Agency Manager Salary in Norwood, MA

General PurposeThe primary purpose of your job position is to provide direct nursing care to the residents, and to supervise the day-to-day nursing activities performed by nursing assistants. Such supervision must be in accordance with current federal, state, and local standards, guidelines, and regulations that govern our facility, and as may be required by the Director of Nursing Services or Nurse Supervisor to ensure that the highest degree of quality care is maintained at all times.Essential DutiesEvery effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.Administrative Functions• Direct the day-to-day functions of the nursing assistants in accordance with current rules, regulations, and guidelines that govern the long-term care facility.• Ensure that all nursing personnel assigned to you comply with the written policies and procedures established by this facility.• Periodically review the department's policies, procedure manuals, job descriptions, etc. Make recommendations for revisions.• Meet with your assigned nursing staff, as well as support personnel, in planning the shifts' services, programs, and activities.• Ensure that the Nursing Service Procedures Manual is current and reflects the day-to-day nursing procedures performed in this facility.• Ensure that all nursing service personnel comply with the procedures set forth in the Nursing Service Procedures Manual.• Make written and oral reports/recommendations concerning the activities of your shift as required.• Cooperate with other resident services when coordinating nursing services to ensure that the resident's total regimen of care is maintained.• Ensure that all nursing service personnel are in compliance with their respective job descriptions.• Participate in the development, maintenance, and implementation of the facility's quality assurance program for the nursing service department.• Participate in facility surveys (inspections) made by authorized government agencies as may be requested.• Periodically review the resident's written discharge plan. Participate in the updating of the resident's written discharge plan as required.• Assist in planning the nursing services portion of the resident's discharge plan as necessary.• Interpret the department's policies and procedures to personnel, residents, visitors, and government agencies as required.• Admit, transfer, and discharge residents as required.• Complete accident/incident reports as necessary.• Write resident charge slips and forward to the Business Office.• Maintain the Daily Census Report and submit to the Business Office as required.• Perform administrative duties such as completing medical forms, reports, evaluations, studies, charting, etc., as necessary.• Agree not to disclose assigned user ID code and password for accessing resident/facility information and promptly report suspected or known violations of such disclosure to the Administrator.• Agree not to disclose resident's protected health information and promptly report suspected or known violations of such disclosure to the Administrator.• Report any known or suspected unauthorized attempt to access facility's information system.Charting and Documentation• Complete and file required recordkeeping forms/charts upon the resident's admission, transfer, and/or discharge.• Encourage attending physicians to review treatment plans, record and sign their orders, progress notes, etc., in accordance with established policies.• Receive telephone orders from physicians and record on the Physicians' Order Form.• Transcribe physician's orders to resident charts, cardex, medication cards, treatment/care plans, as required.• Chart nurses' notes in an informative and descriptive manner that reflects the care provided to the resident, as well as the resident's response to the care.• Fill out and complete accident/incident reports. Submit to Director as required.• Chart all reports of accidents/incidents involving residents. Follow established procedures.• Record new/changed diet orders. Forward information to the Food Services Department.• Report all discrepancies noted concerning physician's orders, diet change, charting error, etc., to the Nurse Supervisor.• Fill out and complete transfer forms in accordance with established procedures.• Ensure that appropriate documentation concerning unauthorized discharges is entered in the resident's medical record in accordance with established procedures.• Perform routine charting duties as required and in accordance with established charting and documentation policies and procedures.• Sign and date all entries made in the resident's medical record.Drug Administration Functions• Prepare and administer medications as ordered by the physician.• Verify the identity of the resident before administering the medication/treatment.• Ensure that prescribed medication for one resident is not administered to another.• Ensure that an adequate supply of floor stock medications, supplies, and equipment is on hand to meet the nursing needs of the residents. Report needs to the Nurse Supervisor.• Order prescribed medications, supplies, and equipment as necessary, and in accordance with established policies.• Ensure that narcotic records are accurate for your shift.• Notify the Nurse Supervisor of all drug and narcotic discrepancies noted on your shift.• Review medication cards for completeness of information, accuracy in the transcription of the physician's order, and adherence to stop order policies.• Notify the attending physician of automatic stop orders prior to the last dosage being administered.• Dispose of drugs and narcotics as required, and in accordance with established procedures.Personnel Functions• Participate in employee performance evaluations, determining your shift's staffing requirements, and making recommendations to the Nurse Supervisor concerning employee dismissals, transfers, etc.• Inform the Nurse Supervisor of staffing needs when assigned personnel fail to report to work.• Report absentee call-ins to the Nurse Supervisor.• Review and evaluate your department's work force and make recommendations to the Nurse Supervisor.• Develop work assignments and/or assist in completing and performing such assignments.• Provide leadership to nursing personnel assigned to your unit/shift.• Make daily rounds of your unit/shift to ensure that nursing service personnel are performing their work assignments in accordance with acceptable nursing standards. Report problem areas to the Nurse Supervisor.• Ensure that all nursing assistants are enrolled in or have graduated from an approved nursing assistant training program.• Ensure that all nurse aide trainees are under the direct supervision of a licensed nurse.• Meet with your shift's nursing personnel, on a regularly scheduled basis, to assist in identifying and correcting problem areas, and/or to improve services.• Ensure that department personnel, residents, and visitors follow the department's established policies and procedures at all times.• Develop and maintain a good working rapport with inter-departmental personnel, as well as other departments within the facility to ensure that nursing services and activities can be adequately maintained to meet the needs of the residents.• Create and maintain an atmosphere of warmth, personal interest and positive emphasis, as well as a calm environment throughout the unit and shift.• Review complaints and grievances made or filed by your assigned personnel. Make appropriate reports to the Nurse Supervisor as required or as may be necessary. Follow facility's established procedures.• Ensure that departmental disciplinary action is administered fairly and without regard to race, color, creed, national origin, age, sex, religion, handicap, or marital status.• Receive/give the nursing report upon reporting in and ending shift duty hours.• Report occupational exposures to blood, body fluids, infectious materials, and hazardous chemicals in accordance with the facility's policies and procedures governing accidents and incidents.• Report known or suspected incidents of fraud to the Administrator.• Ensure that departmental computer workstations left unattended are properly logged off or the password protected automatic screen-saver activates within established facility policy guidelines.Nursing Care Functions• Inform nursing personnel of new admissions, their expected time of arrival, room assignment, etc.• Ensure that rooms are ready for new admissions.• Greet newly admitted residents upon admission. Escort them to their rooms as necessary.• Participate in the orientation of new residents/family members to the facility.• Make rounds with physicians as necessary.• Requisition and arrange for diagnostic and therapeutic services, as ordered by the physician, and in accordance with our established procedures.• Consult with the resident's physician in providing the resident's care, treatment, rehabilitation, etc., as necessary.• Review the resident's chart for specific treatments, medication orders, diets, etc., as necessary.• Implement and maintain established nursing objectives and standards.• Make periodic checks to ensure that prescribed treatments are being properly administered by certified nursing assistants and to evaluate the resident's physical and emotional status.• Ensure that direct nursing care be provided by a licensed nurse, a certified nursing assistant, and/or a nurse aide trainee qualified to perform the procedure.• Cooperate with and coordinate social and activity programs with nursing service schedules.• Notify the resident's attending physician when the resident is involved in an accident or incident.• Notify the resident's attending physician and next-of-kin when there is a change in the resident's condition.• Carry out restorative and rehabilitative programs, to include self-help and care.• Inspect the nursing service treatment areas daily to ensure that they are maintained in a clean and safe manner.• Administer professional services such as; catheterization, tube feedings, suction, applying and changing dressings/bandages, packs, colostomy, and drainage bags, taking blood, giving massages and range of motion exercises, care for the dead/dying, etc., as required.• Use restraints when necessary and in accordance with established policies and procedures.• Obtain sputum, urine and other specimens for lab tests as ordered• Take and record TPRs, blood pressures, etc., as necessary.• Monitor seriously ill residents as necessary.• Check foods brought into the facility by the resident's family/visitors to ensure that it is within the resident's dietary allowances. Report problem areas to the Nurse Supervisor and Dietary Supervisor.• Ensure that personnel providing direct care to residents are providing such care in accordance with the resident's care plan and wishes.• Ensure that residents who are unable to call for help are checked frequently.• Meet with residents, and/or family members, as necessary. Report problem areas to the Nurse Supervisor• Admit, transfer and discharge residents as necessary.• Assist in arranging transportation for discharged residents as necessary.• Ensure that discharged residents are escorted to the pick-up area.• Inform family members of the death of the resident.• Call funeral homes when requested by the family. Ensure that established post-mortem procedures are followed.Staff Development• Participate in developing, planning, conducting, and scheduling in-service training classes that provide instructions on "how to do the job," and ensure a well-educated nursing service department.• Implement and maintain an effective orientation program that orients the new employee to your shift, its policies and procedures, and to his/her job position and duties.• Assist in standardizing the methods in which work will be accomplished.• Assist in training department personnel in identifying tasks that involve potential exposure to blood/body fluids.• Assist the Director in planning clinical supervision for nurse aide trainees.• Attend and participate in outside training programs.• Attend and participate in annual facility in-service training programs as scheduled (e.g., OSHA, TB, HIPAA, Abuse Prevention, Safety, Infection Control, etc.).• Attend and participate in advance directive in-service training programs for the staff and community.• Attend and participate in continuing education programs designed to keep you abreast of changes in your profession, as well as to maintain your license on a current status.Safety and Sanitation• Monitor your assigned personnel to ensure that they are following established safety regulations in the use of equipment and supplies.• Ensure that established departmental policies and procedures, including dress codes, are followed by your assigned nursing personnel.• Assist the Director and/or Infection Control Coordinator in identifying, evaluating, and classifying routine and job-related functions to ensure that tasks in which there is potential exposure to blood/body fluids are properly identified and recorded.• Ensure that all personnel performing tasks that involve potential exposure to blood/body fluids participate in appropriate in-service training programs prior to performing such tasks.• Ensure that an adequate supply of personal protective equipment are on hand and are readily available to personnel who perform procedures that involve exposure to blood or body fluids.• Ensure that your assigned work areas (i.e., nurses' stations, medicine preparation rooms, etc.) are maintained in a clean and sanitary manner.• Ensure that your unit's resident care rooms, treatment areas, etc., are maintained in a clean, safe, and sanitary manner.• Ensure that your assigned personnel follow established handwashing and hand hygiene technique in the administering of nursing care procedures.• Ensure that your assigned personnel participate in and conduct all fire safety and disaster preparedness drills in a safe and professional manner.• Participate in the development, implementation, and maintenance of the infection control program for monitoring communicable and/or infectious diseases among the residents and personnel.• Ensure that your assigned personnel follow established infection control procedures when isolation precautions become necessary.• Ensure that nursing personnel follow established procedures in the use and disposal of personal protective equipment.• Participate in the development, implementation and maintenance of the procedures for reporting hazardous conditions or equipment.• Ensure that all personnel wear and/or use safety equipment and supplies (e.g., back brace, mechanical lifts, etc.) when lifting or moving residents.• Report missing/illegible labels and MSDSs to the safety officer or other designated person.Equipment and Supply Functions• Recommend to the Nurse Supervisor the equipment and supply needs of your unit/shift.• Ensure that an adequate stock level of medications, medical supplies, equipment, etc., is maintained on your unit/shift at all times to meet the needs of the residents.• Participate in the development and implementation of the procedures for the safe operation of all nursing service equipment.• Ensure that only trained and authorized personnel operate your unit/shift's equipment.• Ensure that all personnel operate nursing service equipment in a safe manner.• Monitor nursing procedures to ensure that nursing service supplies are used in an efficient manner to avoid waste.• Ensure that appropriate MSDSs are on file for hazardous chemicals used in the nursing service department.Care Plan and Assessment Functions• Review care plans daily to ensure that appropriate care is being rendered.• Inform the Nurse Supervisor of any changes that need to be made on the care plan.• Ensure that your nurses' notes reflect that the care plan is being followed when administering nursing care or treatment.• Review resident care plans for appropriate resident goals, problems, approaches, and revisions based on nursing needs.• Ensure that your assigned certified nursing assistants (CNAs) are aware of the resident care plans. Ensure that the CNAs refer to the resident's care plan prior to administering daily care to the resident.• Assist the Resident Assessment/Care Plan Coordinator in planning, scheduling, and revising the MDS, including the implementation of RAPs and Triggers.Budget and Planning Functions• Report suspected or known incidence of fraud relative to false billings, cost reports, kickbacks, etc.Miscellaneous• Provide data to the Quality Assurance & Assessment Committee as requested.Supervisory RequirementsAs LPN / LVN you are delegated the administrative authority, responsibility, and accountability necessary for carrying out your assigned duties.QualificationEducation and/or Experience Must possess, as a minimum, a Nursing Degree from an accredited college or university, or be a graduate of an approved LPN/LVN program.Must possess a current, unencumbered, active license to practice as an LPN/LVN in this state.Language Skills Must be able to read, write, speak, and understand the English language. Ability to read technical procedures. Ability to read and comprehend policy and procedure manuals. Ability to effectively present information and respond to questions from managers and employees. Must be able to relate information concerning a resident's condition.Mathematical Skills Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.Reasoning Ability Must demonstrate knowledge and skills necessary to provide care appropriate to the age-related needs of the residents served.Must be a supportive team member, contribute to and be an example of team work and team concept.Must possess the ability to make independent decisions when circumstances warrant such action.Must possess the ability to deal tactfully with personnel, residents, family members, visitors, government agencies/personnel, and the general public.Must be knowledgeable of nursing and medical practices and procedures, as well as laws, regulations, and guidelines that pertain to nursing care facilities.Must possess leadership and supervisory ability and the willingness to work harmoniously with and supervise other personnel.Must possess the ability to plan, organize, develop, implement, and interpret the programs, goals, objectives, policies and procedures, etc., that are necessary for providing quality care.Must have patience, tact, a cheerful disposition and enthusiasm, as well as the willingness to handle difficult residents.Must be willing to seek out new methods and principles and be willing to incorporate them into existing nursing practices.Must not pose a direct threat to the health or safety of other individuals in the workplace.Certificates, Licenses, Registrations Must posess a current, unencumbered, active license to practice as an LPN/LVN in this state. Current CPR certification.Knowledge and experience with PCC preferred.Must maintain all required continuing education/licensing.Must remain in good standing with the State Board of Nursing at all times.Physical DemandsMust be able to move intermittently throughout the workday.Must be able to speak and write the English language in an understandable manner.Must be able to cope with the mental and emotional stress of the position.Must be able to see and hear or use prosthetics that will enable these senses to function adequately to ensure that the requirements of this position can be fully met.Must function independently and have flexibility, personal integrity, and the ability to work effectively with residents, personnel, and support agencies.Must meet the general health requirements set forth by the policies of this facility, which include a medical and physical examination.Must be able to relate to and work with the ill, disabled, elderly, emotionally upset, and, at times, hostile people within the facility.Must be able to push, pull, move, and/or lift a minimum of 25 pounds to a minimum height of 5 feet and be able to push, pull, move, and/or carry such weight a minimum distance of 50 feet.May be necessary to assist in the evacuation of residents during emergency situations.Work EnvironmentThe work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Works in office area(s) as well as throughout the nursing service area (i.e., drug rooms, nurses' stations, resident rooms, etc.).Moves intermittently during working hours.Is subject to frequent interruptions.Is involved with residents, personnel, visitors, government agencies/personnel, etc., under all conditions and circumstances.Is subject to hostile and emotionally upset residents, family members, personnel, and visitors.Communicates with the medical staff, nursing personnel, and other department directors.Works beyond normal working hours, and in other positions temporarily, when necessary.Is subject to call back during emergency conditions (e.g., severe weather, evacuation, post-disaster, etc.).Attends and participates in continuing educational programs.Is subject to injury from falls, burns from equipment, odors, etc., throughout the workday, as well as to reactions from dust, disinfectants, tobacco smoke, and other air contaminants.Is subject to exposure to infectious waste, diseases, conditions, etc., including TB and the AIDS and Hepatitis B viruses, COVID19May be subject to the handling of and exposure to hazardous chemicals.Maintains a liaison with the residents, their families, support departments, etc., to adequately plan for the residents' needs.

The Role:This role will be responsible for ensuring continuous improvement and sustained compliance of GMP manufacturing process equipment located at the Moderna manufacturing facilities. This position will provide engineering support for utilities and HVAC to the campus, support in the execution of day-to-day operation, projects, and troubleshooting. Lead investigations relating to non-conformance events in partnership with Quality, IT, and Manufacturing. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Proven problem-solving skills with a proactive, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for plant and clean utility system (purified water system, WFI, autoclaves, process gasses, HVAC, etc.) This includes serving as the system owner for plant and clean utility systems.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early-stage manufacturing processes.Lead and manage large sized, complex projects. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Manage project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors.Collaborate with Quality functions to streamline processes and remove obstacles to allow for agile and compliant project execution.Own quality records such as Change Controls, Deviations, and CAPAs, related to plant utility systems, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Here's What You'll Bring to the Table:Bachelor's degree EngineeringMinimum of 5 years relevant experience preferably as a Plant Engineer5 years of experience in a GxP biopharmaceutical operations environment preferred.Experience with plant and clean utility systems. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. A comprehensive understanding of regulatory requirements and their applications in a cGMP environmentFamiliarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements.Experience interacting with representatives of regulatory agencies.Experience with facility, utility, systems, and equipment commissioning and qualification.Excellent written and oral English language skillsProject management experienceModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-NB1-

The Role:Reporting to the Associate Director, E_Data (CSV) Quality, located at Moderna in Norwood, MA, the Manager of Digital Quality, applies established knowledge and experience in systems validation and lifecycle. The Manager should be familiar with global Health Authority Regulations including US FDA, ICH and guidelines (GAMP, Computer Systems Used in Clinical Investigations, etc.) and is responsible for the oversight, review, and approval of GCP/GLP/GVP-related computer system validation activities with a focus on quality support over GcLP internal validation activities of computerized systems/instruments/equipment, research computer systems vendor audits and internal system audits. The Manager will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it will require travel for auditing vendors.Here's What You'll Do:Lead and co-lead internal and vendor computer system audits related to GCP/GLP/GVP systems including but not limited to pre/post audit meetings, agenda, partnering with key stakeholders, review of legal contracts and vendor/internal processes ensuring systems are developed, validated, managed, and controlled based on applicable regulations and guidelines.Manage audit-related observations and CAPAs.Work closely with the Digital Technology department, system owners and business owners to implement new systems/instruments/equipment effectively and efficiently, system upgrades, or system modifications.Participate in the change control program for modifications to qualified systems and/or implementation of new systems.Review and approve computerized system, GcLP laboratory instruments, and GcLP equipment-related documents and procedures.Support regulatory agency inspections as needed.Participate and actively engage in strategic initiatives which require CSV support.Provide support and input into the full CSV and SDLC program.Contribute to the continuing development of a quality culture at Moderna.Perform other tasks as assigned by the line manager.Here's What You'll Bring to the Table:BS/BA with 8 to 10 years of experience or MS with 5 to 8 years of experience in the pharmaceutical/biotech industry with experience in the R&D Computer Systems Validation GCP/GLP/GVP environment.Demonstrated ability to work in a risk-based CSV environment following the associated regulatory expectations.Knowledge of Software Development Life Cycle (SDLC) principles including planning, analysis, design, development, testing, implementation, and maintenance is required.Experience and practical understanding of the development and validation of custom GAMP category 5 software, modules, interfaces, and reports is desired.Experience and proficiency with CSV audit for Research computerized systems is desired.Practical understanding of GAMP and ERES standards and guidance.Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations (understanding of regulatory guidelines for other countries a plus), CFR 21 Part 11.Expertise with business office applications, word processing and spreadsheets.Demonstrated knowledge and/or prior experience in Quality Assurance and oversight of GVP systems such as Argus and Signal Detection.Outstanding communication skills (verbal and written)Ability to manage multiple projects in a fast-paced environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.Relies on experience and judgment to plan and accomplish goals.Excellent organizational skills and keen attention to detail.Travel Requirements (as a %)Travel up to 30% based on business needs.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. (EEO/AAP Employer) #LI-LG1-

Description Be Part of an Extraordinary Team A proud member of the Elevance Health family of companies, Paragon Healthcare brings over 20 years in providing life-saving and life-giving infusible and injectable drug therapies through our specialty pharmacies, our infusion centers, and the home setting. Build the Possibilities. Make an Extraordinary Impact. Candidates must reside within 50 miles or 1-hour commute each way of a 4803 Montgomery Rd, STE 100, Norwood, OH 45212 The CarelonRx Account Executive is responsible for all sales activities for physicians' offices in a specified territory within a specific line of business which include home infusion therapy, infusion centers, etc. How you will make an impact: Primary duties may include, but are not limited to: Builds and maintains relationships with key customers for the infusion center line of business which will include physician offices. Works with leadership to develop territory sales forecasts and acheive goals. Qualifies opportunities in the territory with private insurance and/or federal or state funded plans as well as potential revenue. Assists customer service and provides necessary information to meet customer's needs. Identifies and resolves customer service issues in territory. Networks with industry partners. Assesses and reports on competitive sales activities. Assists in the development and implementation of competitive sales strategies. Represents region appropriately in sales efforts. Minimum Requirements: Requires a BA/BS and minimum of 5 years business analysis experience; or any combination of education and experience which would provide an equivalent background. Preferred Skills, Capabilities and Experiences: Healthcare experience strongly preferred. Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. Candidates must reside within 50 miles or 1-hour commute each way of a relevant Elevance Health location. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact [email protected] assistance.

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Who we are: We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at www.siemens.com/careers. Overview The Head of Regulatory Affairs will lead the regulatory strategy and operations for a Point of Care business. This role requires an expert in medical device regulations, global market access strategy, and regulatory submissions (e.g., FDA, CE Mark). This role is responsible for ensuring that products meet all regulatory requirements and for executing a timely regulatory go-to-market strategy. Position Reports To : President of Point of Care. Siemens Healthineers DX POC Key Responsibilities Serving as a key and active member of the POC leadership team, interacting with the team and other business functions to ensure objectives are aligned and that the company is performing to operational objectives. Leading, coaching and mentoring the Regulatory organization ensuring appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization Providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to gain product approvals worldwide. Tracking and maintaining product approvals and completes all necessary notifications, supplements, amendments, listings, and yearly reports for products on a global basis Oversee the regulatory lifecycle management of products to ensure continuous compliance with all applicable regulations. Collaborate with R&D and product development teams to integrate regulatory requirements into product design and development processes, facilitating smooth regulatory approvals and clearances. Collaborate with the clinical team to align clinical affairs activities with the regulatory strategy. • Providing counsel, training and interpretation and guidance on FDA, EU, China and other regulatory requirements to all company personnel. Overseeing preparation and filing of all regulatory documents with the FDA and international regulatory agencies. Developing and maintaining functional external relationships with FDA and Notified Body and other regulatory officials. Ensuring current and ongoing Regulatory Intelligence information is provided with analysis of impact to the business. Directing the development of systems, practices and processes to ensure effective ongoing review of product design and change requirements to ensure ability to launch new products into the market Providing leadership and direction for significant deviation events that may impact compliance status or significant business risk. • Represent the company at industry associations, regulatory meetings, and public forums to advocate for favorable regulatory policies and enhance the company's presence in the Point of Care sector. Travel may be up to 30% for this position. This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers Demonstrated success in Regulatory Affairs, including oversight or submissions for new products and product changes in Point of Care Diagnostics and with audits. Technical and scientific knowledge is required to understand the products and to review scientific issues and submission documents, labelling claims and clinical data. Experience with Point of Care instrument and Assay manufacturing and/or research and development strongly preferred. High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction. Excellent communications and presentation skills. Ability to lead, influence, create and work within cross-functional, cross geography (including remote) team environments. Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude, ability to adapt to changing regulatory and business environment and a sense of urgency to get things done. Strong written and verbal communication skills; must be articulate and able to communicate effectively with corporate officers, DVPs, directors, managers, and employees across the organization. Very strong attention to detail. Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint. Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment Required skills to have for the success of this role Master of Science degree required, advanced degree preferred. 15+ years of medical device, including Point of Care Diagnostics. 10+ years leadership experience required. Experience in strategic planning and collaboration with executive and key operational groups. Progressive & proven record of leadership in managing regulatory organizations with global responsibility and establishing long term strategic growth initiatives. Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization. Extensive experience in cGMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA), EU, China and other key countries/regions. Experience with managing or supporting clinical studies is desired. Proven track record of successful regulatory submissions and negotiations, including 510(k) and CLIA waiver applications. At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. The pay range for this position is $224,616 - $308,847 U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. The annual incentive target is 30% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html Beware of Job Scams Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site . If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers. If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about . "Successful candidate must be able to work with controlled technology in accordance with US export control law." "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations." As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Equal Employment Opportunity StatementSiemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. Reasonable AccommodationsIf you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form by clicking on this link Accomodation for disablity form If you're unable to complete the form, you can reach out to our AskHR team for support at 1-866-743-6367. Please note our AskHR representatives do not have visibility of application or interview status. EEO is the LawApplicants and employees are protected under Federal law from discrimination. To learn more, Click here .Pay Transparency Non-Discrimination ProvisionSiemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here .California Privacy NoticeCalifornia residents have the right to receive additional notices about their personal information. To learn more, click here .