Jobs at Exact Sciences
394,276 open positions
Document Capture Systems Developer
Company: Access Sciences
Location: Baton Rouge, LA
Posted Sep 18, 2023
As the Document Capture System Developer you will administer, develop, install/configure test, debug, and maintain applications and databases (Kofax, SQL, Scanners, Drivers, automation routines, window services, custom interfaces). Kofax Backup and Disaster Recovery procedures.Create and enforce application test criteria, protocols, and methods to ensure consistent system change controlSupport and troubleshoot software, servers, desktops, and scanning equipmentCreate productivity and application utilization status reportsCreate technical documentationUpgrade legacy platform into current technology Required Skills, Experience, and Knowledge: Programming languages: .NETDatabases: MS SQL Server or OraclePlatforms / Applications: Microsoft WindowsExperience providing customer or end user IT / Technical supportSoftware development, web application developmentExperience using application API's Education Bachelor's Degree or equivalent experience in Computer Science, Information Systems, or commensurate experience required Desired Skills Programming languages: C, REACT, Angular, Java, JavaScript, JSON, jQuery, CSS, HTML 5, IISKofax or Datacap hardware and software application and supportContent Management experience (FileNet, Content Manager, OnBase, OpenText, SharePoint) If this sounds like just the kind of flexible opportunity you are looking for, then please fill out our short initial application. Job Responsibilities Kofax Server and Client installations, Batch and Document class creation and maintenance. Our employees enjoy a range of benefits, including: Opportunities for professional growthProfit sharing based on company performanceEmployee Stock Ownership Plan (ESOP)401(k) with company matchMedical, Dental, and VisionFlexible Spending AccountHealth Savings Account with company contributionDisability and Life Insurance, company paidVoluntary Life InsurancePaid Time Off, Holidays, and Sick TimePaid Volunteer Hours WHAT OUR EMPLOYEES HAVE TO SAY: " Work hours were flexible. Good luck! Candidates who meet our initial screening will be immediately reviewed & moved forward in our hiring process which includes meeting the team. The hardest part was learning the standards and process. I really enjoyed learning while I was there." I quickly had a feeling of belonging with Access Sciences. The team brought me up to speed on the tasks/jobs.
Account Executive
Company: AIS (Applied Information Sciences)
Location: Washington DC
Posted Sep 17, 2023
Employment decisions are based solely on qualifications, merit, and business need. Experience in professional services, including service delivery, estimating, scheduling, budgeting, managing profitability, issue resolution, and authoring proposals/statements of work. We are committed to our employee's success; however, they define it. We are looking for: Smart people with a passion for technology Strong technical capabilities with a consultancy mindset Close involvement with local technical communities A willingness to think outside of the box to provide innovative solutions to clients Ability to solve challenging technical business problems Self-directed professionals Our Core Values Client Success C ontinued Learning and Technical Excellence Strong Client Relationships Citizenship and Community EEO Statement Applied Information Sciences is an Equal Opportunity Employer and does not discriminate on the basis of race, national origin, religion, color, gender, sexual orientation, age, disability, protected veteran status, or any other basis covered by law. About AIS AIS, Dedicated to Our People AIS employees can spend their entire career at AIS doing challenging, rewarding work and reach their desired level of achievement and responsibility. Our employees are our greatest strength, and we do all that we can to serve them. We hire outstanding individuals who are committed to curiosity, passionate about emerging technology, and who are excited to find innovative solutions for the biggest tech challenges facing international brands and government agencies today. We invest in technology as early adopters, allowing us to create transformative and innovative solutions for our customers while exposing our team to cutting edge technology. We Invest in Individuals Committed to Innovation AIS is seeking professionals of a certain character and level of excellence. We offer the opportunity to move up, without the obligation to move out of a position where one excels.
Director/Senior Director, GCP & GVP Quality Assurance, Telavant (Remote)
Company: Roivant Sciences
Location: Remote
Posted Sep 27, 2023
Ability to communicate and work independently with scientific/technical personnel.Experience with managing either direct reports and/or consultants.Skilled in developing collaborative internal and external relationships with experience in building teams, through coaching and development.Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).Ability to think critically and demonstrate troubleshooting and problem-solving skills.Self-motivated, detail-oriented, and comfortable in a fast-paced, rapidly evolving, highly unique company environment with minimal direction and able to adjust workload based upon changing priorities.Must be absolutely competent in, and comfortable with, managing through influence and developing champions to advance the Roivant QA agenda and objectives.Telavant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes from agencies. Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction to follow through with specific tasks.Continuously demonstrates a positive, 'can do' and service-oriented attitude.Excellent interpersonal, verbal, and written communication skills with commitment to accuracy. Please do not send agency resumes to our website or Roivant Sciences, affiliated employees, or any of our subsidiary companies. Trial Master Files, Clinical Study Reports, Protocols, etc. Ensure manufacturing and packaging of clinical materials meet study and trial requirements, and with GMP QA to ensure testing and stability is initiated compliantly and tested on time.Evaluate quality events, incidents, queries, and complaints and perform risk analysis on any GCP violation reported from the clinical site or CROs (including CTM service provider), take actions to remediate, and communicate to senior management on the overall compliance status.Support the development and delivery of GCP GPV training of internal company employees.Planning, coordination, control, and continuous improvement of processes and systems to assure the quality & compliance of clinical studies. Experience with EMA, MHRA and WHO regulations a plus.Demonstrates initiative and proactively provides collaborative support to the clinical team as a credible communicator. Late Development experience is required.Broad knowledge of clinical processes and procedures, electronic documentation systems, and GCP and GPVP regulations and guidance with demonstrated effectiveness in maintaining CQA control processes for compliance with regulations.Experience conducting quality audits of CROs and Investigational sites.Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.In-depth knowledge of FDA and ICH regulatory requirements. Minimum of 15 years of experience in the pharmaceutical industry with a GCP and/or GPV focus, ideally covering all clinical phases through commercial drug product, with at least 5 years in a GCP quality/compliance role. Promote collaboration to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines.Work with Clinical Operations and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GCP guidelines. Perform QC checks of relevant clinical documents and regulatory dossiers, e.g., Investigator's Brochure, CRF, Clinical Study Reports and non-clinical/clinical sections in the IND/NDA/BLA/MAA submission to ensure data integrity and accuracyWork with Clinical Operations and Pharmacovigilance to develop a robust and integrated risk management program in accordance with ICH E6 (R2), including systems and processes associated with product complaints.Work collaboratively with GMP QA Operations teams.
Technical Writer
Company: Exela Pharma Sciences
Location: Other US Location
Posted Sep 29, 2023
The Technical Writer is responsible for creating and maintaining quality documentation, collaborating with SMEs and FAMs, and ensuring regulatory compliance. The role requires exceptional written and verbal communication skills, technical research abilities, and proficiency in Microsoft Office and Adobe Acrobat. A BA or BS degree in a scientific discipline with a strong writing background is preferred, along with one year of experience in the pharmaceutical industry. Experience with document control systems is a plus.
Director, Pharmacovigilance, Telavant (Remote)
Company: Roivant Sciences
Location: Remote
Posted Sep 27, 2023
Finally, engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.Reviewing and synthesizing scientific literature and competitive intelligence to support study and program strategyMonitor industry best practices and changes in global safety regulations and guidelinesContribute to preparation and quality control activities for key safety documentsCollaborate with a team of professionals who provide medical monitoring support for ongoing clinical trials on a global basisEnsure departmental budgets and schedules meet corporate requirementsCoordinate responses and resolutions to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plansProvide input to potential in-licensing opportunities and pharmacovigilance agreements with partnersSkills, Qualifications, and RequirementsAdvanced degree (MD, DO, PhD, RN or PharmD preferred)Minimum 8+ years of Pharmacovigilance/drug safety/drug development experience in the biopharmaceutical industryProficiency in strategizing, planning, monitoring and problem solvingExcellent strategic thinking skills, with demonstrated ability to successfully create and implement both short- and long-term plans to support the direction of the function and the organizationFlexibility to work in a fast-paced environmentAbility to manage multiple and diverse issuesStrong facilitation, organizational, analytical and time management skillsTelavant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or Roivant Sciences, affiliated employees, or any of our subsidiary companies. Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define the clinical strategy. S/he must effectively collaborate effectively cross-functionally within the organization as well as with external safety service providers and regulatory authorities. Responsibilities Responsible and accountable for supporting PV systems, CRO relationship/process improvement, outsourced activities and deliverables related to PVAuthor and review drug safety sections of protocols, ICFs, IBs, CSRs and other documents including safety management plans, aggregate safety reports [e.g., DSURs, Annual Reports etc. ], Safety Surveillance Plans and IND/BLA packages.Conduct adverse event, literature, and other safety-relevant data analysis for the purpose of signal detectionEvaluate need and lead implementation, if applicable, of a safety database including informing on configuration and validationPerform ongoing safety surveillance (including signal detection/evaluation) of safety data from clinical studiesAssist in the formation of an appropriate safety governance structure processes in order to provide CRO oversight and be a Vant thought partner in the identification, assessment and communication of potential safety signalsCollaborate with Regulatory Affairs, Clinical and Quality to ensure appropriate reporting of PV and drug safety information and help inform risk mitigation measures that achieve the expected risk management outcomesLiaising with other functions to arrange external expert consultations, contribute to the development of study concepts, protocol designs, and study essential documents. This person will provide strategic safety data analyses and input to support clinical development activities, ensuring compliance for all pharmacovigilance regulatory reviews and submissions. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.Position Summary: The Director, Pharmacovigilance (PV) will support the evaluation/implementation of a core PV system, identification/management of “preferred” PV vendors for outsourced activities, and SOP library creation in collaboration with Central Roivant PV team. Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical study design and execution. We are developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach.To learn more about our company and pipeline, visit us at https://www.telavanttx.com/.About RoivantRoivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families.
Senior Manager/Manager, Compensation and People Analytics
Company: Roivant Sciences
Location: New York City, NY
Posted Sep 28, 2023
This individual will partner with Roivant leadership and its portfolio companies to provide strategic guidance on all areas of compensation to build scalable programs and data insights to help attract, motivate, and retain the best talent.Key Responsibilities:Compensation:Collaborate with the Head of People, COO, and legal counsel, to develop and prepare all required disclosures and materials for the Compensation Committee of the Board of Directors (agendas, analyses, and presentations)Conduct research and detailed proxy analysis on executive pay plan design, methodology, and industry trends and provide extensive data reporting and materials for Board of Directors and/or committee meetingsMonitor developments in executive compensation regulation, disclosure, and shareholder votingLead the year-end compensation planning process (e.g., merit increases, bonuses, equity incentives, performance evaluation process including the generation and distribution of annual compensation statements, pay equity analysis, and company communications)Review salary grades annually to ensure market competitivenessCoordinate with HR Business Partner on compensation matters (e.g., salary adjustments, promotions)Partner with Talent Acquisition to develop competitive compensation packagesReview annual salary survey participation submissions to all outside vendorsAssist in the development of compensation infrastructure, programs, playbook, and library to be leveraged across Roivant’s portfolio that align company goals, market dynamics, and performancePeople AnalyticsPartner with the Head of People to develop Roivant’s People Analytics strategyConceptualize and build high-impact scalable data and analytics solutions (e.g., self-service reporting, visualizations, dashboards) to empower our leaders and enable critical people decisions to be successfully driven by dataIdentify, synthesize, and translate large amounts of data into meaningful insights, automating and digitizing solutions for key stakeholdersPartner with the Equity Administration team to provide strategic equity analyses (e.g., ongoing evaluation of equity utilization, participation and holdings against targets and market data)Assist in the development and maintenance of a rolling equity forecast for operating companiesProvide detailed analyses of employee equity holdings including impactful visuals to develop award recommendations consistent with Roivant’s compensation philosophyPartner with Head of HR Operations to continuously improve Roviant’s HRIS, data, and reporting functionalitiesKnowledge, Skills & Abilities:EssentialBachelor’s degree or equivalent, CCP desirable5+ years’ progressive experienceAdvanced knowledge of Excel and PowerPointStrong compensation expertise in merit pay programs, incentive and bonus plans, job evaluation, and salary survey use and methodologySignificant experience conducting thorough compensation analysis with a focus on equity and/or executive compensation is preferredExposure to Executive Compensation and benchmarking presentations and documents as they relate to Compensation Committee/Board meetings and approvalsExpertise in using Radford and other data sources for compensation benchmarkingA deep understanding of RSUs, stock options, and other equity offeringsStrong analytical skills, including a working knowledge of statistics used in compensation analysisStrong verbal and written communication skills to develop and deliver effective documentation, reports, and presentationsDemonstrated experience with People Analytics, including the development of baseline reports and trend dashboards, including data from multiple sourcesSkilled in data storytellingDemonstrated experience in defining new People Data sets, linking disparate datasets, and generating insights from these datasets used within a broadly Predictive or Prescriptive Analytics programSolid understanding of People processes and all enabling technologiesStrong project management skills: proven ability to manage multiple projects and ad-hoc requestsProven record of success with attention to detail, creative problem-solving capabilities, and demonstrable self-driven initiative to improve operational processesHighly attuned discretion regarding employee data, queries, transactions, and general supportCollaborative team player with a “no task too small” attitudeBase salary for this role will be determined during the interview process and will vary based on multiple factors, including but not limited to prior experience, relevant expertise, current business needs, and market conditions. The expected base salary for the role will generally be between $140,000 - $170,000 per year at the commencement of employment, but the final salary offered may be outside this range based on individual circumstances and business and market conditions. Base salary if hired is only part of the total compensation package, which, depending on the position, may also include other components such as discretionary bonuses, equity, and Company-sponsored benefit programs.This position is at-will and Roivant reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance and business and market conditions.Roivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.We will not accept unsolicited resumes nor outreach from agencies. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.To learn more about our story and company culture, please visit us at https://roivant.com/Position Summary:The Senior Manager/Manager, Compensation and People Analytics will lead the administration of compensation programs, policies, and procedures and will develop a people analytics strategy to enable data-driven decision-making. Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!
Project Coordinator
Company: Exela Pharma Sciences
Location: Other US Location
Posted Sep 29, 2023
The Project Coordinator is a crucial role responsible for managing drug product projects from R&D to completion. Key responsibilities include coordinating projects, managing timelines, preparing meeting minutes, communicating project issues, and leading team meetings. The role requires strong organizational skills, pharmaceutical industry experience, and proficiency in Microsoft Office applications. The ideal candidate should be detail-oriented, comfortable communicating at various business levels, and capable of working independently.
Sales Development Representative - Inbound
Company: Exact Payments
Location: San Francisco, CA
Posted Sep 29, 2023
Exact Payments, a leading provider of embedded software payments, is seeking a Sales Development Representative (SDR) for a remote position. The SDR will educate and qualify leads, collaborate with sales reps, and maintain CRM data. The company values diversity, creativity, innovation, collaboration, integrity, and respect, and offers comprehensive benefits including health, dental, vision, life insurance, disability, FSAs, paid time off, and a 401k plan.
Senior Manager, Drug Safety/Pharmacovigilance (Remote)
Company: Roivant Sciences
Location: Remote
Posted Sep 29, 2023
The Senior Manager, DSPV may also be involved in the more scientific and/or clinical aspects of drug safety practice, time permitting and as assigned by the Director, DSPV.Key Responsibilities:Support the Director, PV in development/maintenance of all aspects of the company’s PV system, coordination/oversight of outsourced PV activities/deliverables, CRO relationship/process improvement, and safety inspection preparedness activitiesRepresent safety on assigned clinical study teams and provide review, writing, and quality control support for drug safety sections of protocols, ICFs, IBs, and CSRsCollaborate with Biometrics and Data Management in the review of EDC system SAE forms/notifications and safety tables, figures, and listings for assigned clinical studiesCollaborate with Regulatory Affairs, Clinical, and Quality to ensure the appropriate reporting of DSPV information and provide input into mitigation measures to achieve the expected risk management outcomesContribute to the development of documents governing safety activities, such as Pharmacovigilance Agreements and Safety Management Plans for assigned programsAuthor, coordinate, oversee development, and/or provide quality control for aggregate safety reports (eg, DSURs) for assigned programsHelp develop and maintain Drug Safety & PV Standard Operating Procedures, Work Instructions, and FormsConduct adverse event, literature, and other safety-relevant data analysis for the purpose of signal detection, and document signal management activities under the guidance of the Director, PVHelp prepare agendas, minutes, and other meeting materials for Product Safety Management Committee meetingsWith the Director, PV, serve as Business Administrator for Roivant’s cloud-hosted ArisGlobal LifeSphere MultiVigilance safety database system and the associatedLifeSphere Reporting and Analytics tool (eg, coordinate/verify training, manage user account requests, review system version notes before upgrades for business impact)Skills, Qualifications, and RequirementsLife sciences degree and/or background in a clinical field (eg, RN, PharmD) requiredMinimum 6 years of pharmacovigilance/drug safety experience in the biopharmaceutical industry, including processing cases, preparing aggregate safety reports, and ensuring the quality of safety activities/deliverablesMinimum 2 years of experience directly providing oversight of safety case processing, including negotiating Safety Management PlansExperience representing the safety function on clinical study teams, including reviewing safety-related content in clinical documents (eg, protocols, ICFs, IBs, CSRs)Experience writing/maintaining procedural documents on safety topicsRecent experience working in ArisGlobal’s LifeSphere MultiVigilance and Reporting and Analytics tool preferredFamiliarity with Veeva’s EDC and quality document management systems is preferredExperience supporting safety inspections and/or inspection readiness activities is preferredStrong verbal communication and interpersonal skillsProficiency in technical and business writingProficiency in planning, monitoring and operational problem solvingFlexibility to work in a fast-paced environment, shifting on and off projects as neededAbility to manage multiple and diverse issuesStrong organization, analytical, documentation, and time management skillsRoivant Sciences provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.We will not accept unsolicited resumes nor outreach from agencies. The Senior Manager, DSPV must be an effective collaborator, both cross-functionally within the Roivant family of businesses and with external safety service providers. The Senior Manager, DSPV will participate in the continued development and maintenance of the core PV system at Roivant, including helping expand the library of safety-related SOPs/Work Instructions, identifying and managing preferred PV vendors for outsourced activities (eg, case processing, DSUR preparation), serving as a Business Administrator for the safety database system, supporting the activities of the Product Safety Management Committee, and working toward continuous safety inspection readiness. This person will also represent DSPV on assigned clinical study teams and participate in the development of various business, regulatory, and clinical documents in his/her capacity as DSPV Subject Matter Expert. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Since its inception in 2014 Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 10 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.To learn more about our story and company culture, please visit us at https://roivant.com/Position Summary:The Senior Manager, Drug Safety/Pharmacovigilance (DSPV) is an operational role reporting to the Director, DSPV in the Drug Safety Operations (DSO) group within the Regulatory Affairs & Drug Safety department at Roivant. DSO supports the safety needs of clinical-phase Roivant subsidiaries (Vants) from the time a development program is in-licensed and a new Vant is created until the subsidiary is equipped to cover its own DSPV needs. Thanks! Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families.
Director/Senior Director, Product Quality Operations, Telavant (Remote)
Company: Roivant Sciences
Location: Remote
Posted Sep 27, 2023
Please do not send agency resumes to our website or Roivant Sciences, affiliated employees, or any of our subsidiary companies. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 9 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.Position SummaryThe Product Quality Operations role will be the primary Quality Leader for the Chemistry, Manufacturing, and Controls (CMC) unit at Telavant, Inc. The successful candidate will ensure that the technical CMC strategy and operations for RVT-3101 meets Telavant Standards for GMP compliance through an active partnership with the CMC teams. The successful candidate must have a deep scientific background with Quality experience and has led projects across multiple CMC areas for both biologics and pharmaceuticals. They will be expected to operate simultaneously at a strategic and tactical level. Additionally, this leader will assist with Supplier Quality Management and other QA Operations, including GLP and related laboratory functions. This position reports to the Chief Medical Officer. This position is a remote, work from home opportunity. ResponsibilitiesAttend all CMC product teams’ meetings providing timely quality strategies and tactics to the project team enabling rapid program progression to phase-appropriate compliance expectationsQA review/approval of GMP records and documentation, including although not limited to, batch records, test method validations, specifications, deviations/investigations, CAPAsAssist in the creation, development, and implementation of procedures for CMC and GLP operations or other laboratory functionsAssist with the Supplier Quality Management program for all GXP areasEnsure that CMC has the best Quality guidance possible to simultaneously optimize the triple constraint within the framework of complianceMaintain a continuous improvement focus facilitating the growth of the quality mindset in TelavantParticipate in other assignments, as needed.Skills, Qualifications, and RequirementsBA/BS degree with 15+ years of experience in the pharmaceutical industry (MS +10; PhD + 8) with a scientific or engineering degreeDeep knowledge of the product development lifecycle (Phase 1 through commercial) and application of phase-appropriate quality for manufacturing, analytics, and formulation/stability for both biological and pharmaceutical assets; GMP experience is required.Practicing knowledge of compendial affairs topics related to analytics, primary containers and raw materials at a minimum.Development and/or critical evaluation for Justification of Specifications for biologics and pharmaceutical assets.Experience in quality assurance as related to program development for CMC Teams and the relevant regulations across major markets.A strategic thinker who can work seamlessly with other team members and brings solid technical capabilities to effectively merge science and quality meeting program timelines.Experience with Supplier Quality Management programs; auditing experience a plus.GLP experience, including bioanalytical assays, is highly desired.Experience with managing either direct reports and/or consultants.Proficient in quality management platforms and tools, specifically Veeva.Resourceful and relentless: independently capable of seeking information, solving conceptual problems, corralling resources, and delivering results in challenging situations.Excellent verbal and written communication skills; ability to deal with complex problems, determine and evaluate risk, and present recommendations and findings in a clear, concise format.Experience in fast paced, start-up environments is preferred - able to work comfortably under pressure, frequently changing landscape and tight deadlines.Telavant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes from agencies. Telavant, a Roivant company, is a clinical-stage biotechnology company developing innovative therapies to treat inflammatory and fibrotic diseases. Telavant’s first investigational product, RVT-3101, is a fully human monoclonal antibody targeting TL1A. We are developing RVT-3101 as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis and Crohn’s disease, including for patients with a prospectively defined biomarker who may benefit from a precision approach.To learn more about our company and pipeline, visit us at https://www.telavanttx.com/.About RoivantRoivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families.
Information Assurance Engineer
Company: AIS (Applied Information Sciences)
Location: Washington DC
Posted Sep 17, 2023
Employment decisions are based solely on qualifications, merit, and business need. We are looking for: Smart people with a passion for technology Strong technical capabilities with a consultancy mindset Close involvement with local technical communities A willingness to think outside of the box to provide innovative solutions to clients Ability to solve challenging technical business problems Self-directed professionals Our Core Values Client Success C ontinued Learning and Technical Excellence Strong Client Relationships Citizenship and Community EEO Statement Applied Information Sciences is an Equal Opportunity Employer and does not discriminate on the basis of race, national origin, religion, color, gender, sexual orientation, age, disability, protected veteran status, or any other basis covered by law. 5 security controls through stakeholder interviews, security artifact review, technical review, etc. Working knowledge of MS Office Suite, especially MS Word and Excel Ability to leverage various trusted sources of information (articles, webinars, internet, etc.) Ability to understand complex, technical issues and communicate them into meaningful business and risk guidance and recommendation Strong knowledge of operating systems (information and process) and networks Strong knowledge of computer vulnerabilities, hacker methodologies, and other threats Experience working with enterprise-level information security programs, including governance, risk assessment, policy/standards, technical controls, oversight and assurance, risk treatment, and security education/awareness. We are committed to our employee's success; however, they define it. We hire outstanding individuals who are committed to curiosity, passionate about emerging technology, and who are excited to find innovative solutions for the biggest tech challenges facing international brands and government agencies today. Our employees are our greatest strength, and we do all that we can to serve them. Previously worked with 3rd party security assessment tools Demonstrated ability to work collaboratively with technical experts, business managers, and senior leadership. We invest in technology as early adopters, allowing us to create transformative and innovative solutions for our customers while exposing our team to cutting edge technology.
Senior API Engineer
Company: AIS (Applied Information Sciences)
Location: Washington DC
Posted Sep 22, 2023
Employment decisions are based solely on qualifications, merit, and business need. We are looking for: Smart people with a passion for technology Strong technical capabilities with a consultancy mindset Close involvement with local technical communities A willingness to think outside of the box to provide innovative solutions to clients Ability to solve challenging technical business problems Self-directed professionals Our Core Values Client Success C ontinued Learning and Technical Excellence Strong Client Relationships Citizenship and Community EEO Statement Applied Information Sciences is an Equal Opportunity Employer and does not discriminate on the basis of race, national origin, religion, color, gender, sexual orientation, age, disability, protected veteran status, or any other basis covered by law. We hire outstanding individuals who are committed to curiosity, passionate about emerging technology, and who are excited to find innovative solutions for the biggest tech challenges facing international brands and government agencies today. Profile of Success Minimum of 5 years' experience with .NET technologies (C, ASP.NET, ASP.NET), Database development (SQL, Stored Procedure Logic, Schema updates), and NodeJS to develop software solutions Typescript, Git, Bash, PowerShell experience Proven development background with front-end web technologies, including (Angular 10+, React) Azure DevOps (Boards, Repos, Pipelines, and Test Plans) Troubleshooting experience with Application Insights, and Postman is preferred Desirable Skills Experience with front-end web technologies, including (Angular 10+, React) Experience with Azure PaaS (Azure Functions, Logic Apps, etc.) We invest in technology as early adopters, allowing us to create transformative and innovative solutions for our customers while exposing our team to cutting edge technology. We are committed to our employee's success; however, they define it. Our employees are our greatest strength, and we do all that we can to serve them. Experience with cloud technologies (Azure, O365, AWS), Desire to obtain or utilize relevant technical certifications as part of continuous professional growth About AIS AIS, Dedicated to Our People AIS employees can spend their entire career at AIS doing challenging, rewarding work and reach their desired level of achievement and responsibility. We offer the opportunity to move up, without the obligation to move out of a position where one excels. We Invest in Individuals Committed to Innovation AIS is seeking professionals of a certain character and level of excellence.