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Clinical Pharmacist, Medicine - Surgery
Massachusetts General Hospital(MGH), Boston
GENERAL SUMMARY/ OVERVIEW STATEMENT:The Massachusetts General Hospital is seeking motivated individuals to join our team of diverse Internal Medicine and Surgery Clinical Pharmacists. In collaboration with a multidisciplinary team, this clinical pharmacist will provide comprehensive patient-centered pharmacological therapy to a wide variety of patients admitted to the Medicine (Teaching and Hospitalist) and Surgical Areas. This position will allow the pharmacist to round, provide therapeutic recommendations, respond to drug information questions, respond to hospital emergencies, and provide a diverse range of clinical interventions to admitted patients. Opportunities to make a broad impact include participation in the optimization of policies, procedures, workflows, and clinical initiatives. This rewarding position provides opportunities for professional development, growth, and career advancement. Clinical Pharmacists assume responsibility and accountability for the provision of safe, effective, and prompt medication therapy. Clinical Pharmacists proficiently provide direct patient-centered care and integrated pharmacy operational services with physicians, nurses, and other hospital personnel to deliver optimal medication therapy to patients with a broad range of disease states. These clinicians are aligned with target interdisciplinary programs and specialty services to deliver medication therapy management and to ensure pharmaceutical care programs are appropriately integrated throughout the institution. Pharmaceutical care services include, but are not limited to, assessing patient needs, incorporating age and disease specific characteristics into drug therapy and patient education, adjusting care according to patient response, and providing clinical interventions to detect, mitigate, and prevent medication adverse events. Clinical Pharmacists serve as departmental resources and liaisons to other departments, hospital personnel, or external groups. They proficiently manage the appropriate use of medications according to professional and regulatory standards. They also conduct practice-related research and patient care, quality, and regulatory compliance initiatives designed to improve medication-use processes or pharmacy practice. Finally, Clinical Pharmacists provide medication and practice-related education/training and actively serve as preceptors for pharmacy residents and Doctor of Pharmacy students (MGH Pharmacy Residency website: https://www.massgeneral.org/education/pharmacy-residency.)PRINCIPAL DUTIES AND RESPONSIBILITIES: § As it pertains to the service area in the pharmacy department, responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes.§ Responsible for providing direct or indirect patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. When assigned to particular pharmacy service teams, may be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM).§ Works independently, and within the limits of established pharmacy/ambulatory care practice site's policies and procedures, as a member of the patient care team. Directs and coordinates the activities of a pharmacy service area. Supervises all support personnel during an assigned shift, operating within the limits of pharmacy policy and procedures, and the regulations of the Board of Registration Pharmacy. Takes lead as a subject matter expert in their areas of practice at the site and system level.The following are essential job functions for Clinical Pharmacists:Percent of Time SpentLead assigned patient service lines, clinical areas, and therapeutic programs: § Facilitate pharmaceutical care, direct patient care programs, medication utilization systems within assigned care areas to assure drug utilization activities are aligned with patient care needs, evidence-based best practices, hospital guidelines, and regulatory standards§ Design and implement new pharmacy programs, quality improvement changes, and continuous quality assurance initiatives to advance the organization's medication-use systems and promote optimal patient outcomes§ Design and implement stewardship activities and restriction/surveillance programs§ Track and evaluate assigned pharmacy programs for operational, quality, and financial efficiency and routinely benchmark against local and national best practices§ Develop strategies to optimize medication utilization, including but not limited to clinical guidelines, disease-specific pathways, formulary management, and medication-use policies§ Provide departmental and institutional leadership for committees/meetings, hospital group/task forces, and approved external programs/organizations§ Assure pharmacy is an integral part of the health-care delivery system and facilitates enhancement and expansion of pharmacy services/programs5Deliver direct patient-care and clinical practice, including decentralized and service-based programs:§ Maintain proficiency in decentralized pharmacy services and clinical pharmacy programs§ Place practice priority on the delivery of patient-centered care§ Work as an active member of multidisciplinary team and collaborate with healthcare personnel within care areas§ Establish collaborative pharmacist-patient relationships§ Maintain patient information and interpret patients' health care needs including patient problem lists and prioritized pharmacist interventions§ Collect and document accurate patient medication histories and reconcile discrepancies§ Identify high-risk patients and implement interventions to improve care quality and safety§ Make appropriate evidence-based, patient-centered medication recommendations§ Implement, evaluate, and redesign pharmaceutical care plans based on patient progress and evolving goals for medication usage, including drug dosing and monitoring § Provide written documentation in the patient's medical record when requested§ Obtain and maintain ACLS and BLS certification§ Participate in the management of medical emergencies§ Provide discharge medication review, reconciliation, and counseling as appropriate to help with the transition of care§ Provide evidence-based medication education to physicians, nurses, and other professionals§ Educate patients and care givers regarding safe and effective use of medications, possible medication side effects, and the role of prescribed medications in the overall treatment plan§ Maintain proficiency in hospital computer systems and medication ordering systems§ Interpret, evaluate, and accurately process medication orders§ Complete critical patient monitoring and review patient chart to identify, prevent, or mitigate drug-related problems, improper drug or dose selection, subtherapeutic dosage, over dosage, adverse drug reactions, drug interactions, untreated indications, medication use without an indication, and treatment failures§ Follow established standard work parameters and maintains standard work environments60Participates in pharmacy operations and medication dispensing: § Maintain proficiency in and actively engage in operational programs, central dispensing pharmacies, satellite dispensing pharmacies, and specialty pharmacy areas as appropriate for job assignment§ Facilitate medication procurement, ordering, and dispensing procedures including, but not limited to, chemotherapy, parenteral nutrition, controlled substances, etc.§ Utilize pharmacy automation and supportive technology proficiently § Oversee pharmacy operations and technician practice/activities when assigned § Promote the use of the formulary by converting non-formulary medications to formulary alternatives when possible, evaluate appropriateness of non-formulary medication requests, and support procurement of non-formulary drugs when necessary10Facilitate experiential education and preceptorship: § Maintain proficiency in the four preceptor roles and actively emulate education/mentorship § Serve as a preceptor/educator for MGH pharmacy residency (PGY1 and PGY2) and student experiential programs, including maintaining training and experience in pharmacy practice areas appropriate for teaching assignments§ Develop student, resident, and staff training experiences/competencies and create new relationships for teaching and training opportunities§ Identify, design, and mentor learners in implementing improvements in the medication-use system to advance patient safety, maximize therapeutic outcomes, or control costs§ Demonstrate personal leadership qualities, role model, and business acumen to advance the profession and practice of pharmacy20Performs other duties as assigned: § Maintain a sustained record of contribution to the total body of knowledge in pharmacy practice through presentations, publications, and professional affiliation activities§ Participate as a formal reviewer for a peer-reviewed medical or pharmacy journals§ Maintain up-to-date knowledge of contemporary hospital practice and clinical service, trends and innovations in pharmacy leadership, and updates in traditional therapeutics, professional practice standards, or health care regulatory requirements§ Maintain a specialized evidence-based knowledge of drug and drug therapy by reviewing relevant professional journals and suggested readings5Relationships:§ Clinical Pharmacists report directly to a Pharmacy Manager or Area Director and work collaboratively with administrative, pharmacist, and technical to support department initiatives§ Clinical Pharmacists have frequent interactions with physicians, nurses, other members of the health care team, students, residents, and external professional groups§ Clinical Pharmacists supervise all support staff (e.g., pharmacy technicians) as assignedQualifications QUALIFICATIONS:REQUIRED:Must be eligible for licensure to practice pharmacy in the Commonwealth of MassachusettsPostgraduate residency/fellowship training is preferredBoard Certification by examination, or equivalent certification, in the relevant specialty is preferred, required within 18 months of hiringMust meet all Board of Pharmacy requirements to enter into a collaborative drug therapy management agreement, when applicable Massachusetts Controlled Substance Registration license, National Provider Index number, and a Drug Enforcement Administration Registration number, when applicablePREFERRED:Completion of ASHP-accredited PGY1 and PGY2 Internal Medicine or Pharmacotherapy Pharmacy Residency or Fellowship preferredSKILLS/ ABILITIES/ COMPETENCIES REQUIRED:• Extensive knowledge and ability in all areas of the department including: IV Admixtures, Drug Information, Ambulatory, Manufacturing, and Drug Distribution• As it pertains to the service area in the pharmacy department, demonstrate appropriate knowledge of principles of growth and development over the life span of the neonate, adolescent, adult, and geriatric patient. Possess ability to assess patient data relative to age specific needs. Provide care as described in the department's policies/proceduresAdditional General Skills/Abilities:Knowledge of contemporary hospital/clinical practice and serviceKnowledge and understanding of general hospital operations and regulatory complianceStrong written and verbal communication skillsAbility to interact constructively with supervisors, peers, and support personnelAbility to integrate clinical and distributive pharmacy services with quality improvement, teaching, research, and professional development activitiesSignificant general clinical knowledge and expertise in traditional therapeutics and patient-centered careSignificant knowledge and expertise in advanced pharmacy practice, specialty medication therapy management, and specialty evidence-based medicine in area appropriate for clinical assignmentsStrong teaching and precepting skills and expertise in experiential trainingWORKING CONDITIONS:Able to lift up to 20 lbsAble to stand for extended periods of timeAble to sit for extended periods of timeEEO Statement Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law.
Clinical Pharmacist - Transitions of Care / Emergency Department Boarder Service
Massachusetts General Hospital(MGH), Boston
GENERAL SUMMARY/ OVERVIEW STATEMENTThe MGH Department of Pharmacy is seeking a Transitions of Care/Boarder Emergency Department Boarder Service Clinical Pharmacist to join our growing team at the Main Campus. This new position will be focused on collaborating with multidisciplinary team members to optimize care for Border patients (primarily medicine patients) residing in the Emergency Department and supervise pharmacy technicians/learners participating in the daily conduct of medication histories. This is an exciting opportunity for those looking to lead, build, and expand future services to include all aspects of care transitions for patients, and optimize care for Border patients at our Main Campus. Pharmacists in this role are positioned to fulfill their professional aspirations and make a positive impact on the lives and care for our patients. Hired candidates have the opportunity to weigh in on the scheduling for this position which may include 7 on 7 off. Emergency medicine experience is not required. Clinical Pharmacists assume responsibility and accountability for the provision of safe, effective, and prompt medication therapy. Clinical Pharmacists proficiently provide direct patient-centered care and integrated pharmacy operational services with physicians, nurses, and other hospital personnel to deliver optimal medication therapy to patients with a broad range of disease states. These clinicians are aligned with target interdisciplinary programs and specialty services to deliver medication therapy management and to ensure pharmaceutical care programs are appropriately integrated throughout the institution. Pharmaceutical care services include, but are not limited to, assessing patient needs, incorporating age and disease specific characteristics into drug therapy and patient education, adjusting care according to patient response, and providing clinical interventions to detect, mitigate, and prevent medication adverse events. Clinical Pharmacists serve as a departmental resources and liaisons to other departments, hospital personnel, or external groups. They proficiently manage the appropriate use of medications according to professional and regulatory standards. They also conduct practice-related research and patient care, quality, and regulatory compliance initiatives designed to improve medication-use processes or pharmacy practice. Finally, Clinical Pharmacists provide medication and practice-related education/training and actively serve as preceptors for pharmacy residents and Doctor of Pharmacy students (MGH Pharmacy Residency website: https://www.massgeneral.org/education/pharmacy-residency.)PRINCIPAL DUTIES AND RESPONSIBILITIES§ As it pertains to the service area in the pharmacy department, responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes.§ Responsible for providing direct or indirect patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. When assigned to particular pharmacy service teams, may be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM).§ Works independently, and within the limits of established pharmacy/ambulatory care practice site's policies and procedures, as a member of the patient care team. Directs and coordinates the activities of a pharmacy service area. Supervises all support personnel during an assigned shift, operating within the limits of pharmacy policy and procedures, and the regulations of the Board of Registration Pharmacy. Takes lead as a subject matter expert in their areas of practice at the site and system level.The following are essential job functions for Clinical Pharmacists:Percent of Time SpentLead assigned patient service lines, clinical areas, and therapeutic programs: § Facilitate pharmaceutical care, direct patient care programs, medication utilization systems within assigned care areas to assure drug utilization activities are aligned with patient care needs, evidence-based best practices, hospital guidelines, and regulatory standards§ Design and implement new pharmacy programs, quality improvement changes, and continuous quality assurance initiatives to advance the organization's medication-use systems and promote optimal patient outcomes§ Design and implement stewardship activities and restriction/surveillance programs§ Track and evaluate assigned pharmacy programs for operational, quality, and financial efficiency and routinely benchmark against local and national best practices§ Develop strategies to optimize medication utilization, including but not limited to clinical guidelines, disease-specific pathways, formulary management, and medication-use policies§ Provide departmental and institutional leadership for committees/meetings, hospital group/task forces, and approved external programs/organizations§ Assure pharmacy is an integral part of the health-care delivery system and facilitates enhancement and expansion of pharmacy services/programs5Deliver direct patient-care and clinical practice, including decentralized and service-based programs:§ Maintain proficiency in decentralized pharmacy services and clinical pharmacy programs§ Place practice priority on the delivery of patient-centered care§ Work as an active member of multidisciplinary team and collaborate with healthcare personnel within care areas§ Establish collaborative pharmacist-patient relationships§ Maintain patient information and interpret patients' health care needs including patient problem lists and prioritized pharmacist interventions§ Collect and document accurate patient medication histories and reconcile discrepancies§ Identify high-risk patients and implement interventions to improve care quality and safety§ Make appropriate evidence-based, patient-centered medication recommendations§ Implement, evaluate, and redesign pharmaceutical care plans based on patient progress and evolving goals for medication usage, including drug dosing and monitoring § Provide written documentation in the patient's medical record when requested§ Obtain and maintain ACLS and BLS certification§ Participate in the management of medical emergencies§ Provide discharge medication review, reconciliation, and counseling as appropriate to help with the transition of care§ Provide evidence-based medication education to physicians, nurses, and other professionals§ Educate patients and care givers regarding safe and effective use of medications, possible medication side effects, and the role of prescribed medications in the overall treatment plan§ Maintain proficiency in hospital computer systems and medication ordering systems§ Interpret, evaluate, and accurately process medication orders§ Complete critical patient monitoring and review patient chart to identify, prevent, or mitigate drug-related problems, improper drug or dose selection, subtherapeutic dosage, over dosage, adverse drug reactions, drug interactions, untreated indications, medication use without an indication, and treatment failures§ Follow established standard work parameters and maintains standard work environments60Participates in pharmacy operations and medication dispensing: § Maintain proficiency in and actively engage in operational programs, central dispensing pharmacies, satellite dispensing pharmacies, and specialty pharmacy areas as appropriate for job assignment§ Facilitate medication procurement, ordering, and dispensing procedures including, but not limited to, chemotherapy, parenteral nutrition, controlled substances, etc.§ Utilize pharmacy automation and supportive technology proficiently § Oversee pharmacy operations and technician practice/activities when assigned § Promote the use of the formulary by converting non-formulary medications to formulary alternatives when possible, evaluate appropriateness of non-formulary medication requests, and support procurement of non-formulary drugs when necessary10Facilitate experiential education and preceptorship: § Maintain proficiency in the four preceptor roles and actively emulate education/mentorship § Serve as a preceptor/educator for MGH pharmacy residency (PGY1 and PGY2) and student experiential programs, including maintaining training and experience in pharmacy practice areas appropriate for teaching assignments§ Develop student, resident, and staff training experiences/competencies and create new relationships for teaching and training opportunities§ Identify, design, and mentor learners in implementing improvements in the medication-use system to advance patient safety, maximize therapeutic outcomes, or control costs§ Demonstrate personal leadership qualities, role model, and business acumen to advance the profession and practice of pharmacy20Performs other duties as assigned: § Maintain a sustained record of contribution to the total body of knowledge in pharmacy practice through presentations, publications, and professional affiliation activities§ Participate as a formal reviewer for a peer-reviewed medical or pharmacy journals§ Maintain up-to-date knowledge of contemporary hospital practice and clinical service, trends and innovations in pharmacy leadership, and updates in traditional therapeutics, professional practice standards, or health care regulatory requirements§ Maintain a specialized evidence-based knowledge of drug and drug therapy by reviewing relevant professional journals and suggested readings5Relationships:§ Clinical Pharmacists report directly to a Pharmacy Manager or Area Director and work collaboratively with administrative, pharmacist, and technical to support department initiatives§ Clinical Pharmacists have frequent interactions with physicians, nurses, other members of the health care team, students, residents, and external professional groups§ Clinical Pharmacists supervise all support staff (e.g., pharmacy technicians) as assignedQualifications QUALIFICATIONSREQUIRED:Must be eligible for licensure to practice pharmacy in the Commonwealth of MassachusettsPostgraduate residency/fellowship training is preferredBoard Certification by examination, or equivalent certification, in the relevant specialty is preferred, required within 18 months of hiringMust meet all Board of Pharmacy requirements to enter into a collaborative drug therapy management agreement, when applicable Massachusetts Controlled Substance Registration license, National Provider Index number, and a Drug Enforcement Administration Registration number, when applicablePREFERRED:Completion of ASHP-accredited PGY1 residency, PGY-2 in internal medicine, pharmacotherapy, or emergency medicine, is preferred. SKILLS/ ABILITIES/ COMPETENCIES REQUIREDExtensive knowledge and ability in all areas of the department including: IV Admixtures, Drug Information, Ambulatory, Manufacturing, and Drug DistributionAs it pertains to the service area in the pharmacy department, demonstrate appropriate knowledge of principles of growth and development over the life span of the neonate, adolescent, adult, and geriatric patient. Possess ability to assess patient data relative to age specific needs. Provide care as described in the department's policies/proceduresAdditional General Skills/Abilities:Knowledge of contemporary hospital/clinical practice and serviceKnowledge and understanding of general hospital operations and regulatory complianceStrong written and verbal communication skillsAbility to interact constructively with supervisors, peers, and support personnelAbility to integrate clinical and distributive pharmacy services with quality improvement, teaching, research, and professional development activitiesSignificant general clinical knowledge and expertise in traditional therapeutics and patient-centered careSignificant knowledge and expertise in advanced pharmacy practice, specialty medication therapy management, and specialty evidence-based medicine in area appropriate for clinical assignmentsStrong teaching and precepting skills and expertise in experiential trainingWORKING CONDITIONSAble to lift up to 20 lbsAble to stand for extended periods of timeAble to sit for extended periods of time
Senior Director, Medical Writing
Ironwood Pharmaceuticals, Boston
Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options.The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence.The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines.The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation.Responsibilities:Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals.Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization.Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents.Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials.Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices.Represent Medical Writing and provide medical writing expertise on cross-functional teams.Develop detailed timelines for document development in line with company goals and SOPs.Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers.Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables).Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable.Coordinate with the Regulatory Operations team to publish documents that meet eSubmissionready standards.Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates.Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations.Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable.Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines.Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC).Qualifications:BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferredSuccess in managing resources (internal, external, or hybrid)Prior direct experience leading medical writing teams responsible for global marketing authorization applicationsExperience with a broad range of clinical regulatory documents spanning the drug development lifecycleStrong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines.Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminologyExcellent technical writing and editorial skills; excellent attention to detailStrong ability to understand and interpret medical and scientific dataProficient in Microsoft Word, PowerPoint, Excel, Project, and SharePointExperience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNoteExcellent communication, interpersonal, and organizational skillsExperience working on cross-functional teamsWell organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelinesIronwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.#LI-HybridPDN-9bd56056-9ded-4ba0-a821-a48a12231459
Regulatory Affairs Specialist--Temporary- 12-24 Months (Remote)
AngioDynamics, Marlborough
JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE It takes a team of talented people to become one of the world's leading providers of innovative medical devices. AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.We accomplish this through: A Commitment to the Highest Standards of Quality Relentless Innovation Operational Excellence Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry. We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families. Job SummaryResponsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for guiding teams on the required deliverables to support the Regulatory status of products distributed by AngioDynamics Inc.Essential Duties and Responsibilities Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review. Assist with developing and implementing regulatory strategies for new and modified medical devices. Research and prepare recommendations on pathway for a new device, proposed device change or modification to support International Registrations. Apply scientific/technical knowledge to guide and strengthen development of regulatory submissions. Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers; and IC Dossiers) Review device labeling and advertising materials for compliance with regulatory product approvals (submissions/licenses) and applicable country regulations; analyze and recommend appropriate changes. Review and recommend action on product and manufacturing changes in compliance with applicable regulations. May act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle. Prepare Export Certificates (CFGs, CFS, etc.)- apply knowledge of specific country requirements to obtain approvals from USA regulatory agencies and International embassies Prepare product and establishment registration/listing with International Regulators primarily for the EU and APAC. Collaborate with internal (Quality/Ops/R&D) and external (Partners/Distributors) groups to obtain documentation necessary to develop required Field Action reports to Regulators (e.g., FDA, CA, EU) including Initial, Interim and Close-out Report Liaison with global Regulatory partners. Contribute as a team member on projects sustaining the regulatory and quality compliance of products and the continued enhancement of the organization Support and maintain Quality initiatives in accordance with the Quality Policy. Continuously assess ways to improve Quality. This position has potential for travel to domestic and international facilities and meetings. May perform other duties as assigned Regulatory Responsibilities Manages in order to ensure compliance with all relevant regulatory/legal requirements. Quality Systems Duties and Responsibilities Build Quality into all aspects of their work by maintaining compliance to all quality requirements Education and Experience Bachelors Level of Degree in a scientific or technical discipline field of study Equivalent work related experience acceptable in lieu of degree 1-2+years of experience in Regulatory Affairs supporting EU MDR/International registrations. Medical industry experience required. Skills/Knowledge Experience in the following computer software applications: Microsoft Office General understanding of product development process and design control. Effective written and oral communication, technical writing and editing skills. Effective research and analytical skills. Ability to work independently with minimal supervision. Working knowledge of FDA and international regulations. Ability to manage several projects simultaneously Exceptional interpersonal skills. Strong organizational skills. Strong communication skills (written and verbal). Ability to effectively communicate both internally and externally. Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence. Physical/Work RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job: § Work safely and follow all OSHA regulations and company safety policies and procedures. § For all on-the-job injuries or accidents, must notify manager/supervisor immediately. § Exposure to standard office environment § Ability to frequently lift and/or move up to 15 lbs § Ability to occasionally lift and/or move up to 50lbs § Ability to regularly sit or stand for extended periods of time This position requires some travel up to 5% of the time All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other legally protected status. The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract. Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.
Manager, Compensation & Benefits Consulting
Alvarez & Marsal Tax, LLC, Boston
DescriptionManager, Compensation & Benefits ConsultingThe Opportunity:A&M is a group of entrepreneurial, action and results-oriented professionals who take a hands-on approach to solving our clients' problems and assisting them in reaching their potential. Our culture celebrates independent thinkers and doers who can positively impact our clients and shape our industry. The collaborative environment and engaging work-guided by A&M's core values of Integrity, Quality, Objectivity, Fun, Personal Reward, and Inclusive Diversity-are why our people love working at A&M.We provide tax, turnaround management, restructuring, performance improvement, and corporate advisory services. Our tax practice is unique in that we offer the opportunity to work without audit conflict and truly act a trusted business advisor. We provide our teams with opportunities and support to develop and cultivate careers that are most meaningful to them and reward them based on their achievements.A&M's Compensation & Benefits practice is currently seeking a Manager with key expertise in the area of Executive Compensation. The ideal candidate will work with our team of professionals to advise companies of all sizes on various compensation and benefits matters. When you join us, you will gain unique experiences and valuable knowledge working across capabilities, sectors, and geographies, and have the opportunity to take control of your career progression.As a Manager, you will assist clients with the design, implementation, communication, and monitoring of their compensation philosophy and strategy. The types of programs we consult on include base salary, annual incentives, long-term incentives, executive-level retirement, deferred compensation, and fringe benefit plans.Primary Responsibilities Include: Complete complex compensation and benefits projectsProvide compensation, tax, accounting, and business advice in regards to complex transactionsProvide competitive market data, quantitative/qualitative analysesHave proficiency in the taxation of executive compensation and knowledge of Code sections 83, 162(m), 280G, and 409AParticipate in multiple executive compensation engagements for a diverse client base, both in and out of the transaction settingContribute to client satisfaction by providing timely and effective responses to client needs and concernsParticipate in client meetings and work within a team environment to deliver fully integrated compensation and benefit services to clientsConduct proxy statement studies and analyses of other publicly available data sourcesBenchmark, design, and implement annual incentive plans and long-term incentive plansConduct statistical analyses of compensation dataModel financial impact of compensation plansConduct performance metrics studiesMonitor executive and other compensation trendsBenchmark, design, and implement bankruptcy compensation programs, including Key Employee Incentive Programs ("KEIPs"), Key Employee Retention Programs ("KERPs"), Management Incentive Plans ("MIPs"), severance programs, etc.Assist clients with stakeholder awareness and negotiations (e.g., board of directors, creditors committee, U.S. Trustee, etc.), as applicable.Participate in marketing initiatives including support on developing compensation work and methodology approaches, writing and supporting proposals and conducting surveysWith this position, you will further your analytical and communication skills while adding value for our clients by helping solve their complex problemsManage client engagements on a day-to-day basis and manage staff members on various projects, including:Benchmark compensation and develop reports to support the compensation recommendationsDesign annual and long-term incentive awards while considering the tax, accounting, and other regulatory ramificationsPrepare tax calculations and various analyses/models to help clients make better informed compensation decisions and comply with the applicable rules and regulationsReview/draft technical memorandums and letters related to compensation & benefits issuesReview the calculations and work product of peers for accuracy and reasonableness, serving as a thorough reviewer of data and results (most of the work product reviewed will be in Excel and PowerPoint)Interpreting and applying laws, regulations, judicial precedent and other guidanceManage risk, resources, staffing and financial performance for multiple engagements at once including billing, collections and project budgetsIdentify key tax issues and accurately quantify the impact to in a clear, concise, and thoughtful analysisBuild client relationships and demonstrate a working knowledge of client businessesConduct day-to-day management of accounts to ensure delivery of timely and accurate work productSupervise, develop, mentor, and motivate our Associates and Senior Associates by actively participating in their advancement through on-the-job training, providing performance feedback, counseling, and fostering our team-based atmosphereManage workload and deadlines for Associates and Senior Associates with a focus on quality, efficiency, and effectiveness of the project teamsDemonstrate commitment and desired behaviors while working with others that have diverse experiences, skills and perspectivesRegularly support business development efforts. Identify opportunities for add on work, thought leadership, new client pitches, and optimizing the compliance processQualifications: Bachelor's Degree required; advanced degree preferredOne of the following required: Juris Doctor, Masters in Tax, licensed CPA, or specialty compensation and benefits certification5-7 years of experience working with technical issues regarding compensation & benefitsStrong knowledge of executive compensation and statistical analysis, incentive plan design and analysis, and pay structure analysis and designExcellent verbal and written communication skills and ability to articulate complex information, including presenting complex topics in easily understood terms to clientsStrong analytical skillsAbility to simultaneously work on and manage several projects and effectively manage deadlinesHigh motivation to learn and growProficient in Excel, PowerPoint, and WordCompensation StatementThe salary range is $105,000 - $115,000 annually, dependent on several variables including but not limited to education, experience, skills, and geography. In addition, A&M offers a discretionary bonus program which is based on a number of factors, including individual and firm performance. Please ask your recruiter for details.#LI-NS1
Head of Medical Writing (Hybrid MA)
Aerovate Therapeutics, Inc., Waltham
Aerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease. Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercialization and company building.Our exceptional team of experts, industry veterans, and scientists is uniquely equipped to overcome the current challenges of treating these diseases and deliver novel therapeutics to make a meaningful difference for patients.At Aerovate, we know the diversity of our team's backgrounds, talents, skills, and experiences not only makes us unique, but makes us stronger. Tenacious in our pursuit to make a difference and helping each other along the way, we know we can achieve better therapies to make a meaningful impact for patients.Why Aerovate Aerovate fosters an uplifting environment, collaborative peers, and a passion for learning that translates into making a difference for people with cardiopulmonary disease and their communities.Aerovate's culture is one of inclusion, excellence, and respect in every way - for each other, the science, the community, and our mission. Both at work and in the clinic, we are committed to recruiting individuals that exemplify diversity in culture and life experience and are always striving to grow and improve. We recognize the urgency of our efforts, and we accept the challenge to do what's right for our patients and their communities.Position Summary: Reporting to the Head Development Operations the Head of Medical Writing is responsible for developing and implementing medical writing strategies, operational plans, and oversight and delivery of the medical writing function throughout the lifecycle of clinical development programs. This role will work collaboratively and strategically with our cross-functional teams and external partners to ensure that writing deliverables generated by Aerovate Therapeutics and third-party vendors are generated with the highest Good Clinical Practice (GCP), Good Documentation Practices (GDP), patient safety and quality standards, in accordance with regulatory requirements, established contractual agreements, budgets and timelines.Responsibilities: Create and influence medical writing strategies and processes within and across functional areasProvide guidance to colleagues regarding industry and medical writing best practicesCreate writing guidelines based on familiarity with relevant document templates (e.g., NIH-FDA and Global Health Authorities clinical trial protocol templates, Structure and Content of CSRs)Lead in-house and outsourced medical writing team to prepare clinical sections of regulatory documents (e.g., marketing applications, annual reports, briefing books,)Coordinate and contribute to preparation of Clinical documents (i.e. Investigator's Brochures, Clinical Study Reports)Ensure and coordinate document quality checks for accuracy, collating reviewers' comments, adjusting content of documents as required based on internal/external input, and preparation of the final versionMaintain and enhance therapeutic area working knowledge, including disease state and compound, for assigned projects and support literature searches required for document generationMaintain and enhance working knowledge of regulatory guidelines and publication guidelinesContribute to process improvement within and across functional areasWork with teams to develop project specific metrics compliant with standard project metrics; influencing or negotiating change of timelines and content with other team members as neededCoordinate activities related to preparation of scientific publications, including and not limited to, abstracts, posters, manuscripts and presentations as neededCompetencies:Excellent written and verbal communication skills as well as proven ability to interact with multiple functional groupsStrong organizational skills and the ability to work in team-based environmentDemonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fieldsGood organizational, time management and interpersonal skillsStrong 'Customer Focus'Self-motivated with the ability to influence othersResult driven with the ability to demonstrate time management and project planningAbility to analyze & interpret clinical dataQualificationsBS/BA in a science or industry-related disciplineMinimum of 10+ years' experience in pharmaceutical R&D environment, including at least 3-5 years as a Medical WriterRecognized for technical expertise in specific document developmentExcellent, high-level, end-user computer skills (e.g., word processing, tables, graphics, spreadsheets, presentation and templates) and Microsoft software suite skillsWorking knowledge of ICH and other regulatory guidelines. Broad knowledge of global pharmaceutical regulatory requirementsThorough working knowledge/understanding of clinical trial design, methodology and statistical concepts; working knowledge of the IND/BLA/NDA process and ex-US marketing applicationsPulmonary Arterial Hypertension (PAH) experience a plusAerovate Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation 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, and Local laws.
Associate Director, Biostatistics
Biogen, Cambridge
Job DescriptionThe Associate Director of Biostatistics is responsible for leading complex or integrated study design and data analysis in clinical development. He/She act as RDPT Biostatistician, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality. He/she builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework. He/She provides responses to statistical issues arising in regulatory, other legal settings, or external development partners. He/She provides mentorship to new/junior biostatisticians. He/She also contributes to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development. Principal AccountabilitiesKey player in the strategic planning and execution of the clinical development plan for the assigned project; provides strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs.Manages assigned staff and FSPs statisticians to ensure quality and consistency of the deliverables; provides guidance and support to facilitate their development and enhanced efficiency; provides regular feedback to staff and management. Provides key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required.Serves as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industryParticipates in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environmentQualificationsWho You Are: You are an experienced biostatistician with a thorough understanding of statistical principles and clinical trial design/methods and with experience in submission or responding to regulatory questions and with proven ability to develop creative statistical/technical/regulatory acceptable solutions to complex problems in the design/analyses of clinical trials. You have leadership skills in effective communication, proactive strategy thinking, priority evaluations, and team working. PhD in Biostatistics/Statistics or equivalent with a preferred 6+ years relevant work experience or MS in Biostatistics/Statistics with a preferred 8+ years relevant experienceBroad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.Ability to develop innovative/creative statistical/technical solutions to complex problems.Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.Strong verbal and written communication skills.Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership.Submission experience with BLA or NDAAdditional InformationThe base compensation range for this role is $139,500 to $232,500. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen's LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9bffb0b3-8def-4e9b-9f9a-22bec1ec8e3f
Clinical Pharmacist, Critical Care and Complex Care Service
Massachusetts General Hospital(MGH), Boston
Massachusetts General Hospital is currently seeking highly motivated candidates to join our critical care and complex care services teams. This position is a split position: 60% of service to ICU patients and 40% of service to Complex Care Service patients on a weekly basis. This position is five weeks of days, every sixth week of evenings and every fourth weekend. Evening shift and weekend duties rotate through covering ICU patients or medical-surgical patients. Clinical Pharmacists assume responsibility and accountability for the provision of safe, effective, and prompt medication therapy. Clinical Pharmacists proficiently provide direct patient-centered care and integrated pharmacy operational services with physicians, nurses, and other hospital personnel to deliver optimal medication therapy to patients with a broad range of disease states. These clinicians are aligned with target interdisciplinary programs and specialty services to deliver medication therapy management and to ensure pharmaceutical care programs are appropriately integrated throughout the institution. Pharmaceutical care services include, but are not limited to, assessing patient needs, incorporating age and disease specific characteristics into drug therapy and patient education, adjusting care according to patient response, and providing clinical interventions to detect, mitigate, and prevent medication adverse events. Clinical Pharmacists serve as departmental resources and liaisons to other departments, hospital personnel, or external groups. They proficiently manage the appropriate use of medications according to professional and regulatory standards. They also conduct practice-related research and patient care, quality, and regulatory compliance initiatives designed to improve medication-use processes or pharmacy practice. Finally, Clinical Pharmacists provide medication and practice-related education/training and actively serve as preceptors for pharmacy residents and Doctor of Pharmacy students (MGH Pharmacy Residency website: https://www.massgeneral.org/education/pharmacy-residency.)PRINCIPAL DUTIES AND RESPONSIBILITIES: § As it pertains to the service area in the pharmacy department, responsible for the optimization of drug therapy by identification, resolution, and prevention of drug related problems and improving therapeutic outcomes.§ Responsible for providing direct or indirect patient care according to the laws and regulations governing pharmacists and the practice of pharmacy by the appropriate state and federal agencies. When assigned to particular pharmacy service teams, may be responsible for prescribing medications under specific collaborative drug therapy management agreements (CDTM).§ Works independently, and within the limits of established pharmacy/ambulatory care practice site's policies and procedures, as a member of the patient care team. Directs and coordinates the activities of a pharmacy service area. Supervises all support personnel during an assigned shift, operating within the limits of pharmacy policy and procedures, and the regulations of the Board of Registration Pharmacy. Takes lead as a subject matter expert in their areas of practice at the site and system level.The following are essential job functions for Clinical Pharmacists:Percent of Time SpentLead assigned patient service lines, clinical areas, and therapeutic programs:Facilitate pharmaceutical care, direct patient care programs, medication utilization systems within assigned care areas to assure drug utilization activities are aligned with patient care needs, evidence-based best practices, hospital guidelines, and regulatory standardsDesign and implement new pharmacy programs, quality improvement changes, and continuous quality assurance initiatives to advance the organization's medication-use systems and promote optimal patient outcomesDesign and implement stewardship activities and restriction/surveillance programsTrack and evaluate assigned pharmacy programs for operational, quality, and financial efficiency and routinely benchmark against local and national best practicesDevelop strategies to optimize medication utilization, including but not limited to clinical guidelines, disease-specific pathways, formulary management, and medication-use policiesProvide departmental and institutional leadership for committees/meetings, hospital group/task forces, and approved external programs/organizationsAssure pharmacy is an integral part of the health-care delivery system and facilitates enhancement and expansion of pharmacy services/programs5Deliver direct patient-care and clinical practice, including decentralized and service-based programs:Maintain proficiency in decentralized pharmacy services and clinical pharmacy programsPlace practice priority on the delivery of patient-centered careWork as an active member of multidisciplinary team and collaborate with healthcare personnel within care areasEstablish collaborative pharmacist-patient relationshipsMaintain patient information and interpret patients' health care needs including patient problem lists and prioritized pharmacist interventionsCollect and document accurate patient medication histories and reconcile discrepanciesIdentify high-risk patients and implement interventions to improve care quality and safetyMake appropriate evidence-based, patient-centered medication recommendationsImplement, evaluate, and redesign pharmaceutical care plans based on patient progress and evolving goals for medication usage, including drug dosing and monitoring Provide written documentation in the patient's medical record when requestedObtain and maintain ACLS and BLS certificationParticipate in the management of medical emergenciesProvide discharge medication review, reconciliation, and counseling as appropriate to help with the transition of careProvide evidence-based medication education to physicians, nurses, and other professionalsEducate patients and care givers regarding safe and effective use of medications, possible medication side effects, and the role of prescribed medications in the overall treatment planMaintain proficiency in hospital computer systems and medication ordering systemsInterpret, evaluate, and accurately process medication ordersComplete critical patient monitoring and review patient chart to identify, prevent, or mitigate drug-related problems, improper drug or dose selection, subtherapeutic dosage, over dosage, adverse drug reactions, drug interactions, untreated indications, medication use without an indication, and treatment failuresFollow established standard work parameters and maintains standard work environments60Participates in pharmacy operations and medication dispensing:Maintain proficiency in and actively engage in operational programs, central dispensing pharmacies, satellite dispensing pharmacies, and specialty pharmacy areas as appropriate for job assignmentFacilitate medication procurement, ordering, and dispensing procedures including, but not limited to, chemotherapy, parenteral nutrition, controlled substances, etc.Utilize pharmacy automation and supportive technology proficiently Oversee pharmacy operations and technician practice/activities when assigned Promote the use of the formulary by converting non-formulary medications to formulary alternatives when possible, evaluate appropriateness of non-formulary medication requests, and support procurement of non-formulary drugs when necessary10Facilitate experiential education and preceptorship:Maintain proficiency in the four preceptor roles and actively emulate education/mentorship Serve as a preceptor/educator for MGH pharmacy residency (PGY1 and PGY2) and student experiential programs, including maintaining training and experience in pharmacy practice areas appropriate for teaching assignmentsDevelop student, resident, and staff training experiences/competencies and create new relationships for teaching and training opportunitiesIdentify, design, and mentor learners in implementing improvements in the medication-use system to advance patient safety, maximize therapeutic outcomes, or control costsDemonstrate personal leadership qualities, role model, and business acumen to advance the profession and practice of pharmacy20Performs other duties as assigned:Maintain a sustained record of contribution to the total body of knowledge in pharmacy practice through presentations, publications, and professional affiliation activitiesParticipate as a formal reviewer for a peer-reviewed medical or pharmacy journalsMaintain up-to-date knowledge of contemporary hospital practice and clinical service, trends and innovations in pharmacy leadership, and updates in traditional therapeutics, professional practice standards, or health care regulatory requirementsMaintain a specialized evidence-based knowledge of drug and drug therapy by reviewing relevant professional journals and suggested readings5Relationships:Clinical Pharmacists report directly to a Pharmacy Manager or Area Director and work collaboratively with administrative, pharmacist, and technical to support department initiativesClinical Pharmacists have frequent interactions with physicians, nurses, other members of the health care team, students, residents, and external professional groupsClinical Pharmacists supervise all support staff (e.g., pharmacy technicians) as assigned Qualifications QUALIFICATIONS:REQUIRED:Must be eligible for licensure to practice pharmacy in the Commonwealth of MassachusettsPostgraduate residency/fellowship training is preferredBoard Certification by examination, or equivalent certification, in the relevant specialty is preferred, required within 18 months of hiringMust meet all Board of Pharmacy requirements to enter into a collaborative drug therapy management agreement, when applicable Massachusetts Controlled Substance Registration license, National Provider Index number, and a Drug Enforcement Administration Registration number, when applicablePREFERRED:Completion of ASHP-accredited PGY1 and PGY2 Critical Care Pharmacy Residency or Fellowship preferredSKILLS/ ABILITIES/ COMPETENCIES REQUIRED:Extensive knowledge and ability in all areas of the department including: IV Admixtures, Drug Information, Ambulatory, Manufacturing, and Drug DistributionAs it pertains to the service area in the pharmacy department, demonstrate appropriate knowledge of principles of growth and development over the life span of the neonate, adolescent, adult, and geriatric patient. Possess ability to assess patient data relative to age specific needs. Provide care as described in the department's policies/proceduresAdditional General Skills/Abilities:Knowledge of contemporary hospital/clinical practice and serviceKnowledge and understanding of general hospital operations and regulatory complianceStrong written and verbal communication skillsAbility to interact constructively with supervisors, peers, and support personnelAbility to integrate clinical and distributive pharmacy services with quality improvement, teaching, research, and professional development activitiesSignificant general clinical knowledge and expertise in traditional therapeutics and patient-centered careSignificant knowledge and expertise in advanced pharmacy practice, specialty medication therapy management, and specialty evidence-based medicine in area appropriate for clinical assignmentsStrong teaching and precepting skills and expertise in experiential trainingWORKING CONDITIONS:Able to lift up to 20 lbsAble to stand for extended periods of timeAble to sit for extended periods of time
Technical Accounting Manager
Nexthink, Boston
Company DescriptionHi, we're Nexthink! We're not just the leader in the digital employee experience category, we invented the category. Our solutions combine real-time analytics, automation and employee feedback across all endpoints to help IT teams delight people at work. Our cloud-native platform pinpoints issues and solutions, automates response, and helps companies continuously improve their employees' experience, making them more productive, efficient, and happy at work. We have millions of endpoints deployed, we've surpassed $230M in ARR, and we've recently secured a company valuation of $1.1B, but we're just getting started.Job DescriptionKey ResponsibilitiesReport to the global corporate controller and lead all the technical accounting and global accounting policy initiatives. Being the subject matter expert in purchase accounting, pension accounting, stock-based compensation, 409A valuation, equity accounting, debt accounting, goodwill and intangible asset impairment testing, R&D capitalization, commission capitalization, income tax accounting, and other technical accounting topics as needed; independently research technical accounting topics and prepare whitepapers. Lead and drive the enhancement of global accounting policies; collaborate with cross functional teams and business owners to implement new accounting policies and procedures. Lead the preparation of US GAAP consolidated financial statements and footnotes. Collaborate with the internal control team to drive the enhancement of Internal Controls over Financial Reporting ("ICFR") for IPO readiness. Support the monthly, quarterly, and year end close processes; prepare and review the assigned monthly balance sheet reconciliations. Support the annual audit of consolidated financial statements under US GAAP and statutory audit of legal entities. Liaise with the global tax manager to support US GAAP income tax reporting and computation. Be the backup support of global operational processes such as sales tax, VAT, statutory reporting/filing, as needed. Proactively identify opportunities for process improvement and system optimization for IPO readiness. Assist in ad-hoc projects (e.g. M&A due diligence, M&A integration, system implementation, tax audit, financing, etc.) for the Finance organization as needed.QualificationsBS/MS in Accounting or FinanceCPA highly preferred. Minimum of 7 years of progressive accounting experience in a global complex environment. NetSuite (Oracle) experience highly preferred. In-depth of knowledge of US GAAP and SEC reporting. A combination of corporate and public accounting experiences; experience in Big 4 and major national accounting firms highly preferred. Thrive in a global fast-paced and dynamic environment, comfortable working with multi-cultural teams in different countries. Independent, analytical. And a good problem solver. Hands on, detail-oriented, organized, and structured. Can step up to be a reviewer and step in to be a preparer whenever needed.Additional InformationWe are 900+ employees strong in 21 countries across 8 different time zones speaking 60+ languages. We are positive, we get things done, we keep growing, and we are one team, we are Nexthink. We believe actions are stronger than words when it comes to diversity, inclusion, and equity in the workplace. Nexthinkers are multinational and multilingual, and come from all walks of life. We are committed to hiring a genuinely representative workforce that can create solutions and foster innovation for the modern digital employee experience.Total Rewards @ NexthinkAt Nexthink, we offer one of the most comprehensive and generous benefits plans. Your total rewards compensation package includes base salary and may also include a commission or performance bonus plan, as well as equity. We provide our US employees with 100% covered company benefits that consist of health, dental, vision, life insurance, long-term disability, and accidental death/personal loss coverage.Base salary ranges are determined by country, role, level, experience, and skills. The range displayed on each job posting reflects Nexthink's good faith determination of the minimum and maximum targets for new hire salaries across all US locations. Individual pay is determined by related factors, including job skills, experience, and relevant education or training, which may impact a final offer. Your Talent Acquisition Partner can share more about the specific salary range during the hiring process.