Boston, Massachusetts, United States
Records Management Own day-to-day document control and quality systems support for a Class II medical device manufacturer, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820. Manage the full lifecycle of controlled documents in Arena PLM (SOPs, work instructions, forms), including creation, routing, review, approval, release, revision, and archival. Administer company-wide training programs for new hires and existing staff, including onboarding, role-based training, and change-related retraining; monitor and close training gaps with department managers. Support and help facilitate internal and external audits (ISO, FDA, notified body), providing fast, accurate document retrieval and maintaining an audit-ready state for procedures, records, and training. Collaborate with Quality, Regulatory, Engineering, and Operations to implement process and document changes via established change control processes (ECR/DCR/ECO), ensuring impacts to procedures, forms, and training are captured and executed. Maintain and enforce document control standards and governance, ensuring that templates, naming conventions, metadata, and approval workflows are applied consistently across the quality system. Track and communicate key quality metrics (e.g., training completion status, document change progress, audit readiness indicators) to management to support decision-making and continuous improvement.
๏ Conduct marketing research to identify industry trends and commercial opportunities ๏ Point of contact for vendors and clients ๏ Liaise with external vendors ๏ Writes reports and sugges:ons for improvements and new ideas ๏ Run campaigns for ambassador programs ๏ Cold call leads ๏ Servicing accounts ๏ Contracted with Massachusetts state gov’t to sell health ins. To small businesses ๏ Develop and build brand awareness, relevance, reputation, and credibility among target audiences. ๏ Servicing accounts
๏ Follow established policies for addressing member inquiries and meet service quality goals ๏ Mail out new memberships to patients ๏ Renewing accounts ๏ Eligibility application reviews ๏ Work with dental offices and vendors for efficient service ๏ Run day to day operations for the dental plan ๏ Report to CEO of organiza:on for reporting and training ๏ Administrative duties
๏ Transcribing and typing from recorded dictation, shorthand or rough dra\ correspondence, reports, manuscripts, charts and other materials for clinical, administrave or research purposes, including highly complex and/or confidential information ๏ Type all medical and administra:ve correspondence, medical staff notes, memoranda, minutes, reports and schedules. Composes, proofreads, and edits as necessary. ๏ Handles all telephone calls and messages having to do with physician(s) administra:ve prac:ce, triaging calls, as necessary, to appropriate personnel. ๏ Performs all other du:es, related to physician(s) administra:ve prac:ce at Brigham and Women's Hospital, Faulkner Hospital, Foxboro Health Care Center, and the Dana-Farber Cancer Ins:tute, as they arise. ๏ Types all medical repor:ng and administra:ve notes and schedules. Composes, proofreads, and edits as necessary. ๏ Contact review organiza:ons and insurance companies to ensure prior approval requirements are met. Present necessary medical informa:on such as history, diagnosis and prognosis. Provide specific medical informa:on to financial services to maximize reimbursement to the hospital and physicians.