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Writing Tutor

University of Alaska System
4207 N Lee Cir, Palmer, AK 99645

The Learning Resource Center (LRC) of Mat-Su College is seeking writing tutors for the 2018-19 academic year. Associated topics: chess, dance, driver, driving school, equestrian, evening, gre, lsat, piano, shooting... Read More

The Learning Resource Center (LRC) of Mat-Su College is seeking writing tutors for the 2018-19 academic year. Associated topics: chess, dance, driver, driving school, equestrian, evening, gre, lsat, piano, shooting

Writing Tutor

Johns Hopkins Hospital
Washington, DC 20044

Classified Title: Tutor ??????? Working Title: Writing Tutor ??????? Role/Level/Range: ACRP/03/MA Starting Salary Range: $17.03 - $20/hour Employee group: Casual / On Call Schedule: varies Employee subgroup: S1 Hrly Exmpt Location: 25-MD:JH at Columb... Read More

Classified Title: Tutor ??????? Working Title: Writing Tutor ??????? Role/Level/Range: ACRP/03/MA Starting Salary Range: $17.03 - $20/hour Employee group: Casual / On Call Schedule: varies Employee subgroup: S1 Hrly Exmpt Location: 25-MD:JH at Columbia Center Department name: 60000051-Student Services Personnel area: Carey Business School **Purpose of Position:** Student Success Center (SSC) writing tutors serve as consultants to Carey Business School students by providing assistance with presentation skills and all areas of the writing process, specifically for business assignments. The tutor?s goal is to support the Student Success Center?s mission by providing students with additional academic support in a professional manner. Tutors do not edit or proofread papers, and instead elicit critical thinking, aiding in students? understanding of their writing. Tutors work with students in-person and online and use various teaching and tutoring strategies. The tutor will also attend a mandatory orientation and may be asked to proctor final exams and assist in the design and delivery of periodic workshops throughout the academic term. **Essential Duties & Responsibilities (Include % of time):** **_In-person/online Tutoring (95%)_** + Provide students with assistance in all stages of writing and presentation assignments + Use various teaching strategies to tutor + Keep records of appointments and student progress + Attend a mandatory orientation + Assist in the design and delivery of group workshops related to expertise **_Administrative Tasks (5%)_** + Filing, copying, creating resources, updating marketing materials as assigned by supervisor + Proctoring of final exams **Education, Experience, Licensure, Certification:** + At least a Bachelor?s degree, Master?s preferred. + Experience teaching or tutoring. + Experience working with international students. + Experience using online platforms, such as Zoom, Skype, Adobe Connect, or Google Hangouts **Knowledge and Skill:** + Mastery of written communication skills, including organization, paragraph structure, audience tone, and grammar. + Familiarity with business writing, clarity, and conciseness.Excellent speaking skills and ability to provide feedback and suggestions for oral presentations.Individuals with vast knowledge of English grammar and usage are encouraged to apply. + Ability to maintain a professional working relationship with faculty, students and administrative staff. + Ability to communicate effectively and enjoy working with students. **Additional Information:** + Must submit a writing sample that demonstrates excellent written communication skills. + Must be able to work on site and online, evenings and weekends. + Up to 20 hours/week depending on student and center needs. The successful candidate(s) for this position will be subject to a pre-employment background check. If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at ...@jhu.edu . For TTY users, call via Maryland Relay or dial 711. **The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.** During the Influenza (\"the flu\") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. **Equal Opportunity Employer** Note: Job Postings are updated daily and remain online until filled. **EEO is the Law** Learn more: Important legal information Equal Opportunity Employer:Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans. Associated topics: after school, ballroom, driver, evening, extra, incorporated, instructor, jrotc, piano, sat

Writing Coordinator

OSF Healthcare
4620 N University St, Peoria, IL 61601

Reporting to the Director of Creative Services, the Writing Coordinator is responsible for major writing assignments and content development for multiple, strategic and executive digital and traditional communication channels to enhance the OSF brand... Read More

Reporting to the Director of Creative Services, the Writing Coordinator is responsible for major writing assignments and content development for multiple, strategic and executive digital and traditional communication channels to enhance the OSF brand, increase market share, inform and engage Mission Partners, and inform and engage patients. Position requires in-depth knowledge of the health care industry and exceptional understanding of OSF HealthCare strategy. REQUIRED QUALIFICATIONS: Bachelor's degree in journalism, public relations, communications, writing or a related field required. Minimum of 5 to 7 years of experience with professional writing and communicating. Must be able to work with confidential information with discretion and professionalism. Must have exceptional grasp of spelling and grammar. Must have excellent command of AP style. Must have exceptional customer service skills. Must have the ability to manage multiple projects and work assignments. Must have the ability to produce excellent copy in high-pressure situations with tight deadlines with calm and professionalism. Must have excellent interpersonal skills with a high degree of professionalism. Must have the ability to lead teams on complex projects with intricate communication needs with minimal supervision. Must have the ability to problem solve and work independently in a changing and multi-tasking environment with numerous deadlines. Must have excellent organizational, planning and project management skills. Must be able to translate high-level strategy into conversational communication accessible to employees at every level of the Ministry. Must be able to adapt messages to different digital and traditional communication channels. Must maintain knowledge of emerging trends in communication. Expected to possess and exhibit significant knowledge of health care industry, accountable care, transformation efforts and new care models. Must be willing to mentor and coach less-experienced writers. Must be proficient in Microsoft Office Suite of products. EOE/Minorities/Females/Vet/Disabled Applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, marital status, national origin or ancestry, age physical or mental handicap unrelated to ability or an unfavorable discharge from military service. Experience the OSF culture and community by clicking here.SDL2017

Writing Major Tutor needed for Writing Skills

College Nannies and Tutors
745 Minorca Ave, Miami, FL 33134

About the Position Position Type:Tutor Office:Miami - Coral Gables Location of Position:Coral Gables Job Description: Embodies the CNST Core Values and:* Provides students with academic assistance and guidance as directed by CNST management and the S... Read More

About the Position Position Type:Tutor Office:Miami - Coral Gables Location of Position:Coral Gables Job Description: Embodies the CNST Core Values and:* Provides students with academic assistance and guidance as directed by CNST management and the Statement of Goals; serves as a role model to students* Implements the tutoring strategy within timelines established by family and CNST* Plans and prepares for each tutoring session using student and learning center resources* Evaluates student progress toward goals and determines appropriate courses of action* Communicates frequently with CNST management on student progress; discusses appropriate changes or needs to meet goals within established timelines* Maintains student records and materials, including assessments and progress, in proper locations* Assists in the development of a positive attitude toward learning, studying and academics* Corresponds with teachers or other school staff as necessary to support the Statement of Goals* Submits online/mobile Timesheets for work within 24 hours of completion* Maintains updated availability via online/mobile Calendar as directed by local CNST office Competencies:* Market/Customer Understanding: ability to professionally represent company's marketing messaging and brand promise of Building Stronger Families? with each family client* Critical Thinking: maintains good judgment, time management, trustworthiness, and responsibility. Can evaluate student understanding and use appropriate teaching methods* Business Operational Understanding: can evaluate client service needs and provide ongoing service. Has expertise in practices, procedures of business operations* Communication Skills: ability to listen to others, provide appropriate feedback, communicate professionally to develop and maintain successful work relationships. Demonstrated ability for effective report writing and communication with both students and adults* Interpersonal Skills - can build rapport with student, parents, family members and CNST management; able to work both independently and collaboratively Qualifications:* CPR/First Aid certified or willingness to obtain certification* At least one year certificate from a college or technical school or currently enrolled in higher education institution* Educational development knowledge and skills: has experience related to education or field of study; can demonstrate competency. Can design, deliver and monitor effective tutoring strategies* Ownership of a mobile phone and consistent internet access are required for regular communication* Effective communication with students, parents, CNST, teachers and others related to assignments Physical Environment:* Works in a clean, well-lit environment Travel may be required with reliable transportation to and from tutoring location(s). Access to a vehicle Apply For This PositionBack To Team Page Associated topics: dancing, driver, evening, extracurricular, gmat, gre, gymnastics, sat, summer, weekend

Online Writing Tutor

Liberty University
Lynchburg, VA 24501

Posting Summary Posting Number Stu00256P Classification Title Position Type Student Disclaimer Liberty University's hiring practices and EEO Statement are fully in compliance with both federal and state law. Federal law creates an exception to the \"... Read More

Posting Summary Posting Number Stu00256P Classification Title Position Type Student Disclaimer Liberty University's hiring practices and EEO Statement are fully in compliance with both federal and state law. Federal law creates an exception to the \"religion\" component of the employment discrimination laws for religious organizations (including educational institutions), and permits them to give employment preference to members of their own religion. Liberty University is in that category. Position Title Online Writing Tutor Does this position require driving? No Contact Dr. Shelah Y. Simpson Contact Phone Ext Contact Email ...@liberty.edu Job Summary/Basic Function Reviewing Liberty University Online (LUO, formerly DLP) student papers for content development, organization, formatting, and grammar; conducting one-on-one tutorials with online students via computer-to-computer calls; creating writing aids and resources for the website; and answering writing and formatting questions via email. Minimum Qualifications Must be currently enrolled as an online Liberty student in high academic standing and must be a U.S. citizen. Must be qualified for work study status and may not hold any other position at Liberty University. Must be willing to work summers (online). Must have your own computer equipped with Windows 7 or higher, or a recent Mac operating system, a recent version of Microsoft Word, and a microphone and headset or speakers. Must also have your own strong internet access, as you will be working from home. Other requirements: willing to work through the summers, excellent writing and people skills; the ability to learn quickly, especially computer technology; a good understanding of Microsoft Word; initiative and self-discipline; the ability to work well under pressure and follow written instructions; reliability, thoroughness, and an excellent work ethic; the desire to help other students succeed. EXTENSIVE UNDERSTANDING OF APA ALONE OR APA AND TURABIAN FORMATTING NEEDED. OR EXPERTISE IN TURABIAN FORMATS WITH WILLINGNESS TO THOROUGHLY LEARN APA. Preferred Qualifications 1. Eligible for work study status 2. Can work (from home) during summers 3. 3.5 or higher GPA 4. Expertise in one or more formatting styles 5. Own internet access and updated computer equipment 6. Expertise in writing and grammar 7. Expertise in Microsoft Word 8. U.S. Citizen 8. Currently enrolled in LUO Graduate-Level degree program 9. Does not work for Liberty in any other capacity Work Hours 20 hours per week spread across all 7 days (though not always 20) Associated topics: ballroom, cooking, dance, gardening, gre, paint, rotc, sierra club, violin, voice

Writing Center Coordinator

Johns Hopkins Hospital
1968 E Coast Greenway, Baltimore, MD 21203

WRITING CENTER COORDINATOR General Description SAIS is looking for a part-time Writing Center Coordinator for a ten-month term appointment.This position provides administrative and pedagogical leadership in the design, implementation and supervision ... Read More

WRITING CENTER COORDINATOR General Description SAIS is looking for a part-time Writing Center Coordinator for a ten-month term appointment.This position provides administrative and pedagogical leadership in the design, implementation and supervision of best practices to support the academic writing needs of the SAIS community.The Writing Center is open to all SAIS students and offers academic support related to a graduate-level professional program. JOB RESPONSIBILITIES* Create clear goals and objectives for the Writing Center coaches in order to support the current student population* Select, train and supervise the writing coaches* Create, maintain and oversee the scheduling for virtual and face-to-face sessions for individual student appointments* Manage a caseload of individual student appointments* Monitor and evaluate the standards of service and needs of the student population* Track and report the usage of the Writing Center* Develop and teach writing workshops and tutorials (minimum two per semester)* Consult with faculty on student writing needs* Recommend purchases of instructional materials and other resources relevant to the activities of the Writing Center Qualifications* Bachelor's degree required. Master's degree in Rhetoric & Composition, Writing Studies, English, or related field strongly preferred.* Three years related experience required. At least two years of experience as an administrator of a Writing Center in a university setting or comparable position preferred.* Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.* Previous writing instruction experience strongly desired.* Prior development and implementation of instructional materials and curriculum design strongly preferred JH at SAIS - Washington DC

Director, Medical Writing

AstraZeneca
115 Woodland Rd, Gaithersburg, MD 20877

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions ? join us. MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a di... Read More

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions ? join us. MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. Here at MedImmune, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules. MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Position Summary: Responsible for the leadership and management of therapeutic area support provided by the MC group. Provides oversight for development of high-quality clinical regulatory and other supporting documents. Line manages a therapeutically aligned MC business unit and is accountable for its successful delivery to quality, time, and budget. Major Duties and Responsibilities: * Manages therapeutically aligned MC staff and is accountable for line management, staff development, recruitment, resource planning/capacity management, and budget. Determines and establishes group structure to meet the needs of MC and the clinical organization in general. * Provides leadership for ensuring consistency and compliance in the development and approval of clinical regulatory and other supporting documents, and reviews deliverables to ensure alignment with clinical and regulatory strategy. Provides writing support as needed to ensure group output is delivered to time and quality. * Collaborates with peers in scientific publication team to support TA * Collaborates with peers in MC group to develop the strategy for supporting the medical writing needs of the clinical organization. * Drives cross-functional and cross-project learning across the organization. * Interacts and collaborates with other functional area heads across Clinical Biologics, MedImmune R&D, and AstraZeneca to ensure department alignment, deliver workgroup solutions, and lead organizational change. * Contributes substantially to the MC vision and purpose, merging technical and business strategies, plans, and actions. * Assists Head of MC with alignment and improvement of processes, systems and other leadership initiatives Education: * Requires a PhD or PharmD in a scientific discipline or a master's degree with relevant work experience. Other Skills and Qualifications: * 10+ years experience in the medical/regulatory writing field in a pharmaceutical/biotech industry or CRO environment in positions with increasing levels of responsibility. Includes proficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions (eg, study level, program level, health authority responses, marketing applications), and extensive knowledge and experience relevant to multiple therapeutic areas, disease areas, and technical disciplines. Previous experience managing the medical writing activities for multiple original and supplemental licensing applications (NDA, BLA, MAA) or equivalent submissions (IND, End of Phase 2). Background in biologics a plus. * 5+ years of supervisory experience for multiple direct reports or contract staff in a medical writing group or equivalent. Includes hiring, training, leading, and mentoring staff, setting goals within the function, and managing performance issues. Previous experience developing and overseeing project/department budget and resource allocation. * Broad cross-functional understanding of the drug development process from scientific, technical and business perspectives. * Ability to negotiate and influence stakeholders across the organization to drive and promote consistent and repeatable high performance. * Ability to accomplish results through effective influencing, focus the work on what is important, and eliminate roadblocks. Next Steps ? Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience ? it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.SDL2017 Associated topics: care physician, clinic, family medicine, family practice, family practice physician, hospitalist, outpatient, physician, urgent, urgent care

Writing Tutor (Baltimore)

Johns Hopkins Hospital
538 Gold St, Baltimore, MD 21217

Classified Title: Tutor ??????? Working Title: Writing Tutor (Baltimore) ??????? Role/Level/Range: ACRP/03/MA Starting Salary Range: $17.03 - $20/hour Employee group: Casual / On Call Schedule: Varies Employee subgroup: S1 Hrly Exmpt Location: 46-MD:... Read More

Classified Title: Tutor ??????? Working Title: Writing Tutor (Baltimore) ??????? Role/Level/Range: ACRP/03/MA Starting Salary Range: $17.03 - $20/hour Employee group: Casual / On Call Schedule: Varies Employee subgroup: S1 Hrly Exmpt Location: 46-MD:JH at Harbor East Department name: 60000051-Student Services Personnel area: Carey Business School **Purpose of Position:** Student Success Center (SSC) writing tutors serve as consultants to Carey Business School students by providing assistance with presentation skills and all areas of the writing process, specifically for business assignments. The tutor?s goal is to support the Student Success Center?s mission by providing students with additional academic support in a professional manner. Tutors do not edit or proofread papers, and instead elicit critical thinking, aiding in students? understanding of their writing. Tutors work with students in-person and online and use various teaching and tutoring strategies. The tutor will also attend a mandatory orientation and may be asked to proctor final exams and assist in the design and delivery of periodic workshops throughout the academic term. **Essential Duties & Responsibilities:** **_In-person/online Tutoring (95%)_** + Provide students with assistance in all stages of writing and presentation assignments + Use various teaching strategies to tutor + Keep records of appointments and student progress + Attend a mandatory orientation + Assist in the design and delivery of group workshops related to expertise **_Administrative Tasks (5%)_** + Filing, copying, creating resources, updating marketing materials as assigned by supervisor + Proctoring of final exams **Education, Experience, Licensure, Certification:** + At least a Bachelor?s degree, Master?s preferred. + Experience teaching or tutoring. + Experience working with international students. + Experience using online platforms, such as Zoom, Skype, Adobe Connect, or Google Hangouts **Knowledge and Skill:** + Mastery of written communication skills, including organization, paragraph structure, audience, tone, and grammar. + Familiarity with business writing, clarity, and conciseness.Excellent speaking skills and ability to provide feedback and suggestions for oral presentations.Individuals with vast knowledge of English grammar and usage are encouraged to apply. + Ability to maintain a professional working relationship with faculty, students and administrative staff. + Ability to communicate effectively and enjoy working with students. **Additional Information:** + Must submit a writing sample that demonstrates excellent written communication skills. + Must be able to work on site and online, evenings and weekends. + Up to 20 hours/week depending on student and center needs. + Pay rate: up to $20/hour depending on education and experience + Individuals with vast knowledge of English grammar and usage are encouraged to apply. The successful candidate(s) for this position will be subject to a pre-employment background check. If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at ...@jhu.edu . For TTY users, call via Maryland Relay or dial 711. **The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.** During the Influenza (\"the flu\") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment. The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office. **Equal Opportunity Employer** Note: Job Postings are updated daily and remain online until filled. **EEO is the Law** Learn more: Important legal information Equal Opportunity Employer:Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans. Associated topics: after school, dance, dancing, extra, gre, mcat, piano, voice, weapons, weekend

Medical Writing Manager

i-hire
4053 Brooks Ct, Pleasanton, CA 94588

Overall, the Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effe... Read More

Overall, the Medical Writing Manager will be accountable for the high quality, properly formatted and timely delivery of documents. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to SOPs, regulatory requirements and submission-specific requirements. Medical Writers will work closely with internal project-level SMEs (e.g., Medical and Scientific Affairs, Clinical Operations, Regulatory Affairs, Biostatistics, R&D, etc.) and external SMEs (e.g., customers, KOLs, etc.) that are responsible for generating, changing and/or updating scientific content. Accountable for and manages day-to-day activities of the Medical Writing team, such as assignment delegation, performance reviews, professional development/coaching, budgeting and time-tracking, process improvement, document standardization and KPI reporting/tracking. Independently leads process improvement initiatives, such as updating SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc. Periodically communicates team activities, progress, and goals to leadership through one-on-one (e.g., in-person meetings, emails) and group communications (e.g., PowerPoint presentations) For selected and high priority medical documents, will serve as primary point of contact with oversight and management responsibility for the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.) Partners with the Publications Manager to assign (to the Medical Writing team) and complete selected Scientific Communications. Collaborates with other Medical Writing teams within Roche to share best practices, harmonize documents and improve related processes/procedures. Effectively communicates and builds healthy working relationships with Medical Writing team members and key stakeholders throughout the organization with whom he/she will work closely. Actively participates in Medical Writing team meetings and activities. Successfully completes all assigned curricula and on-the-job training modules. Performs his/her work in accordance with corporate cultural beliefs and agreed upon Key Performance Indicators (KPIs). Provides appropriate and transparent notification for work absences. Required: Master's degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English proficiency (both spoken and written) Preferred: Doctoral degree or higher (e.g., PhD, PharmD, DVM) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English as a primary language Experience: 5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA). Supervisory and/or project management experience Submission and publication management of scientific manuscripts to at least 5 different journals Preferred 10 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports. Submission and publication management of scientific manuscripts to at least 10 different journals Experience with in vitro diagnostics, molecular diagnostics and/or Infectious Disease Knowledge of drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research) Process improvement and/or Six Sigma training Knowledge, Skills, and Abilities: Knowledge and understanding of the clinical research process, including ICH GCP and FDA regulations Knowledge on Good Publication Practices Experience in working with Templates, Style Guides, SharePoint and Document Management Tools Calendar management skills/ expertise using Google Calendar Reference management skills/ expertise with EndNote (preferred) or equivalent Meticulous attention to detail Strong interpersonal and communication skills, including conflict resolution and influencing Comfortable with virtual work environments and meetings Ability to work effectively in a fast-paced environment and with multiple high priority projects Ability to problem solve and delegate appropriate tasks to collaborators and follow-up as needed to meet - provided by Dice5+ years scientific research and/or medical writing experience Associated topics: emergency room, ems, emt, life, lpct, paramedic, pmt, technician, technician basic, transport

Medical Writing Manager

GlaxoSmithKline
1103 Market St, Philadelphia, PA 19107

Your Responsibilities: Scientific and Medical Writing Manager I (Grade level 7):* Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards... Read More

Your Responsibilities: Scientific and Medical Writing Manager I (Grade level 7):* Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements* Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions* Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide* Demonstrated effectiveness in management of projects of increasing scope and complexity* Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)* Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions* High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data* Assess trends and patterns in text and statistical data, and effectively organizes content and messages in clinical reports and summary documents* Review reporting and analysis plans and provides critical input on the content and display of tables* Familiarity with approaches to expedite document preparation such as review tools and automation* Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment (e.g., ability to support documents in different therapeutic areas)* Effectiveness in both oral and written communications Scientific and Medical Writing Manager II (Grade level 6): (In addition to items listed above)* Direct the work of medical writing teams in medical writing projects in support of the clinical project strategy. May manage development of contracts/invoices for outsources medical writing activities* Contribute to the planning, authoring, review, and approval of clinical documents for medical writing project to achieve a successful outcome within the required timelines* Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level* Provide major input to submission teams in development of submission plans, timelines, document content and dependencies. Advises on or recommends methods for achieving accelerated timelines as necessary* Actively contribute to development of training materials for clinical document preparation; provides mentoring and/or training on clinical documentation and submission planning to individuals or teams* Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents* Manage development of contracts/invoices and provide oversight for outsourced medical writing activities* Effectively contribute to process improvement activities Why You?Basic qualifications:* Bachelor degree in life sciences* Scientific and Medical Writing Manager I: Up to 5 years of industry experience* Scientific and Medical Writing Manager II: = 6 years of industry experience Preferred qualifications:* Post-graduate degree in life sciences* Expertise in one of the follow areas:* Immuno-inflammation* Infectious disease* Oncology* Respiratory* Renal Disease* Cardiovascular Disease* Neurosciences Why GSK?: GSK has a 150-year legacy of helping to transform the health, lives and futures of millions of people around the world. We're a science-led healthcare company with more than 100,000 people working in 115 countries. Each year we produce around 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products. Our focus of helping people do more, feel better and live longer is at the center of all that we aim to do. Contact information: You may apply for this position online by selecting the Apply now button. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. Associated topics: family, family medicine, family medicine physician, nocturnist, outpatient, physician, physician md, practitioner, provider, urgent

Tutor, Professional, Writing

Guilford Technical Community College
99 Olde England Ct, Jamestown, NC 27282

Position Information Job Title Tutor, Professional, Writing Job Description The Center for Academic Engagement Professional Writing Tutor provides effective tutoring to enhance students' learning and respects students' autonomy as independent learne... Read More

Position Information Job Title Tutor, Professional, Writing Job Description The Center for Academic Engagement Professional Writing Tutor provides effective tutoring to enhance students' learning and respects students' autonomy as independent learners. The Professional Writing Tutor responds to the individual needs of each student by personalizing tutoring strategies and methodologies. Duties/Functions Use a variety of tutoring techniques to meet students' learning needs. Integrate effective study, learning, writing, and reading strategies to maximize students' potential for academic progress. Conduct group tutoring sessions and workshops as needed. Collaborate with Center for Academic Engagement staff, faculty, student support services staff, and other college constituents to deliver a comprehensive learning support program. Maintain a positive, professional, learner-centered environment. Develop resources for student, faculty, and staff use. Follow and communicate Center for Academic Engagement policies and procedures. Keep accurate records of tutoring sessions. Participate in professional development opportunities to enhance learning support skills. Promote the college's tutoring program during outreach activities and events. Demonstrate and model the college's employability skills: adaptability, communication, information processing, problem solving, responsibility, and teamwork. Additional Duties & Responsibilities: Participate in job-related workshops and training to enhance job performance. Perform all duties as assigned by supervisor. Difficult Challenges Contacts Education Required Associate degree from a regionally accredited postsecondary institution or junior status at a regionally accredited four-year college with documented successful completion of undergraduate coursework in English or related field. Education Preferred Bachelor's degree or higher in English or related field from a regionally accredited postsecondary institution College Reading and Learning Association (CRLA) certification Experience Required Previous experience providing learning support and/or instruction Demonstrated expertise in the subject area (e.g. academic and/or professional writing and editing experience) Experience Preferred Three years of experience providing learning support and/or instruction Previous tutoring experience in an educational institution and/or tutoring service Experience tutoring and/or instructing English language learners Experience tutoring and/or instructing students with disabilities Proficiency in keeping accurate records of tutoring sessions (i.e. session notes, start and end times, etc.) using tracking software (e.g. TutorTrac) Proficiency in using learning management systems (e.g. Moodle, Blackboard) KSA Required The Professional Writing Tutor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Professional Writing Tutor must be able to: 1. Multi-task 2. Respect diversity and promote an inclusive, culturally responsive environment 3. Adapt to procedures, protocols, or assignments 4. Communicate and promote the Center for Academic Engagement with a wide range of individuals and constituents KSA Preferred Department/Job Specific Requirements Mandatory GTCC Trainings (upon initial hire) and annual updates as required; other required trainings may be added as needed): 1. Reporting Requirements 2. Discrimination & Anti-Harassment (within 30 days of hire; annual refresher thereafter) 3. Shooter on Campus (within 30 days of hire; annual refresher thereafter) 4. Personal Information Protection (within 30 days of hire; annual refresher thereafter) 5. Ethics and Social Responsibility (within 30 days of hire; annual refresher thereafter) 6. Safety training (Bloodborne Pathogens and E-Vac Chair) Physical Demands 1. Must be able to get to other offices, buildings, campus locations and off-site locations as necessary to complete requirements of the job. 2. Must be able to work flexible hours. 3. Physical requirements include periods of sitting at a computer and standing. 4. Must be able to lift, pull/push and carry up to 20 pounds. Other: Criminal history checks, with acceptable results, are required. Posting Type Part-Time Staff News & Record. Category: Education, Keywords: Student Tutor Associated topics: chess, extra, extracurricular, gymnastics, incorporated, instructor, jrotc, music, piano, weekend

Director, Medical Writing

Vertex Pharmaceuticals
2 Joy St, Boston, MA 02108

The Vertex Medical Writing department is a collaborative team of about 25 people who are responsible for preparing clinical regulatory documents to support development programs throughout the product lifecycle. Medical Writers are key members of stud... Read More

The Vertex Medical Writing department is a collaborative team of about 25 people who are responsible for preparing clinical regulatory documents to support development programs throughout the product lifecycle. Medical Writers are key members of study teams and submission teams.The Director, Medical Writing will be a strategic, hands-on medical writing expert with responsibility for leading and managing??a team of writers and for preparing high-quality clinical regulatory documents. The Director will??contribute both??strategic and operational perspectives. The Director will make significant contributions to department initiatives and will collaborate with key functions across the organization. This role will report to the Vice President, Medical Writing and will be a key member of the Medical Writing management team. This will be a full time role located in Boston, MA.????Key Responsibilities?? Advise teams on the content and presentation of clinical regulatory documents Participate as a member of team involved in defining the direction of the clinical development program or regulatory strategy Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on program objectives Optimize interdisciplinary understanding and integrate activities with those of other departments and project teams Predict and plan resource requirements and staffing needs, ensuring appropriate staff are available to meet program goals Participate in developing and implementing processes and templates to ensure efficient preparation of high quality medical writing deliverables Provide input to strategies and tactics for the Medical Writing department Oversee hiring of staff; provide coaching and performance management ?? ?? Minimum Qualifications ?? PhD (or equivalent degree) and 7+ years of relevant work experience Experience authoring clinical regulatory documents Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA) Experience managing direct and indirect reports, including medical writing contractors Ability to plan, manage, and optimize resources Strong leadership and influencing skills Attention to detail ?? ?? Company Information ?? Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.?? Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.?? Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ...@vrtx.com. Associated topics: administrative coordinator, assist, beverage, chief operations officer, front desk, food, operational assistant, operational support, operations director, records management

Manager, Medical Writing

Emergent BioSolutions
115 Woodland Rd, Gaithersburg, MD 20877

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientif... Read More

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. This position will provide leadership within the Medical Writing function for Emergent BioSolutions Clinical Development & Operations. A strategic and pro-active role with responsibility for ensuring the function is professionally managed and represented both within and external to the company, providing support and expertise to members of the clinical team. This role includes providing and overseeing medical writing aspects of several outsourced clinical research programmes securing quality and best value at all times. Responsibilites * Author clinical submission documents and manuscripts including: * Clinical study reports (CSRs) * Clinical study protocols * Informed consent forms * Investigational brochures * Statistical analysis plans * Safety monitoring committee/data safety monitoring committee charters * Summary documents (including integrated summary of safety [ISS], integrated summary of efficacy [ISE], clinical overview, clinical summary CTD sections) * Risk management plans * Summary of Product Characteristics and US package circulars * Clinical sections of integrated product reviews * Clinical development plans * Manuscripts and abstracts for publication * Clinical sections of grant and contract proposals to NGO and government partners * Regulatory meeting briefing packages * IND and EU Annual Safety Updates * Responses to agency questions * Other documents that may be assigned * Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation. * Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner. * Provide process, content, and submission/document planning expertise. Advise team on resource utilization, efficiencies, timelines and interdependencies. * Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style. * Reviewing protocols, statistical analysis plans and tables figures and listings. * Prepare abstracts and articles. * Ensure adherence to established regulatory, company SOPs and House Style, general quality and ICH/GCP guidelines. * Write, review and update company SOPs and related templates (eg CSR, protocol, narratives, IB). * Prepare and represent Medical Writing for internal (QA) and external audits (MHRA, FDA) * Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents. Continually share best practices in an effort to create higher quality documents more efficiently. * Summarise clinical trial data and analyse and interpret clinical data, discussing results with internal teams and KOLs * Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced. * Prepare study data summaries and other documentation for public disclosure in accordance with data transparency guidance and regulations. * Mentor, coach, and/or otherwise assist in the training and development of other Medical Writers. The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills * Bachelor's or Master's degree required in Life Sciences/Health Related Sciences or equivalent; PhD (or MD) preferred * 5-7 years of Medical Writing experience in biopharmaceutical industry, with a minimum of 5 years gained within a clinical research setting. Professional Medical Writing certification (e.g., AMWA, EMWA, RAPS) an advantage, but not mandatory. * Preferably with vaccine/immunology, relevant biologics, or device experience with a proven track record of delivery. * Excellent written and verbal communication skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation. * Expert knowledge of medical, pharmaceutical, and clinical research concepts. * Ability to exercise independent judgement in developing methods, techniques, and evaluation criteria for obtaining results. Expert knowledge of the methods, techniques, and procedures of medical writing tasks. * A high degree of familiarity with statistical and data output. * Prior CSR and Summary Document generation experience. Prior experience with submissions in Common Technical Document (CTD) format. * Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management). * Detailed and experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content. * Detailed and experience-based understanding of applicable regulations and guidelines (eg, Code of Federal Regualtions, European Directive, and International Conference on Harmonisation). * Strong computer skills; proficiency in MS Word, Excel, and Power Point. Experience with Visio or similar graphics program a plus. * Strategic thinker with excellent problem solving and decision making skills. * A resilient self-starter, who will be able to act independently, and learn quickly, within a rapidly evolving environment * An excellent communicator with strong interpersonal skills. Capable of interacting effectively at all levels with external contacts including collaborators, partners and contract organisations, and at every level within the Company. A team builder. * Good intercultural sensitivity and previous experience of working internationally. * Well-developed planning and tracking skills with a demonstrable understanding of the importance of effective planning and tracking in project and resource management. * Requires presentation, documentation and interpersonal skills as well as team oriented approach. * Experience of working within dynamic and growing environments. * A person with perception and flair, who has presence, and the ability to contribute new ideas and to influence. * A person who can develop and maintain good relationships, gain the confidence of other professionals to work effectively in a multidisciplinary project environment * Must possess an open and transparent working style with excellent prioritisation skills being approachable, personable and supportive of others Physical/Mental Requirements Type/keyboard, visual acuity, good eye/hand coordination, reach outward, reach above shoulder, hand dexterity, sense of hearing, lift/carry 25 lbs, and pull 25 lbs. Use phone, fax, copier, and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work in multiple locations, with restricted access to laboratory, in contact with Select Agents, and with exposure to animals, animal areas, or equipment used in animal areas. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.SDL2017

Medical Writing Manager

Icon
9490 I-65 Service Rd S, Creola, AL 36525

This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON's Clinical Research Services group. Our remit is to produce high quality clinical/regulatory documents supporting Phase II-IIIb studies and regulatory ... Read More

This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON's Clinical Research Services group. Our remit is to produce high quality clinical/regulatory documents supporting Phase II-IIIb studies and regulatory submissions. Our key department values are: * Passionate about partnership * Quality without compromise * Flexibility in a dynamic environment We have an opening for a Medical Writing Manager on the East Coast US. The position could be home-based or located at our North Wales, PA, offices. In this role you will have the following responsibilities: Participate alongside 4 other Medical Writing Managers in the management of aspects of the Medical Writing department including, but not limited to: * Preparation and QC of clinical and regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Aggregate Reports, and Manuscripts. This includes: o Working with internal study teams and clients to determine/clarify project requirements and obtaining necessary information. o Understanding of contractual documentation and pricing tools. o Tracking and recording progress against contracted hours/budget using financial tracking tools and the department's project database. Early flagging to management of projects not on track and facilitation of the Change Order process. o Attendance at internal and external projects meetings either face-to-face or (usually) via teleconference/Webex. o Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance. o Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments. o Liaison with Publishing colleagues on the creation on submission-ready versions. o Perform QC of documents written by other writers. * Line management of ~5 Medical Writers. * Oversight of a portfolio of clients including ensuring that assigned writers deliver projects to a high quality, and within timelines and contractual obligations. * Review of the quality of documents written by other writers with appropriate feedback/training that facilitates development of the writer's competencies. * Liaison with sponsors and ICON colleagues, e.g., Project Managers, Business Development and Contracts colleagues, with regard to new business proposals, costings and awards, including attendance at Bid Defense Meetings. * To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations. * To lead department initiatives, as required, e.g., development of a new business area, implementation of process improvements, training. * Assistance in achieving the department's strategic business targets, e.g., sales, revenue, utilization, growth, outward-facing leadership and talent development. * General operational assistance to the Medical Writing team. * Assistance in work scheduling. * Active participation in all meetings. * Reporting of department metrics relating to quality, timeliness and productivity. * Achievement of individual utilization (billability) target. * Any other task deemed reasonable by department senior management. Skills & experience required: Essential: * Bachelor's degree in a life science. * At least 7 years' experience as a clinical/regulatory Medical Writer, i.e., preparation of a wide range of clinical/regulatory documents including Clinical Study Reports, Protocols, Subject Narratives, Investigator Brochures, Regulatory Submission Modules, Safety Aggregate Reports, and Manuscripts. * Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely. * Wider oversight/coordination responsibilities beyond writing individual documents, e.g., managing large programs of work or client oversight. * Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars. * Excellent verbal English. * Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting. * Excellent attention to detail. Preferred: * Advanced (post-graduate) degree. * At least 1 year's line management. * Experience of working for a large CRO. * Familiarity with Veeva Vault, Salesforce and Box. Competencies: * Able to recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership. * Able to promote a culture of process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. * Leadership skills. * Proactive, gracious and collaborative communication skills. * Able to work in a fast-paced, results-driven environment. * Culturally aware and able to work comfortably within a global team. Other: * Travel (approximately 10%) domestic and/or international. What's Next? Following your application, you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity. ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment #LI-AA1SDL2017

Director, Medical Writing

Nektar Therapeutics
451 4th Ave, San Francisco, CA 94118

This position will lead scientific, medical and regulatory writing activities for all development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents ... Read More

This position will lead scientific, medical and regulatory writing activities for all development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs). The professional will also perform the review, edit, and writing of documents and be responsible for the management, planning and direction of a team of medical writers. The professional will provide mentoring and career development to the medical writing team; will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Manages all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents, offers guidance, and takes lead in mentoring writers in the preparation of regulatory and publication documents. Organizes, conducts, and leads document production meetings and other meetings as necessary. Projects Medical Writing budget, resource, and timeline requirements for CDP. Responsible for timeline management, budget and managing outside vendors on regulatory document writing projects. Responsible for developing and managing Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections. Provides and manages internal and external writing activities. Responsible for developing department infrastructure such as establishing style guides, and generation of templates and processes. Manages internal staffing and performance management, including hiring, training, coaching and performance reviews. A Bachelors/Masters degree in a scientific discipline with a strong journalism background is required. Equivalent experience may be accepted. PhD. in a scientific or life sciences discipline preferred. Demonstrated experience as a primary author writing regulated scientific documents. Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents. Knowledge of CTD format. Ability to produce Protocols, Clinical Study Reports, Informed consent forms and Full ICH reports. Strong analytical and strategic thinking skills with the ability to implement. A minimum of 13 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 8 years writing management experience is also required. A minimum of 10 years previous supervisory experience is required. An ability to create effective presentations from raw data is essential. An ability to interpret statistical and clinical data is essential. Must have an ability to work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required. Must have experience writing clinical protocols, clinical study reports, and IND/NDA sections. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required.SDL2017 Associated topics: administrative, administrative assistant, administrative staff, administrative support, asso, associate, beverage, document, staff, support

Manager, Technical Writing

ServiceNow
San Diego, CA 92140

Manager, Information Development San Diego, CA This position reports to: Senior Manager, Information Development ServiceNow is changing the way people work. With a service-orientation toward the activities, tasks and processes that make up day-to-day... Read More

Manager, Information Development San Diego, CA This position reports to: Senior Manager, Information Development ServiceNow is changing the way people work. With a service-orientation toward the activities, tasks and processes that make up day-to-day work life, we help the modern enterprise operate faster and be more scalable than ever before. We're disruptive. We work hard but try not to take ourselves too seriously. We are highly adaptable and constantly evolving. We are passionate about our product, and we live for our customers. We have high expectations and a career at ServiceNow means challenging yourself to always be better. ServiceNow is looking for a manager for the Information Development team to work in our San Diego, CA office. The Info Dev team is made up of experienced and effective technical writers. We are looking for someone who can jump in and help us keep our well-oiled machine running. The best person for the job is someone who is experienced writing in an Agile development environment, and who has a strong history of advocating for writers while maintaining a positive and supportive relationship with cross-functional team members. What you get to do in this role:* Work closely with Information Development leadership team to plan how to distribute resources effectively across scrum teams and be able to adjust when unexpected projects arise.* Collaborate with other content-producing teams to share knowledge and avoid duplicating efforts.* Check in regularly with development team managers to get feedback and, if necessary, help course correct to get deliverables back on track.* Meet one-on-one with each direct report on a weekly or bi-weekly basis.* Conduct quarterly performance-related conversations with team members, provide feedback about areas of improvement, and recognize outstanding efforts.* Recruit excellent team members who are not only solid information developers, but who work well with the rest of the team.* When required, support the team in the development of product documentation for current and future releases of our product.* Review content on a regular basis, provide feedback on progress, adherence to standards, and overall completeness. In order to be successful in this role, we need someone who has:* BS/BA in Technical Communication, English, Computer Science, related field, or equivalent experience, with 5+ years of experience writing software documentation for a technical audience.* 3+ years of team management experience.* Strong background in HTML, XML, and DITA.* High level of creativity, flexibility, and dependability, and the ability to react quickly in a fast-paced environment.* Knowledge of structured task-based writing is a plus.* Experience with scripting, APIs, and integrations is strongly preferred.* Knowledge of documenting complex administration systems processes in a SAAS environment.* Proven experience relating to different levels of the organization and working effectively with peers. We provide competitive compensation, generous benefits and a professional atmosphere. This is a very collaborative and inclusive work environment where individuals strong on aptitude and attitude will have an opportunity to grow their professional careers through working with some of the most advanced technology and talented developers in the business. Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

Director, Medical Writing

Aimmune Therapeutics
320 Valley Dr, Brisbane, CA 94005

The Director, Medical Writing will be responsible for overseeing the development and finalization of key clinical and regulatory documents across therapeutic areas and throughout the product lifecycle.Specific Responsibilities: Lead and contribute t... Read More

The Director, Medical Writing will be responsible for overseeing the development and finalization of key clinical and regulatory documents across therapeutic areas and throughout the product lifecycle.Specific Responsibilities: Lead and contribute to the development of clinical and regulatory documents such as clinical protocols, clinical study reports, investigator brochures, DSURs, briefing packages, INDs and amendments, BLA/MAA documents, and regulatory responses according to company standards, processes, and timelines Participate on cross-functional teams and collaborate with team members to develop strategy and finalize project timelines Identify resources for projects; recruit/oversee consultants as needed Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance Mentor junior medical writers, editors, and other team members Critically review project work and training materials/guidelines generated by team members Coordinate with Regulatory Science Information to execute scientific review processes. Lead SOP development and review; implement work process improvements Keep up-to-date with professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department. Other duties as assignedQualifications / Requirements: Bachelor s degree in a science discipline or healthcare-related field. Advanced degree strongly preferred 10+ years of experience as a clinical/regulatory writer within the biotechnology or pharmaceutical industry required; freelance or closely related experience may be taken into consideration 5+ years of manager experience Expert knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards Expert skills in researching, writing, editing, reviewing, and managing clinical and scientific content Able to manage multiple projects in a fast-paced environment with challenging deadlines and rapidly changing priorities Good judgment and willingness to adapt working style and work product as required while adhering to quality standards Record of collaborative multidisciplinary teamwork and problem solving; help facilitate cross-functional team agreement and complete projects without authority Highly proficient in organization and project management skills Expert knowledge of AMA style, medical terminology, and clinical data analysis Expert knowledge and skills using Microsoft Word to generate complex document Exceptional attention to detail, goal-oriented with assigned tasks, and self-motivated PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Strong team-building skills Excellent interpersonal and influencing skills; ability to negotiate well and build good relationships with coworkers Professional and friendly demeanor, flexible, accommodatingPreferred Experience, Special Skills, Knowledge: AMWA member with certificate a plus BELS certification a plus Associated topics: ad, alumni, lead generation, media, newspaper, policy, presale, principle gift, public relations, twitter

Pittsburgh Writing Tutor Jobs

Varsity Tutors
1255 Waterfront Pl, Pittsburgh, PA 15222

Pittsburgh Writing Tutor JobsVarsity Tutors has students in Pittsburgh looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Wr... Read More

Pittsburgh Writing Tutor JobsVarsity Tutors has students in Pittsburgh looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: child care, company, dancing, driver, driving school, equestrian, gmat, jrotc, voice, weekend

Lombard Writing Tutor Jobs

Varsity Tutors
1212 Dryden Pl, Evanston, IL 60208

Lombard Writing Tutor JobsVarsity Tutors has students in Lombard looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing,... Read More

Lombard Writing Tutor JobsVarsity Tutors has students in Lombard looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: after school, chess, company, cooking, extracurricular, horse, jrotc, tutor, violin, weekend

Wayne Writing Tutor Jobs

Varsity Tutors
326 W 45th St, New York, NY 10036

Wayne Writing Tutor JobsVarsity Tutors has students in Wayne looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, cli... Read More

Wayne Writing Tutor JobsVarsity Tutors has students in Wayne looking for Writing tutoring. Varsity Tutors is a live learning platform that connects tutors with students to provide personalized learning. In addition to having knowledge in Writing, clients also look for tutors who are friendly, articulate, and reliable. Working as a tutor on the Varsity Tutors platform includes several benefits, such as the flexibility to schedule your own sessions and to choose your own hours. We put forth great effort to match tutors to students, resulting in productive learning experiences.Tutors working with Varsity Tutors are paid twice a week and choose their own tutoring load. There are multiple ways for tutors to earn while tutoring on the Varsity Tutors platform: In-Person tutoringOnline tutoring (you can use the Varsity Tutors online tutoring platform to tutor anywhere and at anytime)On-Demand tutoring (no need to schedule sessions ahead of time - simply take on opportunities as they arise.)Tutors are independent contractors and have the freedom to use their own teaching styles and methods. Associated topics: child care, dance, equestrian, extra, gardening, incorporated, jrotc, painting, summer, weekend