Medical Writer / Regulatory Writer
Details: Large Sponsor Company in Central New Jersey is seeking a Clinical Trial Results Analyst for a 1 year contract with the option to be extended. The contract is located in Wallingford, CT. Responsibilities include: To report results from clinical trials in accordance with the FDA Amendment Act. Carefully assess the data within a Clinical Study Report (CSR) to find all necessary information required to be publicly reported. Critically evaluate the data to ensure accuracy and completeness of the information, as well as file any extensions with NIH that may be needed if results cannot be reported on time. Problem solving complex issues is required and can be done by developing recommendations for the medical monitor and statistician to evaluate. All trial results must be entered into the NIH database in accordance with COMPANY policy. Follow up and management of all issues must be done for each clinical trial result submitted to NIH via the ClinicalTrials.gov website. Function as a liaison with the Statistician, Medical Monitor and Medical Writer on all trials and work as part of the team to ensure the data best supports the results, and is consistent with other public forms of trial results (i.e. publication in a clinical journal). Work with the Clinical Programmer to generate Adverse Event XML files, work in the Clinical Trials Transparency mailbox daily to manage communications to/from clinical teams as well as NIH. Document the status of each study in the Clinical Trials Transparency (CTT) SharePoint site and keep it updated weekly. Work in the Clinical Trial Disclosure application as needed to resolve data discrepancies or check the eligibility of a trial. Participate in regular department meetings. Train new staff as needed, and develop job aids or update user guides as needed.
Sr. DEA / Safety Compliance Specialist
Details: This position will provide support in maintaining the company's compliance with DEA regulations, controlled substance handling and Environmental, Health and Safety regulations at the Waltham facility. Reporting to the Associate Director of EHS, this position will include the following duties and responsibilities: Ensure compliance with all State and Federal Controlled Substance Regulations. Develop and maintain compliance programs (policies, procedures, etc.). Train personnel who work with controlled substances. Submit and track reports required by the DEA and Massachusetts DPH. Procure and maintain required DEA and Massachusetts DPH registrations. Procure required quotas. * Conduct required inventories of controlled substances. Oversee destruction activities of controlled substances. Conduct internal controlled substance audits to ensure compliance. Monitor changes in regulations to ensure policies and procedures are current. Direct communication with DEA/Mass DPH. Perform and/or assist in the performance of hazard assessments. Develop and maintain EHS programs and procedures. Conduct periodic EHS inspections to assess compliance with regulatory and Alkermes requirements. Recommend corrective actions where appropriate and follow-up to verify completion. Provide training programs in technical areas as required. Perform industrial hygiene sampling for various potential hazards including noise, organic solvents, and/or active pharmaceutical ingredients. Monitor compliance of chemical use. Monitor environmental compliance. Prepare environmental-related regulatory reports and compile any necessary data to support them. Coordinate EHS-related emergency response preparation efforts. Internal Communication: Works with Pharmaceutical R&D, Process Development, Facilities, and Purchasing to ensure compliance with all DEA regulatory requirements. External Communication: Regularly communicates with DEA on status of registrations, schedule changes, quota applications, etc. Minimum Education & Experience Requirements: Bachelor degree in science or health-related field and five (5) years experience primarily in DEA compliance for the pharmaceutical or biotech industry. Additional experience in Environmental Health and Safety compliance is also desirable. Candidates without pharmaceutical or biotech experience may be considered if demonstrating exceptional qualifications. Knowledge/Skills Needed: The candidate must be well versed in regulations pertaining to controlled substances and be knowledgeable of DEA regulations and ideally Mass DPH regulations as they apply to controlled substances. Knowledge of occupational health/safety and environmental issues is also desired. This individual must be able to communicate efficiently and effectively in both oral and written presentations. Additionally, the candidate must be competent with Microsoft Word and sufficiently skilled with computers to easily navigate through the Microsoft Windows platform, Microsoft Outlook and Excel. The successful candidate will be expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. He/she will be expected to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. The individual may determine methods and procedures on new assignments and may provide guidance to contractors, vendors and all levels of the Alkermes organization. The candidate should be capable of leading problem-solving exercises. Personal Attributes Needed: The individual must demonstrate values consistent with those important to Alkermes: integrity, excellence, respect, teamwork, and accountability. He/she must also demonstrate a high degree of reliability and self-discipline. Flexibility in problem-solving will be important. Equally important will be the need for rational fact-based decision making. A reasonable amount of on-site mobility will be required. Office desk work is also required of this position. substance abuse testing.
Medical Technologist
Details: Performs antibody screening on all units and identification procedures as required to determine the presence/identity of clinically significant blood group antibodies and documents findings.Performs manual procedures such as blood typing and RPR, as appropriate.Performs ABO-Rh typing, STS, and/or CMV testing procedures utilizing the PK7300.Performs infectious disease (EIA) testing on all units of collected blood and other samples as requested using automated microplate instrumentation (e.g. Ortho) for tests such as HBsAg, anti-HBc, HIV-1/2, anti-HCV, and anti-T.cruzi. Enters test data into computer files.Coordinates send-out of samples for required NAT testing (performed by third party lab)Performs daily quality control (reagents and equipment), and equipment maintenance and trouble-shooting as required. Documents results/actions.Performs residual white cell counts using BD flow cytometer for product acceptability and/or quality control purposes. Documents findings.Reviews data sheets from other techs to ensure all testing is performed accurately and results are correctly recorded.Utilizes laboratory computer system to enter all test results via manual data entry or computerized interfaces.Locates and quarantines blood products from units as required, e.g. due to reactive test results. Full-time lab techs participate in “on-call" rotation, providing technical coverage to hospital customers (i.e.: technical work-ups and/or provision of antigen negative blood) for urgent needs after hours. In addition, “on-call" personnel are responsible for responding (as appropriate) to storage device alarms after hours.
Data Entry Professionals Needed!!
Details: Several of our clients in the Montgomery County area are seeking Data Entry Professionals. The ideal candidate must be a master at 10 key, with keystrokes per hour above 10,000, and extreme accuracy.Candidates must be professional, flexible, and possess great communication skills.**For immediate consideration please send your resume to .
Biostatistician
Details: Large pharmaceutical company in Central NJ has an immediate for a contract Biostatistician. The role for the is Biostatistician position is initially 12 months with the option to be extended. Responsibilities; The Biostatistician will support clinical pharmacology efforts. The Biostatistician will provide protocol related stats support including stat analysis plan, CRF review, interim analysis & final stat reports. The Biostatistician will serve as STAT Consultant to clinical study team. The Biostatistician will provide STAT leadership on Early Development projects. Previous cardio and/or metabolics experience is helpful, but not required.
Clinical Data Managment / Data Manager
Details: A large International CRO is seeking several Clinical Data Manager candidates to fill permanent Work From Home positions The Clinical Data Manager will provide expert skills as part of a Clinical Data Management team to provide efficient, quality data management products that meet customer needs. The Clinical Data Manager will provide leadership to the team in the area of Project Management and viewed as an expert in data management. The Clinical Data Manager will provide leadership to the team as Data Team Lead (DTL), Data Operations Coordinator (DOC) or Subject Matter Expert for DTLs or DOCs. The Clinical Data Manager will manage DM customer relationship for DM project team to include leading (with minimal guidance) DM customer negotiations on complex timeline, budgetary and other issues, and provide marketing capabilities presentations and business development presentations. The Clinical Data Manager will manage delivery of projects through full data management process life-cycle. The Clinical Data Manage will adhere to project timelines, quality issues, resource management and SOW / budget. Provide justification for customer negotiations. May serve as Project Manager for single service data management projects. Manage comprehensive data management tasks pertaining to the Data Management Plan. Manage comprehensive quality control procedures
International Product Mgr/Sr International Product Mgr
Details: Roche Molecular Systems Inc. Leads HPV medical marketing for new message and campaign development directed towards clinicians, patients, policy makers and other key stakeholders Oversees the development of medical marketing tools and globally organized marketing activities in support of HPV Manages the delivery of global plans to the affiliate and supervises the implementation of the global marketing strategy Provides high level support and guidance to the affiliate companies to build their medical marketing capabilities for HPV Leads planning of major gynecological congresses Acts as a product champion to both internal and external stakeholders Cultivates and develops Key Opinion Leaders, product advocates, speakers Manages HPV medical marketing budget Provides high level input into public relations and health economics strategy Establishes metrics for evaluating the performance of medical marketing intiatives Liaises cross-functionally with communications, medical, laboratory, digital, and health economics teams
Direct Care Manager – Residential Social Services Supervisor
Details: If you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual and developmental disabilities, join our Direct Care Management team at RHA Health Services! We are seeking organized and hard-working Direct Care Managers to supervise and coordinate the activities of six to eight Direct Support Associates and ensure that person-centered plans are implemented successfully. As a Direct Care Manager or Group Home Manager with RHA, you will ensure that the people we support are able to work towards their individual goals in a healthy, safe and nurturing home environment and participate as a member of an interdisciplinary team in the development of person-centered plans. You will also interview and hire Direct Support Associates, delegate work activities, prepare employee schedules and ensure that there is adequate staffing coverage at all times. Direct Care Manager or Group Home Manager – Residential Social Services Supervisor Job ResponsibilitiesAs a Direct Care Manager or Group Home Manager with RHA, you will coordinate closely with clinical and professional staff to maintain communication and provide feedback, standardize procedures and expedite the implementation of person-centered plans. You will also perform all personal care duties that Direct Support Associates perform, such as personal hygiene tasks, meal preparation and goal implementation.Additional responsibilities of the Direct Care Manager or Group Home Manager include: Maintaining harmony between employees and the people we support and serving as a positive role model Resolving employee issues and conducting performance reviews Ensuring that employees meet training requirements and attend required events Monitoring select budget items and staying within guidelines Monitoring and providing feedback to employees during all three shifts in interactions and relationships with the people supported Providing afterhours and on-call coverage as part of the direct care rotation Direct Care Manager or Group Home Manager – Residential Social Services Supervisor
Personal Care Assistant - Non-Medical Senior Home Health Aide
Details: Hands at Home, LLC, affiliated with Bethany Village and Graceworks Lutheran Services, offers personal care and transportation services to residents of Bethany Village in Centerville, Ohio as well as to residents in the southern Montgomery County community. We are seeking a dependable and compassionate Personal Care Aide to provide our clients with personal care, light housekeeping, medication reminders and companionship in their homes. No medical care is required. This is a great part-time opportunity with flexible scheduling that allows you to select the work hours that are convenient for you. As we are experiencing a growing need for senior care assistant services, you will find that we have plenty of assignments available that will fit with your schedule. If you are a kind and patient individual with a desire to help improve the lives of seniors, we want to talk with you!Personal Care Assistant - Non - Medical Senior Home Health AideJob ResponsibilitiesAs a Personal Care Assistant, you will help seniors to maintain their independence in their own homes. This will include providing clients with personal care (including assisting them with incontinence-related matters), cleaning up, changing bedding, driving them to appointments, taking walks, playing games and even just sitting and talking with them.Your specific duties as a Personal Care Assistant will include: Under the direction of the Manager of Hands At Home, providing care in response to the outlined care plan in the home Providing a safe and secure environment Attempting to meet clients’ physical, emotional and spiritual needs Completing all required paperwork to support services and billing requirements Attending scheduled in-services, training hours and staff meetings Promptly reporting any changes in clients’ condition (such as skin breakdown, weight changes, etc.), incidents, theft, damage and/or abuse to the Manager of Hands At Home Adhering to all policies and procedures of the organization and to all federal and state laws regarding the privacy of protected health information Adhering to all policies and procedures of the organization regarding the use of technology and technology-based information Performing other duties as directed, including assisting in the Hands At Home office as needed
Content Manager
Details: Content Managertrustaff, a rapidly growing staffing firm, is seeking applicants for a Content Manager position in Wichita, KS._______________________________________________________________________________The content manager will have a demonstrated understanding of clinical office workflows, billing, and terminology as well as basic knowledge of change management principles. A basic understanding of business systems application software and implementation processes and methods. A demonstrated understanding of external and internal customer relationship management. Strong issue analysis and communication skills (both verbal and written) are required for all aspects of this role. A demonstrated ability to identify relevant processes and then interview a customer to identify the relevant tasks, their sequence, and dependencies in an identified process. The ability to build and develop high customer satisfaction based on demonstrated results._______________________________________________________________________________RESPONSIBILIES: Assist internal and external customers in resolving outstanding application issues. Oversee the department process for evaluation and documentation of Client workflows and outline for product configuration, setup, preferences, and clinical documentation. Working on multiple projects concurrently and meeting deadlines. Working in partnership with the Project Leads and Implementation Specialists, Content Specialists, product team, and customer service representatives. Assist in identifying, evaluating, and prioritizing pertinent medical, scientific, and/or other data from media and government sources to update product and procedures. Perform quality control testing of proprietary content; assist in developing quality assurance protocols. Assist in researching and resolving internal and external clients questions or process inquiries, requiring advanced clinical expertise. Keep up-to-date on current practices within clinical content area(s). Maintain an awareness of current controversies, issues and developments. Manage the content requests from clients and oversee the development and maintenance of the clinical content library. Other tasks and projects as may be assigned by CMO.
Administrative Assistant - Executive Assistant- Philadelphia, PA-
Details: Division/EntityResponsible for acting as a personal and confidential secretary tosenior management and his/her staff. Contacts Company personnel at all levels of the organization to gather information to prepare reports. Maintains knowledge of corporate activities to assist in policy, procedure, and administrative matters. Performs responsibilities in such a way as to project the appropriate professional image of the Company. Has developed specialized knowledge/skills in own area. May act as a resource for colleagues with less experience.Job Overview-Arrange logistics for meetings and events including catering, A/V equipment, and physical set up. Serve as concierge for visitors, vendors, or other Comcast executives outside of the organization when they visit the Comcast Center. -Produce reports, metrics, or other measurable criteria to assess group performance, based on input data from other sources; ensure all reports and data files are arranged in a perfect manner so as to avoid any inconvenience in business mattersCore ResponsibilitiesCritical Competencies-Adaptability; ability to change (or be changed) to fit circumstances-Forward Thinking; anticipates the executive's needs and able to prioritize the Executive's time -Self-directed/Self-organized; capable of remembering and managing assigned items to on-time completion with little to no supervision. -Diplomacy & Tact; is open and approachable by the entire team and works well with others; produces a positive experience when interacting -Managing Relationships; builds rapport and relates well to all kinds of people, up, down, and sideways inside and outside the organization; manages positive key relationships with business process owners -Follow through; Check deadlines on incoming requests and put preliminary work in play; ability to ensure completed work is achieved to agreed deadlines. Tasks- Screens telephone calls, visitors, and letters; answers routinequestions and furnishes information.- Responsible for the coordination and scheduling of internal meetingsand presentations; gathers and prepares necessary materials and/orequipment.- Assures the planning and coordination of the executive's calendar ofevents; schedules appointments and prepares detailed itineraries,complete with travel accommodations, etc.- Assures the maintenance of travel and expense account and records,including form preparation and figure reconciliation.- Displays a strong knowledge of desktop tools such as the MicrosoftSuite of Office products and electronic mail systems.- Regular, consistent and punctual attendance. Must be able to worknights and weekends, variable schedule(s) and overtime as necessary.- Other duties and responsibilities as assigned.
Accounting Clerk
Details: Job Classification: Contract We are looking for someone to fill an Accounting Clerk position for a manufacturing company located in Everett, WA. Candidates need to be proficient in MS Excel, Word, and Outlook. Candidates with prior experience entering information in ERP/MRP systems are preferred, but not required. Interested candidates should call Perry at 425-249-4901 or email pchang[at]aerotek.comJob Responsibilities:-Entering employee time sheets into internal system and Excel spreadsheets-Processing A/P invoices-Reconcile credit card statements-Supporting HR department Join Aerotek Professional Services®. Our customized employment solutions and personalized approach give job seekers access to great opportunities with competitive salaries. Aerotek offers comprehensive benefits that can include medical, dental, optical, and optional 401k. Don't put your career in the hands of just anyone; put it in the hands of a specialist. Launch or rejuvenate your career today with Aerotek Professional Services! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law.
Access Control Specialist
Details: Access Control Specialist GCC Technologies, LLC., a rapidly growing Department of Veterans Affairs (VA) verified Service Disabled Veteran Owned and a US Small Business Administration (SBA) certified HUBZone Small Business, seeks experienced, highly motivated access control specialist to be responsible for the assurance of accountability measures are established for vehicle, personnel, and property entering and departing federal buildings and facilities. General Responsibilities: Monitor and control access into and from sponsor facilities by ensuring personnel identification throughout the production, issuance, and verification of identification media. Operates and ensures the proper administration control of equipment designed for the management of property, delivers, packages, controlled/prohibited items. Monitor the compliance with the sponsor’s established rules and regulations. Takes all reasonable precautions for health and safety of persons, and promptly report or correct unsafe conditions, procedures, or activities if possible. Operate and maintain manual and computer based access control and other computer related systems, databases, and equipment. Provide access control and other related administrative support as required. Produce and issue badges, ID cards, and other identification media. Conduct random inspections to ensure prohibits items are not introduced into facilities in accordance with established regulations, policies, and directives. Incumbent will be responsible for the effective operation of walk through metal detectors (fixed and portable), X-Ray equipment, and other equipment to facilitate this process at pedestrian control points. Conduct package inspections of personnel departing the facility as per post/position orders. Monitor closed circuit television systems, intrusion detection systems, fire alarm systems, and dispatch personnel as necessary.
Communications Specialist
Details: Communications Specialist: Full-time, 12-month position in the dean's office of the College of Liberal Arts & Education at the University of Wisconsin-Platteville, reporting to the dean. The successful candidate will be responsible for coordinating all public relations activities for the dean's office, including creating and/or editing press releases, the college newsletter, e-mail communications, and other college publications as assigned.
INSTRUCTOR - COMPUTERIZED OFFICE SPECIALIST
Details: Charter College, LLC., Long Beach, a fast growing vocational and degree granting institution is expanding it’s Computer Science area and is looking for adjunct faculty. Our faculty needs classroom or public speaking experience and will efficiently and effectively teach up to 30 students. Additionally, our faculty provides guidance to students in solving technical issues in the courses they teach while demonstrating vision and leadership for developing students’ ability for real world jobs. We are looking for a Computerized Office Specialist Instructor to join our team. JOB DUTIES Prepare for each course to be taught a syllabus consistent with course descriptions Impress upon each student the importance of exhibiting appropriate conduct in the work setting Acquire feedback to determine whether students understand each segment of the course Maintain academic standards Evaluate students' progress often and share those evaluations with them promptly Be available to students with concerns Review and be guided by student evaluations of instruction Play an intricate role in student retention efforts Serve on faculty committees Attend and participate in official college functions Keep on file official transcripts of your formal studies Enroll in such courses of study and participate in such programs of professional growth
