Associate Director, RA Gateway RecruitingAssociate Director, RABoston, MAAs a manager, the function of an Associate Director, Regulatory Affairs, is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Maintain expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicate such knowledge to all internal stakeholders.
Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorJob Description: Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. Collaborates with the R&D QA, and other global entities to provide a consistent quality approach, including: Develops and presents periodic reports for assigned project describing VBU compliance trends and identifying areas of potential risk to VBU senior management.
Sr. Manager/ Associate Director - Pharma SME Tiger Analytics Inc.Sr. Manager/ Associate Director - Pharma SMEBoston, MAStrong experience with sales performance, patient services, speciality pharmacy, Veeva CRM, HCP/HCO, territory alignment, claims/prescription data , or related commercial domains. This role will serve as the functional expert across commercial data, Snowflake/lakehouse assets, reporting, and analytics while partnering closely with business and technology teams.
Patient Access Manager IV Integrated Resources, IncPatient Access Manager IVLexington, MassachusettsFull timeWorking directly with the following internal and external groups to revolve access issues described above: patients and/or their families and caregivers; public and private payers (local, regional, and national); specialty pharmacies and specialty distributors; physician offices, hospitals, infusion centers, and other sites of care; patient advocacy. Participate in regular cross-functional team meetings to coordinate patient services activities and field activities; cross-functional team includes case managers and field sales, and may include other functions as appropriate.
Manager Regulatory Affairs-CMC Integrated Resources, IncManager Regulatory Affairs-CMCLexington, MassachusettsContractorLocation: Lexington, MA Duration: 4+months (Possibility of extension) Business Function: R&D Department Name: Global Regulatory Affairs Primary Role: Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions. Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in biologics/small molecule drug development and registration activities.
Regulatory Affairs Manager. Integrated Resources, IncRegulatory Affairs Manager.Lexington, MassachusettsFull timePrimary Role: Under the general direction of the CMC Regulatory Affairs team, develop a Core Dossier for Module 2.3 and Module 3 CTD sections for a marketed product, and leverage the Core Dossier documents to support Marketing Authorization Applications for international regions. Key Skills and Competencies: Knowledgeable in ICH guidelines, Latin American CMC and core dossier requirement.
Clinical Safety Data Manager Integrated Resources, IncClinical Safety Data ManagerCambridge, MassachusettsFull timeThe AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%.
Senior CMC Regulatory Submission Manager Integrated Resources, IncSenior CMC Regulatory Submission ManagerLexington, MassachusettsContractorThe Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and Commercial Implementation of CMC Dossiers for Marketing Applications and Post-Approval) by working closely with Product Development, Regulatory, QA, GPT and MS&T cross-functional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools. Under the direction of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC Regulatory Submissions for Global Portfolio of early development programs (IMPD/CTA/IND).
Clinical Trials Safety Data Manager Integrated Resources, IncClinical Trials Safety Data ManagerCambridge, MassachusettsContractorClinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials.
Critical Care, ICU RN Manager Wheeler Staffing PartnersCritical Care, ICU RN ManagerFramingham, MAThe ICU RN Manager partners closely with executive nursing leadership to ensure the delivery of safe, high-quality, and patient-centered care while supporting staff development, operational efficiency, regulatory compliance, and resource management. The ideal candidate is a strong nursing leader with acute care and critical care experience who possesses exceptional communication skills, proven leadership capabilities, and a commitment to delivering outstanding patient outcomes.
Assistant Nurse Manager Pyramid HealthcareAssistant Nurse ManagerConcord, MA$95,000–$110,000 / yearThe Assistant Nurse Manager (RN) provides clinical leadership and operational support to the nursing department, ensuring the delivery of safe, high-quality patient care. Working alongside the Nurse Manager, this role helps oversee daily nursing operations, staff development, regulatory compliance, and interdisciplinary collaboration while promoting Pyramid Healthcare's mission and values.
Restaurant Zone Manager Raising Cane'sRestaurant Zone ManagerSaugus, MA$20–$21 / hourFull timeIt also includes both inside and outside work in varied temperatures, working with and around food products, common allergens, industrial equipment, commercial cleaning products that require the use of personal protective equipment and physical activities necessary to complete the responsibilities of the job. The physical work environment includes working in a fast-paced kitchen environment (which requires extended periods of physical exertion, such as walking, standing, lifting and bending) and interacting with customers.
Restaurant Manager Raising Cane'sRestaurant ManagerMarlborough, MA$20–$24 / hourFull timeIt also includes both inside and outside work in varied temperatures, working with and around food products, common allergens, industrial equipment, commercial cleaning products that require the use of personal protective equipment and physical activities necessary to complete the responsibilities of the job. The physical work environment includes working in a fast-paced kitchen environment (which requires extended periods of physical exertion, such as walking, standing, lifting and bending) and interacting with customers.
Operations Manager Raising Cane'sOperations ManagerFramingham, MA$25–$26 / hourFull timeOccasionally drive on behalf of the Company for work-related purposes (e.g., picking up product for the Restaurant) when required by business needs (e.g., when a salaried leader is on a leave of absence or there is a role vacancy). Perkspot Employee Discount Programs*Raising Cane's pays weekly, except in some states (e.g., California) where the company pays bi-weekly.
Salary Restaurant Manager Raising Cane'sSalary Restaurant ManagerMarlborough, MA$65,000–$70,000 / yearFull timeIt also includes both inside and outside work in varied temperatures, working with and around food products, common allergens, industrial equipment, commercial cleaning products that require the use of personal protective equipment and physical activities necessary to complete the responsibilities of the job. The physical work environment includes working in a fast-paced kitchen environment (which requires extended periods of physical exertion, such as walking, standing, lifting and bending) and interacting with customers.
Project Manager Dane Street, LLCProject ManagerBoston, MARemoteWe process over 200,000 insurance claims annually for leading national and regional Workers’ Compensation, Disability, Auto, and Group Health Carriers, Third-Party Administrators, Managed Care Organizations, Employers, and Pharmacy Benefit Managers. We are seeking a highly organized and results-driven Project Manager to lead and manage cross-functional strategic initiatives that support organizational growth and operational excellence.
Director/Senior Director, Patient Services Zevra TherapeuticsDirector/Senior Director, Patient ServicesBoston, MassachusettsThe Senior Director, Patient Services is expected to deliver Patient Support Programs across disease states and patient populations aimed to ensure patient access, and successful initiation; to initiate benefits investigation and identify relevant and timely information to empower prescribers and patients with the resources they need to gain access to Zevra’s medications as prescribed. In this pivotal role, they will lead the operations and external partners (Specialty Pharmacy, HUB, Field Case Managers) to provide a best-in-class patient experience focused on providing helpful resources and information to assist in the reimbursement and access journey, from the time they are prescribed a Zevra product, throughout their duration of therapy and beyond.
NewDirector of Regulatory Affairs, Post-Market Compliance WerfenDirector of Regulatory Affairs, Post-Market ComplianceBedford, Massachusetts$200,000–$240,000 / yearFull timeReporting to the Senior Director of Regulatory Affairs, this position is responsible for ensuring worldwide regulatory compliance of commercially distributed products through effective management of vigilance reporting, field actions, post-market surveillance activities, regulatory assessments, and product lifecycle compliance programs. The Director serves as the regulatory leader for post-market compliance activities and collaborates closely with Quality Assurance, Medical Affairs, R&D, Operations, Manufacturing, Supply Chain, and Commercial teams to ensure timely identification, assessment, communication, and resolution of product-related regulatory issues.
Medical Science Liaison, Cardiovascular - Milvexian (ME, VT, NH, MA, RI) Bristol Myers SquibbMedical Science Liaison, Cardiovascular - Milvexian (ME, VT, NH, MA, RI)Boston, MARemote$166,090–$201,262 / yearThe purpose of their interactions is to engage in meaningful scientific exchange that will ensure patients have access to BMS medicines, to ensure their safe and appropriate usethrough peer to peer discussions aligned with medical strategies and needs expressed by external stakeholders, and to facilitate research. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director of Nursing Sunrise Senior LivingDirector of NursingBurlington, MAProvide clinical care through the direct application of the nursing process; perform and document resident assessments and progress notes, evaluate changes in care needs, complete Individualized Service Plans (ISP), provide or delegate hands-on clinical care as indicated by the plan of care, and evaluate resident outcomes. The Director of Nursing (Resident Care Director) serves as the nursing clinical leader for the community and is responsible to lead and manage the health and wellness along with coordination of care and services to residents within the community.