(US-Connecticut) Our client, a major pharmaceutical company in New London, CT is looking for a Portfolio Specialist with the following qualifications: Summary Description: Support in the management of the Family Hub portfolio of projects, specifically the associated cost and resource information. This role also supports the Line Portfolio Director, Site heads and business leads (ITBM/Ls) in handling family hub-specific operational issues. Responsibilities: * Coordinate monthly updates to financial forecasts by project for presentation at the project, program, and strategy level. Summaries to be provided to Senior Mgmt and Finance * Maintain resource administration and cost data within the family hub. * Single Point of Contact for requisition process - MSP and Non-MSP. * Ensure accurate project coding to allow for accurate project reporting * Facilitate family hub program reviews and milestone updates. * Support annual budget preparation process. * Liaison to Family Portfolio Management team, Finance, Procurement, and Human Resources Key activities include: * Maintaining HUB census information and reporting of family hub resource allocation * Coordination of contract resource information, primarily through establishment and monitoring of Purchase Orders * Invoice processing * Partnering with global Finance representatives to provide the appropriate project accrual information at month-end, resulting in the distribution of financial reports and analysis to Hub managers. * Coordination of standard business practices for procurement and project management * Maintain local procedures in adherence with global policy * Assist in reporting of performance metrics to business customers and site management * Maintain link to Total Cost of Ownership model Qualifications: 3-5 years progressive experience in process improvement, business management, and operations coordination within the pharmaceutical industry. Proficient with Microsoft Office applications, particularly Excel and Powerpoint. Organized and detail oriented with excellent communications skills. Ability to work independently with minimum direction and interact with personnel at all levels of the organization. Key Behaviors: * Demonstrated technical knowledge and skill * Ensures quality in deliverables and implements continuous improvement * Demonstrated understanding of the organization and drug development process * Proactively meets client needs * Initiates change and takes action before a problem develops * Challenges underlying assumptions with goal of improvement * Identifies and addresses own development needs * Recognized as a resource for internal and external information * Ability to break down complex projects into manageable tasks * Balances need for planning with need for action * Helps others solve problems 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 County, 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. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. BS Preferred. 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-Maryland-Montgomery County) Qualified and enthusiastic software development applicants are sought to support our rapidly expanding proteomics / bioinformatics research and development activities. Job responsibilities include the development of perl scripts for proteomics data manipulation and implementation of complex SQL database searches. The ideal candidate will also be interested in becoming proficient in specific scientific programming environments such as MatLab, and be familiar with basic IT infrastructure support issues. 2+ years (or equivalent proficiency) in Perl, CGI, and SQL database programming are required. Java and MySQL experience are also desirable. Prior experience in bioinformatics is not required.
(US-New Jersey) Our client, a major pharmaceutical company in Morris Plains, NJ is looking for a Unix Technical Support candidate with the following qualifications: Must be very process and project oriented with excellent communication and documentation skills. Individual must have advanced Solaris administration skills with strong knowledge of 3rd party products, including Veritas VxVM, VxFS,VCS and Legato. All candidates must be proficient in Legato. Must have experience on SunFire enterprise systems. Must be able to provide and follow technical documentations and Standard Operations Procedures for assigned tasks. Working experience using IQ/OQ procedures is a plus. Knowledge of SAN storage infrastructure is a plus but not required. All candidates must have excellent process oriented skills. Must have excellent communication skills as they will be meeting and interacting with senior managers and clients. The ideal candidate will have experience with IQ/OQ in the pharmaceutical industry. 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-California-Ventura County) As the largest biotechnology company on the planet, Amgen offers the chance to truly innovate and contribute to the big picture in science. Our R&D focus on nephrology, oncology, inflammation and bone disease, and neurology has already produced six marketed products with a promising pipeline of new human therapeutics to come. A world-class sales force, global manufacturing operations, and clinical development sites on three continents complete our picture as a Fortune 500 company and a leading biotechnology company committed to improving people's lives. And Amgen continues to grow with our successes. We currently have the following opportunity at our Thousand Oaks, CA facility. GLP Compliance Advisor III Requirements: A minimum of four (4) years of experience in a regulated environment is required along with 2 years of related computer system validation and/or quality assurance experience. The candidate must be able to routinely handle multiple tasks and be timeline driven. The candidate will possess the ability to work independently and within teams; strong written, oral, and organizational skills; and excellent attention to detail. The candidate should also possess detailed knowledge of the software development life cycle, 21 CFR Part 11, and IT processes. A working knowledge of the GLP regulations and preclinical development processes are preferred. Candidates should possess an undergraduate degree in the physical or computer sciences. Job Summary: Provide GLP quality assurance oversight, with emphasis in the area of computerized system validation and electronic record handling. Communicate the compliance requirements associated with computer systems and electronic records and signatures to appropriate management and client departments. Conduct inspections and audits to assure management that associated documentation is accurate, and complete; follows approved methodology and protocols, and adheres to all applicable SOPs and regulatory requirements. Perform process and facility inspections to assure management that electronic record handling and security measures are adequate to assure compliance with GLP regulatory requirements; and assess other activities such as system acquisition, vendor assessment, change control, and system retirement for proper documentation and adherence to approved methodologies, SOPs, and applicable regulations. Prepare written reports of inspection observations, review of corrective actions and provide Quality Assurance Statements for systems assessed. As assigned by management, assist in the evaluation and monitoring of contract laboratories in support of GLP studies to ensure compliance with Good Laboratory (GLP) regulations. Minimal travel (20%) may be required. Amgen’s outstanding compensation package features comprehensive benefits and relocation assistance. Come be a part of the big picture at Amgen.
(US) Do you have 5-10 years of Clinical Development experience in a CRO or biopharmaceutical company? Do you have a PharmD or a Phd? Have you experience in the therapeutic area of Neuroscience? If so - Read on. An opportunity exists to join a rapidly expanding, financially stable company . Your track record of success in leading clinical programs will now provide you with the opportunity to develop and implement early clinical development programs to include the clinical pharmacology component. Your experience will allow you to manage this early clinical stage product through the clinical/regulatory process and into approval. You will be the recognized expert in all clinical pharmacology issues/questions. Your qualifications must be a PhD / PharmD with significant experience in a clinical pharmacology related discipline. Global project management experience is a must as well as budgetary/financial responsibilities. A track record of leading a pharmaceutical development is a necessity.
(US) A well capitalized biotechnology company in New England is currently recruiting a Medical Director. Job Description: Design and write clinical trial protocols and development plans. Hire, train and manage staff to monitor clinical trials. Negotiate and manage vendors/third parties within the clinical trials and development process. Education/Experience: MD with board certification - Oncology experience preferred. Excellent communication skills. 2+ years pharmaceutical/biotechnology/CRO experience.
(US-Massachusetts-Boston) The Biostatistician will be a statistical resource for the clinical trials related sectors of the company. Responsibilities Include: Analysis of data from Phase 2 and Phase 3 clinical trials. Collaboration and statistical consultation with clinical operations personnel as well as QA and Regulatory Affairs. Development of statistical analysis plan and protocol statistical methods sections for clinical studies. Design, develop and implement various analysis protocols. Use the various statistical methods to analyze data to support clinical filings including: Kaplan – Meier, logistic regressions, Fisher’s Exact, and categorical data analysis.Job Requirements: MS in Biostatistics 2-3 years experience in a Pharmaceutical / Biologics environment including experience working with Phase 2 & Phase 3 Clinical trial data . Experience in developing and implementing statistical analysis plans. Excellent oral and written communication skills. Demonstrated expertise in SAS programming.
(US-Massachusetts-Boston) The Clinical Data Manager will ensure high quality data for timely clinical trial analysis and reporting. Will be responsible for all clinical data management (in-house/CRO).Responsibilities Include: Draft/update SOPs for the assurance of quality of clinical data Provide input into protocol designs Draft / review clinical data management plans and specifications for clinical studies Design databases and annotate CRFs Design / review CRFs (eCRFs) Design / review Query Plans for clinical data and review data for inconsistencies Collaborate with Clinical Operations to assure the integrity of data flow Collaborate with QA to design and implement data audit procedures Manage CROs conducting data management activities Create / maintain study documentation including data locks and archiving of dataJob Requirements: Five years of clinical data management experience for a Pharm/Biotech/CRO including use of coding dictionaries, CRF design (eCRF desirable), database design. Knowledge of GCP/ICH guidelines. SAS and Oracle clinical experience is desirable. CRO management experience a plus. BA/BS in Life Science, Nursing or related discipline.
(US-Massachusetts-Boston) The Director of Biostatistics and Data Management will oversee all corporate biostatistics and clinical data management activities. Provide statistical input on the design of clinical trials, selection of clinical endpoints, and sample size requirements.Responsibilities Include: Develop statistical analysis plans, perform statistical analyses and manage outsourcing of statistical analyses and clinical data. Work in accordance with all internal and external regulatory bodies including ICH and Biopure SOP’s. Collaborate with clinical researchers in the design of clinical trial selection of clinical endpoints, sample size requirements, protocol development, and case report form design. Develop detailed statistical analysis plans and supervise the development of analysis plans by outside contractors. Manage outsourcing of statistical analysis and reporting of clinical trial data. Manage outsourcing of clinical data management, including coordination of clinical database design requirements, implementation of coding dictionaries, and development of quality control and audit plans. Perform statistical analyses and write statistical reports. Coordinate the integration of clinical trial databases to support creation of integrated summaries of safety and efficiency. Review and approve all clinical trial protocols, case report forms, and final reports. Develop, review, and approve, as needed, SOP’s related to statistics and clinical data management. Represent the company to FDA on matters involving clinical trial design, endpoint selection, sample size requirements, and analysis and interpretation of clinical trial data. Install and maintain statistical software as needed. Job Requirements: Requires an advanced degree in Biostatistics related field or equivalent plus eight or more years of clinical trial biostatistical experience. Also must have experience in management of clinical statistical contractors and experience with clinical protocol design, statistical planning, and NDA statistical sections. The ability to ensure and adhere to budgets, schedules and performance standards. Must possess excellent communication skills in order to regularly interact with both senior level managers and lead line staff. Must possess good oral and written communication skills and should exercise tact and diplomacy in sensitive situations. Must be able to direct and control several functional areas and or initiatives concurrently. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
(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 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. BS/MS Preferred. We need someone to "jump in" and help us over the next 3 months with start-up activities for a new trial. This will include writing a protocol, planning and organizing an investigator meeting, working with a CRO for site selection and pre-qual visits, and working with various outside vendors for additional services. 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 County, IL is looking for a Clinical Statistician II - A with the following qualifications: REQUIRES 0-3 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 Preferred (PHD). **MS in statistics or biostatistics required. 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-Connecticut) Our client, a major pharmaceutical company in New London, CT is looking for a Validation Specialist with the following qualifications: Candidates shall have 3-5 years experience in software validation and testing, and shall be responsible for developing and running User Acceptance Test scripts manually and automatically for a complicate application for global pharmacy operations at client site. Candidates shall be detail oriented and will conduct tedious tasks on a daily basis. Oracle testing experience and CFR 21 Part 11 knowledge are required. 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-New Jersey) Our client, a major pharmaceutical company in Parsippany, NJ is looking for a Application Support/Help Desk Analyst with the following qualifications: The first part of the project, the contractor will be working on Peregrine Service Center Change Management and Configuration Management deployment project. They will be a member of the application project team responsible for documentation (FAQ, HOW To’s, and Troubleshooting), L2 application support, perform application training for other users, Application testing (Q/A) and general project support. The candidate may also work to support other functional teams as Change Management, Incident Management, and/or Configuration Management Analysts. The initial project is approx. 3 months. After the completion of this project the contractors may be extended and will work on the helpdesk or within the IT Operations area. Knowledge of Peregrine and IT Change, Incident, Helpdesk, and Configuration Management processes are preferred. Requirements Notes: Business/Professional Skills: * All candidates must have one year of 2nd level call center environment experience. * Heavy user interaction experience with strong customer service skills is required. * Experience supporting Account Administrators is a plus. * Requires knowledge of IT operations, workflow processes and procedures to resolve inquiries independently. * Proven ability to follow SOPs and provide positive feedback for continuous process refinement. * Proven ability to use good judgment for escalation instances. * Strong troubleshooting (password log in issues, network connectivity.) * Strong analytical and communication skills and ability to work efficiently and effectively with clients, co-workers and other infrastructure systems staff. Technical Skills: * Experience with Microsoft Windows NT 4.0 Server, Microsoft Windows 2000 Server and Exchange 5.5 account management. * Experience with file shares, user profiles, groups, permissions and Windows NT and Active Directory domains. * Experience with Microsoft Office Applications: Word, Excel, Access and PowerPoint. * Experience with a wide assortment of business applications. * Experience with any Help Desk call tracking application. * Ability to type 45 wpm. This position requires 1st and 2nd level call center helpdesk experience. The first part of the project, the contractor will be working on Peregrine system. They will be responsible for application support of this product including enhancement, adding new funtions and provide training to other helpdesk analysts. The initial project is approx. 3 months. After the completion of this project the contractors may be extended and will work on the helpdesk. Knowledge of Peregrine or other Help Desk tracking software is required. Project documentation/writing is required. 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.
(France-Champagne / Ardenne) We are seeking a young motivated candidate to work on the chemoenzymatic synthesis of arabinose-based glycoconjugates. This work will include characterization of the enzymatic catalyst and the organic synthesis of modified pentose sugars. A PhD in enzymology or organic chemistry (if chemo-enzymatic methods were used). Preferably, the candidate will already have experience in chemo-enzymatic synthesis and enzymatic reactions in non-conventional media. The candidate should also have working knowledge of analytical methods such as HPLC and knowledge of NMR techniques would be a bonus. The candidate should be independently-minded and capable of autonomous research in a multidisciplinary environment. Candidates who have no knowledge of French (this is preferable) should have a high standard of both spoken and written English.
(Singapore) Job Description 1) Manages the regulatory affairs of current business sectors and new upcoming sectors in line with corporate directions. 2) Responsible for department supervisory, issues management, establishing and maintaining regulatory networking internally and externally and preparing the Company on planned / upcoming regulations to ensure business objectives are met. 3) Ensure submissions for product registrations are carried out in a timely manner in compliance with internal and external regulatory requirements. 4) Establishes and mantains reasonable and responsible regulatory climates locally through networking. 5) Develops, maintains and improves technical knowledge and skills of local DRA & CRA personnel. 6) Continuously acquires updated technical knowledge through training. 7) Principle Poisons Licence Holder and Controlled Drugs Licence Holder for the Company. 8) Supports marketing in providing medical information to the local medical/paramedical fraternity. 9) Performs rudimentary CS&E functions for marketed products and Phase IV trials Requirements Degree in Pharmacy Registered Pharmacist with the Singapore Pharmacy Board At least 5yrs of relevant experience *Candidates MUST be physically in Singapore.
(Singapore) Our client, a subsidiary of a leading Japanese Contract Research Organisation is currently seeking suitable candidate to fill the above position. Requirements Degree in Pharmacy / Nursing / Bioscience At least 5years clinical trial experience, of which 3years experience in managing trials, or project management experience Familiar with ICH-GCP and SGGCP guidelines Exposure to international clinical trials preferred Regulatory affairs experience advantageous Travelling is required.
(Singapore) Our client, world-class supplier of process engineering and automation solutions to the food, beverage, pharmaceutical and healthcare industries. From the supply of engineered components through to a complete process plant equipped with latest automation technology, they specialise in helping thier customers to improve their plants' performance and profitability. Excellent design principles are used to ensure maximum operational efficiency ... is currently seeking suitable candidates to fill the positions: Validation Consultant/Specialists/Engineers Minimum Requirements: - Minimum of 6 years of combined experience in validation or information services roles in a Pharmaceutical or related FDA industry and minimum of 2 years of experience in each area (validation, IS). - Excellent verbal and written communication skills, proven problem solving skills, excellent organizational skills and a strong knowledge of CFRs and FDA GCP and GMP guidance, CGA and EMEA regulations, and ISPE Good Automated Manufacturing Practice guidance. - Working knowledge of cGMP's and 21 CFR part11. - Project experience in ERP, LIMS or MES - Bachelor's Degree Engineering, Life Sciences, Computer Science, Information Systems, or other related scientific or technical discipline. Functional Responsibility: - Provide high-level Validation Compliance consulting to clients. Assignments include supporting clients in development of Validation Programs, Procedures, Validation Master Plans, protocols and summary reports. - Provide high-level Validation Compliance consulting including tasks such as: Create/revise Validation Policies and Programs. Create/revise Validation Master Plans. Develop documentation for Validation of facilities, utility systems, computer-related systems, and process equipment. - Preparation of system specifications and qualification test protocols. - Development of standard operating procedures (SOPs). On-site testing; data analysis; and preparation of final reports. - Perform cGMP and validation compliance audits. - Act as main client interface and supply recommendations for corrective actions when deviations are observed.
(Singapore) This research position shall be filled by a scientist who has previous experience and continued interest in dissecting the molecular basis of viral replication and infection. Preferred candidate will have previous experience with coronaviruses and have an interest in studying the SARS coronavirus, but molecular virologists with other interests are encouraged to apply. You should have a Ph.D. and at least 5 years’ post-doctoral experience in molecular virology. You will be expected to initiate new lines of research in characterization of the SARS virus and the host cells response to infection. This position will complement the ongoing research activities at the institute on host responses to infection by hepatitis virus and cytomegalovirus.
(Singapore) Our client is the national flagship initiative in the genomic sciences for Singapore as the country seeks to be an international center for the biomedical sciences and its relevant industrial research and development. In this research institute, the major technical platforms of high throughput sequencing, genotyping, cDNA library production, bioinformatics, proteomics and expression array technologies have been established and programs in stem cell biology, molecular pharmacology, cancer biology, comparative genomics, computational biology and population genetics have begun. BIOINFORMATICS SCIENTIST Senior level Bioinformatics Scientists are needed who will identify, design, develop and apply advanced computational analyses to biological research throughout the institute. Successful candidates will work closely with investigators in the Biological Investigations, Disease Gene Discovery, Gene Expression Microarrays, and Population Genetics groups. Outstanding candidates will have a Ph.D. and extensive training in bioinformatics, computational biology, mathematical sciences, or a related field. A research background in molecular or cell biology is advantageous. You must be able to work in a fast-paced and dynamic environment. Previous experience in managing bioinformatics scientists and projects is required. We are seeking candidates with expertise in one or more of the following areas: Protein database analysis; Mathematical modelling of protein and gene functions; Statistical analysis and modelling applied to genomic data; Advanced transcript sequence analysis.
