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🔥 Senior Business Intelligence Analyst

McLean Intelligent Workforce
Raleigh, North Carolina

The role will work on issues where analysis of situations or data requires building an in-depth understanding of organizational objectives. The candidate will be charged with providing analytics reporting and data-driven strategic insights, trends an... Read More

The role will work on issues where analysis of situations or data requires building an in-depth understanding of organizational objectives. The candidate will be charged with providing analytics reporting and data-driven strategic insights, trends and perspectives. The ideal candidate will develop and maintain relevant reporting and perform critical data analysis.    Key Responsibilities:   Help rebuild Enterprise Program Management Office (EPMO) Reporting Suite to provide meaningful and actionable insight. (Predictive vs. Descriptive) Assist with the establishment and adoption of EPMO reporting standards and other best practices Streamlining of data analytics and reporting capabilities Own the data, analytics, and reporting to empower senior executives and other business users. Collaborate closely with all areas of the business to provide analysis, reporting and tool-building capabilities that inform our key stakeholders Utilize internal/external data sources to develop and maintain dynamic and scalable dashboards to track key performance metrics for effective project portfolio management. Ensure data integrity across all enterprise wide portfolio, program, project reporting and analytics. Interpret and communicate information in a manner that can be comprehended by non-analytical audience.   Requirements: Undergraduate or Master’s degree in a quantitative field (e.g. engineering, business, economics, finance, statistics, and analytics).  Strong analytical background with a proven track record demonstrating an aptitude to compile data in comprehensive reports, analyze trends and make fact-based recommendations Strong experience with data extraction, manipulation and blending across different data sources. Experience with ETL tools is a plus. Strong experience with MicroStrategy, Tableau and/or other Business Intelligence tools to build dynamic/scalable dashboards. Proficient at writing SQL queries against complex databases for the purpose of data extraction. Ability to translate business questions into problems solvable using analytics tools, and enjoy converting the results of your analyses into visual stories tailored to the needs of the audience.

Writing & Online Writing Center Coordinator | St. Louis, MO

Webster Univ.
Saint Louis, MO 63119

In alignment with Webster University s strategic plan and within the purview of the Academic Resource Center, the Writing and Online Writing Center Coordinator manages and oversees the Webster Groves Writing Center and the global Online Writing Cente... Read More

In alignment with Webster University s strategic plan and within the purview of the Academic Resource Center, the Writing and Online Writing Center Coordinator manages and oversees the Webster Groves Writing Center and the global Online Writing Center. Responsibilities include developing, managing and improving the writing program offered in the Writing Center and the Online Writing Center; providing leadership and oversight of writing-related student and faculty support, programming, and resources; collaborating with faculty and staff members University-wide; supporting and assisting in faculty development related to teaching and supporting academic writing; collecting and evaluating Writing Center and Online Writing Center data; developing Associated topics: academic counselor, affair, attendance, college, counselor, elementary school counselor, healthcare, receptionist, school nurse, secretary

Remote Writing Room Moderator

VirtualVocations.com
Honolulu, HI 96814

A writing consultant company is seeking a Remote Writing Room Moderator.Core Responsibilities Include: Engaging with individual writers via chat, email, and google docsAttending weekly writing room meeting to coordinate activities and review individu... Read More

A writing consultant company is seeking a Remote Writing Room Moderator.Core Responsibilities Include: Engaging with individual writers via chat, email, and google docsAttending weekly writing room meeting to coordinate activities and review individual writers' progressHelping writers who experience technology challengesQualifications Include:Experience teaching writingMFA, PhD or equivalentAdvanced technology skillsExperience facilitating groups of people

Senior Director, Medical Writing

AKEBIA THERAPEUTICS
Cambridge, MA 02138

Job DescriptionThe Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissions.The Senior Director, M... Read More

Job DescriptionThe Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissions.The Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the author, review, and approval of documents and ensure appropriate templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols and Investigator Brochures and other documents necessary for regulatory submissions. This position must ensure appropriate planning and orchestration of writing activities across multiple functions, including nonclinical and CMC, for the completion of high quality, submission ready documents on time in support of Akebia s regulatory submissions.The Sr. Director, Medical Writing is accountable for coordination of all aspects of technical writing for Akebia, including vendor selection and management, resource planning and execution across all areas requiring writing support. The Sr. Director, Medical Writing, provides leadership, guidance, medical writing expertise and direction to both Akebia staff as well as vendors and/or independent consultants responsible for the completion of submission ready documents.The Sr. Director of Medical Writing will ensure sufficient staff and resources are in place to complete all documents of the highest quality necessary to support the regulatory submissions worldwide that adequately represent safety and effectiveness of Akebia s products.This position will report to the VP of Clinical Operations.Required SkillsAccountable for the identification, selection and oversight of qualified vendor(s) or consultants as required to prepare, write, edit, and review clinical and regulatory documents in collaboration with the project teams.Ensure development and maintenance of SOPs that document requirements for completion of regulatory submission ready documentsEstablish Akebia writing standards that include document templates and style guides compliant with regulatory agencies and writing standards in collaboration with subject matter experts and Senior Akebia management.Collaborate with Akebia senior management staff within Medical, Clinical, Nonclinical, CMC, and Regulatory and other areas in scope to appropriately forecast writing needs and ensure appropriate resources are secured.Ensure appropriately trained and experienced medical writers are in place to draft, edit, and finalize documents as needed for specific programs and regulatory commitmentsDirect internal or contracted staff to ensure all Akebia medical writing needs in scope are completed on time and with quality.Set standards for process of document review, completion and approval, ensure adherence to regulatory requirements, standards, and consistent with America Medical Writing Standards or other writing standards, where applicable.Establish standard quality control (QC) system of review of various regulatory and medical documents and oversees management of the process.Ensure proper training of staff and/or vendor on medical writing templates, SOPs, and processes including use of electronic document system within the department and across departments.Ensure identification and selection of electronic document systems and tools necessary for document review, approval and archiving.Provide guidance as needed on clinical data being considered for presentation and/or publications to ensure alignment with scientific strategies and corporate goals.Serve as subject matter expert in writing, coordination, management and completion of submission ready documents and provides guidance to project team(s) as required.Required ExperienceBachelor s degree in a life sciences discipline required and a minimum of 15 years biopharmaceutical industry experience. Masters/PhD degree in a life sciences discipline preferred.Must have at least 10 years in technical writing with 5 years of experience in managing staff of medical writers and/or vendors in preparation of technical documents (e.g., CMC, nonclinical, clinical, regulatory, etc.) including publishing and submissions.Prior NDA/BLA/MAA submission experience, including eCTD, is required.Strong knowledge of FDA/ICH guidelines and GCP.Strong written and verbal communication skills.Expert abilities in Microsoft Word, Excel, and PowerPoint;Experience with Adobe Acrobat and Medical writing software preferred.Experience in coordination and prioritization of multiple projects in a fast-paced environment.Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.Background in anemia, CKD, or oncology drug development is a plusFluent in English (oral and written) Associated topics: administrative assistant, assist, assistant, associate, front office, operational assistant, operational support, records management, staff, support

Writing Program Manager

University of Massachusetts Boston
Boston, MA 02298

General Summary: The Writing Program Manager works directly with the Deans Office and the Senior Director, Office of Student Support, Success and Engagement of the College of Nursing and Health Sciences (CNHS) to enhance the writing outcomes of CNHS... Read More

General Summary: The Writing Program Manager works directly with the Deans Office and the Senior Director, Office of Student Support, Success and Engagement of the College of Nursing and Health Sciences (CNHS) to enhance the writing outcomes of CNHS students in coursework and in clinical settings, as well as the Writing Proficiency Requirement (WPR) and graduate research and scholarship that includes comprehensive examinations, capstone projects and dissertations. The incumbent will work in partnership with the Office of Student Services, Chairs, Program Directors and faculty to evaluate the writing needs of CNHS students in all programs of study; and will develop and implement processes that will assist students in meeting established writing objectives. The process includes, but is not restricted to, the development and articulation of writing objectives; pedagogy and resources for courses; programs of study and specific groups of students; student and faculty workshops; and the establishment of drop-in services to meet articulated writing objectives. The Writing Program Manager is expected to develop, coordinate and evaluate a college-wide program of support services and resources for students and faculty that will connect and undergird all college writing to ensure the consistency and continuity of the written output of CNHS students. Examples of Duties: Establish and maintain a writing program for the students of the College of Nursing and Health Sciences (CNHS); Collaborate with the Office of Student Services, Program Directors and Department Chairs to document the writing assignments and needs of students throughout all programs of study, inclusive of on-site and off-site coursework; Assist in the development and articulation of writing objectives for students in courses and programs of study; Develop program, pedagogy and resources applicable to distance learning, as well as on-campus students and faculty; Develop drop-in writing assistance labs to support both online and on campus CNHS students preparing for the Writing Proficiency Requirement or composing course papers; supervise the graduate assistants that will be directing some of the drop-in writing assistance labs; Evaluate for improvement CNHS mechanisms for assessing CNHS student writing with the Director of Student Services, Program Directors, CCER and faculty to include Test of Essential Academic Skill (TEAS) reports, admission essays and statements; develop reports on common writing challenges and recommendations for meeting those challenges to present to the Administrative Leadership Team, and appropriate program committees; collaborate with faculty and staff to implement strategies and evaluative schemes for implementing recommendations; Provide, on a regular basis, updates as to program development, student performance, progress toward meeting objectives and strategies for continuous quality improvement to the Associate Dean, Director of Student Services, and through Department Meetings structure Department Faculty; Develop an engaging online site to house writing resources and news for CNHS students and faculty; Collaborate with the Director of CCER on strategies for transforming writing into strong clinical writing in electronic medical records; Provide editorial assistance for Student Handbooks and the like to ensure consistency of presentation regarding collegiate writing expectations; Supervise and evaluate writing tutors; Perform other duties as assigned. Qualifications: Masters degree in English, which included graduate-level study in composition pedagogy and teaching, and a minimum of five-seven (5-7) years of teaching and/or instruction in college-level writing at either the secondary or post-secondary level, required. Preferred Qualifications: Additional editorial experience and familiarity with current stylistic conventions of APA, MLA, AMA and Chicago forms preferred. Knowledge of pedagogical issues and success strategies associated with education of non-native writers of English is preferred. Experience in the development of training documents, preferably in an academic setting, is preferred. Experience in utilizing the online environment for teaching and/or academic support is preferred. Knowledge, Skills and Abilities: Demonstrable knowledge in critical thinking, reading and writing; Knowledge of Microsoft Office and familiarity with a variety of writing resources; Familiarity with online learning technology, website development and related software applications; Ability to effectively and efficiently work in a team capacity with a broad range of faculty, staff and administrators to accomplish course, program and college goals and outcomes; Ability to evaluate aggregate data for use in the formulation of interventional writing strategies; Ability to work in a collaborative environment; Ability to supervise the work of writing tutors; Ability to prepare written reports, correspondence and recommendations; Ability to work in a multicultural environment; Strong oral and written communication skills; Strong organizational and interpersonal skills; Strong attention to detail; Strong commitment to student engagement and support. Application Instructions: Please apply online with your resume, cover letter and list of three professional references. Review of candidates will begin following the application closing date. Only Internal candidates in the Professional Staff Bargaining Unit will be considered during the first 7 business days of the posting. All other candidates will be considered after that period. Salary Ranges for the appropriate Pay Grade can be found at the following link: Salary Ranges Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

Regulatory Writing Mgr

Confidential
Newbury Park, CA 91320

Regulatory Writing Mgr Career Category Regulatory Job Description Amgen is seeking a Regulatory Writing Manager. The focus of this position will be on authoring Clinical Trial protocols. This role will be based out of our main corporate campus in Tho... Read More

Regulatory Writing Mgr Career Category Regulatory Job Description Amgen is seeking a Regulatory Writing Manager. The focus of this position will be on authoring Clinical Trial protocols. This role will be based out of our main corporate campus in Thousand Oaks, CA or could be managed as a remote work assignment. The Regulatory Writing Manager responsibilities include: Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator s Brochures for products in all phases of clinical development (phase 1 through 4) Write Common Technical Document (CTD) sections inc ...

Director, Medical Writing - Oncology

Daiichi Sankyo
Bernardsville, NJ 07924

Job SummaryResponsible for all medical writing activities within the oncology ADC therapeutic area (e.g. preparation of protocols, protocol amendments, clinical safety narratives, clinical study reports, investigator brochures, briefing books, CTD cl... Read More

Job SummaryResponsible for all medical writing activities within the oncology ADC therapeutic area (e.g. preparation of protocols, protocol amendments, clinical safety narratives, clinical study reports, investigator brochures, briefing books, CTD clinical Summaries, REMS, RMPs, and other clinical documents necessary for submission to US, European, Japanese and other global regulatory agencies). Accountable for high quality documents in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes. Ensure that all documents were appropriately staffed by internal MW employees and contractors and external writers, that DS procedures were followed, and that the documents met quality standards. Effectively manage stakeholders and influence across all levels of the organization and external collaborators. Work with senior Clinical and Regulatory staff in the US and Japan to ensure that the documents were produced in a timely manner, that regulatory requirements were met, and that the most effective procedures for preparing the documents for early approval were implemented. Lead continuing process improvement and effectively manage changes within and outside medical writing. Responsibilities1. Provide leadership and strategic input to projects/study teams at the organization level; Plan and coordinate medical writing activities in the oncology ADC therapeutic area in collaboration with stakeholders within and across regions.2. Make medical writer and outsourcing assignments to ADC projects and estimate resources needs, costs and timelines for document preparation; Ensure consistency within the ADC franchise3. Provide strategic input and leadership to internal stakeholders including but not limited to the ADC franchise in all aspects of medical writing for in scope document; Manage conflicts effectively4. Assess resources needs based on workload and project priorities and communicate in a timely fashion; Develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects5. Represent Medical Writing on Global Medical Writing Committees; Liaise with Medical Writing Group in Japan to identify Medical Writing process improvement opportunities, potential collaborations and drive changes as needed etc.6. Sourcing Strategy and Management of Outsourced Medical Writing; Provide strategic input on plans for outsourcing medical writing and collaborate with Outsourcing and Legal on CRO/niche CROs selection7. Contributes to NDA/MAA submission strategy and development of submission timelines 8. Manage MWs, assess performance, productivity, and perform mid- and end-of-year performance reviewQualificationsEducation and ExperienceMinimum 7-10 years of experience with a Graduate Degree (Doctorate preferred) in a Biological or related science.Regulatory Medical writing experience requiredCTD submission preparation experience required Associated topics: ancmg, aoa, breast, cancer, hem onc, hematology, lah, oncology, palliative, physician md do

Associate Director, Medical Writing

Confidential
Cranbury, NJ 08512

Associate Director, Medical Writing Location:US-Cranbury, NJDepartment:Regulatory AffairsRequisition ID:1371 Description Associate Director, Medical Writing Position Summary Amicus Therapeutics is a biotechnology company at the forefront of advanced ... Read More

Associate Director, Medical Writing Location:US-Cranbury, NJDepartment:Regulatory AffairsRequisition ID:1371 Description Associate Director, Medical Writing Position Summary Amicus Therapeutics is a biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We are looking to hire an experienced medical writing lead to be based at our headquarters in Cranbury, NJ. This Associate Director, Medical Writing will report to the Senior Director of Medical Writing. This individual works in partnership with the senior management of the Medical Writing Department and is the primary overseer and performer for the medical writin ... Associated topics: lab, laboratory, medical, medical lab science, microbiology, mls, pathology, technician, technologist, toxicology

Director, Medical Writing

Nektar Therapeutics
San Francisco, CA 94199

Position Summary: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, an... Read More

Position Summary: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. Responsibilities: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. Requirements: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. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance. Associated topics: administrative, administrative coordinator, administrative officer, administrative staff, administrative support, assist, front office, food, operations director, records management

Director, Medical Writing

Corcept Therapeutics Incorporated
Menlo Park, CA 94025

This position directs the development of high-quality, strategically aligned medical writing deliverables that support the regulatory requirements of a clinical program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory req... Read More

This position directs the development of high-quality, strategically aligned medical writing deliverables that support the regulatory requirements of a clinical program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. This position builds strong relationships with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Development, Project Management, Drug Safety, and other functional areas.Responsibilities:Author, co-author, critically edit, and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissionsLiaise with functional group leads and key stakeholders to ensure appropriate coordination of and input into medical writing activitiesManage medical writing resources, both internal and external (eg, independent consultants, CROs, and other communication vendors) across project teamsManage overall medical writing timelines across project teams to ensure on-time deliverables that meet business needsFacilitate comment resolution with authors/reviewers when necessaryServe as the functional area lead on project teams and advise such teams on content, format, and style guide requirements for documentsLead the development of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverablesManage communication of and training on these processes, SOPs, etc. for internal and contract staff as neededManage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expandsMaintain subject area expertise related to the company s investigational products, disease indications, and regulatory and publication guidelinesDevelop and manage a budget for the medical writing functionPerform miscellaneous job-related duties and additional duties and responsibilities as neededRequirements:BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) or equivalent experience preferred10 years or more of medical writing experience in the pharmaceutical or biotechnology industry, including experience in the following areas of medical writing: clinical protocols, clinical study reports, Investigator s Brochure(s), clinical sections of INDs, IMPDs and NDAs (ISS/ISE); experience with submission strategy and content of high-level summary documentsExperience with e-CTD and electronic document management systems.Prior experience in a variety of therapeutic areas.Demonstrated supervisory and vendor management experience.Project management experience is essential.Preferred Skills, Qualifications, or Technical Proficiencies:Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines; ability to write and edit complex material to ensure accuracy, clarity, and effectivenessExcellent attention to detail, multitasking, prioritization, and flexibilityExcellent communication skills with proven ability to interact in a cross-functional environmentIn-depth understanding of the drug development process including R&D processes and objectives and the documents required at each stageUp-to-date knowledge of US and EU regulatory requirements and guidelines for documents; knowledge of e-CTD requirements with respect to structure, format, and contentProficiency in MS Office applications, Adobe Acrobat, and electronic document management systemsComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing prioritiesDemonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervisionAbility to think strategically; demonstrated negotiating skills and resourcefulnessAbility to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areasStrong influencing skills; ability to lead without formal authoritySuccessful track record of leading complex clinical / regulatory writing projectsDemonstrated ability to make decisions even in the absence of complete information Associated topics: alumni, endowment, event, facebook, festival, hospital, lead generation, major gift, marketplace, public relations

Senior Director Clinical Writing

JGB BioPharma Consulting
San Francisco, CA 94101

Requirements:Ability to work independently with little supervisionAbility to optimize and standardize writing practices forthe companyHas utilized and understands ICMJE, GPP writing guidesPreviously participated in writing / editing of peer reviewed ... Read More

Requirements:Ability to work independently with little supervisionAbility to optimize and standardize writing practices forthe companyHas utilized and understands ICMJE, GPP writing guidesPreviously participated in writing / editing of peer reviewed scientific journal articles. Comprehends medical scientific data. Previously held leadership position as a Medical Writer in a pharmaceutical company. Has experience with standard clinical documents such as Investigator Brochures, Clinical Study Reports, and the clinical sections of regulatory submissions. Experience with confidential data Ability to work with both internal and external personnel in a collaborative fashion. Ability to interact well with KOLs and to work in a fast paced environment. Project management of document flow from origin to completion. Ensure the creation of high quality final documents by monitoring writing from draft to finalizationMeet timelines for submission of specific documents. Write or edit documents as required. Develop synopsis of complex data as an abstract or for a visual display ensuring that key messages are clear. Search and obtain key journal articles for review by team and use as references in written documents.Formulate writing templates for use by team members Associated topics: copyeditor, editor, editor writer, law, medical writer, regulatory affairs, scientific journal, write, writer, writing

Director,medical Writing

Covance
Raleigh, NC 27601

Job Duties:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.Ensure that the Medical Writing staff is adequately trained and capable of del... Read More

Job Duties:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.Ensure that the Medical Writing staff is adequately trained and capable of delivering high quality documents to internal and external clients.Develop a sense of teamwork and common purpose among the staff, especially among the writers, but extending to the entire Medical Writing group.Ensure excellent communication and interaction within the Medical Writing team and between Medical Writing and the wider teams within Covance.Support the Head of the group on short-term and long-term strategies to improve efficiencies in the department.Predict and plan resource requirements and staffing needs.Maintain awareness of new developments in Medical Writing and in the global regulatory environment which may be applied to the management and reporting of clinical trial data.Provide input into budgetary requirements, perform ongoing financial review of projects, ensure that all issues are highlighted and resolved as quickly as possible and that all non-contract tasks are identified, tracked and included in change order forms.Provide input into salary reviews for direct reports and nominate for promotion when ready.Ensure all Medical Writing activities are carried out in accordance with Covance or project specific processes.Ensure the quality work of the group and department through ongoing quality management and review to ensure high quality deliverables to clients and internal customers.Establish and maintain strategic client relationships and receive client satisfaction surveys. Support corporate business development and marketing activities at client presentations and professional seminars.Manage billability of Medical Writing staff.Ensure that revenue and operating margin meet agreed targets.Ensure that the staff are utilized as fully, but also as efficiently as possible. Ensure that resource information is applied across projects to increase utilization, improve efficiency or amend the resource levels required on a project as necessary.Support writing teams in the planning and execution of major regulatory submissions (e.g., MAA, CTD).To deputize for the Head of the groupEducation/QualificationsMinimum of Bachelors degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferredExperienceTypically minimum 10 years medical writing experienceExcellent people management skills and supervisory skills gained from a minimum of 5 years line management experience.Knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companiesDemonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelinesExcellent oral and written communication and presentation skillsSelf-motivated to work consistently in a fast-paced, rapidly changing environmentLogical thinking, attention to detail Associated topics: analyst, b2e, business, business development, business planning, customer, franchise, franchise owner, territory sales, wholesale

Manager, Medical Writing

Company Confidential
San Francisco, CA 94199

Position Summary:The Medical Writing Manager will work within the Clinical Pharmacology group to ensure timely delivery of Clinical Pharmacology writing projects. Responsible for researching, writing, reviewing and editing nonclinical and clinical st... Read More

Position Summary:The Medical Writing Manager will work within the Clinical Pharmacology group to ensure timely delivery of Clinical Pharmacology writing projects. Responsible for researching, writing, reviewing and editing nonclinical and clinical study reports, documents for submissions to the regulatory agencies and publications. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Responsibilities:Manages all clinical pharmacology writing activities and takes lead in the preparation of regulatory and publication documents. Compiles, writes, reviews and edits clinical pharmacology writing deliverables such as nonclinical, clinical, and modeling and simulation reports, protocols, regulatory documents (Investigator's brochures, annual reports, briefing books, etc), and relevant IND/NDA/MAA sections. Responsible for researching, writing and editing clinical reports, summarizing data from nonclinical DMPK studies and clinical pharmacology studies for submissions to the regulatory agencies and for publication and/or presentation. Ensures all deliverables are in accordance with regulations, standards and meet FDA, ICH, GLP and GCP guidelines. Responsible for timeline management. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals. Responsible for developing and generating templates and processes if needed. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as subject and therapeutic areas. Requirements:A Bachelors/Masters degree in a scientific discipline with knowledge of pharmacokinetics is required. Equivalent experience may be accepted. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 4 years experience in writing clinical pharmacology study reports and clinical pharmacology related IND/NDA/MAA sections is also required. An ability to create effective presentations from raw data and to interpret statistical and clinical PK and PD data is essential. Must have demonstrated problem-solving abilities and be customer and results focused. Effective organizational and time management skills, and strong written and verbal communication skills are required. An understanding of drug metabolism, pharmacokinetics, clinical research, drug development, and regulatory affairs is required. Knowledge of biostatistics is desirable. Must have an ability to work well with others in high-pressure situations and to thrive under challenging deadlines. Good computer skills are required. Working knowledge of MS word, Excel, Power point. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance. Associated topics: medical, mls, pathology, services, sterile processing technician, surgical technologist, technician, technician ii, technician iii, technologist

Director, Medical Writing

Company Confidential
San Francisco, CA 94199

Position Summary: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, an... Read More

Position Summary: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. Responsibilities: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. Requirements: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. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance. Associated topics: administrative coordinator, administrative officer, administrative staff, assist, assistant, asso, facilities, front office, operational support, operations director

Telecommuting Proposal Writing Coordinator

VirtualVocations
Chicago, IL 60290

A provider of security services has a current position open for a Telecommuting Proposal Writing Coordinator.Core Responsibilities Include: Creating and editing high-quality Statements of Work and other documentsMaintaining quality standards and ensu... Read More

A provider of security services has a current position open for a Telecommuting Proposal Writing Coordinator.Core Responsibilities Include: Creating and editing high-quality Statements of Work and other documentsMaintaining quality standards and ensuring timely deliveryOverseeing document organization and productionSkills and Requirements Include:3 years of work experience1 year of experience in proposal development and coordination or corporate writingAdvanced professional writing skills with proven ability to write with clarity and concisenessAdvanced editing skills, including ability to perform full rewriteBachelor's degree or equivalent experienceAdvanced MS Word skills

Procedure Writing Manager

Confidential
Saint Louis, MO 63129

Job Description - Procedure Writing Manager (180017881) Procedure Writing Manager-180017881 At U.S. Bank, we're passionate about helping customers and the communities where we live and work. The fifth-largest bank in the United States, we re on... Read More

Job Description - Procedure Writing Manager (180017881) Procedure Writing Manager-180017881 At U.S. Bank, we're passionate about helping customers and the communities where we live and work. The fifth-largest bank in the United States, we re one of the country's most respected, innovative and successful financial institutions. U.S. Bank is an equal opportunity employer committed to creating a diverse workforce. We consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identity, disability or veteran status, among other factors. U.S. Bank is seeking an effective Procedural Writing Manager with pro ...

Sr. Director, Medical Writing

Confidential
Cambridge, MA 02139

Tracking Code 8R-13 Job Description The Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissio... Read More

Tracking Code 8R-13 Job Description The Head of Medical Writing is responsible for leading a centralized technical writing organization spanning writing and publishing needs across the various development functions to support regulatory submissions. The Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the author, review, and approval of documents and ensure appropriate templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols and Investigator Brochures and other documents necessary for regulatory submissions. This position must ensure appropriate planning and orchestration of writ ... Associated topics: administrative, administrative assistant, administrative support, assist, associate, beverage, front desk, food, operations director, records management

Manager, Medical Writing

Nektar Therapeutics
San Francisco, CA 94199

Position Summary:The Medical Writing Manager will work within the Clinical Pharmacology group to ensure timely delivery of Clinical Pharmacology writing projects. Responsible for researching, writing, reviewing and editing nonclinical and clinical st... Read More

Position Summary:The Medical Writing Manager will work within the Clinical Pharmacology group to ensure timely delivery of Clinical Pharmacology writing projects. Responsible for researching, writing, reviewing and editing nonclinical and clinical study reports, documents for submissions to the regulatory agencies and publications. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Responsibilities:Manages all clinical pharmacology writing activities and takes lead in the preparation of regulatory and publication documents. Compiles, writes, reviews and edits clinical pharmacology writing deliverables such as nonclinical, clinical, and modeling and simulation reports, protocols, regulatory documents (Investigator's brochures, annual reports, briefing books, etc), and relevant IND/NDA/MAA sections. Responsible for researching, writing and editing clinical reports, summarizing data from nonclinical DMPK studies and clinical pharmacology studies for submissions to the regulatory agencies and for publication and/or presentation. Ensures all deliverables are in accordance with regulations, standards and meet FDA, ICH, GLP and GCP guidelines. Responsible for timeline management. Works with all levels of staff and management to resolve issues and update on progress. Able to work with large and small teams to achieve business goals. Responsible for developing and generating templates and processes if needed. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as subject and therapeutic areas. Requirements:A Bachelors/Masters degree in a scientific discipline with knowledge of pharmacokinetics is required. Equivalent experience may be accepted. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 4 years experience in writing clinical pharmacology study reports and clinical pharmacology related IND/NDA/MAA sections is also required. An ability to create effective presentations from raw data and to interpret statistical and clinical PK and PD data is essential. Must have demonstrated problem-solving abilities and be customer and results focused. Effective organizational and time management skills, and strong written and verbal communication skills are required. An understanding of drug metabolism, pharmacokinetics, clinical research, drug development, and regulatory affairs is required. Knowledge of biostatistics is desirable. Must have an ability to work well with others in high-pressure situations and to thrive under challenging deadlines. Good computer skills are required. Working knowledge of MS word, Excel, Power point. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance. Associated topics: hematopathology, medical, microbiology, mlt, sample collection, scientist, technician, technician ii, technician iv, technologist

Writing Product Specialist

Vantage
Langhorne, PA 19047

Job DescriptionAs the Writing Product Specialist, you fuel product quality and engagement by representing the voice of the teaching and learning community. This requires you to develop a deep understanding of our writing products, key audiences and c... Read More

Job DescriptionAs the Writing Product Specialist, you fuel product quality and engagement by representing the voice of the teaching and learning community. This requires you to develop a deep understanding of our writing products, key audiences and customer needs. You will work closely with the VP or product management, and the marketing team to assist with the development and communication of the compelling value propositions that our writing products provide to the education community.ResponsibilitiesAssist with the development and communication of pedagogical content, whether through workshops, online modules, or presentationsAuditing and training our consultants; and, conducting onsite workshops, trainings, and virtual meetings when requiredAssist with the development of value propositions as related to our writing products, updates and releases.Stay abreast of trends in the educational marketplace to ensure the writing product line's competitive position.Interface with internal/external stakeholders and clients to gather feedback in the development of writing product enhancements.Educate internal stakeholders (sales, customer service, implementation...) in all functions and features of our writing products.Participate in writing-related teaching/learning and assessment initiativesSome travel required.Take on miscellaneous duties, as assigned.Knowledge, Skills and AbilitiesMaster's Degree, Education or related fieldTeaching Certification, Literacy/ELA preferred and at least 3 years of classroom experience.Design and development of instructional/curricular materials.Passion for education and technologyExperience interacting with and influencing key decision-makers in the k12 education community.Highly motivated with demonstrated excellent verbal and written communication, presentation and problem solving skillsAbility to work collaboratively with colleagues and cross-functional teams.Ability to lead projects proactivelyCompany DescriptionVantage < www.vantage.com > is a world leader and innovator in the development and leveraging of artificial intelligence and natural language technologies into a broad spectrum of markets and industries. Integrating patented AI and linguistic tools, Vantage offers world-class products and services, including award-winning Software as a Service (SaaS) solutions, into various vertical markets: Education, Government, Healthcare, etc. Associated topics: advocate, attendance, clerk, clinician, counselor, nurse, school clerk, school counselor, secretary, speech language pathologist

Associate Director Regulatory Writing

JGB BioPharma Consulting
San Francisco, CA 94101

Requirements:Bachelors degree in a science discipline with a minimum of 7 years medical writing experience in a Pharmaceutical company or Advanced Degree with 4 years medical writing experience in a pharmaceutical, clinical or laboratory settingExcel... Read More

Requirements:Bachelors degree in a science discipline with a minimum of 7 years medical writing experience in a Pharmaceutical company or Advanced Degree with 4 years medical writing experience in a pharmaceutical, clinical or laboratory settingExcellent understanding of the drug development processRegulatory writing experience for NDA submissions preferredGood understanding of experimental methods, research design, and statistical analysis.Ability to analyze medical data and interpret its significance within a pharmaceutical setting.Ability to interpret, analyze, and present statistical data obtained in a clinical trial.Advanced scientific, technical reading, writing and editing skills.Excellent oral communication skills.Proficient computer and word processing skills.Description: Reviewing analyses and data presentations to be used in study reports or other documents.Providing input to timelines for completion of clinical documents, and ensuring delivery of documents to meet the timelines.Ensuring that all clinical documents are produced according to appropriate SOPs and business practices.Supervising contract medical writersResearching, writing, and managing: IBs, clinical study reports, abstracts, posters, publications, clinical summaries, clinical overviews, protocols, protocol amendments, annual safety updates, and presentations.Developing, implementing and using templates and guidelines for clinical documentation. Potentially providing template training to teams.Reviewing pertinent literature, evaluating its applicability, and incorporating the information into clinical documents.Supporting clinical teams in protocol and CRF development.

Group Head, Regulatory Writing

Confidential
East Hanover, NJ 07936

243254BR Group Head, Regulatory Writing Job Description The Group Head, Regulatory Writing will manage a team of Regulatory Writing associates and collaborate with other RWS Groups and Function Heads to coordinate the timely production of hi... Read More

243254BR Group Head, Regulatory Writing Job Description The Group Head, Regulatory Writing will manage a team of Regulatory Writing associates and collaborate with other RWS Groups and Function Heads to coordinate the timely production of high quality deliverables. Major Responsibilities: 1. Functional and Operational Manager for a group of associates. 2. Oversee day-to-day operations for group of associates and ensure adequate staffing of programs. 3. Ensure high quality and timely delivery of tasks/projects assigned to Group. 4. Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head. 5. Interact ...