landing_page-logo
  1. Home
  2. »All Job Categories
  3. »Writing Jobs

Auto-apply to these writing jobs

We've scanned millions of jobs. Simply select your favorites, and we can fill out the applications for you.

N logo
Neurocrine Biosciences Inc.San Diego, CA
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of a multi-disciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building the submission writing team with in-house and contract resources. The ideal candidate will live in or be able to relocate to San Diego, we offer great relocation support. _ Your Contributions (include, but are not limited to): Leads the authoring process for all clinical/regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, PIPs and PSPs, and other regulatory documents as appropriate Leads multi-disciplinary teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, nonclinical, Clinical Pharmacology and Regulatory) from a writing and scientific perspective Interprets and presents scientific data, leads comment resolution meetings Ensures document content is clear, concise, strategic, and well positioned for public disclosure Leads and implements best authoring best practices and provides continuous training to teams Mentor internal staff Represent Medical Writing on departmental projects and cross-functional teams Assist other writers on NDAs and MAAs Proven leader who is confident, open to new and opposing ideas, and an exemplifies the Neurocrine culture of collegiality and teamwork Other duties as assigned Requirements: BS/BA degree in life sciences or related field and 8+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred OR Master's degree in life sciences or related field and 6+ years of similar experience noted above OR PhD in life sciences or related field and 4+ years of similar experience noted above Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses Strong science background that enables the ability to interpret and communicate scientific and clinical trial data Broad understanding of the medical writing processes, procedures, and systems (eg DMS) Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data Excellent understanding of the writing and regulatory process that enables streamlining of content and processes Experience leading NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) Anticipates business and industry issues; recommends relevant process / technical / service improvements Demonstrates broad expertise or unique knowledge Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Mentoring skills and ability to leads lower levels staff and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Recognizes broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Proven ability to lead cross-functional teams through the authoring process Excellent team player who can effectively navigate differing opinions and personalities Able to work well both independently and as part of a team Excellent project management skills, including managing simultaneous projects Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $153,800.00-$222,850.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 3 weeks ago

Cytokinetics logo
CytokineticsRadnor, Pennsylvania
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Senior Manager, Regulatory Writing is responsible for authoring regulatory documents, including but not limited to clinical study protocols, protocol amendments, clinical study reports (CSRs), clinical summaries, investigator’s brochures (IBs), pediatric documents, and regulatory authority briefing materials and responses. This individual will work independently with minimal oversight and in close collaboration with cross-functional teams to lead the development of these documents. All work must ensure scientific accuracy, alignment with study and submission objectives, compliance with standard operating procedures (SOPs), ICH/GCP and regulatory guidelines, and company goals. The Senior Manager will interpret and summarize complex regulatory data from a variety of sources in a concise, fit-for-purpose manner. This role requires strong attention to detail, critical thinking, and adherence to best writing practices. The Senior Manager will also lead and facilitate cross-functional meetings such as document kickoff meetings, data interpretation meetings, and comment resolution meetings. In addition, the role involves managing multiple complex writing projects, requiring excellent time management, problem-solving, and stakeholder engagement skills. The individual in this role will have demonstrated experience as a lead writer for a range of regulatory documents, including submissions, briefing materials, and responses to health authority questions. The role may also support other departmental Regulatory Writing activities as needed. Responsibilities Write, review, and edit clinical and regulatory documents such as clinical study protocols, CSRs, IBs, clinical summaries, and other documents as required for complex submissions (IND/NDA/BLA/MAA). In addition, provide support for health authority briefing documents, and responses to questions/requests for information, as needed. If a lead writer for assigned programs, serves as the primary point of contact for submission and project teams while acting as the lead author for complex documents while supporting document timelines and content strategy. May oversee additional writing and QC work performed by the vendors. For large, complex documents (e.g., CSRs), plan kickoff meetings, define overall timelines and lead authoring and comment resolution, from the initial draft through final approval. Arrange and conduct comment resolution/review meetings with cross-functional teams and depending on nature and complexity resolve document content issues independently or collaboratively (e.g. comments and questions arising from the writing/review process). Work with cross-functional stakeholder groups, including Clinical Research, Biometrics, Drug Safety, Regulatory, Clinical Pharmacology etc. as a significant contributor to set priorities for document preparation, collaborate on document content, and ensure scientific accuracy and alignment. Represent Regulatory Writing on project teams and advise on fit for purpose content and format requirements for various documents. Develop and drive timelines, and communicate writing process and timelines to team members. Provide status/updates of Regulatory Writing deliverables to management. Share and implement Regulatory Writing best practices to ensure efficiency and consistency across product teams. May contribute content to safety documents (e.g., DSURs, RMPs). May serve as a subject matter expert on systems and process initiatives including document management system implementations and updates to document development practices. Comply with established company policies and procedures, and industry and regulatory guidelines. Other duties as assigned. Qualifications BA/BS in one of the life sciences with a minimum of 8+ years of scientific or medical writing experience at a biotech/pharmaceutical company; or MA/MS/PhD with 5+ years of relevant regulatory/medical writing experience with a deep understanding of regulatory standards and data-driven documentation. Excellent communication skills both orally and in writing. Ability to work both independently and in cross-functional team environments with minimal supervision. Demonstrated ability to lead development of large/complex regulatory and clinical documents including but not limited to CSRs, module 2 summaries, and regulatory authority meeting briefing documents. Ability to engage and disseminate information among appropriate stakeholders for effective document preparation. Strong attention to detail with the ability to effectively write/summarize science-and data-driven content into clear, concise, and complete documents. Skilled in verifying data integrity, identifying errors and inconsistencies across various document types, and addressing them effectively. Ability to work effectively in a fast-paced environment with multiple high-priority projects. Ability to oversee consultants/contractors and serve as a liaison for project purposes. Excellent Project management skills. Knowledge of regulatory guidelines (e.g., ICH) and Good Clinical Practices (GCP). #LI-HYBRID Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $173,700.00 - $202,650.00 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you. Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying. Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves. Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process. Here are some ways to check for authenticity: We do not conduct job interviews through non-standard text messaging applications We will never request personal information such as banking details until after an official offer has been accepted and verified We will never request that you purchase equipment or other items when interviewing or hiring If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.com Please visit our website at: www.cytokinetics.com Cytokinetics is an Equal Opportunity Employer

Posted today

I logo
Impact KidsChicago, IL
About Us: Impact Kids has been providing safe, fun, and meaningful enrichment programs for over 5 years, and today we serve students at public and private schools across the country. Students have a safe space to develop, learn, play, and most importantly, just be kids in our before, during, and after school programs! Who We Are Looking For: Looking for experienced individuals for teaching and instruction of writing for kids. Candidate must possess a high energy, positive approach with a genuine desire to impact young children’s lives through writing. The ideal candidate would be knowledgeable about writing and be passionate about teaching kids. This individual must provide constructive criticism, implement curriculum, and be a team player.  Also demonstrate outstanding communication skills with children and their parents, which include the ability to use clear, concise, and grammatically correct written and oral language in all aspects of professional interaction with students, their families, peers, the leadership team and the larger community. A Child abuse clearance and criminal checks are required. Experience Requirements: A Minimum of 2 years of previous experience working with children; examples include but are not limited to:  academic/athletic tutoring, camp counselor, and youth volunteer. Writing instructor/teaching experience (1 – 5 years minimum) required. Education Requirements: Bachelor’s degree (preferred but not required) Essential Job Responsibilities: The Writing Tutor is responsible for the supervision of students, giving writing instruction, providing a safe and fun learning environment, and serving as a positive role model for students. Implementing daily writing tutoring to students between the ages of 4 and 18 with different ability levels. 1 on 1 Tutoring to connect with individual students for a highly personalized learning experience while managing the group of students. Teach fundamental writing to promote skill development and proficiency. Group supervision of students with attention to: behavior and group management, health and safety, security, and personal and skill development. Ensure the safety of students and team members Organize and prepare daily plans in a fun and creative manner. Use effective classroom management skills to lead the activity and effectively create a fun environment where everyone feels included. Work effectively with fellow Activity Specialists and collaborate on daily responsibilities. Serve as a positive role model to students. Follow the Impact Kids Code of Conduct and maintain the Impact Kids look at all times. Exhibit Impact Kids Core Values at all times and adhere to all company policies. Have fun! Working Conditions and Physical Requirements: Be willing to travel. Ability to respond to emergency situations that may require running and climbing stairs. Good physical condition which enables candidate to execute all responsibilities associated with this position Powered by JazzHR

Posted 30+ days ago

Spanish River Church logo
Spanish River ChurchBoca Raton, FL
Spanish River Christian School (SRCS), located in Boca Raton, FL, has been educating students in a Christ-centered environment for over 40 years. SRCS partners with families to provide a nurturing, academically rigorous education grounded in biblical truth, shaping students to become compassionate, courageous Christian leaders. SRCS seeks a passionate, faith-driven Writing Workshop Teacher for 7th and 8th grade beginning in the 2025–2026 academic year. This teacher will implement The Writing Revolution curriculum while integrating biblical principles and cultivating both skill and joy in writing. The ideal candidate is an engaging educator who inspires students, builds strong relationships, and fosters their academic and spiritual growth. A background screening and drug screening are required of all candidates offered employment. REPORTS TO: Middle School Principal QUALIFICATIONS: · Bachelor’s degree in English, Education, or related field (Master’s preferred) · Valid Florida Teaching Certification in English or Middle Grades Education · Active member of Spanish River Presbyterian Church or another church approved by school leadership · A strong personal commitment to the Christian faith and a biblical worldview · Demonstrated success engaging middle school students and differentiating instruction CORE RESPONSIBILITIES: Spiritual & Relational Leadership · Model a mature Christian faith in word, conduct, and daily life · Integrate biblical principles into lessons, discussions, and classroom culture · Demonstrate daily commitment to prayer, Scripture, and Christian service · Build respectful, caring relationships with students, families, and colleagues Instruction & Curriculum · Deliver engaging, developmentally appropriate writing instruction aligned with school standards · Inspire critical thinking, creativity, and effective written and oral communication · Assess student writing regularly, providing clear feedback and support for growth · Maintain high academic and behavioral expectations with consistent, Christ-centered discipline Professionalism & Collaboration · Partner with faculty and staff to support a unified school community · Attend required faculty meetings, professional development, and parent conferences · Communicate proactively with parents regarding student progress and needs · Support school programs and co-curricular activities as appropriate Schedule: · Schedule: Monday–Friday, 11:45 AM–12:30 PM (one daily 45-minute class, approx. 15 students) · Location: On campus in Boca Raton, FL Why Teach at SRCS? At SRCS, teaching is more than a job—it’s a calling. By joining our faculty, you’ll become part of a legacy of faith, learning, and service. As a Writing Workshop Teacher, you will help shape the hearts and minds of middle school students, preparing them academically and spiritually for lives of purpose and impact. We invite you to bring your passion for teaching, your commitment to Christ, and your creativity to a school community that deeply values its teachers and mission. Spanish River Christian School is a Drug-Free Workplace. We participate in E-Verify. Powered by JazzHR

Posted 2 weeks ago

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

Posted 30+ days ago

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

Posted today

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

Posted 30+ days ago

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

Posted 4 days ago

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

Posted 2 days ago

B logo
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

C logo
Charles R. Drew UniversityLos Angeles, California
Essential Duties and Responsibilities: Meet with students on a one-to-one or small-group basis to give learning assistance. Maintain a weekly schedule of available hours in the Student Education and Services Center and through the online tutoring services scheduling system for student appointments for tutoring in course content areas and/or learning strategies. Support and develop writing skills, strategies, and grammar 101 techniques Familiar with referencing styles (APA and MLA) Excellent understanding of academic writing such as research and thesis papers in one or more disciplines Keep regular and accurate records of tutoring sessions using the required software and/or relevant forms. Visit applicable classes at least once to make contact with faculty members and to obtain any necessary course syllabi or materials. Attend tutor-training sessions as required by the Learning Specialist or the Dean’s Office. Assist with additional duties as needed; for example, organizing materials, performing student data collection and data reporting, or other duties. Provide requested reports and/or updates on tutoring. EDUCATION: Regionally accredited bachelor’s degree or equivalent of combined education; master’s degree is preferred. Must be in good academic standing at a regionally accredited college or university. Must have completed at least 12-18 units in the assigned content areas. EXPERIENCE: Must have a recommendation from a faculty member. Completion of the applicable course or courses related to the subject matter with a grade of “B” or above. Good English-language communication skills. SKILLS: Good interpersonal communication skills and ease in relating to people from varying educational, cultural, and social backgrounds. Reliability and punctuality. Demonstrates and maintains appropriate and professional behavior. Demonstrated data base management skills. Ability to establish priorities, meet deadlines and attain growth-oriented goals. Must possess excellent computer skills and be proficient in MS Windows, Word, Excel, etc. COMPLEXITY: The ability to perform highly detailed work with sustained attention and care while providing/obtaining information on numerous inquiries is paramount to success in this position. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasional stooping. Frequent standing. Constant walking, sitting, climbing, reaching high/low levels, finger movement, feeling, speaking clearly, hearing conversationally, and seeing far and near. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Occasionally required to work in confined space. MENTAL DEMANDS: The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Frequent variety of unrelated tasks. Constant calculating, interrupted work, a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity. Special Requirements: Ability to work effectively with a diverse community. COVID-19 Vaccination : As a health professions institution of higher education, Charles R. Drew University of Medicine and Science seeks to protect the health and safety of the University community. Accordingly, CDU will require COVID-19 vaccinations for all University students, faculty, and staff subject to limited exceptions and exemptions. The University vaccine requirement has been implemented consistent with federal and state law related to medical exemptions for students, faculty, and staff. Requests for disability and religious accommodations from faculty and staff will be evaluated consistent with the law and University policies and procedures. Hourly Rate Range: $17 for undergraduate students; $20 for graduate students Part Time EEO Statement: Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability or covered veteran status. Fair Chance Statement: Charles R. Drew University of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.

Posted 30+ days ago

Johnson & Johnson logo
Johnson & JohnsonTitusville, New Jersey
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Senior Manager/Associate Director, Regulatory Medical Writing X-TA At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Manager /Associate Director , Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area. The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland) or Spring House/Raritan/Titusville (East Coast US). Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company. Are you ready to join our team? Then please read further! You will be responsible for : Leading compound/submission/ indication /disease area writing teams independently. May have additional major responsibility with supervision. Cross-functional, cross-TA, or cross-J&J initiative/collaboration. Larger organizational responsibility ( eg , manage a subset of TA). Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role on with respect to timing, scheduling, and tracking. Leading program-level/submission writing teams independently. Directly leading or setting objectives for others on team projects and tasks. Guiding or training cross‐functional team members on processes, best practices; coach or mentor more junior writers. Proactively identifying , contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes. Leading cross‐functional/cross‐TA, cross‐J&J process improvement initiatives, or other large process working groups. Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences. If a lead writer for a program: Primary point of contact and champion for Medical Writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program. Able to function as a lead writer on any compound independently. Leading discussions in Medical Writing and cross‐functional meetings as appropriate . Interacting with senior cross‐functional colleagues and external partners to strengthen coordination between departments. Able to oversee the work of external contractors. As a people manager: Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meets with direct reports to ensure appropriate development , projects, assignments, and issues are resolved. Ensures direct report’s adherence to established policies, procedural documents, and templates Able to make decision on hiring staff, onboarding new staff , conducting career and talent development discussions for staff, lead in goal setting and performance discussions. Qualifications /Requirements: University/college degree in a scientific discipline is . Masters or PhD preferred. At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of relevant Medical Writing experience is ! A t least 2 years of people management experience. Multiple therapeutic area experience preferred. Strong attention to detail. Strong oral and written communication skills. Fluent written and spoken English. Expert project management skills, expert project/process improvement leadership. Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Strong people management skills. Ability to delegate responsibility to junior writers. Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United Kingdom- Requisition Number: R- 027208 Belgium, Netherlands- Requisition Number: R- 028681 Switzerland- Requisition Number: R-028682 United States- Requisition Number: R-028683 Rememb er, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. For United States applicants: The anticipated base pay range for this position is $137,000 to $235,750 (USD) . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: - Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year - Holiday pay, including Floating Holidays - up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #LI-Hybrid #LI-Remote The anticipated base pay range for this position is : $137,000 to $235,750 (USD) Additional Description for Pay Transparency:

Posted 1 week ago

Collin College logo
Collin CollegeMcKinney, Texas
Primary Location: 2200 W. University Drive, McKinney, Texas, 75071 We are searching for candidates that meet the required qualifications and experience and are able to perform the essential duties and responsibilities. Job Summary: As directed, provide discipline-specific academic assistance to learners and support the operation and promotion of services. Required Qualifications: Essential Duties and Responsibilities Support learners through individual and/or group tutoring in a variety of modalities. Assist students with course-related equipment and supplies. Create, maintain and assure accuracy of records of students tutored as required under department guidelines. Maintain confidentiality of student records in compliance with the Family Educational Rights and Privacy Act (FERPA). Prepare and present workshops as needed. Assist with daily operations and promotion of services. Be available to work a flexible schedule as needed. Supplemental Functions Perform other duties as assigned. Perform all duties to maintain all standards in accordance with college policies, procedures and Core Values. Knowledge, Skills and Abilities Knowledge of content within the specified subject field Knowledge of department guidelines and record-keeping Knowledge of related instructional equipment Organization and time management skills Presentation skills Computer and applicable software skills Interpersonal and customer service skills Ability to create a positive and safe tutoring and learning environment Ability to communicate effectively in the English language, both orally and in writing Ability to establish and maintain effective working relationships Ability to assist students in using technology Ability to work independently and collaboratively Physical Demands, Working Conditions and Physical Effort Light Work - Exerting up to 20 pounds of force occasionally, up to 10 pounds of force frequently, and/or a negligible amount of force constantly having to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for the Sedentary Work category and the worker sits most of the time, the job is rated Light Work. Positions in this class typically include talking, hearing, seeing, grasping, standing, walking and repetitive motions, plus stooping, kneeling, crouching, and reaching. Occasional exposure to unpleasant environmental conditions and/or hazards. Occasional outside work. Occasional physical effort required. Required Bachelor's degree with relevant courses and/or skills connected to the tutoring subject. One (1) year of tutoring and/or teaching college-level writing experience. Licenses and Certifications Official transcript(s) required. International transcripts require an English translation and a course-by-course evaluation from an approved agency. Transcripts must be submitted with the application to be considered for this position. This schedule includes shifts on Saturdays. Applicants must be available to work on Saturday. This position is generally limited to working a maximum of 19.5 hours per week. (Maximum hours for employees with more than one part-time position at Collin College may vary.) This position is Security Sensitive, therefore, candidates will be subject to a criminal background check. The above description is an overview of the job. It is not intended to be an all-inclusive list of duties and responsibilities of the job as duties and responsibilities may change with business needs. Collin College reserves the right to add, change, amend, or delete portions of this job description at any time, with or without notice. Reasonable accommodations may be made by Collin College in its discretion to enable individuals with disabilities to perform the essential functions. Required & Preferred Qualifications (if applicable): The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Fair Labor Standards Act (exempt/non-exempt) is designated by position. The employer actively supports Americans with Disabilities Act and will consider reasonable accommodations. This is a Security Sensitive position. Therefore candidates will be subject to a criminal background check. Compensation Type: Hourly Employment Type: Part time Compensation: $21.50 Hourly For any employment questions, please contact HR at (972) 985-3783 or send an email to: employment@collin.edu . Collin College is an Equal Opportunity Employer and does not discriminate on the basis of any characteristic protected by applicable law.

Posted 3 days ago

Restoration 1 logo
Restoration 1Dallas, Texas
Established Restoration and reconstruction company in the Dallas/Ft Worth metroplex in search of independent contractor to write estimates in Xactimate. Must be proficient in Xactimate and have knowledge of job scope in water mitigation and reconstruction of residential properties. Set your own schedule. Requirements include site visit, working with insurance adjusters to establish proper scope and writing estimates in Xactimate. I can accompany this person on all initial visits. This is a remote position. Compensation: $20.00 - $80.00 per hour Restoration Support to Help You Get Your Normal Back At Restoration 1, we help people get their property and life back to normal when they're dealing with water, mold, or fire damage. We understand that our customers are going through a taxing and emotionally trying time. This is why our restoration specialists strive to be attentive, offer upfront communication, and valuable services to our customers. Most people struggle to clean up the mess after a disaster such as a flood or fire. We've created a straightforward process to guide our customers through their property restoration. With one phone call, your life can get back to normal. What We Do Our reputation for fast response, exceptional quality, and commitment has contributed to our growth as a company throughout the United States. Our restoration specialists understand that a disaster and the need for property restoration services can come without warning, and that is why we are always at hand to assist you 24/7! Restoration 1 aims to go the extra mile for our customers and make sure their property is back the way they remember it. This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to Restoration 1 Corporate.

Posted 1 week ago

University of Miami logo
University of MiamiCoral 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 currently accepting applications for a full-time lecturer position for the Spring 2026 semester with an expected start date of January 1, 2026. The teaching assignment is four courses each semester. Initial appointment(s) will be for one semester and may be renewable depending on enrollments and the university budget. Application materials should include: a cover letter describing your background and experience; a curriculum vitae; and a list of 3 professional references. A PhD (or equivalent terminal degree) in Writing Studies, Rhetoric and Composition, English, Professional and/or Technical Communication or a closely related field is required by the start date of the appointment. Application materials should also demonstrate excellence in equitable and inclusive teaching at the college level, particularly among a diverse student population. 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 until the position is 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 1 week ago

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

Posted 1 week ago

M logo
Midas GEORGETOWN 3642Georgetown, Kentucky
Benefits: 401(k) Bonus based on performance Opportunity for advancement Paid time off Training & development At Midas we are dedicated to providing quality services to customer vehicles in the areas of inspection, diagnosis and repair utilizing the expertise attained through ASE Certifications and/or years of automotive repair experience. We are looking for automotive service managers to manage and direct all service department activities of a retail store engaged in selling tires and related automotive parts and mechanical services. This position is a Store Manager developmental role. Midas is committed to training our associates and promoting from within the organization. Responsibilities As a Midas automotive customer service writer, you will quote customers and direct all automotive and general service technicians in the operation of the shop, including: Deliver exceptional customer service while listening and consulting customers Following up with customers, services requested, estimated completion times etc. Oversee complete vehicle inspections and then make comprehensive recommendations—building computerized repair orders and sourcing parts Deliver and discuss pricing estimates with customers as well as promoting shop service specials Work with the team while keeping in tune with our companies’ vision, purpose, core values, and employee creed Oversee technicians’ inspections, diagnosing and repairing of domestic, European and Asian cars and light trucks Overall cleanliness and organization of the facility Other duties as assigned Qualifications A minimum of 2 years of store or service manager experience General automotive knowledge Excellent customer service disposition Good communication skills Team building skills Ability to work a flexible retail schedule including weekends, evenings and holidays Valid driver’s license Compensation: $18.00 per hour Join Our Team As one of the largest destinations for automotive services, Midas is dominating the industry in developing career paths and building relationships within the communities they serve. At Midas, we take care of everything… tires, brakes, oil… so the opportunities to grow and develop expertise with Midas are endless. www.midas.com

Posted 30+ days ago

The Princeton Review logo
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: High School 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 3 weeks ago

Mission Graduates logo
Mission GraduatesSan Francisco, CA
Mission Graduates increases the number of K-12 students in San Francisco's Mission District who are prepared for and complete a college education. We work towards fulfilling our mission through a wide range of after-school support services that serve over 1,500 children, youth and families each year. Our vision is to transform the culture of our neighborhood so that college becomes the expectation for Mission families, rather than the exception. We would like to invite you to volunteer as High School Mentors to work with our incoming High School seniors as they prepare for their college applications. Every summer, Mission Graduates pair Writing Partners with high school students to work one-on-one on writing their personal insight questions (PIQ) for college applications and scholarships, meeting weekly throughout the academic year. Writing Partners are able to cultivate meaningful relationships with youth and provide them with much-needed support in such an important chapter of their lives. If you are looking to give back to your community, develop meaningful relationships, and impact the lives of our San Francisco youth, you are encourage you to apply for this volunteer opportunity. Ask: 11-12 month commitment 1 hr per week, at our College Connect Office June 2024 - May 2025: Personal Statement Workshops, June 2024 followed by weekly 1:1 mentorship

Posted 30+ days ago

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

Posted 30+ days ago

N logo

Medical Writing Manager/Sr. Medical Writing Manager

Neurocrine Biosciences Inc.San Diego, CA

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.1

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

pay-wall

Job Description

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)

About the Role:

Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of a multi-disciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building the submission writing team with in-house and contract resources. The ideal candidate will live in or be able to relocate to San Diego, we offer great relocation support.

_

Your Contributions (include, but are not limited to):

  • Leads the authoring process for all clinical/regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, PIPs and PSPs, and other regulatory documents as appropriate

  • Leads multi-disciplinary teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, nonclinical, Clinical Pharmacology and Regulatory) from a writing and scientific perspective

  • Interprets and presents scientific data, leads comment resolution meetings

  • Ensures document content is clear, concise, strategic, and well positioned for public disclosure

  • Leads and implements best authoring best practices and provides continuous training to teams

  • Mentor internal staff

  • Represent Medical Writing on departmental projects and cross-functional teams

  • Assist other writers on NDAs and MAAs

  • Proven leader who is confident, open to new and opposing ideas, and an exemplifies the Neurocrine culture of collegiality and teamwork

  • Other duties as assigned

Requirements:

  • BS/BA degree in life sciences or related field and 8+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred OR

  • Master's degree in life sciences or related field and 6+ years of similar experience noted above OR

  • PhD in life sciences or related field and 4+ years of similar experience noted above

  • Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses

  • Strong science background that enables the ability to interpret and communicate scientific and clinical trial data

  • Broad understanding of the medical writing processes, procedures, and systems (eg DMS)

  • Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data

  • Excellent understanding of the writing and regulatory process that enables streamlining of content and processes

  • Experience leading NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.)

  • Anticipates business and industry issues; recommends relevant process / technical / service improvements

  • Demonstrates broad expertise or unique knowledge

  • Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

  • Ability to work as part of and lead multiple teams

  • Mentoring skills and ability to leads lower levels staff and/or indirect teams

  • Excellent computer skills

  • Excellent communications, problem-solving, analytical thinking skills

  • Recognizes broader picture and longer-term impact on division/company

  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency

  • Proven ability to lead cross-functional teams through the authoring process

  • Excellent team player who can effectively navigate differing opinions and personalities

  • Able to work well both independently and as part of a team

  • Excellent project management skills, including managing simultaneous projects

  • Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools

#LI-SA1

Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

_

The annual base salary we reasonably expect to pay is $153,800.00-$222,850.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

pay-wall