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A short summary describing the scope: Review, edit, or write user study portal submissions and associated protocol, ICF, and recruitment documents and provide feedback to team in order to improve efficiency with legal approvals.\nKey Responsibilities:\nReviewing, writing, etc the necessary legal documents for the portal submissions (IC...

","descriptionText","Documentation Specialist Staffing the Universe Writing & Editing Documentation Specialist A short summary describing the scope: Review, edit, or write user study portal submissions and associated protocol, ICF, and recruitment documents and provide feedback to team in order to improve efficiency with legal approvals. Key Responsibilities: Reviewing, writing, etc the necessary legal documents for the portal submissions (IC...","shortDescription","Documentation Specialist

A short summary describing the scope: Review, edit, or write user study portal submissions and associated protoco...","location","locations",[451],{"_452":453,"_454":455,"_456":457,"_458":459,"_460":461},"formatted","Sunnyvale, CA, United States, 94087","city","Sunnyvale","state","CA","country","United States","postal_code","94087","companyName","Staffing the Universe","salaryMin","salaryMax","salaryDescription","https://us.thebigjobsite.com/redirectfeedjob?jobid=2A47E596F46965D8E6E299FAA3D48339&source=mediabistroxmlus&utm_source=mediabistroxmlus&jobSiteKey=1DBC50468E90CCD9DD1539E71505D990","companyDescription","companyWebsite","displayLogo","https://www.mediabistro.com/public/images/desk-100x50.webp","displayThumbnail","displayHeadline","Work at Staffing the Universe","isManualPosted","costPerClick",0.15,"displayUrl","fullUrl","https://www.mediabistro.com/jobs/2833188989-documentation-specialist","strippedDescription","Documentation SpecialistA short summary describing the scope: Review, edit, or write user study portal submissions and associated protocol, ICF, and recruitment documents and provide feedback to team in order to improve efficiency with legal approvals.\nKey Responsibilities:\nReviewing, writing, etc the necessary legal documents for the portal submissions (IC...","parsedLocation",{"_452":485,"_486":199,"_487":199,"_454":455,"_456":457,"_458":459,"_460":461},"Sunnyvale, CA, United States","street1","street2","displayPublishedAt","12 days ago","shortTitle","shortLocation","level","searchCompanyPath","/jobs?keyword=Staffing+the+Universe","searchLocationPath","/jobs?location=Sunnyvale%2C+CA%2C+United+States","searchTitlePath","/jobs?keyword=Documentation+Specialist","featuredCompany",{"_431":501,"_15":379,"_502":434,"_76":-5,"_503":504,"_248":505,"_448":506,"_507":-5,"_508":509,"_510":-5,"_511":512,"_513":514,"_515":516,"_470":517,"_478":518,"_472":519},1072,"agency","slug","hearst-television","

Every career with Hearst Television is like a story. How it develops, where it takes you, the milestones you reach along the way – you’ve got a lot to look forward to as your unique career story unfolds. Hearst Television, a subsidiary of Hearst, owns and operates local television and radio stations serving nearly three dozen U.S. cities, reaching 24 million U.S. television households. Through its partnership with nearly all major networks, Hearst Television distributes national content across more than 120 video channels, including programming from ABC, NBC, CBS, CW, MY Net, MeTV, This TV, Estrella, and more. Hearst Television is recognized as one of the industry's premier companies. It has been honored with numerous awards for distinguished journalism and industry innovation, including the Walter Cronkite Award for political journalism, the national Edward R. Murrow Award, the DuPont-Columbia Award, and the George Foster Peabody Award.

","New York, NY","coloredLogo","logoAttachment","Hearst.png","thumbnail","thumbnailAttachment","Hearst_TV_Careers.png","hexCode","#2D75B9","headline","National multimedia company reaching 24 million households","https://production-rails-default.s3.amazonaws.com/uploads/company/logo_attachment/1072/Hearst.png","/companies/hearst-television","https://production-rails-default.s3.amazonaws.com/uploads/company/thumbnail_attachment/1072/Hearst_TV_Careers.png","hasJobSubmission","isSavedJob","similarJobs",[524,543,552,572,590],{"_435":434,"_439":525,"_470":471,"_462":526,"_248":527,"_446":528,"_433":434,"_113":529,"_437":199,"_438":199,"_472":471,"_448":199,"_449":530,"_431":535,"_473":536,"_436":132,"_488":537,"_478":538,"_490":529,"_491":539,"_493":540,"_495":541,"_497":542},["D",1773864000000],"Frey Consulting Group","Seeking candidates who are regulatory medical writers (not Medical Communication).\nThe Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.\nResponsibilities:\nDrafts and edits documents used for submissions including CTDs and RtQs.\nDrafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms.\nDrafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.).\nManages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes.\nAdheres to departmental procedures and practices and technical and industry standards during all aspects of work.\nWorks effectively with cross-functional groups within the company.\nOther tasks as assigned.\nSkills:\nFulfills one of the following:\nMedical writer in the pharmaceutical industry.\nMedical or scientific writing experience as a primary job responsibility.\nSkill and Experience:\nAt least 6+ years experience required.\nFamiliar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.\nFamiliar with clinical study data collection and results reporting.\nExperience writing, reviewing, or editing protocols and clinical study reports highly preferred.\nExperience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.\nIntermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.\nIntermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.\nAbility to interpret basic tabular and graphical clinical data presentations.\nAbility to create basic tables using AMA style (eg, Schedule of Events).\nIntermediate applied knowledge of basic clinical laboratory tests.\nBasic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).\nBasic understanding of biostatistical and clinical research concepts.\nProficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.\nExperienced with scanners, printers, and copiers.\nBasic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).\nCapable of working on multiple tasks and shifting priorities.\nCapable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.\nMotivated and shows initiative.\nDetail oriented.\nCapable of well organized, concise and clear written and verbal communication.\nCapable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.\nEffective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.\nEducation:\nBachelor's or higher degree; scientific focus desirable.\nEvidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.\nThe hiring range for this position is $61to $71 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.\nHarvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

#J-18808-Ljbffr\n","Seeking candidates who are regulatory medical writers (not Medical Communication).\nThe Contract Medical Writer applies advanced documentation prepa...","Senior Regulatory Medical Writer",[531],{"_458":459,"_454":532,"_452":533,"_456":457,"_460":534},"San Rafael","San Rafael, CA, United States, 94911","94911",["B","1181136381"],"Work at Frey Consulting Group","3 days ago","/jobs/1181136381-senior-regulatory-medical-writer","San Rafael, CA, United States","/jobs?keyword=Frey+Consulting+Group","/jobs?location=San+Rafael%2C+CA%2C+United+States","/jobs?keyword=Senior+Regulatory+Medical+Writer",{"_435":434,"_439":544,"_470":471,"_462":526,"_248":545,"_446":546,"_433":434,"_113":529,"_437":199,"_438":199,"_472":471,"_448":199,"_449":547,"_431":549,"_473":536,"_436":132,"_488":550,"_478":551,"_490":529,"_491":539,"_493":540,"_495":541,"_497":542},["D",1774171504000],"

Seeking candidates who are regulatory medical writers (not Medical Communication).
The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Responsibilities:

Drafts and edits documents used for submissions including CTDs and RtQs.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms.
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.).
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes.
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Works effectively with cross-functional groups within the company.
Other tasks as assigned.

Skills:

Fulfills one of the following:
Medical writer in the pharmaceutical industry.
Medical or scientific writing experience as a primary job responsibility.

Skill and Experience:

At least 6+ years experience required.
Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
Familiar with clinical study data collection and results reporting.
Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg, Schedule of Events).
Intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Basic understanding of biostatistical and clinical research concepts.
Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
Experienced with scanners, printers, and copiers.
Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Capable of working on multiple tasks and shifting priorities.
Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
Motivated and shows initiative.
Detail oriented.
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.

Education:

Bachelor's or higher degree; scientific focus desirable.
Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

The hiring range for this position is $61to $71 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.

#J-18808-Ljbffr","

Seeking candidates who are regulatory medical writers (not Medical Communication).
The Contract Medical Writer applies advanced do...",[548],{"_458":459,"_454":532,"_452":533,"_456":457,"_460":534},["B","2969186707"],"5 hours ago","/jobs/2969186707-senior-regulatory-medical-writer",{"_435":434,"_439":553,"_470":471,"_462":554,"_248":555,"_446":556,"_433":434,"_113":557,"_437":199,"_438":199,"_472":471,"_448":199,"_449":558,"_431":564,"_473":565,"_436":132,"_488":566,"_478":567,"_490":557,"_491":568,"_493":569,"_495":570,"_497":571},["D",1772726400000],"Leeds Professional Resources","Our client is seeking a detail-oriented and motivated Business Immigration Paralegal to join our legal team. The ideal candidate will be responsible for assisting attorneys in the preparation and filing of immigration-related documents, conducting legal research, and managing case files. This role requires strong organizational skills, attention to detail, and the ability to work effectively in a fast-paced environment.

Responsibilities

Assist attorneys in preparing and filing immigration petitions and applications.

Conduct thorough legal research using tools such as Lexis-Nexis to support case preparation.

Interview clients to gather necessary information for case documentation.

Draft legal documents, including briefs and motions, ensuring accuracy and compliance with relevant laws.

Maintain organized case files and manage deadlines for submissions.

Communicate with clients regarding their cases, providing updates and answering questions.

Collaborate with attorneys on litigation matters related to immigration law.

Stay updated on changes in immigration laws and policies to provide informed support.

Experience

A degree in paralegal studies or a related field is preferred.

Previous experience as a paralegal, particularly in immigration law, is highly desirable.

Proficiency in legal research techniques and tools such as Lexis-Nexis is essential.

Strong writing skills with the ability to draft clear and concise legal documents.

Excellent interviewing skills to effectively gather information from clients.

Ability to work both independently and collaboratively within a team environment while managing multiple tasks efficiently.

If you are passionate about immigration law and eager to contribute your skills in a supportive legal environment, we encourage you to apply for this exciting opportunity as an Immigration Paralegal.

#J-18808-Ljbffr\n","Our client is seeking a detail-oriented and motivated Business Immigration Paralegal to join our legal team. The ideal candidate will be responsibl...","Business Immigration Paralegal",[559],{"_458":459,"_454":560,"_452":561,"_456":562,"_460":563},"Florham Park","Florham Park, NJ, United States, 07932","NJ","07932",["B","2788833112"],"Work at Leeds Professional Resources","16 days ago","/jobs/2788833112-business-immigration-paralegal","Florham Park, NJ, United States","/jobs?keyword=Leeds+Professional+Resources","/jobs?location=Florham+Park%2C+NJ%2C+United+States","/jobs?keyword=Business+Immigration+Paralegal",{"_435":434,"_439":573,"_470":471,"_462":574,"_248":575,"_446":576,"_433":434,"_113":577,"_437":199,"_438":199,"_472":471,"_448":199,"_449":578,"_431":583,"_473":584,"_436":132,"_488":585,"_478":586,"_490":577,"_491":581,"_493":587,"_495":588,"_497":589},["D",1774105200000],"Astyra Corporation","Technical Documentation Specialist\n*This is an onsite position

Description\nThis role is a Technical Documentation Specialist to support the additional processing effort required for the North Anna Digital IC project.

Responsibilities

Ensures compliance with regulatory and legal requirements dictated by Nuclear Information Record Management Association standards.

Processing a high volume of documents e.g. engineering drawings designs and transmittals and procedures from the large capital projects department through prepping scanning and indexing.

Providing excellent customer service at the Records Counter and via phone.

Aiding in the retrieval of records.

Specialized Tasks

Creating and maintaining revision-controlled drawings and field books for station craft areas.

This involves processing revision-controlled drawings design changes ETEs calculations specifications and other materials and communicating with the Engineering and projects group to ensure a quality product.

Resolving document management issues and implementing corrective actions.

Researching and retrieving legacy documents and drawings.

Distributing priority-controlled procedures and drawings.

Processing Vendor technical manuals and approval packages for specific revised procedures.

Maintaining and updating applicable Nuclear Records Retentions Schedule NRRS including reviewing every revised procedure to assess effect on retention and making updates as needed.

Providing support to the Electronic Document Management System EDMS Code Manager.

Processing and maintaining applicable electronic media and electronic media database.

Required Skills/Knowledge/Experience

0 - 2 years directly related experience as a records specialist in the nuclear field.

Ability to manage multiple activities resources and task priorities.

Ability to exercise discretion and professional judgment within clearly defined established procedures.

Demonstrates self-motivation.

Analytical and problem-solving skills.Demonstrates strong attention to detail.

Soft Skills

Strong communication skills both verbal and written.

Ability to lead collaborate or work effectively in a variety of teams including multi-disciplinary teams.

Good customer service skills.

Strong computer skills.

Education

Degree or an equivalent combination of education and demonstrated related experience may be accepted in lieu of preferred level of education.

Preferred: Associate degree or min of HS diploma.

Proper email communication will only be done to and from @astyra.com email addresses. Please ensure you are communicating with approved Astyra recruiters by checking this point when receiving offers and messages from us. Please ensure you are communicating within these guidelines and proper channels for the quickest possible interview consideration!

#J-18808-Ljbffr\n","Technical Documentation Specialist\n*This is an onsite position

Description\nThis role is a Technical Documentation Specialist to support th...","Technical Documentation Specialist",[579],{"_458":459,"_454":580,"_452":581,"_456":582},"Denver","Denver, CO, United States","CO",["B","2961900717"],"Work at Astyra Corporation","1 days ago","/jobs/2961900717-technical-documentation-specialist","/jobs?keyword=Astyra+Corporation","/jobs?location=Denver%2C+CO%2C+United+States","/jobs?keyword=Technical+Documentation+Specialist",{"_435":434,"_439":591,"_470":471,"_462":592,"_248":593,"_446":594,"_433":434,"_113":595,"_437":199,"_438":199,"_472":471,"_448":199,"_449":596,"_431":601,"_473":602,"_436":132,"_488":603,"_478":604,"_490":595,"_491":605,"_493":606,"_495":607,"_497":608},["D",1774188998000],"Aequor Technologies","*PIPELINE*
TITLE: Medical Writer
Must have 5 -7 years of experience.

POSITION SUMMARY:
The Medical Writer a ccountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.

Responsibilities and Duties:
- Responsible for the development of high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide regulatory submissions.
- Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives.
- Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors.
- Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
- Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
- Owns and updates assigned Medical Writing SOPs, as necessary.
Educational Requirements:
- Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Experience:
- Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Previous experience in Medical Writing in clinical drug development.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Strong working knowledge of Medical Writing requirements and document components.
- Good interpersonal skills that involves working well in a team environment and the ability to lead others.
- Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized ).
","*PIPELINE*
TITLE: Medical Writer
Must have 5 -7 years of experience.

POSITION SUMMARY: <...","Aequor Technologies is hiring: Medical Writer in Princeton",[597],{"_458":459,"_454":598,"_452":599,"_456":562,"_460":600},"Princeton","Princeton, NJ, United States, 08543","08543",["B","1531197538"],"Work at Aequor Technologies","1 hours ago","/jobs/1531197538-aequor-technologies-is-hiring-medical-writer-in-princeton","Princeton, NJ, United States","/jobs?keyword=Aequor+Technologies","/jobs?location=Princeton%2C+NJ%2C+United+States","/jobs?keyword=Aequor+Technologies+is+hiring%3A+Medical+Writer+in+Princeton","actionData","errors"]