(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake County, IL is looking for a Clinical Medical Services Specialist - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications. BS Preferred. BSN/RPH/PharmD required: Must have good verbal communication skills, and clinical experience. Disseminate medical information on pre-approval and marketed products to health care professionals, consumers, sales representative and client's affiliate medical departments in a timely manner. Research and critically analyze product and clinical data, medical literature, and competitor information. Regularly interact with staff members from Medical, Business Development, Regulatory, and other divisions. Must stay informed of current medical, regulatory and public relations issues, therapeutic trends and business strageties to assure that the response meets the needs of the intended audience, is medically accurate, up-to-date, and consistent world-wide. Work hours: 8:15 am - 4:55 pm. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position.
(US) A leading Contract Research Organization (CRO) has an immediate need for Clinical Research Associates I & II. The successful candidate(s) should have a diverse therapeutic background in hands-on monitoring of clinical trials. These will be decentralized or home-based position(s). REQUIREMENTS: *Bachelor's Degree preferred; others will be considered based on years of experience MUST HAVE *A minimum of 12 months field monitoring experience *Must be within 45 minutes of a major airport *Be able to travel 50%+
(US) Our client, an international pharmaceutical company has three (3) openings for Clinical Support Specialists. Only local candidates in the following areas will be considered: Cincinnati, OH; Los Angeles, CA; and Orlando, FL. The position in Florida requires a candidate who is bilingual (English & Spanish). The ideal candidate will have a background in renal and/or nephroloy as a Dietician or RN JOB RESPONSIBLITIES: Provide a professional clinical service with an educational focus discussing clinical data, study results, drug product related topics and answer questions to help increase product recognition and to support sales of the companies drug products. *Present customer focused & patient related educational materials & programs re: the companies 'secondary hyperparathyroidism'(SHPT) products *Develop & present continuing education for health care professionals concerning the management of 'SHPT' with the use of the companies products *Function as a field resource/trouble-shooter to customers and the sales force *Facilitate roundtable discussions with physicians, pharmasists, nurses etc. on topics related to the companies products *Educate patients and participate in patient support groups *Participate in 'End Stage Renal Disease' (ESRD) network activities *Assist with marketing tools *Organize sales support materials and assist with clinical training of new sales personnel *Able to travel 75%-80% QUALIFICATIONS: *Prefer someone who is a Registered Dietician or Registered Nurse *2+ years experience with Dialysis.
(US-Pennsylvania) Scope of the Job Design and develop custom and special order requests. This includes communication with surgeons and sales consultants, understanding the clinical issues, defining the design parameters to support AO philosophies, and ensuring the correct product is provided to the customer. Responsibilities 1.Designs and develops new implants and instrumentation and develops improvements and modifications to current products. 2.Interacts with surgeons, manufacturing, regulatory affairs, sales consultants, product managers, and other functional departments to define and develop product requirements and concepts. 3.Works directly with surgeons for design concept development, prototype and cadaver evaluation, and clinical follow-up. 4.Generates product models, concept layouts, and prints using a CAD software. Apply geometric dimensioning and tolerancing accordingly. 5.Performs the required activities and generates the appropriate documents to ensure compliance with FDA Design Control regulations, and to support 510(k) submissions or IDE clinical studies. 6.Develops mechanical test protocols according to ASTM standards and coordinates the activities required to fabricate test parts and complete mechanical testing. 7.Works with manufacturing during the design stages to incorporate manufacturability into the product designs. 8.Responsible for the all designs from concept development through product launch. 9.Performs other special projects and functions as assigned by the department manager. Candidate Requirements 3 - 7 years experience in the design and development of mechanical products. Knowledge of CAD software (Pro-E, Medusa, AutoCad, Ideas, etc.). BS in Mechanical Engineering (or equivalent) required. Prior project management experience preferred. Eperience in medical equipment industry desirable. Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel. Demonstrated creative design ability. Demonstrated success in bringing product from design through introduction on time. “Hands-on” engineer.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Research Associate Sr. - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE. Member of the clinical team responsible for conducting Phase I - IV studies according to Federal Regulations and ICH guidelines and study protocol, including planning study conduct, writing study protocols, designing CRF's, CRO selection, CRO training and management, selections and training of study investigators, planning and running study meetings, and overseeing the evaluation, selection and training of new study investigators. Responsible for the initial budget and contract negotiations with study sites or CRO's. Responsible for writing and supervision of contributors of clinical reports and NDA documents, including integrated Summaries of Safety and Efficacy (ISS and ISE), as appropriate. Strong background in protocol development and experience managing Phase I studies and mechanistic studies a plus. Experience conducting trials Ex-US preferred. Must have at least 1 year of Sr. CRA experience. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Clinical Research Professional II - B with the following qualifications: REQUIRES 3-5 YEARS EXPERIENCE Experienced in the finer details of the Clinical Trial process. More directly or indirectly involved through review meetings, and by actively participating in study audits by the Sponsor Company and/or FDA inspectors. Prepare information for NDA sections and/or IND submissions, including reports on data information generated from Phase I - IV studies. Experience of 1 - 5 years in Biotechnology and/or Clinical Research Industry. San Diego, CA-- 1 Field Monitor needed. **BS required** Nursing Background/BSN preferred. Minimum of 1 year experience in field monitoring. Preferred experience in monitoring studies in the following therapeutic areas: Gastrointestinal, rheumatology, urology, or oncology, women's health. Laptops will be provided to field monitors You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. 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. Responsibilities include performing statistical analyses of clinical trial data and producing and validating tables and graphs using SAS. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US) Our dynamic pharma client is seeking a skilled and experienced Peptide Chemist to serve as a primary technical resource and to lead a small peptide synthesis group. You will be responsible for putting program together, protocols. This is a hands-on position so you must be as killed bench scientist as well. You must be able to grow into future additional responsibilities. You must have good written and oral communication skills, be both a skilled team member and able to lead a group.
(US) Client is a Midwest Manufacturer of Parenteral Pharmaceuticals Position: Supervisor - Environmental Microbiology Bench microbiologist, team leader, and supervisory position. Job Duties include: Performing and recording analyses as assigned on a daily basis; Adhering to cGMP’s in all work practices; Attending training sessions as appropriate; Assisting in maintaining a clean, safe workplace on a daily basis; Reviewing peer's work as needed; Reviewing revisions to procedures as needed; Submiting changes to SOPs as needed; Writing and disseminating technical data summaries and reports as needed; Contributing to CMC section reports; Researching and recommending purchase of capital equipment as needed; Purchasing laboratory supplies as needed; Coordinating sending samples and receiving data from contract laboratories as needed; Training other colleagues in methods and procedures; Ascertaining quality of final reported test results; Developing or validating microbiological assays as needed; Leading team by ensuring execution of work assignments by laboratory staff to meet QC cycle times; Routine work involvement and weekly meetings with environmental laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management (including QC department head); Coordinating with other leaders for assistance and closeout of work activities; Heightening the sensitivity within the laboratory to deviations, investigations and quality documentation and timely notification and closeout; Maintaining tracking metrics (GRT and Average QC Cycle Time) and coordinating data checking/review to assure timely closeout and reporting of final data to QA; Providing technical leadership through informal and formal training mechanisms. Required Skills Bachelors Degree in Microbiology or related science with 5-10 years of laboratory experience or Masters Degree in Microbiology or related science with 3-5 years of laboratory experience. Ability to communicate with internal customers and external clients. Ability to maintain records in accordance with cGMP including timely recording of information and review. Ability to respond promptly to changing priorities. Ability to determine when the results of an experiment are not acceptable and take appropriate action. Ability to recommend changes to test methods or laboratory procedures to reduce variability and/or improve efficiency. Experience with writing reports and submitting changes to existing procedures. Ability to interpret both specific Monographs and General Chapters of the USP/NF and Pharmacopoeial Forum. Experience with training others in laboratory procedures. The successful employee will have the ability to function in a microbiological laboratory environment. They should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude their working in a microbiological laboratory environment.
(US) Candidate will be located at Client's pharmaceutical non-union manufacturing facility located in the Midwest. Job Description: Production Manager Providing leadership to the manufacturing of quality pharmaceutical drug products to support both commercial and clinical needs at client's manufacturing facility. Communicating effectively and establish productive working relationships with Materials Mgmt, Quality Control & Quality Assurance. Working on complex problems involving intangible variables. Providing guidance/troubleshooting abilities on manufacturing issues. Providing leadership and management for direct reports: Commercial/Clinical Team Leaders, and Manufacturing Compliance Specialist. Participating in routine meetings: Site's Lead Team, Materials, plant site quality, production etc. Managing the production dept. in the areas of quality, efficiency, planning, customer service, training and employee development. Required Skills Minimum BS/BA in a scientific discipline with 7 years experience in a leadership role in a GMP manufacturing environment with a pharmaceutical company. Has a thorough understanding of the regulatory process from CMC section of the IND through to Commercial manufacturing. Experience in scale up, development and implementing a GMP compliance program in association with bringing a product through clinical trials to commercialization. Thorough understanding of aseptic process, preferably with parenteral drug products. Teacher level knowledge of Manufacturing Total Quality and GMP’s. Can quickly develop a working knowledge of the technology. Parenteral experience is essential. Experienced and capable planner and organizer. Strong written and oral communication skills.
(US) Client is a Midwest manufacturer of parenteral pharmaceuticals. Position: Associate Director, QA Tech Services and Compliance. Job Description: Working under the direction of the Director of Quality, the Associate Director, QA Technical Services and Compliance will be a key member of the Quality Assurance unit supporting clinical and commercial manufacturing. The position will provide Quality leadership to the function and company, and will provide direction to direct reports including the Manager of Validation and the Manager of Technical Services and Compliance. The Associate Director, QA Technical Services and Compliance will be the primary decision maker on matters impacting the QA Technical Services and Compliance function. Responsible for establishing policies and standards regarding validation, change control, internal auditing, investigations and customer complaints. Decisions impact the short- and long-term success of the function, project or program. Acts as the primary contact of the function, project or program internally and externally. Interacts with equivalent professionals concerning matters of significance to the company. Required Skills : Bachelor’s degree in the sciences (Chemistry, Biology, Engineering, etc) with a minimum of 10 years pharmaceutical industry experience in the area of Quality Assurance and Validation and a minimum of 5 years experience in sterile product manufacturing. Extensive knowledge of US and European Drug Product GMP requirements and associated guidance. Knowledge of industry standards for cleaning, process and equipment validation, GMP compliance and manufacturing practices. Experience in the management of Validation Projects. Experience in the qualification of facilities, utilities, equipment, processes and computer systems. Experience in the validation of aseptic /sterile processes, including a working knowledge of sterile products manufacturing and ancillary support equipment. Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations. Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Excellent verbal, project management and interpersonal skills, excellent analytical and decision making ability, good knowledge of regulatory environment. Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others.
(US-New Jersey) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Parsippany, NJ is looking for a Clinical Data Center Technician - B with the following qualifications: Responsible for delivering, receiving, logging and separating Case Report Forms. This could involve up to 25 studies per day with over 1000 forms. Other responsibilities include scanning CRF’s for all studies, validating the indexing for the images, clerical of data into clinical research databases, updates, updates of data in the clinical research databases and any other assignments as requested by management. 3-5 Years Experience Level. Must have Oracle Clinical experience. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position. Unfortunately, at this time we CANNOT work with third parties or relocate anyone.
(US-Georgia-Atlanta) Pharmaceutical Company has opportunity for MD with phase four study experience. Great opportunity for creative thinker to join smaller pharmaceutical company and develop this position. Marketing responsibilities. Paid relocation-base salary plus benefits- Not Big Pharma - great working environment. Interviewing now.
(US-California) Director of Marketing Dermatologic Pharmaceutical Company/ paid relocation, must have successful product launch and product marketing experience documented record of success, advanced degree, excellent presentation skills, creative thinker,team player,plastic and or derm pharma experience a plus. Generous salary,bonus all benefits-interviewing now for immediate consideration.
