(US-Massachusetts-Boston North) Under general direction is responsible for administering, processing and maintaining the Medical, Dental, Life AD&D, STD, LTD and Flex Spending Accounts. Record keeping for the benefit plans includes processing enrollment forms etc. with the carriers. Enter employee information into the Ceridian and Oracle data basis to ensure timely information is available. Filing employee information into personnel files and faxing and or mailing to carriers as necessary. Process self billing information for certain benefits and ensure the timely processing of billings to Accounting for processing. Gathering census information for benefit processing and assisting in processing 5500 information.
(US) In these critically important and highly visible roles you will: Lead a team of Quality Engineers, Inspectors and Document Control professionals, OR Provide hands-on support for Engineering and Production… …as you work directly with customers and suppliers on a wide range of engineering, new product development and manufacturing transfer projects. You will also: Help to develop and support our Supplier Quality Engineering Program, and help lead the way to state-of-the-art Quality systems and procedures. GROW AS RAPIDLY AS YOUR TALENTS ALLOW TO ANYWHERE YOUR AMIBITIONS LEAD. WHAT DO WE NEED? 3 to 5 or more years of medical device, medical products, biotechnology or pharmaceutical industry Quality Engineering experience, OR 5 or more years of non-medical device industry experience in precision products (electronics, etc.) or highly-regulated (aerospace, etc.) non-medical device manufacturing environments. At least 3 years of quality leadership experience for the Quality Management position. Six Sigma or Lean Operations exposure is a competitive advantage, but not required (learning this highly sought-after “toolset” is a great reason to join MedSource)
(US-Tennessee-Knoxville) Innovative Pathology Services, PLLC, the largest anatomic pathology services laboratory in East Tennessee with a thirty five plus year history of providing AP and cytology services in the area (as KPG) is currently seeking to fill the position of Molecular Scientist in our Special Procedures Laboratory, located in Knoxville Tennessee. We are a fast-growing, privately-owned laboratory seeking to expand our Special Procedures team and services. This group is headed by a Hematopathologist and also includes four highly trained Medical Technologists. If you are looking for a challenging position with a stable company that rewards its associates for top performance this position may be of interest to you. We are currently performing flow cytometry, PCR and HPV (by Hybrid Capture 2TM) testing in conjunction with our anatomic pathology and cytology services. In this position you will work closely with our staff Pathologists for evaluation and implementation of additional molecular testing procedures. You will also stay abreast of new and developing molecular technologies, research and recommend, for integration into our testing menu, any that are proven to provide patient benefit and that are a good match with our core services and business plan. The ideal candidate is a team-oriented individual with a PhD in Molecular Biology, Molecular Genetics or Microbiology. Solid PC, communication and people supervisory skills are essential. We offer a competitive salary and benefits package which includes health, dental, disability and life insurance, company matched savings plan, pension, business casual dress and generous paid vacation.
(Southern California) Hello, SAS Professionals!! Once again, I have an EXCELLENT long-term contract opportunity in beautiful Southern California. Our client, a Fortune 500 firm nestled in Thousand Oaks, is seeking a couple SAS Programmers with at least 5 years of clinical trials experience in the biotech/pharmaceutical industry. How can anyone turn this down?? Great company (leading biotech firm), exciting work, long-term contract, and sunny Southern California weather! You could spend the winter by the beach while everyone else freezes their toes off! Please don't pass this up, and if you have friends who are qualified that may be interested, don't begrudge them this opportunity! Resumes can be e-mailed to vanessa.rauda@modisit.com for immediate consideration. Please feel free to e-mail me with any questions or for further information.
(US-California-Silicon Valley/San Jose) Testing of high-quality enterprise software product that stores, and manipulate data coming from biological technologies. Work closely with R&D to design test procedures that ensure quality and reliability prior to release of software. Design test strategies and write Test Procedures based on development and design specifications. Execute the Test Procedures written by self and others covering the company's products. Prepare input data files as required to support test procedures. Install Software to establish the test environment. Analyze test problems/failures. Report and track software problems using a defect tracking system. Write software test reports. Requirements: Bachelor's degree in Computer Science, Scientific disciplines, orEngineering. Experience in software testing and/or quality assurance with an understanding of the software life cycle. Experience in designing and writing test procedures/ test cases. Knowledge of and experience with the Oracle database at the user level, and SQL language is extremely desirable. Good interpersonal, verbal, and written communication skills. Ability to work independently with a minimum of supervision. Knowledge of general chemistry laboratory practices and/or molecular biology is desirable. In short, the hiring manager is seeking candidates with large enterprise SW testing experience. Not just doing test cases but the overall testing/QA/analytical work. LIMS (Laboratory Information Management System) and/or biotech product testing experience preferred. This position is more black box testing experience then white box. Strong skills in writing test procedures. Needs someone who thinks outside the box, not someone who is used to just following procedures/orders. Analytical thinking is a must. SilkTest NOT a requirement for this position.
(US-California-Silicon Valley/Peninsula) A key hire for us right now is an M.D. (and ideally an M.D./PhD) to serve as Vice President of Clinical Research and Development. Like high visibility? Can you handle pressure? Put simply, you will have a major impact on our overall success. The V.P. will report to our Chief Medical Officer and serve on the Operating Committee. To compete for this attractive and challenging position you must have a successful track record in clinical development and strategic clinical research trial design. You may come from Big Pharma with a rigid infrastructure. Here you need an entrepreneurial spirit and a roll up your sleeves mindset. We want someone with the initiative to lead and inspire confidence among those who have chosen a high potential company. We can offer a salary in the $220K to $250K range plus incentives and stock options. You will take on the strategic and operational oversight of our clinical development, and, as you can imagine, will have your hand in: Design and supervision of Phase I – III clinical trials. Preparation of clinical development plans, Protocol designs Clinical site selection Investigator recruitment Investigator meetings IRB approvals Clinical contracts and budgeting Clinical study reports Presentation of study results at scientific meetings. Strategic clinical development plan for new drug candidates. Managing processes for IND filing, IND safety reporting, preparation for ODAC meetings and NDA filings with the FDA. Managing clinical research activities for external collaborations. Prep for ODAC meetings. Clinical support for regulatory affairs. In summary, you will provide medical expertise to the product/project teams and to the drug discovery team. You have the job of integrating the regulatory and clinical programs with the business strategy of the company. Your presentation skills come in to play as you liaise with the scientific and medical community. Your decision making will be called on to contribute to the strategic selection of new projects. Your background will include: Expertise in Oncology or Endocrinology. Extensive experience in clinical trials operations. Submission of one or more NDA’s (highly desired). Phase II and Phase III clinical trials management. Understanding of U.S. and international new product clinical development. Global project leadership, management and negotiation. Oversight of CROs. Leading of multi-disciplinary teams (covering tight timelines, budgets, Clinical Trials Agreements and site selections. Personal characteristics? Ethical, Communicative, Collaborative, Bright, Articulate and Creative. Two additional skills that will be called upon is this role are strong oral presentation and technical writing.
(US-California-San Francisco) To support our new business needs we are searching for a Director of Clinical Quality Assurance. In this senior management role you will develop, implement, and administer QA and QA systems. You thus will ensure that trials are conducted and data are generated, documented (recorded) and reported in compliance both with internal standards, GCP and also with applicable regulatory requirements. Right now you will be a department unto yourself, selling our QA services in presentations to clients. You will support clients on quality issues and host or participate in client and regulatory inspections. You will establish training programs throughout the company and be the go to person for interdepartmental teams on Quality and Clinical Corporate Compliance. Academically we need at least a Bachelor's degree in health related field and/ or licensed health care professional (RN). We want no fewer than three years experience in medical and/ or pharmaceutical quality assurance. From a computer perspective you will need experience with spreadsheet applications. Salary will range from $90k to $115k, depending on experience. We provide full benefits.
(Canada-Prince Edward Island) The Product-Marketing/Communications Specialist will be responsible for preparing and carrying out product surveys; supporting sales and customer service with product training; developing and carrying out the advertising and promotions annual budget and plan; creating marketing communications; organizing marketing events; and creating presentations. literature, product packaging and labelling. Successful candidate for this position should have a B.Sc. degree in chemistry or a biological science; a recognized marketing degree or post-secondary diploma or equivalent experience; excellent creative writing and communication skills; knowledge and extensive experience in the use of computer software programs including the internet; and the desire to learn and advance in a growing company serving the pharmaceutical industry.
(US-Utah) PHARMACOKINETICIST, UTAH for our client, a dynamic and growing Pharmaceutical company focused in multiple therapeutic areas. JOB DESCRIPTION In this role, the Pharmacokineticist will be responsible for the pharmacokinetic characterization of drugs within assigned clinical projects and will report to the Senior Director of Safety Assessment and DMPK specific responsibilities. S/he will design and prepare clinical PK development strategies and study protocols, participate in generating documents for regulatory submission (annual updates, IND and CTD), perform and supervise PK and PK/PD analyses, as well as preparing or editing final reports. Additionally, s/he will manage multiple projects simultaneously as well as working with members of the Clinical Research team to implement PK strategies and word as part of a multidisciplinary team to support the development of drug candidates. QUALIFICATIONS The ideal candidate will have a Ph.D. in Pharmacokinetics or related Pharmaceutical Sciences field complimented by two-five years pharmaceutical industry experience. S/he will have a demonstrated ability to communicate effectively through oral and written presentations as well as the ability to work well in a team environment. NONMEM analysis and/or PK/PD modeling experience are required. COMPENSATION Compensation is competitive and includes a base salary of $88K-$102K and a comprehensive benefit package. Relocation is available for this position.
(US-Massachusetts) My client, a leading research-based Speciality Pharmaceutical Company in Massachusetts, has an opportunity for a Clinical Bioanalytical Research Associate The primary objectives of this position are to assist in the timely completion and coordination of all clinical bioanalytical projects, to assist in the development and validation of bioanalytical methods in human biological matrices. Requirements: BS/MS degree in analytical chemistry, bioanalytical chemistry or related fields; 4+ years of industrial experience in the development and validation of analytical methods. Hands on experience with LC/MS/MS technology and associated computer software is a must, along with a proven track record of successfully applying novel analytical concepts to the drug/product development process. Prior experience working with CRO's is highly desirable. The salary is in the 100K range and the benefits are excellent.
(US-California) MANAGER OF CLINICAL PROGRAMMING, Bay Area, CA for our client, a global bio pharmaceutical focused on therapeutics for Infectious Diseases patients. JOB DESCRIPTION The Manager of Clinical Programming will be responsible for managing a team of Clinical Programmers supporting clinical data management. S/he will work collaboratively with direct report, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. In addition, s/he will ensure completeness, correctness and consistency of clinical data and data structure. Further responsibilities include providing leadership in the area of systems, processes and tools for clinical data collection and management, hiring, supervising, training, and coaching direct reports, and participating on departmental management team, providing strategic direction for clinical programming. QUALIFICATIONS The ideal candidate will have a Masters degree (Ph.D. preferred) in a Biomedical Science, clinical background compliment by eight 8 years working experience in SAS programming in a CRO or bio/pharmaceutical setting, including experience managing people. Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is also required. S/he will ensure clinical programming work is completed in a consistent manner and validated according to department practices, in addition, knowledge of relational database design, FDA regulations. Familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems is also preferred. S/he will have excellent communication, problem solving and people/project leadership skills as well as excellent verbal and written communication skills and interpersonal skills. Further requirements include a knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions. The ideal candidate will be a team player with an entrepreneurial spirit, a strong and assertive communicator in the company of other such people, and someone with sound judgment and flexibility with a dynamic personality. COMPENSATION Compensation is competitive and includes a base salary and a comprehensive benefit package. Relocation is available.
(US-California) MANAGER OF CLINICAL DATA MANAGEMENT, Bay Area, CA for our client, a global bio pharmaceutical focused on therapeutics for Infectious Diseases patients. JOB DESCRIPTION The Manager of Clinical Data Management will be responsible for managing a team of Clinical Data Associates supporting clinical data management. S/he will work collaboratively with direct report including Statistical Programmers, Biostatisticians and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting. In addition, s/he will ensure completeness, correctness and consistency of clinical data and data structure across all projects. Further responsibilities include providing leadership in the area of systems, processes and tools for clinical data collection and management, hiring, supervising, training, and coaching direct reports, participating on departmental management team, providing strategic direction for clinical data management. QUALIFICATIONS The ideal candidate will have a Masters degree in a Biomedical Science, clinical background complimented by five years working experience in Clinical Data Management in a CRO or bio/pharmaceutical setting, including experience managing people (Bachelors degree complimented by eight years of experience will be accepted). Experience with relational database design, knowledge of FDA regulations and familiarity with web-based Electronic Data Capture (EDC), clinical data management systems and industry-wide thesauri, such as MedDRA is required. The ideal candidate will have excellent communication, problem solving and people/project leadership skills as well as excellent verbal and written communication skills and interpersonal skills. S/he will be a team player with an entrepreneurial spirit, a strong and assertive communicator in the company of other such people, and someone with sound judgment and flexibility with a dynamic personality. COMPENSATION Compensation is competitive and includes a base salary and a comprehensive benefit package. Relocation is available.
(US-District of Columbia) The Protein Information Resource (PIR) is seeking a Bioinformatics Software Engineer to join our group at the Georgetown University Medical Center and the National Biomedical Research Foundation to participate in the development of the UniProt project. PIR is a public resource of protein informatics, providing functionally annotated and value-added protein databases as well as bioinformatics tools to support genomic and proteomic research and knowledge discovery. Responsibilities: Develop software and databases systems for protein curation and superfamily classification including: •database design •data warehouse implementation, and •develop tools for data mining and analysis. Requirements: •MS or PhD in Bioinformatics, Computer Sciences or related fields •3+ years experience in software engineering processes and software development life cycle, and knowledge of UML •Experience in n-tier J2EE server technology development •Experience in bioinformatics and software/database development with Oracle, XML, JAVA/C++/PERL in Unix systems •Solid background in biological database development •Good communication skill and team player
(US-California) Seeking an individual with the unique combination of mathematical and/or statistical analysis with proficiency in OOD software development. Must have strong background working with scientific data. Exceptional communication skills with extensive computing skills. (C, C++, Java, Oracle) We are building an elite R&D team who will develop advanced data analysis techniques, create mathematical models, and build simulators for systems in very diverse areas. We are looking for a rare individual who can successfully develop innovative applied mathematics solutions to real-world biology, chemistry, applied physics, engineering or operations research problems. This is neither a bioinformatics nor a programming position. It is an opportunity to make sophisticated mathematics practical and to have a significant, positive impact on the success of the company. Requirements: * 7-10 years of scientific computing * C, C++ or Java * algorithm design * Database knowledge (Oracle preferred) * PhD in, mathematics, engineering or a computer science or physical science (If the degree is computer science or mathematics, then extensive experience with physical science problems in the industry is required. Industry experience is extremely desirable, although the experience does not have to be directly in the pharmaceutical or biotech industries.) The successful candidate must also have a deep understanding of and significant experience with nonlinear sciences and systems theory from an engineering or a mathematical perspective. Mathematical biology experience is desirable. Familiarity with cross department projects that are also interdisciplinary is very desirable. Good team skills and the ability to learn quickly are essential. Good oral and written communication skills are important. Frequent formal presentations will be required and formal reports documenting concepts and the delivered proof of principle software must be written. The ability to communicate results to those who are neither comfortable nor familiar with mathematical terminology is necessary.
(US-West Virginia) Product Manager will have the responsibility to manage the development and commercialization of new protein and cell biology research products, under development at the company. This will include guiding the product through its laboratory development phase, setting specifications, and positioning products for sale into the life science research market . This is an outstanding opportunity for those who have a technical background, experience in sales or technical service, who are looking for product management responsibility, and moving onto a marketing management career track. Located at West Virginia University in beautiful Morgantown, WV, we are only a three hour drive from NIH and the nation's capital.
(US-West Virginia) Responsible for the development of novel sample preparation biochemical procedures, for use with Mass Spectrometry, and novel biochemical (protein, RNA) target validation assays, for use in protein separation and identification procedures. Outstanding opportunity for a biochemist who seeks an entrepreneurial culture, and enjoys the process of new product and methods development. Adjunct affiliation with WVU also available.
(US-California-Silicon Valley/Peninsula) Technically trained and motivated individuals are sought to participate in applications support. Responsibilities will include: development of applications for current and forthcoming products through laboratory experimentation; technical writing to prepare technical literature from experimental data; presentation of results for in-house and professional forums, and applications training for MJ personnel. Candidates with a M.S. or Ph.D. degree in Molecular Biology or related field and experience in PCR, DNA sequencing and customer support or training are preferred. Some travel will be required to fulfill presentation assignments in professional forums.
