Pay RangeThis range is provided by TALENT Software Services. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$70.00/hr - $80.00/hrSr. Medical WriterJob Summary: Talent Software Services is in search of a Sr. Medical Writer for a contract position in CA (Remote). The opportunity will be six months with a strong chance for a long-term extension.Position Summary: This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable Client to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.Primary Responsibilities/AccountabilitiesDrafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reportsDrafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processesRepresents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams)Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are metProvides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materialsAssists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departmentsAdheres to departmental procedures and practices and technical and industry standards during all aspects of workWorks effectively with cross-functional groups within Client'sOther tasks as assignedQualificationsBachelor's or higher degree required; scientific focus desirableMinimum requirement: Experience in medical writingEvidence of medical writing career development desirable, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information AssociationFulfills one of the following:Up to 6 years as a medical writer in the pharmaceutical industryAt least 10 years of medical or scientific writing experience as a primary job responsibilityClinical StudiesAdvanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasetsIntermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detectionIntermediate to advanced applied knowledge ofDocumentation required for the conduct of clinical studiesProtocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)Study results reportingIntegrated results reportingDirect experience with documentation in all phases of drug developmentMedical WritingExperience writing, reviewing, or editing protocols and clinical study reports requiredExperience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferredExperience writing, reviewing, or editing regulatory briefing books preferredAdvanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe contentAbility to interpret and create complex tabular and graphical clinical data presentationsAdvanced applied knowledge of basic clinical laboratory testsUnderstanding of the concepts of coding dictionaries (MedDRA, WHO Drug)Computer/office equipment SkillsProficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPointExperience using document management software (eg, LiveLink, SharePoint, Veeva)Experienced with scanners, printers, and copiersRegulatoryIntermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports)Prior familiarity with standard eCTD IND/NDA work, including:Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD formatIntegrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISS)Project ManagementCapable of working on multiple tasks and shifting prioritiesCapable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparationCapable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflictsGood conflict management skillsMotivated and shows initiativeDetail orientedCommunicationCapable of well organized, concise and clear written and verbal communicationCapable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirementsEffective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skillsIf this job is a match for your background, we would be honoured to receive your application! Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!Seniority levelMid-Senior levelEmployment typeFull-timeJob functionOtherIndustries: IT Services and IT ConsultingReferrals increase your chances of interviewing at TALENT Software Services by 2xGet notified about new Senior Medical Writer jobs in California, United States.J-18808-Ljbffr TALENT Software Services
At Meliora Academy, we provide individualized education for students with autism and related challenges, focusing on academics... ...confidence. Join us and make a difference every day. As a Special Education Teacher at Meliora Academy, you will create individualized learning...
...Our client, an industry leader in manufacturing and industrial services, is seeking a Maintenance Mechanic to join their team. As a Maintenance Mechanic, you will be part of the maintenance department supporting the production operations. The ideal candidate will demonstrate...
...About the Role: We are seeking organized and detail-oriented volunteers to support our upcoming community events across multiple... ...nonprofit operations, event planning, community engagement, or research. Key Responsibilities May Include: Researching local...
...everyday essentials, from cleaning supplies, home needs and OTC medications to food, drinks and more. Sign up to be a Gopuff Delivery... ...you want! Previous delivery experience as a delivery driver or courier driver is not required, but we encourage drivers from other...
...Job Title: Mental Health Screener Location: Monmouth Medical Center Department Name: Mobile Screening Req #: 0000242412 Status: Hourly Shift: Night Pay Range: $28.64 - $35.57 per hour Pay Transparency: The above reflects the anticipated hourly wage...