers competitive benefits, a dynamic training program, resources, career advancement, mentoring, and networking opportunities. We are an Equal Opportunity Employer and strongly encourage a diverse pool of candidates to apply. SALARY RANGE: $60,000 - $90,000 The exact salary varies within range based on years of relevant experience and education.

Posted 3 weeks ago

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

Posted 30+ days ago

CAS- Full-Time Lecturer - Department of Writing Studies-logo
CAS- Full-Time Lecturer - Department of Writing Studies
AcademyCoral Gables, Florida
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet . The Department of Writing Studies at the University of Miami is accepting applications for full-time lecturer positions with an expected start date of August 15, 2025. The normal teaching assignment is four courses each semester. With permission of the chair, Lecturers may also choose to substitute one course per semester for consulting 10 hours per week in the University’s Writing Center. Initial appointment(s) are for one year and may be renewable depending on enrollments and the university budget. We encourage applications from candidates with an interest in or experience with professional writing, grant writing, legal and policy writing, artificial intelligence, and data visualization. In addition to housing a vibrant and richly diverse first-year writing program, the Department regularly offers courses in professional writing, legal writing, STEM, and civic and community engagement. As well, the department has a Minor in Professional Writing and a new Writing-Enriched Curriculum initiative. Application materials should include: A cover letter describing your background and experience A curriculum vitae A list of 3 professional references Applicants must hold a PhD, MFA, or JD (or equivalent terminal degree) with a background in Writing Studies, Rhetoric and Composition, English, Professional and/or Technical Communication, or a closely related field, by the start date of the appointment. For consideration, applicants must submit their application materials, assembled as a single PDF file, to the University of Miami’s Career Opportunities website, located at: https://umiami.wd1.myworkdayjobs.com/UMFaculty . Review of applications will begin immediately and will continue until the positions are filled. Inquiries and requests for information can be sent to Dr. Ben Lauren, Chair of the Department of Writing Studies: blauren@miami.edu . The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Faculty

Posted 30+ days ago

Independent Contractor-Hospital RN (Appeal Writing/Denials Mgmt) (Remote)-logo
Independent Contractor-Hospital RN (Appeal Writing/Denials Mgmt) (Remote)
CorroHealthPlano, Texas
About Us: Our purpose is to help clients exceed their financial health goals. Across the reimbursement cycle, our scalable solutions and clinical expertise help solve programmatic needs. Enabling our teams with leading technology allows analytics to guide our solutions and keeps us accountable achieving goals. We build long-term careers by investing in YOU. We seek to create an environment that cultivates your professional development and personal growth, as we believe your success is our success. JOB SUMMARY: This will be a generic IC profile for any clinician that is contracted to work with Corro. ESSENTIAL DUTIES AND RESPONSIBILITIES: Note: The essential duties and responsibilities below are intended to describe the general duties and responsibilities of this position and are not intended to be an exhaustive statement of duties. This position may perform all or most of the primary duties listed below. Specific tasks, responsibilities or competencies may be documented in the Team Member’s performance objectives as outlined by the Team Member’s immediate Leadership Team Member. At CorroHealth our purpose is to help clients exceed their financial health goals. Across the reimbursement cycle, our scalable solutions and clinical expertise help solve programmatic needs. Enabling our teams with leading technology allows analytics to guide our solutions and keeps us accountable achieving goals. We build long-term careers by investing in YOU. We seek to create an environment that cultivates your professional development and personal growth, as we believe your success is our success. Job Description Status – Independent Contractor (Part-Time/Flexible) (20 hours per week min.) **Must complete and pass a technical and inpt clinical assessment. (link to be sent) ** JOB SUMMARY: As a Denial Management Appeals Clinician, you will have the unique opportunity to evaluate hospitalizations across the country while utilizing your medical knowledge and gaining experience as an expert advisor. You will perform retrospective clinical case reviews and draft appeals that focus on establishing the Medical Necessity of the services performed, both Inpatient and Outpatient. Essential Duties and Responsibilities: Performs retrospective medical necessity reviews to determine appeal eligibility of clinical disputes/denials. Constructs and documents a succinct and fact-based clinical case to support appeal utilizing appropriate medical necessity criteria and other pertinent clinical facts. Pertinent clinical facts include, but are not limited to, documentation preventing a safe transfer/discharge or documentation of medical necessary services denied for no authorization. Demonstrates ability to critically think, problem solve and make independent decisions supporting the clinical appeal process. Minimum Qualifications & Competencies: RN or MD degree with strong clinical knowledge - Active unrestricted clinical license in at least one state within the United States. Minimum of 5 years recent acute-care hospital experience, preferred. Minimum of 2 years Utilization Review / Case Management experience within the last 5 years. Managed care payor experience a plus in either Utilization Review, Case Management or Appeals. Must have excellent attention to detail, written communication skills and be computer proficient . Work will be assigned on an as-needed basis. It will consistent and weekly for the next several months at least. As such, Consultant will receive a queue assignment/ report a) on Tuesday each week with a due date of the end of the business day the following Thursday and b) on Friday each week with due date of the end of the business day the following Monday. Consultant must provide a minimum of 20 hours per week and not exceed 40 hours per week unless approved by manager. Consultant shall be paid bi-weekly as follows: Training: $1500 Stipend Meetings: $45 an hour for meetings attended (prorated for actual time spent) Written Appeals: $45 / completed written Inpatient appeal letter, $25 / completed written Outpatient appeal letter PHYSICAL DEMANDS: Note: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. Regular eye-hand coordination and manual dexterity is required to operate office equipment. The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. At times, Team Members are subject to sitting for prolonged periods. Infrequently, Team Member must be able to lift and move material weighing up to 20 lbs. Team Member may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines. A job description is only intended as a guideline and is only part of the Team Member’s function. The company has reviewed this job description to ensure that the essential functions and basic duties have been included. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

Posted today

Executive Director, Medical Writing-logo
Executive Director, Medical Writing
BridgeBio Pharma, Inc.San Francisco, CA
Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The primary responsibility for this role is to establish and manage the Medical Writing group for the Cardiorenal affiliates (currently includes Eidos Therapeutics and Calcilytix) at BridgeBio. The ideal candidate must have a strong understanding of health authority guidance(s) and requirements for clinical and regulatory documents, including public disclosure requirements in applicable regions. The Senior/Executive Director will be responsible for overseeing the development and finalization of clinical and regulatory documents such as INDs, briefing documents, NDA/MAA summaries, regulatory responses, and key clinical documents (eg, protocols, clinical study reports, investigator brochures). This person will direct, plan, author, and review documents, as well as manage internal and external Medical Writers, for the preparation of high quality documents. Other responsiblites include managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. Additional oversight of any vendor/contractor leveraged to complete projects. The role requires innovative problem-solving, influencing others, and change-management skills. The Cardiorenal Medical Writing department will support multiple clinical development programs across the Cardiorenal Diseases division of BridgeBio. Currently this includes acoramidis for ATTR (Eidos affiliate) and encaleret for ADH1 (Calcilytix affiliate). The role reports to the VP of Regulatory Affairs. Responsibilities Oversee the Cardiorenal Medical Writing group, including leading, training, and mentoring for effective performance Lead medical writing (including coordination of other Medical Writers) from concept to final product for clinical study protocols and associated forms, protocol amendments, clinical study reports, investigator brochures, and related clinical study documents Provide strategic leadership to study teams to direct the preparation of protocols and CSRs, submissions, and other regulatory documents, and associated public disclosure documents. Lead medical writing (including coordination of other Medical Writers) from concept to final product for regulatory submissions including IND applications, health agency interaction Meeting Requests, Briefing Documents, , and related submissions, NDA/MAA data modules and overall submission packages, and other related documentation for initial and/or supplemental applications for marketing authorization or label expansion Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements Ensure company SOPs related to document development, templates, and medical writing deliverables conform with regulatory requirements (eg, International Conference on Harmonization (ICH) and other relevant regulatory guidelines). Take ownership of processes related to documents and guide teams through these processes Partner with clinical development, biostatistics, and data management in the review and development of tables, figures, and listings (TFLs), and for case narrative planning Work closely with study teams to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other data sources Project manage the document review process, ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed in a timely and efficient manner Ensure documents are generated in accordance with agreed internal processes and standards, are submission-ready, and are appropriately archived in the agreed document management system Ensure that appropriate documented quality control (QC) checks are performed on medical writing deliverables, respond to findings, and recommend quality process improvements Establish Medical Writing support models and implement strategies to improve operational efficiencies. Suggest or identify modifications and improvements to document preparation processes and company templates to continuously improve quality, efficiency, and productivity. Apply relevant experience in process initiative and/or vendor management Where You'll Work This is a hybrid role and requires in-office collaboration 2-3x per week, or as needed, in our San Francisco, CA & Palo Alto, CA offices. Who You Are Post-graduate scientific or medical degree (eg, MS, MPH, PhD, PharmD, MD, DO) with 10+ years of experience as a regulatory medical writer within the biotechnology or pharmaceutical industry Experienced in medical writing activities for multiple regulatory filings at various development stages Experience managing consultants and their projects Excellent oral and written communication skills, with the ability to summarize and present complex scientific and clinical data effectively with concise, accurate, and clear narrative flow and syntax Proficient in the drug development process, and strong understanding of health authority regulations, ICH guidelines, and medical writing standards, with the ability to interpret and apply these to document writing Excellent interpersonal, active listening, and influencing skills Strong project management skills, ability to work independently, multi-task, and work effectively under pressure Experience with EndNote, StartingPoint templates, and Veeva Vault preferred Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Posted 2 weeks ago

The Culinary Institute Of America logo
College Writing Adjunct
The Culinary Institute Of AmericaSaint Helena, CA
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Job Description

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