Business Process Improvement Analyst Integrated Resources, IncBusiness Process Improvement AnalystCambridge, MassachusettsContractorPosition Summary: • The Business Process Improvement (BPI) Analyst is responsible for future state process analysis, documentation, solution design, implementation and training/communication of BPI initiatives for Global HR and Shared Services. • This role will be responsible for streamlining, simplifying and improving HR end-to-end processes, driving a continuous improvement culture, with systems & tools to drive productivity and a unified user experience.
Corporate Responsibility Integrated Resources, IncCorporate ResponsibilityBillerica, MassachusettsTemporaryCommunity Engagement: Help support project to identify key cause areas that align to the business and development of a strategy for global community engagement; research skills-based volunteer opportunities that align with defined cause areas; process Matching Gifts requests; coordinate internal employee events and campaigns. In support of the Corporate Responsibility (CR) strategy, the CR team is hiring an intern to support the development and implementation of key programs to help us meet our goals and 2015 targets in the areas of products, operations and people.
Quality Assurance Specialist Integrated Resources, IncQuality Assurance SpecialistLexington, MassachusettsContractorTrending, support of Quality System data analysis and metrics for QMR, KPIs, and other reportable forums Work Order review Batch Record review of more complex process records. Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Disinfection Specialist Integrated Resources, IncDisinfection SpecialistCambridge, MassachusettsContractorThe Individual will manage equipment and support facility related projects by supporting changeover/return to service/ area clearance activities and assisting in the assembly and disassembly of process equipment. Performs manufacturing cleaning and disinfection activities including but not limited to areas in Cell Culture, Purification, and Solution & Equipment Prep areas.
Bioprocess Associate Integrated Resources, IncBioprocess AssociateAndover, MassachusettsContractorRequires demonstrated effectiveness in collaborative projects, and ability to communicate effectively with scientists and management in a highly matrixed organization. Requires demonstrated competency in aseptic laboratory technique, bioreactor operations and the ability to design complex experiments and interpret data.
Contract and Agreement Specialist Integrated Resources, IncContract and Agreement SpecialistCambridge, MassachusettsContractorContract management; responsible for initiating contract renewals with MW functional service providers and partners, including negotiations/follow-up with vendors, ensuring appropriate signatures are obtained, ensuring purchase orders are in place, and filing final, fully executed contracts in Selectica. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Process Engineer Integrated Resources, IncProcess EngineerLexington, MassachusettsFull timeGood knowledge in protein purification and characterization; DoE study, Proficiency in column chromatography, filtration and TFF; Proficiency in AKTA explorer and avant; Must be well-organized and self-motivated, and possess an independent work style; Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside of work. As a member of the Manufacturing Science & Technology group, this individual will join a group of process scientists and engineers to support downstream processes of commercial productions and late stage clinical process development and productions.
Medical Writer Integrated Resources, IncMedical WriterMassachusettsContractorPosition Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project Manager Job Function Summary The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Program Manager Integrated Resources, IncProgram ManagerMansfield, MassachusettsContractorPosition Summary: · The PMV Data Manager is responsible for leading a group of PMV Data Analysts in developing statistically based ad hoc reports utilizing data generated by the Client complaint system to assist in the evaluation of safety triggers by PMV Analysts, providing leadership in the administration of the Client Complaint Tracking System (CTS) across the various Surgical Solutions Group sites, developing systems to provide support and tracking of ad hoc reporting outside the complaint group, as well as development and maintenance of the PMV SharePoint site. Location: Mansfield, MA Duration: 12+Months (Possibility of extension) Job Role: · This position is probably most closely associated with a Quality Systems Manager (IT oriented), with good program management skills.
NewClinical Research Associate (Portuguese Fluency) Software Guidance & AssistanceClinical Research Associate (Portuguese Fluency)Boston, MA$65–$80 / hourVerify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Responsible for medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; Required Skills : Must be fluent in Portuguese. Minimum 2 years experience with direct interim monitoring experience including SDV (Source Document Verification), SDR (Source Data Review) and MRR (Medical Record Review).
Physician Assistant Boston Medical CenterPhysician AssistantBoston, MAUnder the general supervision of the Chief Physician Assistant, Attending physician and Operations Manager, the Physician Assistant is responsible for providing varied medical services, which may include: Initial and follow-up evaluation of orthopedic related complaints including formulating a diagnosis and treatment plan, ordering and interpreting laboratory tests and diagnostic studies; prescribing and/or dispensing medication; assisting in surgery or other invasive procedures; rounding on admitted patients; counseling patients and families, preforming pre-operative and other patient care duties. Additionally, the Physician Assistant may be involved in a patient's medical care in any capacity the attending physician deems proper and consistent with applicable law, hospital regulations, delineation of privileges, and the Physician Assistant's training, knowledge, skills, and experience.
New(Sr.) Manager, GCP Quality Assurance Aura Biosciences Inc.(Sr.) Manager, GCP Quality AssuranceBrighton, MA$130,000–$185,000 / yearPerform and/or manage GCP audits of CROs, vendors, investigator sites, Trial Master Files (TMFs) and internal R&D processes, including assessment of root cause analyses and CAPA effectiveness, while driving the timely resolution of audit observations and quality issues. The successful candidate will bring strong GCP Quality experience across the planning, execution, reporting, and follow-up of audits, including Investigator Site, Clinical Process, TMF, Database, and Clinical Vendor/Supplier audits.
Regulatory affairs Manager Integrated Resources, IncRegulatory affairs ManagerLexington, MassachusettsFull timeExperience Requirements: • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch. Must have skill-set Job Function and Description: • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
Regulatory Affairs Manager Integrated Resources, IncRegulatory Affairs ManagerLexington, MassachusettsContractorMust have skill-set [Job Description] Job Function and Description: • Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. • Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
Data Management Vendor Manager Associate Integrated Resources, IncData Management Vendor Manager AssociateCambridge, MassachusettsContractorThe Data Management (DM) Vendor Manager Associate is responsible for supporting functional service provider and full-service relationships and performing tasks such as the development of outsourcing budgets, coordination of vendor governance activities with the oversight of experienced DM Vendor Managers. 5+ years in the Vendor Management field (DM and/or BIOS experience is a plus), previous work with full service CROs (and full service contracts) is required; working in a global/cross cultural setting is preferred.
NewAssociate Director, Clinical Operations Clinical Dynamix, Inc.Associate Director, Clinical OperationsWatertown, MAWork closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review. Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
Bookstore Operations Assistant CYNET SYSTEMSBookstore Operations AssistantWellesley Hills, MA$24–$29 / hourTemporaryContractorPart timeAs a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
NewAnatomic and Clinical Pathologist Sante Consulting LLCAnatomic and Clinical PathologistNewburyport, MAThe successful candidate will work closely with a small team of experienced pathologists, providing comprehensive pathology services while overseeing laboratory operations at an affiliated technical processing facility. Santé Consulting is representing a well-established physician-led pathology practice seeking a Board Certified or Board Eligible AP/CP Pathologist to join a collaborative community hospital practice in the Northeast.
Senior Project Manager, Clinical Operations Bicara TherapeuticsSenior Project Manager, Clinical OperationsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Ability to work independently and successfully in a fast-paced, results-driven, highly accountable environment with large potential impact; ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
Clinical Supply Chain Operations Manager RD PartnersClinical Supply Chain Operations ManagerCambridge, Massachusetts£141,440–£176,800Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout. R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.