DNAjobs.com is proud to feature the following 37 jobs posted March 6 - 13 (listed in chronological order). For each position, I have listed a short description and a link for more information.
As always, I wish you tremendous success in your searching!
Jason
Account Development Specialist
(US-California-Oakland/East Bay) BioGenex has immediate openings for Account Development Specialists. Responsibilities: Maintain and nurture our domestic/international accounts Develop and qualify leads for medical instrument and reagent opportunities Conduct sales through telephone Develops customer base within the niche market area Partner with Sales Manager and distributors in a team selling environment Qualifications: Sales experience, either inside or outside Strong telephone, communication, teaming, and interpersonal skills Proven track record of success in sales Life Sciences or biomedical background is required Experience in distributor relationship capacity is desirable Strong territory management and customer satisfaction skills Bachelor's degree or equivalent in a Life Sciences discipline, like Cell/Molecular Biology or Microbiology.
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Scientist
(US-California-Silicon Valley/San Jose) Scientist to join our Systems Integrations team to develop and troubleshoot capillary electrophoresis separations for our technology. You will interact with a diverse group of scientists ranging from molecular and cell biologists to organic chemists. Requirements: Should have a Ph.D. in chemistry or analytical chemistry. Must have experience with the theory and practice of capillary electrophoresis. Familiarity with either the Mega BACE 1000 or ABI 3100 CE instrument is an advantage. Experience with assay development for genomic or proteomic assays is preferred. Good communications, team and problem solving skills are essential.
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Toxicologist
(US-California-Oakland/East Bay) ChevronTexaco is seeking a toxicologist with 0-5 years post-graduate experience to join our Toxicology and Health Risk Assessment team. As a member of our team in Richmond, California, you will provide toxicology services to ChevronTexaco operating companies world-wide, including: Assessing and characterizing human health hazards, exposure and risks from raw materials, process streams, facility emissions, components and finished products. Working with Product Stewardship and product development groups to ensure that potential adverse effects of products are understood and to recommend proper product stewardship actions, including meeting global regulatory requirements, recommendations for information for MSDSs and precautionary labels, tox testing, exposure standards, etc. Participating on industry-wide technical committees to address toxicology issues of interest to ChevronTexaco. Serving on the ChevronTexaco Emergency Information Center, being on-call on rotation.
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Computational Chemist
(US-Massachusetts) RESPONSIBILITIES: 1)Implement QSAR-ADME/Toxicology studies to support compound selection and virtual screening. 2)Correlate data to generate predictions for screening and lead optimization(initially using MDL QSAR package and Tripos software). 3) Perform docking and pharmacophore modeling to support virtual screening and compound selection in support of proprietary hit series identification primarily uses Tripos, Glide and InsightII software). 4) Maintain cheminformatics related hardware and software(this will include installation and upgrade of server and client side software, user training and immediate customer support). 5)Maintain data registration process, training and helping scientists to register biological assay and in vivo data into RS3 and ActivityBase databases. 6) Provide support for Compound Control and Screening as co-administrator of ActivityBase and support/programming as needed. EXPERIENCE: PhD in a related discipline with solid experience in scientific computing.
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Vice President, Regulatory Affairs
(Canada-British Columbia) A pharmaceutical company is searching for a Vice President, Regulatory Affairs. This exciting regulatory role will provide the worldwide leadership in all regulatory aspects in autoimmune disease, shaping the emerging clinical/regulatory strategy. Whilst building the group, you will influence and guide the development of regulatory packages within the company. Leading by example, you will ensure robust, professional planning and the timely delivery of CTA/IND/NDA/MAA designations. As you manage multiple, complex relationships with key leaders in the medical, scientific and regulatory communities including FDA, EMEA, Japan/Asia-Pacific, you will also foster and maintain solid relationships within our partner and their regulatory groups in the USA and Switzerland. Energetic and enthusiastic, with the drive and determination to set standards, you should be an MD (or equivalent) or with a higher degree in a discipline relevant to the pharmaceutical industry. You should have 5+ years regulatory experience in increasingly demanding roles.
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Toxicology/Preclinical Scientist
(US-Massachusetts) The candidate who fills this position will be involved in registration-enabeling preclinical studies to support lead candidate development for both biologic and small molecule development programs. RESPONSIBILITIES: Design and oversight of preclinical pharmacology and toxicology studies. In addition, the candidate will be responsible for analysis of the resultant data and the reporting of study results at both internal and external forums, as necessary. The qualified candidate will also participate in the preparation of regulatory documents for both domestic and non-domestic regulatory agencies. EXPERIENCE: Ph.D in Pharmacology, Toxicology or related plus a minimum of 2 years in industry designing / conducting various aspects of preclinical safety evaluations of drug molecules; basic knowledge of drug development principles; must possess speaking and writing skills that will enable him/her to provide clear ideas, arguments, and rationale for study designs and analyses; must also be capable of engaging in scientific dialog among large groups scientists, senior management and regulatory authorities.
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Vice President, Medical and Scientific Affairs
(Canada-British Columbia) A pharmaceutical company is searching for a Vice President, Medical and Scientific Affairs (N. America). This is a rare opportunity to make your mark in an exciting new organization and to help shape its future. You will combine leading the medical marketing and strategic scientific communication activities across N. America. This critical role will oversee the Medical Liaison, Investigator Initiated Clinical Research, Scientific Communications, Product PR, and Medical Information functions within the business. You will use your expertise to apply the principles of medical marketing to the particular rigours of highly specialized underserved markets. Based in their BC headquarters, you will also lead a medical liaison team that will develop and build relationships with key opinion leaders throughout N. America. Key to success is a strong track record in directing and leading scientific affairs programs across the Sales & Marketing, Clinical Development and Regulatory Affairs functions of the company. You should be an MD with 7+ years experience in the pharmaceutical industry, with at least 4 years medical marketing experience, ideally gained with specialist products.
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Formulation Scientist
(US-Massachusetts) Develop and characterize formulations to support small molecule drug discovery and development programs. The position requires hands on laboratory work. RESPONSIBILITIES: Establish a formulation development and testing lab. Develop prototypes of formulations (solid and liquid dosage forms for injection and oral dosing). Characterize new drug substances and formulations with respect to relevant thermal, solid state, solubility, and stability properties. Hands on operation and maintenance of analytical instruments. Effectively transfer research formulations developed in the lab to the manufacturing facilities. Assist with defining QC specifications / audits / generation of documents for regulatory agencies. The successful candidate will be responsible for planning and the prioritization of multiple projects in a cGMP environment, must have excellent managerial, organizational, communication skills and will be required to function on multi-disciplinary teams. He/She will also be responsible for drafting SOPs, validation protocols, technical reports and conduct validation activities in conjunction with QC personnel.
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Global Clinical Team Leader
(Canada-British Columbia) A pharmaceutical company is searching for a Global Clinical Team Leader. This is a pivotal role within the clinical function, this position provides a unique challenge. As an energetic leader you must balance the delivery of concrete operational challenges with global strategic thinking for all clinical aspects of the company's activities. You will build and direct the clinical group responsible for the design of clinical program strategy & protocols, including pivotal phase III studies in autoimmune indications, specifically in patients with lupus nephritis. You will proactively identify and address potential medical issues and ensure the implementation of risk management strategies. You will work actively with key opinion leaders in the medical and scientific community and within our partner. In addition, you will provide balanced clinical evaluations of emerging opportunities. An MD with experience in rheumatology, you should have 5+ years drug development experience in either industry or academia. You should be comfortable working in a highly networked organization with many partners.
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Associate Director Protein Engineering
(US-Massachusetts) JOB SUMMARY: To lead a scientific team involved in the development of 2nd generation protein-based products, RESPONSIBILITIES: Associate Director will be responsible for leading a team of 10-12 Scientists who are responsible for the development of second generation therapeutic proteins using a variety of methods including protein and carbohydrate modification, and conjugation techniques. This key position will interface between research and product development. In addition, it will involve the planning and the prioritization of multiple projects. EXPERIENCE: The successful candidate will have excellent managerial, organizational, and communication skills. In addition, the candidate will have extensive experience leading multi-disciplinary teams with a background in protein engineering and have a proven track record in the production of products with improved biological properties. A Ph.D in biochemistry, cell, or molecular biology and 10 plus years is required.
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Global Market Research and Business Analytics Team Leader
(Canada-British Columbia) A pharmaceutical company is searching for a Global Market Research and Business Analytics Team Leader. You will guide and drive the development and execution of the company's global market research and business analysis activities. Through the acquisition of data from multiple market research agencies, combined with detailed analysis of complex epidemiological data, you will need to deliver sophisticated sales and market forecasts for new and existing products on a world-wide basis. By working closely with sales and marketing planning teams, and by monitoring and identifying changes in the marketing environment, this individual will play a key role in ensuring the global success of the company. This is a challenging senior position and candidates should therefore have a minimum of 5 years direct experience in pharmaceutical market research, including: multi-country forecasting; primary and secondary research; and the application of qualitative and quantitative methodologies. You must be willing and able to travel extensively.
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Manager Preclinical Development
(US-Massachusetts) RESPONSIBILITIES: Responsible for managing project support services for all programs across preclinical research. Direct the development and implementation of tools, procedures and metrics to track projects to ensure timely completion of studies and department initiatives. Works with preclinical therapeutic area directors/managers to standardize and streamline steps common to all preclinical projects. Assist to assign resources along business unit priorities based on iterative assessment of preclinical workload compared with current project priorities. Participates in or advises in the negotiation of contract and contract changes, internally as well as in partner relationships. Coordinates the preparation and tracking of animal study plans and synopses through internal processes and communicates the status of all projects to preclinical management on a periodic basis. Establishes milestones and monitors adherence to master plans and schedules identifies program problems and obtains solutions, such as allocation of resources or changing internal or external contractual specifications. Coach project managers in setting up a project, completing each task and assembling the required study output at completion. Organizes and maintains process for receiving, responding to, and fulfilling requests for preclinical research services with business units.
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Global Marketing Team Leader
(Canada-British Columbia) A pharmaceutical company is searching for a Global Marketing Team Leader, Autoimmune Disease. This pivotal marketing position offers a complex and varied opportunity. You will lead an extremely busy team developing and implementing short and long-term strategic marketing plans across the globe, while also ensuring the timely execution of key tactical aspects. Harnessing multiple third party agencies, developing key opinion leaders and fostering advocacy partners worldwide is all in a day's work. Working closely with and influencing clinical, regulatory, medical affairs, sales and marketing colleagues, you will positively impact the global success of this key product. Candidates must demonstrate extensive global pharmaceutical marketing experience including sales and product management, ideally with specialist products. In addition, you will have a solid track record of delivery, team leadership, strategic thinking and an eye for detail. You will need to be confident influencing colleagues throughout the organization.
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Medical Director-Clinical Development
(US-Massachusetts) Currently we have several companies searching for just the right person to lead their clinical development team. Areas of interest are numerous but could include Oncology, Neurology (drugs or devices), Cardiovascular (drugs or interventional) and Infectious Disease are some of the areas. A prototype job description is as follows: Job Description: The purpose of this position is to design, direct, and function as a Study Director of clinical studies (Phase II and phase III) as a part of the global clinical development plans in Neurology for worldwide registration and to provide Neurologic clinical input/support. As such, you will be ..... Responsible for all medical & scientific aspects of the study from design phase, through implementation, and finalization, including scientific and medical input into the final review and sign-off of all pertinent clinical trial documentation. Responsible for assuring that study conduct is in compliance with all applicable national, and internationally accepted regulations. Review clinical research proposals within the therapeutic area for medical and scientific merit. Ensure publication plans and publication contents are scientifically and medically valid and compatible with the strategic messages of the Neurology therapeutic area.
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Director of Clinical Affairs
(US-Massachusetts) The Director of Clinical Affairs will be responsible for all aspects of clinical trial management. These responsibilities include the management of contract research organizations (CROs), design and writing of protocols and clinical trial reports, preparation and monitoring of budgets and trial timelines, and recommendation on resource requirements. The Director will represent Clinical Affairs on Program Teams and provide strategic input on new development-stage products. This person will lead the cross-functional Clinical subteam for development of cellular and protein therapy products. RESPONSIBILITIES: Act as principal director of Phase I, II, and III clinical trials. Manage CRO, data management firm, central laboratory and other vendors. Interface with investigative sites, including investigators, pharmacists, and study coordinators. Proactively identify and resolve issues. Participate in site recruitment and evaluation for new clinical trials. Participate in the design of clinical trial protocols and clinical development plans. Facilitate clinical planning and trial execution within team environment.
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Director Protein Formulation
(US-Massachusetts) Reporting to the Vice President, the qualified candidate will lead and manage the BioFormulations Development Group. This group is responsible for developing recombinant protein formulations suitable for commercial product use. This group interfaces with multiple Research and Development teams and also supports physical chemical characterization of candidate molecules, as well as early formulations, used during initial preclinical studies. Additionally, the group’s responsibilities entail profiling the physical chemical properties of lead formulation candidates and identifying potential development challenges in terms of stability as well as bioavailability and delivery. This group plays a lead role in the formulation selection process working in close collaboration with the Science, Clinical Research, Manufacturing Support, Quality and Regulatory teams. This individual will be responsible for supervising multiple levels of research associates and scientists, managing the day-to-day operations of the group, representing BioFormulations Development on both Research and Development project teams and will be a critical member of the management team.
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Medicinal Chemists-Research Associates (Multiple openings)
(US-Massachusetts) Job Description: A productive synthetic chemist, well-versed in modern synthetic methods and spectroscopy techniques, who will work closely with scientists in medicinal chemistry to plan and execute syntheses of compounds required in lead identification and lead optimization programs. The successful candidate will devise and execute synthetic routes to agreed target compounds; as well as monitor and evaluate new synthetic technologies (e.g. parallel synthesis and purification techniques). Record work in laboratory notebooks and present progress at chemistry group and project team meetings. Maintain current knowledge of synthetic methodology through literature reading and meeting attendance. Requirements: 5 years of synthesis experience, preferably in a biotechnology or pharmaceutical industry setting. Demonstrated experience executing multi-step organic syntheses and familiarity with application of modern spectroscopic and separations techniques are requisites.
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Director of Quality
(US-Wisconsin-Madison) Our client, a leading pharmaceutical company in Wisconsin, has an opening for a Director of Quality. This position will be responsible for all quality assurance/quality control issues and documentation for clinical sites, manufacturing facilities and off-site contracted work. The Director will head up a department of 17 people with 4 direct reports. QUALIFICATIONS: Bachelor's degree in biology, chemistry, pharmacy or related field. Must have 8+ years pharmaceutical industry experience in quality assurance, quality control, and/or compliance. Must have strong QA/QC experience in pharmaceutical manufacturing. Excellent knowledge of GLP, GMP, and GCP regulations and documentation. Experience managing a Quality Department; recruit, mentor, evaluate team members. Familiarity with pharmaceutical FDA regulatory affairs Responsible for internal audits and SOP's Competitive salary; 15-20% bonus; stocks; relocation assistance.
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Director of New Business Development
(US-Maryland-Montgomery County) Our client, a leader in clinical trial services, has an immediate need for a Director of New Business Development for one of their newly acquired companies. This position will be responsible for growing the business by identifying and bringing in new clients in need of FDA regulatory, compliance and validation services. QUALIFICATIONS: Bachelor's degree in science, marketing or business administration; advanced degree, MBA and international experience is a plus. 10+ years experience selling consulting services as they pertain to FDA regulatory affairs, validation and compliance. Excellent leadership and decision making skills. Able to work independently yet able to interact with staff and multiple departments and offices to determine capabilities and resources in preparation of proposals. Computer proficient in MS Office Suites Competitive salary; bonus is flexible and will be based on experience; relocation assistance.
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Clinical Data Coordinator - B
(US-California) Our client, a major pharmaceutical company located in Redwood City, CA is looking for a Clinical Data Coordinator - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Experienced data management professional who is responsible for all activities relating to over 20 studies over the course of 1 year. The primary goals are to provide accurate data acquisition and to furnish accurate and well-documented study databases to the statistical and clinical teams. Also includes Case Report Forms; initiating the purchase of CRFs, diaries, and related documents from clinical protocols, preparing the study database dictionary; developing quality assurance database checks. Under direct supervision this position is responsible for providing DM support on US and International clinical trials and for ensuring that clinical DM activities are conducted in accordance with regulatory and company standards Responsibilities: Review and provide input from DM perspective on protocols. Work in conjunction with Clinical group on CRF design. In collaboration with Clinical, create CRF completion guidelines to be utilized by sites and CRA's. Work with Database Programmer Analyst and Manager of DM to set up, program (when trained), validate, user-test and maintain clinical databases. Develop Edit Checks.
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Manager, Regulatory Labeling and Promotion
(US-Massachusetts) The Manager, Regulatory Labeling and Promotion, is responsible for the management of regulatory activities in the support of external commercial communications, labeling development, and labeling maintenance. This person represents regulatory in cross-functional teams that review and/or approve promotional materials, sales training materials, press materials, and other external communications. This person represents regulatory in cross-functional teams that develop draft labeling for regulatory authority review and approval and maintains labeling after approval. and will be a liaison with regulatory authorities and other functional teams in matters relating to labeling and promotions. EXPERIENCE/EDUCATION: MS/PharmD preferred. Good knowledge of labeling and advertising regulations, guidance, and agency regulatory action history is required. Minimum experience 2 years in regulatory promotional review or labeling required.
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Regulatory Affairs Associate
(US-Massachusetts) Provide Regulatory guidance, strategic advice and contribute to a Regulatory project team planning on CMC issues. Handles all aspects of CMC-related activities for assigned biological development project. RESPONSIBILITIES: Review and assessment of all CMC documents for consistency, accuracy and conformance with all regulatory requirements; Identification of content, responsibility and timing of CMC documents for regulatory submissions; Coordinating and monitoring the progress of all CMC regulatory submissions; Providing regulatory guidance for CMC issues, processes and templates by working closely with Manufacturing and Quality through all phases of drug development; defining current regulatory requirements for technical submission (INDs, CTXs, BLAs, and DMFs); Directly interacting with regulatory authorities(internal) and Manufacturing and Quality (external) on CMC issues requiring agency feedback; and participating in pre-approval inspection activities. EXPERIENCE: A minimum of a BA or BS in chemistry (although other physical or biological sciences will be considered) with 2-5 year’s prior experience.
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Regulatory Affairs Manager
(US-Massachusetts) Reporting to the Associate Director of Regulatory Affairs, the Manager will be responsible for determining Regulatory strategy for specific projects relating to the development of new formulations, new delivery systems and new indications for commercial products as well as post-marketing commitments and Phase 4 studies. The Manager will also serve as the RA representative on relevant project teams and as the primary regulatory contact with regulatory authorities in the US and Canada. Specific duties include but are not limited to: Represent RA on all relevant project teams. Responsible for the development and implementation of RA strategy for assigned projects and programs. Responsible as the primary contact for all communications with the regulatory agencies relevant to assigned projects or programs. Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs. Prepares written and oral presentations of Regulatory plans to project teams and Senior Management.
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Vice President -Regulatory Affairs
(US-Massachusetts) MISSION STATEMENT: To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications. RESPONSIBILITIES: Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company's strategies. Review and approve key segments of regulatory submissions. Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. Communicate to senior management regulatory strategic & tactical plans to achieve company goals. Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas. Work closely with R&D to develop an overall drug development strategy for all of the company's products.
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Vice-President Medical Director
(US-Massachusetts) Your responsibilities will be numerous in this hands on position. Two (2) positions exist! You will report to, and work closely with the Sr. Vice President of Medical Affairs to plan, direct and oversee clinical studies intended for FDA and foreign regulatory submission. Other duties include: providing clinical expertise and leadership to the company, design, coordinate and finalize clinical research protocols, consent forms, protocol amendments, and CRFs for assigned project(s), establish and maintain relationships with FDA medical staff, consult with Investigators on exceptions to eligibility or deviations from protocols, be responsible for ensuring the successful and timely recruitment of clinical research study participants, review, finalize, and update Investigator Brochures, finalize drug supply forecasts and study drug distribution plans. Requirements: 3-5 years experience overseeing Clinical Trial Activity is necessary. Your training should be in one of two (2) areas: Oncology (preferably Lymphoma) or CNS (preferably Alzheimers).
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Group Leader-Cancer Biology
(US-Massachusetts) Join a team of leading researchers at one of the world's premier biotechnology Companies. Currently, this Company is expanding thier research program in Signal Transduction-Based Drug Discovery in Molecular Oncology and Cancer Biology. There is now a need for an experienced, highly talented Group Leader to take responsibility for establishing a retroviral RNAi-based mouse model engineering platform and leading a team of scientific personnel researching Signal Treansduction-based drug discovery in molecular oncology and cancer biology. RESPONSIBILITIES and QUALIFICATIONS: The incumbent will be involved in the hiring and identification of additional persons for this group involved in RNAi-based target validation. The successful individual will have extensive experience in the generation, phenotypic, and molecular analyses of genetically engineered mice, and ideally with the generation and use of retro/ lentiviral vectors and/or with siRNA.
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Sr. Quality Assurance Specialist
(US-Massachusetts) The qualified candidate will assist in the routine performance of Quality Systems to assure compliance with in-house specifications, standards and cGxPs, with an emphasis on auditing, documentation, data review and training. Responsibilities include the production of batch record/test report review, SOP review and approval, review and maintenance of investigations and change control requests. This position will require 5-10% travel both internationally and within the US. Qualifications: The successful candidate will have a BS or equivalent and 5+ years of relevant QA or industry experience. Demonstrated knowledge of GMP operations will be required. Experience in both internal and external compliance audits is required. Strong written and verbal communication skills, as well as strong organizational skills are required in order to assure that turnaround times are met in support of further manufacturing. Knowledge of GLP is desired and GCP is preferred.
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Director of Engineering
(US-Massachusetts) This position is responsible for directing the R&D Engineering group responsible for supporting a R&D site. The primary function of this group is to provide safe, functional cost effective buildings and equipment in a timely and professional manner. Responsibilities include facilities design, capital planning, project/construction management, technical studies, master planning, identification and remediation for ongoing facility/process issues. The performance of this group directly affects the ability of the business to meet strategic objectives by planning for and providing facilities in a timely and compliant manner while maximizing shareholder value. MINIMUM QUALIFICATIONS: Demonstrated leadership, team building and staff development skills. Strong Financial acumen and ability to forecast and manage budgets. BS in Engineering / prefer MS. 10 to 15 years relevant experience in managing engineering and construction projects in a Pharmaceutical R&D environment and 10 years experience managing engineers, architects and related support staff, A&E and CM contractors.
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Clinical Regulatory Affairs Associate - A
(US-Illinois) Specific Responsibilities: Receive documents from various sources and review for completeness and suitability for submission to FDA. Request missing and/or illegible pages, arrange for translations as needed. Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies. Including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance. Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment. Handle drug re-supplies for the above-mentioned studies. Prepare 30-day investigator submissions. Gather information and prepare IND and NDA annual reports. With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements. Must have the following: Needs to be able to organize and prioritize tasks and work independent of manager. Be able to think of new and better ways to accomplish tasks. Direct temporary help in heavy work situations.
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Validation Engineer
(US-New Hampshire) Our client, a worldwide medical device leader, has an immediate opening for a Validation Engineer. This position will entail understanding and following the guidance documents set forth in the Quality System operating procedures detailing packaging, process, and product shelf life. Responsibilities: Complete documentation and validation of a segment of manufacturing process. Handling validation assignments from conception to completion. Carrying out the validation including any pilot studies that may need to be performed to start the validation. Analyzing all pertinent data to determine the result of the validation using appropriate statistical methods. Complete special projects as assigned by the Director, Technical Services. Requirements: ISO 9001 and 21 CFR 820 training. Two years minimum experience in a Medical Device or Pharmaceutical environment. Knowledge of basic statistics and process validation. Education: Minimum four year degree in a physical science or engineering. Competitive Salary;annual bonus.
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Pharmacist
(US-Illinois) Our client, a major pharmaceutical company in Waukegan, IL is looking for a Pharmacist with the following qualifications: Reviews prescriptions issued by Physician, or other authorized prescriber to assure accuracy and determine formulas and ingredients needed. Compounds medications, using standard formulas and processes such as weighing, measuring, and mixing ingredients. Directs pharmacy workers engaged in mixing, packaging, and labeling pharmaceuticals. Answers questions and provides information to pharmacy customers on drug interactions, side effects, dosage and storage of pharmaceuticals. Maintains established procedures concerning quality assurance, security of controlled substances, and disposal of hazardous waste drugs. Enters data such as patient name, prescribed medication and cost, to maintain pharmacy files, charge system, and inventory. Pharmaceutical Information position. Responsibilities include responding to technical inquiries regarding Abbott PPD products.
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Clinical Documentation Specialist - A
(US-Illinois) Our client, a major pharmaceutical company in Waukegan, IL is looking for a Clinical Documentation Specialist - A with the following qualifications: REQUIRES 5+ YEARS EXPERIENCE Manage Phase I-IV study activities, including: participate in the development of protocols, participate in CRF design, manage drug supply, initiate and monitor sites directly or indirectly, monitor CRO activities and provide training as necessary, act as primary liaison between central lab, CRO and sites, assist with identification and recruitment of study sites, review and track contracts, review regulatory documents prior to drug shipment, participate and present at Investigator Meetings and other training sessions. BS Preferred. Additional job requirements: Track receipt and entry of CRFs in tracking database; preparation of documents for e-submissions. You MUST meet all of the above qualifications in order to be considered for this position.
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Post-doctoral Research Associate
(US-New York-New York City) Post doctoral position to study early/late events in HIV-1 Replication A post-doctoral position is available immediately to work on a series of exciting projects on HIV-1 reverse transcriptase. The projects are aimed at delineating structural determinants of RT function (processivity, fidelity, strand displacement synthesis and enzyme translocation); developing novel, potent aptamers directed to HIV-1 RT and other proteins; identifying host proteins involved in early events. Candidates with experience in the areas of nucleic acid biochemistry, protein chemistry, DNA/RNA polymerase Biology and Virology should directly email their curriculum vitae and names of three references to prasad@aecom.yu.edu.
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Molecular Pharmacology Director
(US-California-San Francisco) I am been asked by a genomics-based drug discovery company focused on the discovery and development of potential new drug therapies to assist them with their search for a Director, Molecular Pharmacology. This person will manage a group of 25+ scientists engaged in the development and implementation of a range of cell-based assays required for supporting small molecule lead validation and optimization. The position involves coordination and prioritization of the group's activities to meet discovery goals, strategic guidance and scientific leadership regarding development of new assays and implementation of new technologies and effective management of the departmental budget. It is required that this person have a PhD and 10+ years post graduate experience. They most have significant industry experience (6-7 years) in the small molecule drug discovery arena and an excellent grasp of cell-based assay development and in vitro pharmacology, strong background in oncology and/or metabolic diseases.
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Clinical Medical Reviewer / Safety Reviewer - B
(US-Illinois) Our client, a major pharmaceutical company in Abbott Park, IL is looking for a Clinical Medical Reviewer/Safety Reviewer B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
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Clinical Statistician II - C
(US-Illinois) Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Statistician II - C with the following qualifications: REQUIRES 5+ YEARS EXPERIENCE Provide in-depth statistical expertise in the areas of; experiment, protocol, case report form design, data base structure, and analysis plan; collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity. May also contribute to the decision for optimal study design and contribute to the proper use of statistical methodologies for a study. Must have clinical research experience. MS or PhD in statistics (or related field), clinical trials experience, and strong SAS programming skills required.
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Clinical Project Manager, Assistant - B
(US-Illinois) Our client, a major pharmaceutical company in Abbott Park, IL is looking for a Clinical Project Manager, Assistant - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Under the supervision of a Project Manager or Assistant Director, support one or more project teams with routine project management activities. Assists Project Management teams in the implementation, monitoring and tracking of planned development activities for the development, registration and approval of new drug compounds. BS Preferred. Responsible for project management of multiple clinical supply projects including all study (Phases I-IV) by planning and delivering on time, on cost drug supplies to support studies. Conceptualize, development and implement clinical supply and re-supply project plans. Communicate with consultants and third-party vendors to ensure timely delivery of clinical supplies that meet study protocol, regulatory and budgetary requirements. Responsible for producing documentation for all processes involved in packaging, labeling and distribution of clinical supplies.
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