313 jobs found

Our client is a well known manufacturer of electrical and electronic equipment that is often found in the corporate data center. They are creating a new software engineering team and need someone who can help guide it through the startup period. The team will be writing both embedded software / firmware as well as user control software. The team will be developing software that measures and controls the flow of power through various devices and systems. This is a contract role that can evolve into a permanent one. Requirements Experience developing or leading the development of software technology that controls electrical/electronic devices is absolutely essential. Experience in project management Local Chicago only. (NW side, near O’Hare)

Global Pharmaceutical company is hiring a Director, Scientific Communications- VERY COMPETITIVE base salary, bonus, stock and other Long Term Incentives Succesfull Pharma with marketed products and pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Company has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility Ohio. Position Description: As a product and disease state expert within Medical Affairs, the Director, Scientific Communications will provide medical, scientific and technical expertise to support product scientific communications planning and to provide essential medical support to marketed products and late-stage products. Manage and direct the scientific communication personnel within the Scientific Communications function. Oversee, develop, manage and track scientific communications plans. Oversee, develop and review publications for medical and scientific content accuracy. Ensure compliance with publication-related policies and procedures within the function. Leads, co-leads or supports the development of key product materials including abstracts, posters/presentations, peer-reviewed manuscripts, etc. Major Accountabilities â?¢ Manage and oversee the Scientific Communications personnel Setting the direction, organization and strategy for the Scientific Communication functions Create, manage and track strategic scientific communications plans in a cross-functional manner â?¢ Content development: manuscripts, abstracts, posters, slide decks, monographs, etc. â?¢ Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs â?¢ Serve as medical communications contact and resource to internal teams, especially Project Teams regarding product and therapeutic area â?¢ Create and/or review for accuracy and strategic alignment communications containing medical and scientific content intended for internal and external customers, including a scientific communication platform â?¢ Proactively reach out and collaborate closely with members of other internal teams â?¢ Identify, collect and provide relevant information and input into business activities such as product and competitor insights, medical product plan and deliverables, new business assessments and other requests â?¢ Serve as authoritative source of medical/ scientific expertise â?¢ Scientific & Medical Communications lead for therapeutic area publication working groups or projects â?¢ Partner with Medical Directors to develop scientific communications â?¢ Ensure compliance with company policies and procedures â?¢ Maintain close interactions with Compliance, Clinical Development, Marketing and other internal and external stakeholders Key Performance Indicators â?¢ Demonstrates and models excellent performance in the Scientific Communications role. â?¢ Takes initiative and works independently and collaboratively with minimal supervision. â?¢ Demonstrates and models excellent performance in the medical communications role. Is a resource to other colleagues; provides guidance, coaching and mentoring within Medical Affairs â?¢ Ability to work in a fast paced environment with competing priorities â?¢ Ability to read, interpret, and convey complex scientific information â?¢ Excellent written and verbal communication skills â?¢ Excellent management and employee developmental skills Excellent customer service skills â?¢ Exceptional interpersonal skills â?¢ Ability to work collaboratively towards a common goal â?¢ Knowledge of pharmaceutical industry regulations, guidelines, standards and practices, including GPP3, ICMJE guidelines. â?¢ Experience working in a team environment â?¢ Demonstrated results orientation and problem solving skills â?¢ Domestic and International travel may be required (20%) Ideal Background/Education/Certifications Advanced scientific degree preferred (MD, PhD, PharmD, APRN) Healthcare/scientific related degrees may be accepted. CMPP certification is a plus, but not required Experience â?¢ Minimum 10 years of experience in Medical Affairs, Clinical Development or related field in the industry, preferably in Serious Mental Illness (schizophrenia, depression and/or addiction) â?¢ Excellent scientific writing skills and publication development experiences â?¢ Ability to lead initiatives and teams within Medical Affairs and cross functionally â?¢ Knowledge of pharmaceutical industry regulations, guidelines, standards and practices â?¢ Demonstrated problem solving skills in a complex and matrixed environment and in complex situations

Pharmaceutical company in Cambridge, MA is looking for a Manager, Medical Writing: Summary of Key Responsibilities Produce high quality and on-time writing deliverables. Plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications. Facilitate efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors. Represent Medical Writing on project teams Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders. Serve as subject matter expert for clinical documents and their production. Contribute to SOP and template development and maintenance. Qualifications Bachelor’s degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred. 4+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus. In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process. Successful track record of managing multiple projects in a fast-paced and deadline-driven environment. Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight. Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint

Interventional Radiology RN opportunities are available at a leading medical center located in beautiful community in central Virginia! We invite you to join our dynamic team as we embark on the newest and exciting cutting-edge technology that includes highly specialized technical procedures such as MRI Guided Focused Ultrasound, rotational angiography, endovascular repair of thoracic and abdominal aortic aneurysms, and multimodal locoregional treatment of hepatic, prostate, renal and lung tumors. We are dedicated to excellence, providing innovative care to enhance lives and improve patient outcomes. We are looking for energetic, positive nurses who share our vision with an unmistakable desire to make a difference. If this sounds like you, we would love to speak to you about a possible future here in IR. Our IR team consists of nurses, nurse practitioners, technologists, physicians, physician assistants, and nursing assistants. This picturesque Virginia city in the rolling foothills of the historic Blue Ridge Mountains offers many of the cultural, educational and professional advantages of a large metropolitan area. Charming for both its academic, recreational and leisure opportunities, including hiking, biking, canoeing, rappelling, golf and other athletics, as well as theater and music, it is consistently acclaimed by publications as one of the most livable cities in the country. Shopping, dining and entertainment, as well as convenient proximity to the beach or Washington DC, make this an ideal place for families, singles and active adults. This location consistently ranks high on quality-of-life rankings, including Happiest, Best College Town, Best City to Live, Healthiest, Best Place to Live in America, and more! Qualifications: Graduate of an accredited nursing program required. BS in Nursing preferred. Minimum one year of relevant experience Licensed (or eligible) to practice as a Registered Nurse in Virginia. BLS certification required. Paid relocation, excellent compensation package!

Systems Analyst opportunity for a hospital system in upstate NY. Employee satisfaction ranks in the top 10% of all hospitals in the country! This is a full time, permanent position. You will analyze clinical needs and develop solutions through the use of information systems and procedures; assist in justification, selection and implementation of clinical systems; consult with users to determine problems, identify needs and develop or recommend potential solutions; lead project teams and serve on other committees as required; assist in the preparation, installation and setup of clinical systems; and coordinate training of medical staff and others. Keywords: SDLC, system configuration, EMR, healthcare, SQL, report writing Requirements: BS or AS degree with experience in EMR system configuration and in the software implementation life cycle: requirements gathering, software design, testing and implementation. Clinical background preferred. This area boasts beautiful rolling hills, a major university, lakes and rivers, parks and trails, a small-city environment, and a very affordable housing market! Come join a leading regional healthcare system with competitive compensation and great benefits, including paid relocation.

OB/GYN Phone Triage Nurse Full time position with benefits including profit-sharing! RN opportunity at a prestigious Maternal Fetal Medicine practice located on the Upper East Side of Manhattan. Under general supervision, provides professional nursing services through education and patient care in the office setting. Follows established nursing process, including patient assessment, nursing diagnosis, planning, intervention, and evaluation. Assists providers and staff in coordinating patient care. Functions as a primary liaison between patients, staff and providers. Functions: â?¢ Triages and responds to patient phone calls. â?¢ Calls prescriptions into pharmacies as required. â?¢ Assures that results for all outgoing laboratory tests are received in a timely fashion. â?¢ Screens incoming lab results and reports abnormal values to physicians â?¢ Assesses the physical and psycho-social needs of patients and makes appropriate nursing interventions; assists physicians and health care practitioners with examinations, treatments, and other procedures. â?¢ Educates and counsels patients on procedures,medical care, and sensitive health issues, including need for follow-up; provides informational literature and makes referrals to mental health, social services, and other agencies as needed. â?¢ Participates on the diabetic management team. Requirements: â?¢ NY license as an RN â?¢ Experience in an OB/GYN setting; Maternal Fetal Medicine experience a plus. â?¢ Knowledge of OB/GYN nursing principles and practice. â?¢ Knowledge of medications and treatments. Hours: Mon-Wed 9 to 5, Thurs 7 to 5 and Friday 9 to 5 Local candidates only.

Nurse Practitioner or Physician Assistant opportunity at a Rheumatology practice affiliated with a teaching hospital system in upstate NY. You will receive top benefits and competitive compensation, including relocation assistance. Requirements: NP must possess current NY State RN and NP license. PA must be board certified and have NY license. Schedule: Full time, Mon.-Fri., daytime only This area boasts beautiful rolling hills, a major university, lakes and rivers, parks and trails, a small-city environment, and an affordable housing market!

Nurse Practitioner or Physician Assistant opportunity at an outpatient Ortho practice affiliated with a teaching hospital in upstate NY. You will be working with an orthopedic spine surgeon performing interventional pain management procedures in an office setting. You will receive top benefits and competitive compensation, including relocation assistance. Requirements: NP must possess current NY State RN and NP license. PA must be board certified and have NY license. Schedule: Full time, Mon.-Fri., daytime only This area boasts beautiful rolling hills, a major university, lakes and rivers, parks and trails, a small-city environment, and an affordable housing market!

Clinical Systems Manager opportunity for a teaching hospital system in upstate New York. Responsibilities: Manage a team of systems analysts who support several hospital IT systems, including OR scheduling and peri-operative documentation, anesthesia documentation, Telehealth and other applications. The manager provides technical and operational oversight and direction to staff and ensures organizational activities and structures are developed to meet established needs. Requirements: BS in IT, management, business or related field; MS preferred 5 years’ relevant systems experience to include: IT analyst experience; project management/quality improvement. This area boasts beautiful rolling hills, a major university, lakes and rivers, parks and trails, a small-city environment, and a very affordable housing market! Come join a leading regional healthcare system with competitive compensation and great benefits, including paid relocation.

Registered Sleep Tech (Polysomnographic Tech) opportunity is available at a leading teaching hospital in upstate NY. Come join a regional medical center with high employee satisfaction! The very latest in diagnosis and treatment for sleep-related medical conditions is available in our Sleep and Neurodiagnostic Center. It offers the finest in medical expertise and equipment to determine the cause and find the best treatment for many sleep-related disorders. Job Responsibilities: Performs and is knowledgeable in polysomnographic diagnostic testing. Must have the ability to integrate a basic understanding of anatomy and physiology with sleep/wake pathology. Excellent communication skills are required. Attention to detail is critical since the quality of data from the polysomnogram is solely the responsibility of the technologist. Must be able to assimilate data from several sources and anticipate initiation of care, in accordance with protocols. Must know when to consult the physician regarding the patient’s care. Must react quickly and calmly in emergency situations. Requirements: Associates Degree or Certification from an Accredited School in Polysomnography. New York State license and board certified RPSGT. Experience in sleep medicine preferred. This area boasts beautiful rolling hills, a major university, lakes and rivers, parks and trails, a small-city environment, and a very affordable housing market! This is a full-time,permanent position offering competitive salary, full benefits and paid relocation!

Specialty Pharmaceutical Company is hiring a Safety Coordinator for Somerset, NJ Competitive Salary, bonus and incentives Provide support for environmental, health and safety matters for the Somerset site including maintaining compliance with federal, state, and local regulations. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Responsible for coordinating regulatory programs, audits, permits and ensure compliance. Support the development and coordination of all EHS related programs and SOPs. Maintain compliance with OSHA, DOT, EPA, NJDEP, IATA, MCUA and local Fire Marshall. Maintain logs, documentation, manage records and assist in regulatory audits and inspections. Active participation in the safety committee and provide daily guidance and direction with EHS programs to re-enforce safety policies, guidelines and procedures established by the Company. Assist in the preparation of Job Hazard Analyses, accident, near miss, investigations and corrective actions. Participate and assist in the development, management and training of all EHS required programs. Ensure all hazardous materials, universal, non-hazardous and medical waste are handled, labeled and/or shipped in accordance with regulatory guidelines. Arrange for the purchase and distribution of personal protective equipment, including safety shoes and prescriptive eyewear. Manage the fire and sprinkler inspection, fire extinguisher, safety shower and eyewash inspections and records. Manage Safety Data Sheet record keeping and updating the log. Manage and ensure the cleanup and response to all emergencies are handled in accordance with the state and federal regulations. Manage sampling and reporting as required by the siteâ??s water discharge permits. Stay current on all new safety and environmental regulations as they apply to the site. Draft and review SOPâ??s on an ongoing basis. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions EDUCATION AND EXPERIENCE: Five (5) yearsâ?? experience in a production or manufacturing environment, pharmaceutical industry is a plus. Able to work independently with minimal supervision. Bachelorâ??s Degree in Environmental Sciences preferred. Working knowledge of Microsoft Office programs. DOT certified and OSHA 40 hours certified. CIH and IATA certified is preferred JOB PREREQUISITES: Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed. Strong verbal and written communication skills. Resourceful and well organized. PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT The position requires prolonged sitting. Requires eye-hand coordination and manual dexterity to operate keyboard, photocopier, telephone, calculator and other office equipment. Occasional high stress work requires dealing with customers/clients and regulatory agencies. May have exposure to hazardous chemicals. Work will primarily be completed in an office environment. However, there will be a portion of the employeesâ?? time on the production floor, which could require certain Personal Protective Equipment (PPE) that will be provided by the employer. Mental Requirements include: Ability to hear accurately the spoken word with moderate office noise or plant noise Ability to apply deductive reasoning and understand complicated issues Ability to receive instructions and follow work rules and company policies Ability to follow safety and security practices Ability to meet deadlines and effectively deal with office stress Ability to accurately communicate ideas, facts and technical information Maintain confidentiality of certain information

Leading Pharmaceutical Company with marketed products and strong Neurology Pipeline is looking for a Director, Medical Information for their growing US Headquarters in Waltham, MA Competitive Base, Bonus, Long Term Incentives and Relocation The Director, Medical Information (MI) will be responsible for leading the MI function within the Medical Affairs. The Director, Medical Information will be responsible for managing the member of the MI function who are providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. He/She will monitor the scientific literature and communicate new data to relevant internal groups as well as work cross-functionally in support of Medical Affairs. The Director, Medical InformationI will assist in the development of core disease state curriculum and contribute to providing disease state and product training to internal and external stakeholders. Candidates applying for this position must have the ability to take initiative and work independently requiring minimal supervision. The Director, Medical Information will report directly to the Head of Medical Affairs Operations. Responsibilities: Manage day to day operations for the medical information call center Provide guidance and supervision to the medical information call center pharmacists and nurses Provide guidance and supervision to the medical information staff at Company headquarters Ensure accurate, balanced and timely medical and scientific information is provided compliantly to internal and external customers (such as health care professionals, consumers and other customers) Receive, identify, document and triage adverse events and product complaints to ensure compliance with health authority regulations and internal procedures Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Company colleagues. Contribute to departmental/organization efforts to support new product launch preparation and activities Independently research and write medical response documents (Standard Response Letters, Medicaid Submission Documents, AMCP Dossier, etc.), create unique responses and proactively update existing response documents on an ongoing basis; obtain approval for use to ensure compliance with existing regulations, policies and procedures; train others (call center, medical affairs, medical science directors) on their content and use either by directly doing or by supervising those doing the work Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints and are triaged accordingly to PV and QA Proactively monitor the literature for new scientific information; identify relevant publications, analyze and communicate information of interest internally in an accurate, balanced and timely manner Create and/or review for accuracy, communications containing medical and scientific content intended for internal and external customers (e.g., communications Q&A material, dear health care provider letters, documents for public comment, ect.) either by directly doing or by supervising those doing the work Develop and/or identify content for the development of disease and product training material for sales associates and others as needed; provide live training upon request Work with internal and external legal counsel to ensure compliance with company policies and procedures Provide medical and scientific input and contribute to assigned product and project teams Collaborate closely with members of other internal groups (e.g., Regulatory, Marketing, Sales, Legal, Clinical R&D) as needed Contribute to the review of internal promotional and medical materials either by directly doing or by supervising those doing the work Provide information and support for business activities such as relevant insights, knowledge of product data, etc. Attend scientific conferences to provide medical support and to staff medical information booth as assigned Lead pre-conference Medical Affairs/Medical Information activities Develop post-conference reviews and reports for internal stakeholders Domestic and International travel will be required (30%) Education and Experience: Advanced scientific degree preferred (PharmD, PhD) Knowledge or Skills Needed: Advanced scientific degree with 5-7 years of medical information within the pharmaceutical industry required Experience in people management required Experience in medical information, medical affairs, and/or clinical development preferred Ability to work in a fast paced environment with competing priorities Ability to read, interpret, and convey complex scientific information Ability to work independently with minimal supervision Excellent written and verbal communication skills Excellent customer service skills Exceptional interpersonal skills Experience working in a team environment and the ability to work collaboratively towards a common goal Knowledge of pharmaceutical industry regulations, guidelines, standards and practices Demonstrated results orientation and problem solving skills

Validation Engineer Process Engineer Global Chemical /Biotech company looking to hire: Greenville, Soth Carolina location competitive salary and full relocation and full benefits Would love someone who has: affiliation with: IVT (International Validation Technology), KEN X (Knowledge Exchange Network), PDA, ISPE Responsibilities Remain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices. Provide validation requirements, strategy, protocols, execution and final reports for changes impacting validated products and critical process parameters. Oversight of validation activities for R&D trials and new products. Support engineering testing/trials and requirements for final product changes. Creation, review, and update of risk analysis for changes and new processes that impact products. Perform statistical analysis related to process validation. Conduct periodic review of validated processes and equipment. Support product annual product review. Peer review validation studies executed by other validation team members. Provide inputs in validation and regulatory requirement for current direct impact equipment, new equipment, and processes. Able to self-train in new regulation and industry standards Demonstrate enough knowledge in basic validation skills and the ability to lead change control, approve quality changes request, and other discipline protocols in lieu of the Validation Supervisor, as needed. Qualifications Required: FDA Process Validation Guidance, Statistical Sampling, Technical Writing, Use of MiniTab, product validation Desired: Conducting and leading investigation, project management, Design of Experiments, knowledge in aseptic simulation (media fills) Education: BS Engineering or Science Experience - Required: 8+years Process Validation experience in Pharmaceutical, Medical Device or Parenterals. Must have experience in either an FDA or ISO Regulated Industry Experience - Desired: Demonstrated experience and proficiency with cGXP, ICH and PIC/S. Experience with regulatory and/or third party audits Special Skills: Strong Verbal and Written Communication; Self Driven, TEAM WORK, Result Oriented, Strong knowledge of Process Validation, Project Management, Multi-tasking, Intermediate Statistics Knowledge (sampling plans, hypothesis testing, etc), use of PFEMA risk assessment or similar, and solution aseptic filling experience

Growing Global Pharmaceutical company with marketed products and strong Neurology Pipeline is looking for a Director, Medical Information for their growing US Headquarters in Waltham, MA Competitive Base, Bonus, Long Term Incentives and Relocation Senior Engineer, Drug Product Process Development This position will provide technical leadership for drug product unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process understanding and robustness, interpret data, participate in cross-functional teams, write technical reports and mentor fellow engineers. The candidate should have strong communication, a commitment to continuous learning, a strong sense of curiosity and be a good team player. A solid background in chemical engineering is required. Responsibilities include but are not limited to: Collaborate within cross-functional teams, specifically with Formulation and Analytical Development to define and execute development strategies that enable successful launch of Company products Implement scale-up strategies for drug product unit operations with a focus on process understanding, identification of critical process parameters and process optimization Apply particle engineering and process modeling in development activities. Identify and deploy new technologies as needed. Design manufacture processes that deliver drug product of desired attributes Support technology transfer of drug product unit operations and production at CMO(s) Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into project activities in accordance with ICH Q9 & Q11 Write technical reports and deliver presentations to technical, CMC and broader project groups. Author & review CMC sections of regulatory filing documents Mentor fellow engineers Minimum Education & Experience Requirements: MS in Chemical Engineering with 10+ years of experience PhD in Chemical Engineering with 3+ years of experience Knowledge/Skills Needed: Excellent written and oral communication Experience in introducing, implementing and/or executing new chemical processes in pilot, commercial plants and/or contract manufacturing facilities Proven ability to apply scientific principles to design, execute and interpret experiments Pharmaceutical cGMP manufacturing experience Statistical design of experiment experience Team player with good interpersonal skills Desired but not required: Continuous process development and manufacturing PAT experience & chemometrics (e.g. NIR, Raman) Experience in working with DEA controlled substances Quality by Design experience Personal Attributes Needed: Motivated self-starter Positive, adaptable, can-do attitude Ability to work independently Ability to travel and work flexible hours as required Functional ability to work in a pilot plant and commercial facility

POSITION TITLE: Corporate Manager-Regulatory & Accreditation POSITION LOCATION: Near Any Major Airport POSITION DESCRIPTION: Manager, Regulatory and Accreditation is responsible for assessing, developing, educating, implementing, monitoring, and leading the system wide Regulatory and Accreditation activities within the companyâ??s hospitals. This includes preparation and survey readiness. The position develops and implements processes for current safe practices within the organization. The Manager Regulatory and Accreditation work closely with other corporate departments, regions, and facilities for collaboration and synergy around identified priorities. Assesses emergency management and refers disaster preparedness and business continuity to appropriate personnel. Develops, educates, implements, monitors, and leads regulatory requirements and accreditation standards, goals and targets through collaboration with corporate departments and the Regional Directors of Regulatory and Accreditation [RDRA]. Is a leader for the Quality Department in the formulation of organizational regulatory and accreditation related goals and targets. Assists with the development of the corporate strategy and tactics for regulatory and accreditation preparation and successful surveys based on the company Regulatory and Accreditation Plan. Tracks progression and sustainment of the company regulatory and accreditation strategy and tactics per standardized reporting process. Provides input for strategic development, planning and implementation of system Quality Department Regulatory and Accreditation Plan/activities. POSITION REQUIREMENTS: Bachelorâ??s degree in nursing preferred, with experience in regulatory requirements and accreditation standards, performance improvement as applicable in other related areas of responsibility. Requires an advanced degree in a health related field (Masters or Doctorate) within five years of relevant facility management experience. Knowledge of TJC and other regulatory standards. Knowledge of CMS CoP Conditions of Participation and other federal requirements. Knowledge of CMS CoP Conditions of Participation and other state requirements. Knowledge of principles of quality improvement. Relevant clinical experience. At least 10 years of experience leading a multi-hospital system Regulatory and Accreditation program. Experience leading interdisciplinary initiatives in process improvement and directly with improving reliability of healthcare delivery at the point of care. Certified Joint Commission Professional (CJCP) within six months of hire date. Experienced with and practiced at performance improvement activities. Skilled at developing and conducting educational presentations. Expert at remediating findings when in a facility. Adept at developing methods, tools, reports, data aggregation and conducting regulatory and operational surveys for facilities, including the review of regulatory requirements and accreditation standards and Conditions of Participation. Prepares written reports of clinical and operational survey findings. Skilled in developing corrective action plans, provide educational programs, monitor implementation of action plan and other oversight activities through follow-up visits to facilities as needed, and provide guidance on regulatory and accreditation communications as needed. Expert on regulatory requirements and accreditation standards, preparation activities, and success with surveys. Trained on outcomes and quality management and using and applying quality management diagnostic tools (defect analysis, fault tree analysis). Knowledgeable in the areas of peer review, risk management, patient safety, infection control prevention and reporting. Expert on TJC, Centers for Medicaid and Medicare, Quality Improvement Organization (QIO), state requirements and other regulatory standards / processes.

Psychiatrist â?? General or Geriatric Location: Pembroke MA Inpatient work with no mandatory call. Fulltime employed staff position. Competitive compensation plans plus full benefits packages that cover Malpractice, Health insurance, matching 401k, PTO, CME; sign on bonus and relocation if moving. No call but if Physician opts to take call schedule it is paid extra in addition to salary

Pharmaceutical company in Cambridge, MA is looking for a Manager, Medical Writing: Summary of Key Responsibilities Produce high quality and on-time writing deliverables. Plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications. Facilitate efficient review and finalization process for documents produced internally and/or externally by consultants, contractors and vendors. Represent Medical Writing on project teams Collaborate effectively with Biometrics, Clinical Operations, Clinical Development, Regulatory Affairs, Pre-Clinical Development, Program Management, Research, Quality, and Corporate Communications, as well as with external stakeholders. Serve as subject matter expert for clinical documents and their production. Contribute to SOP and template development and maintenance. Qualifications Bachelor’s degree in Life Science with relevant writing expertise or in English/Communications with relevant science expertise. Advanced degree and/or professional certification/credentials preferred. 4+ years of experience as a medical writer in the sponsor and/or CRO setting. Experience with regulatory submissions (CTA/IND/NDA/BLA) and knowledge of eCTD formatting is a plus. In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process. Successful track record of managing multiple projects in a fast-paced and deadline-driven environment. Impeccable attention to detail and ability to complete writing assignments in a timely manner with minimal oversight. Must be proficient with Microsoft Windows, Word, Excel, and PowerPoint

Regional Sales Manager â?? Account Manager North â?? Northeast USA - Live in the territory and work from a home office near a major airport. Philadelphia, New York, Pittsburgh, Boston, Baltimore maybe Chicago Territory includes: PA, NJ, NY, MD, DE, VA, OH, VT, MA, IL, WI, and MO. An opportunity for Technical Sales professional to join a thriving well-established manufacturing company as they strive to increase market share. Account Management responsibilities include on-site visits to various power industry customers â?? combined cycle, nuclear, and fossil fuels power generation. Interesting facts about the company/ industry: High level of brand recognition helps attract new sales prospects; this company has been in business for well over 50 years! Position is open due to promotion. There are plenty of opportunities to build relationships through customer service. Some new business will be derived through â??warm-callâ?? opportunities. (â??What else can we help you with? How can we improve our products?â??). Products within a growing industry: â??Water-treatmentâ??, is a experiencing both domestic and international growth- Chemical Week January 9/ February 5 2018 issue feature story (Pg 19) No need to uproot your family. Relocation is NOT REQUIRED. You will work from a homebased office and live within the territory. The work: As Eastern Regional Sales Manager, you will be responsible for account management, technical service, and business development primarily selling filtration medium to the electrical power industry. The position is open due promotion and there is an existing book of business to build upon. Estimate spending about 50% of your time servicing established account providing aftermarket replacements filtration medium and the balance of your time working to develop new business. Some leads for new business will also be generated via a sister company as they sell the full water-treatment systems. Territory includes: PA, NJ, NY, MD, DE, VA, OH, VT, MA, IL, WI, and MO. Expect 30 to 50% domestic travel includes overnight trips This company has a very strong presence providing aftermarket products into 75+% of the primary industry that they serve and they plan to further grow through innovation. This implies that your 20% commission target is highly attainable with a realistic possibility to exceed targets. Responsibilities: Account Management; on-site visits to power industry customers, provides Technical/Product data and prepares proposals Manage account data through CRM software (Salesforce) Develop short term sales forecasts â?? sorted by customer and by product line Develops strategic annual sales forecasts; Work with the sales/marketing team to develop sales strategies Prepare and deliver presentations to new and existing customers including following leads generated by a sister organization that sells water treatment systems and equipment. Insure target margins through price setting Represents the company at conferences and trade shows Maintain and update competitive information database Requirements: A confident service minded technical sales engineer will good listening skills will thrive in in this position. 4 year technical degree- B.S. Engineering, Chemistry or related 10+ years serving the power generation industry (any position) â?? nuclear power preferred 5+ years in sales, marketing or customer service into power generation plants Knowledge of industrial water treatment processes; best if this includes condensate polishing, ion-exchange, IX or IEX systems Some Sale of Equipment (SOE) experience is another plus

Specialty Pharmaceutical Company is hiring a Safety Coordinator for Somerset, NJ Competitive Salary, bonus and incentives Provide support for environmental, health and safety matters for the Somerset site including maintaining compliance with federal, state, and local regulations. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Responsible for coordinating regulatory programs, audits, permits and ensure compliance. Support the development and coordination of all EHS related programs and SOPs. Maintain compliance with OSHA, DOT, EPA, NJDEP, IATA, MCUA and local Fire Marshall. Maintain logs, documentation, manage records and assist in regulatory audits and inspections. Active participation in the safety committee and provide daily guidance and direction with EHS programs to re-enforce safety policies, guidelines and procedures established by the Company. Assist in the preparation of Job Hazard Analyses, accident, near miss, investigations and corrective actions. Participate and assist in the development, management and training of all EHS required programs. Ensure all hazardous materials, universal, non-hazardous and medical waste are handled, labeled and/or shipped in accordance with regulatory guidelines. Arrange for the purchase and distribution of personal protective equipment, including safety shoes and prescriptive eyewear. Manage the fire and sprinkler inspection, fire extinguisher, safety shower and eyewash inspections and records. Manage Safety Data Sheet record keeping and updating the log. Manage and ensure the cleanup and response to all emergencies are handled in accordance with the state and federal regulations. Manage sampling and reporting as required by the siteâ??s water discharge permits. Stay current on all new safety and environmental regulations as they apply to the site. Draft and review SOPâ??s on an ongoing basis. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions EDUCATION AND EXPERIENCE: Five (5) yearsâ?? experience in a production or manufacturing environment, pharmaceutical industry is a plus. Able to work independently with minimal supervision. Bachelorâ??s Degree in Environmental Sciences preferred. Working knowledge of Microsoft Office programs. DOT certified and OSHA 40 hours certified. CIH and IATA certified is preferred JOB PREREQUISITES: Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed. Strong verbal and written communication skills. Resourceful and well organized. PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT The position requires prolonged sitting. Requires eye-hand coordination and manual dexterity to operate keyboard, photocopier, telephone, calculator and other office equipment. Occasional high stress work requires dealing with customers/clients and regulatory agencies. May have exposure to hazardous chemicals. Work will primarily be completed in an office environment. However, there will be a portion of the employeesâ?? time on the production floor, which could require certain Personal Protective Equipment (PPE) that will be provided by the employer. Mental Requirements include: Ability to hear accurately the spoken word with moderate office noise or plant noise Ability to apply deductive reasoning and understand complicated issues Ability to receive instructions and follow work rules and company policies Ability to follow safety and security practices Ability to meet deadlines and effectively deal with office stress Ability to accurately communicate ideas, facts and technical information Maintain confidentiality of certain information

This opportunity is with a leader in the snack food and bakery manufacturing industry. Their culture focuses on continuous improvement, with a need for leaders and workers who want to improve efficiency, reduce waste, and enjoy finding ways to add value. The company is recognized as a world class manufacturer by its peers. Despite challenges faced by food manufacturers in the United States, this company has experienced vast amounts of growth in a short time period, offering applicants an attractive opportunity. Production Supervisor 1st Shift Job Summary: Supervise assigned team of employees (25) twenty-five â?? (85) eighty-five employees/ shift. Responsible for the overall direction, coordination and evaluation of these employees. Also, directly supervise non-supervisory (lead) employees. Responsible for all packaging activities as required to safely produce quality products with the most efficient use of labor and materials on the appropriate/scheduled shifts and lines. Minimum Requirements: 2 year degree required; 4 year preferred. (2) Two â?? (3) Three years supervisory experience in a FOOD manufacturing environment. Heavy knowledge of continuous improvement or lean manufacturing a must. Highlights: This job offers the following Outstanding opportunities with progressive and growing organization. Excellent benefits, including: Comprehensive healthcare Dental Vision 401k Opportunity for career advancement. Are You A Good Fit? Essential Skills for Success: Innovator and leader in change. Promote and utilize otherâ??s talents. Actions are plan-based and result from strategy as opposed to reactionary. Goals achieved by teamwork instead of own personal efforts. Leadership style yields influence and trust. Youâ??re not just â??the bossâ??. Achieves results. Consider This Before Applying: Does this job describe work you would enjoy doing? Do you meet most of the minimum requirements? Have you considered everything if you would need to relocate?