http://www.newscientistjobs.com/jobsNew Scientist Jobshttp://www.newscientistjobs.com/jobs/job/hot-job-associate-study-manager-switzerland-200644733.htmFri, 20 Nov 2009 14:15:26 +0000195232HOT JOB!!Want to take the next step in your career in Switzerland?Associate Clinical Research Specialist. My client is an innovative and enterprising global Medical technologies company who are well established and well respected within the industry. They are a successful solutions oriented company who are proud of their continued success. They are looking for a Clinical Research Specialist to join their growing team. This is a good opportunity for the right candidate to develop and gain experience within an international environment. Please contact me for more information on this role, Ludo Doche at l.doche@nonstop-pharma.com or by calling me directly on +44 (0)207 234 05 50 You will gain international experience as you will be working on several majors international studies. The successful candidate will be assisting in the design, planning and implementation of clinical studies and writing the clinical protocol, monitoring plans, preparing materials relative to the company's clinical operations, according to the regulatory standards. You will bridges the responsibilities of the Study Coordinator and the Senior Study Specialist. This is a permanent Associate Clinical Research Specialist role - so in the current economic situation it is an opportunity to be grabbed! The right candidate will bridges the responsibilities of the clinical Study coordinator and the Senior clinical Research specialist and focuses on study management activities. The ideal candidate for this role should have at least 3 year of post-university experiences both in monitoring and drafting documents relevant to clinical studies. He or she should have a good level of English as it is the corporate language. Other languages such as French will be a plus. Please contact me for more information on this role, Ludo Doche at l.doche@nonstop-pharma.com or by calling me directly on +44 (0) 207 940 21 12 http://www.newscientistjobs.com/jobs/job/drug-safety-signal-detection-risk-management-director-united-kingdom-200638495.htmThu, 12 Nov 2009 15:31:00 +0000180467Drug Safety - Signal Detection / Risk Management Director RBW Consulting is working closely with a highly regarded Pharma who, due to growth, have an excellent opportunity for an Evaluation and Risk Management professional to join an outstanding team. The successful candidate will be responsible for all drug safety evaluation and risk management work on a range of products. This includes safety signal detection, labelling, aggregate safety reports for regulatory agencies, signal work-up documents, risk management plans (in liaison with other departments), responses to regulatory safety enquiries and safety analyses for other submissions to regulatory agencies. Ideally, you should have a Masters / PhD, 3+ years Pharmacovigilance experience and already be recognised as a safety subject matter expert. For full details, contact Lloyd Dennis - lloyd.dennis@rbwconsulting.com http://www.newscientistjobs.com/jobs/job/career-opportunities-in-drug-safety-pharmacovigilance-uxbridge-200634059.htmMon, 09 Nov 2009 09:26:14 +0000173680New skills in Safety Uxbridge or Cambridge Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in their fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. Drug safety is a key part of the development and life cycle management of these medicines. Our European regional Safety team, based in the UK, has an important role in Amgen’s Global Safety organisation, focusing on the therapeutic safety needs of patients, healthcare professionals and regulators. We work with our innovative products within the legislative framework of a highly regulated industry and use specialist systems and professional expertise to understand and enhance product safety in support of optimum patient care. We have some exciting opportunities within our regional Safety team to work on a range of projects as we move into a very dynamic phase in the evolution of the Global Safety organisation. There are database, product-related and educational initiatives to suit the skill sets of the successful candidates. We need two enthusiastic, versatile, high-calibre individuals who have a real desire to apply their scientific background to explore a career in Safety. With a good degree in life sciences, pharmacy or another healthcare subject, ideally you will have some knowledge of the pharmaceutical industry, possibly gained while working in an area such as pre-clinical or clinical development, data management, QA/QC or product quality. Alternatively, you may be seeking a change of direction from a current academic or healthcare environment. You will also have good team working and organising abilities, diplomacy and interpersonal skills, as well as high proficiency in verbal and written communication. If you would like to join our business at this exciting time, then please apply online, attaching your covering letter, via the job posting ‘Safety Associates’, by clicking the Apply Now button below. Closing date: 27th November 2009. These two posts provide initial eleven month assignments. Candidates should be available for interviews during the week commencing 23rd November or 30th November. http://www.newscientistjobs.com/jobs/job/pharmacovigilance-physician-south-east-200633353.htmFri, 06 Nov 2009 16:00:52 +0000171550Pharmacovigilance Physician Type: Permanent Salary: Flexible depending on experience Location: Home counties Our client is a global company providing clients with expert advice at all stages of the drug development process. They offer a range of services including consulting, development, regulatory and pharmacovigilance management. The main purpose of the role is to provide pharmacovigilance expertise and advice on medical safety aspects of client projects. Main Duties * To ensure all post marketing pharmacovigilance work conducted or planned has adequate safeguards with regard to patient safety and is ethical. * To work with and on behalf of Project teams to overview and assess adverse events and adverse event patterns * To provide medical oversight of post marketing pharmacovigilance services. To assist in providing medical oversight in pre-approval and peri-approval pharmacovigilance services * To provide medical review and writing support (case narratives, PSURs, ASRs) * To represent the company at client meetings where medical/pharmacovigilance issues need to be discussed * To be the designated signatory, if appropriate, where this is required by a medically qualified person * To act as a QPPV/deputy QPPV on behalf of clients, if required * Where necessary to provide strategic input into clinical development programmes Requirements * Relevant Medical qualifications (to include at least one higher medical qualification), significant and recent direct medical experience * Expertise in pharmacovigilance processes and associated medical issues (minimum 5 years) including PSURs, literature search review and AE management * Knowledge of medical monitoring * Therapeutic knowledge to provide input into project design, proposal development and bid preparation in a range of therapeutic areas: * Computer literate/ effective use of available technology For more information or to apply please email peter@clinicalprofessionals.co.uk or call 0118 959 4990 Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs GMC We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/pharmacovigilance-physician-south-east-200632279.htmThu, 05 Nov 2009 16:00:59 +0000169102Pharmacovigilance Physician var addthis_pub="jobsiteuk";var addthis_options = 'print, favorites, facebook, myspace, twitter, linkedin, delicious, more'; Pharmacovigilance Physician Type: Permanent Salary: Flexible depending on experience Location: Home counties Our client is a global company providing clients with expert advice at all stages of the drug development process. They offer a range of services including consulting, development, regulatory and pharmacovigilance management. The main purpose of the role is to provide pharmacovigilance expertise and advice on medical safety aspects of client projects. Main Duties * To ensure all post marketing pharmacovigilance work conducted or planned has adequate safeguards with regard to patient safety and is ethical. * To work with and on behalf of Project teams to overview and assess adverse events and adverse event patterns * To provide medical oversight of post marketing pharmacovigilance services. To assist in providing medical oversight in pre-approval and peri-approval pharmacovigilance services * To provide medical review and writing support (case narratives, PSURs, ASRs) * To represent the company at client meetings where medical/pharmacovigilance issues need to be discussed * To be the designated signatory, if appropriate, where this is required by a medically qualified person * To act as a QPPV/deputy QPPV on behalf of clients, if required * Where necessary to provide strategic input into clinical development programmes Requirements * Relevant Medical qualifications (to include at least one higher medical qualification), significant and recent direct medical experience * Expertise in pharmacovigilance processes and associated medical issues (minimum 5 years) including PSURs, literature search review and AE management * Knowledge of medical monitoring * Therapeutic knowledge to provide input into project design, proposal development and bid preparation in a range of therapeutic areas: * Computer literate/ effective use of available technology For more information or to apply please email peter@clinicalprofessionals.co.uk or call 0118 959 4990 Key words: Periodic safety update reports safety signal detection clinical pharmaceutical biotechnology medical devices CRO clinical trials clinical development pharmacology health medical research drug safety pharmacovigilance adverse event reporting aris g Arisg PSUR adverse event case processing ADR data physician GMC QP narrative Argus SAE reconciliation safety PV DS PVG PVO SUSARs SARs GMC We are dedicated to the clinical research industry, offering candidates a unique service including our free \"Pipeline Watch\" career advisory consultation. To find out more call us on 0118 9594990 or email apply@clinicalprofessionals.co.uk http://www.newscientistjobs.com/jobs/job/assoc-dir-process-dev-mgmt-ca-california-200627235.htmMon, 02 Nov 2009 04:24:34 +0000162079Responsibilities The successful candidate will lead a group of scientists and engineers to develop and commercialize injection devices for Genentech's therapeutic proteins in conjunction with external partners.  Injection devices may include pens, auto-injectors and/or other delivery devices.  Major responsibilities will include technical oversight for all phases of design, industrialization, and commercialization of the delivery devices, including work conducted by external development partners and component suppliers.  He/she will provide guidance and input to project core teams and sub-teams in the area of device and combination product development, including integration with the full spectrum of drug development activities.  He/she will serve as key resource and provide input into Marketing, Operations, Development and Regulatory strategy for Combination Product projects.  This person will regularly interface with staff and leaders in Manufacturing Collaborations, Project Core Teams, Marketing, Early and Late Stage Pharmaceutical Development, Quality and Regulatory Affairs.  He/she will also regularly interact with external development partners and component suppliers.  He/she will also provide input to efforts to develop business processes for combination products. Job Requirements The ideal candidate will have a Ph.D. in Engineering, Pharmaceutical Sciences or the equivalent.  Experience in the Pharmaceutical or Medical Device industry is required, with at least 10 years of experience in device, combination product and/or pharmaceutical development. The candidate must have deep expertise in delivery device design, development, industrialization, and commercialization, combined with a broad knowledge of manufacturing, quality control, preclinical and clinical development, and regulatory issues pertaining to delivery devices and combination products. The candidate must have a proven track record of taking delivery devices and/or combination products from conception to successful implementation and commercialization. He/she must have experience managing groups of engineers and scientists.  A proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable. Excellent people management, communication, and influencing skills are required.  Experience in managing partnerships with external companies is also highly desirable. DIVISION:  Process Dev & New Manuf Facil REQUISITION NUMBER:  09-1000027514 (DEVICE DEVELOPMENT) http://www.newscientistjobs.com/jobs/job/research-scientist-senior-research-scientist-protein-sciences-united-kingdom-200624783.htmThu, 29 Oct 2009 13:37:43 +0000157077MedImmune, the global biologics unit of AstraZeneca, is committed to developing better medicines that help people live healthier, longer and more satisfying lives. The company is focused on the areas of infection, respiratory and inflammatory disease, oncology and neuroscience, with two marketed products and a robust pipeline of promising new product candidates. MedImmune’s state-of- the-art Cambridge site (formerly Cambridge Antibody Technology) is home to around 390 employees, and serves the company’s European hub for research and development. As part of the Protein Sciences team the individual will be responsible for cloning protein targets, expressing recombinant proteins in a variety of host cells and purifying the recombinant proteins. A particular focus of the role will be cloning, expression and purification of multi-spanning membrane proteins and their reconstitution into liposomes. You will have: Practical experience in modern molecular biology techniques and their application to the cloning and expression of proteins in prokaryotic and eukaryotic host cells. Practical experience of protein purification using current purification platforms and chromatographic techniques (e.g. AKTA) Practical experience of detergent solubilisation of membrane proteins and their purification and reconstitution into artificial lipid bilayers (e.g. liposomes, magnetic proteoliposomes). Up to date knowledge of developments in these technical areas (e.g. new platforms). Communicating with project teams to ensure project needs are discussed, understood and fulfilled and providing intellectual input into project strategy. Maintain scientific knowledge and best practice with respect to cloning, expression and purification of proteins with a particular focus on multispanning membrane proteins. Providing written reports of work as required and oral presentation of work to project teams. Recording and conducting work according to current codes of practice (e.g. lab book recording and health and safety legislation). Additional responsibilities would depend on the candidate but could be extended to biophysical characterisation of proteins and affinity determination for protein-protein interactions. Experience You will hold a PhD (or have equivalent industrial experience) in Molecular Biology, Protein Biochemistry or related discipline in addition to experience of working within an industrial environment. Evidence of working successfully in a project team. Knowledge/Skills Essential: Molecular biology (e.g. PCR, cloning), extraction of membrane proteins using detergents and their subsequent purification, reconstitution of membrane proteins into liposomes or other forms of lipid bilayers. Desirable: Protein analytical techniques, protein-protein interaction analysis. Behavioural Competencies Essential: Good communicator. Strong evidence of team working. Ability to work independently and accurately. Evidence of an interest in innovating. Ability to deliver to multiple assigned goals. Ability to communicate complex information to a non-specialist audience. http://www.newscientistjobs.com/jobs/job/lab-head-dmpk-switzerland-basel-200621533.htmTue, 27 Oct 2009 17:02:57 +0000171393Stelfox are looking for a DMPK Laboratory Head to work for a global pharmaceutical company. Based in Basel you will be working on cutting edge technologies in a "Lab of the future". You will: *Be providing isotopically labelled compounds to researchers *Manage a small team of tab associates *Develop and adapt new labelling methodology *Ensure safe working with radioactive compounds *Have a background in organic chemistry This is a great chance to take the next step in your pharmaceutical quality career. You will join a professional and determined team and be working on cutting edge technology. If have the skills and experience within pharmaceuticals for this opportunity and the ambition to take on this position, please call Steve for further details or email your CV today. Steve is a development recruitment expert at Stelfox Pharmaceutical recruitment covering the UK and Europe. http://www.newscientistjobs.com/jobs/job/scientist-dmpk-ca-california-200620795.htmMon, 26 Oct 2009 12:50:57 +0000150930Responsibilities: The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated individual with proven abilities who will be involved in the design, execution, supervision, and interpretation of nonclinical pharmacokinetic studies.  These studies will enable the selection of small molecule drug development candidates and provide assessment of their pharmacokinetic/ADME characteristics to support drug development.  The individual will be involved in the following activities as part of their role: -Representation of DMPK at interdisciplinary project teams Pharmacokinetic & pharmacodynamic data analysis and modeling -Report writing & IND and NDA filings Mentoring & supervision of staff -Set-up and validation of in vivo/in vitro ADME/PK models Requirements:  A PhD degree in pharmacokinetics, drug metabolism or other relevant fields.   5+ years of relevant pharmaceutical industry experience.  Experience with regulatory filings is required.  Good organization skills, teamwork, communication skills and flexibility are essential.         Desirable:  Familiarity with pharmacokinetic software such as WinNonLin, ADAPT, SAAMII, NONMEM and drug metabolism concepts.  Experience in supervision of staff. DIVISION:  Research REQUISITION NUMBER:  09-1000028171 Sci DMPK SME http://www.newscientistjobs.com/jobs/job/sap-business-process-manager-md-maryland-200620237.htmFri, 23 Oct 2009 19:11:04 +0000148710My company shares my passion for helping to improve human health around the world.” “This is My MedImmune.” Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world. Title: SAP Business Process Manager Location: MD, Gaithersburg - Corporate Headquarters Req: 01718 The Senior Manager, Business Process Improvement position within MedImmune is responsible for working in partnership with the business to assess and define business needs and business process improvements. This position will work with the business process owners to identify opportunities for continuous improvement that align with business strategies and objectives and ultimately increase efficiency, mitigate risks and improve overall operational effectiveness. The position will be responsible for partnering with the cross functional stakeholders to drive process improvement through exemplary process design/improvement/management skills using proven best practice techniques such as Lean Six Sigma or equivalent. Responsibilities include but are not limited to: Identifying, qualifying, selecting, structuring, and prioritizing process improvement projects that are aligned with overarching business goals. Providing hands-on team leadership and subject matter expertise. Driving the "As-is” and “Future State” analysis. Facilitating the development, assessment and implementation of key (business) performance measures (KPIs) Facilitating executive briefings, progress status reporting, definition of measures and the generation of new ideas for continuous improvement. This position primarily interacts with departmental managers both within the various business units and IT but may also be required to interact with senior leadership at MedImmune. The value this role brings to the MedImmune business and IT departments include: • Providing business process engineering and re-engineering expertise • Domain as well as technical expertise that allows for the identification of the client organizations strengths and weaknesses and helps them realize potential new approaches and technology enablers. • Working with the IT Business Partner to provide leadership for bringing people, process, and technology to the business • Enabling business strategy and objectives • Facilitating collaboration • Influencing business process improvements • Enabling business strategy and objectives • Facilitating collaboration • Influencing business process improvements • Enabling IT as an integral part of the business • Assuring bi-lateral communication between IT and our business partners • Encouraging innovative solutions to business problems • Promoting business effectiveness and efficiency while striving for innovation, flexibility and integration with technology. • Continually seeks opportunities to increase customer satisfaction and deepen client relationships Special Skills/Abilities: • Deep domain expertise in Finance • Extensive experience with SAP • Proven communication, facilitation, consulting and interpersonal skills. • Strong oral and written communication skills • The ability to mange effectively across all levels of the organization • Ability to work in a matrix organization • Ability to foster a collaborative and cross-functional team across distinct business units • Able to travel to other sites from two to five days per month as required • Ability and desire to help evolve and implement improved processes • Ability to understand the Customer’s business and how IT contributes to the delivery of that product or service • Ability to lead business process re-engineering sessions • Knowledge and performance in data analysis, process mapping, process analysis, process modeling, and facilitation techniques are essential. • Proficient with Word, Excel, MS Project, Visio and PowerPoint JOB REQUIREMENTS: Education: MBA a plus. Experience: 5 -10 years of experience in a managerial position or above related to specific functional areas of the business, with IT experience a plus. Experience in an FDA or government regulated industry preferred but not required. Experience in large-scale business transformation, business process reengineering or operational improvement projects. Six Sigma Certified Green or Black Belt is desirable Supervision: Must work with minimal supervision and guidance. May require occasional supervision of project/program teams and managers If you are interested in this position please click Apply Now below and search for Req #. 01718 MedImmune is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. http://www.newscientistjobs.com/jobs/job/senior-project-feasibility-associate-maidenhead-200619420.htmFri, 23 Oct 2009 12:53:32 +0000148537COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job Coordinate the delivery of the Global Site Services (GSS) component of assigned studies across a region or globally. Including overall accountability for delivery to time, cost and quality • Leading the drafting and finalization of Study Plans related to GSS activities • Responsible for directing day to day work flow of assigned GSS staff in the collection and review of investigator and regulatory documents • Oversee site start-up activities for studies in which GSS is working with customers: ensure compliance with timelines / milestones for site activation through planning & review of work with individual team members • Ensuring, through training and quality monitoring, that these documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor • May be responsible for line management of GSS personnel: mentoring, performance management: ensuring understanding of project specific and GSS policies • Works with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials • Provide Covance input into Drug Supplies coordination as applicable, including authoring Clinical Trial Supplies Plan (including liaison with external vendors and clients) and management of labeling requirements. About You: University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) with typically 4 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 6 years work experience in study start-up activities, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered. Preferred: • An understanding of aspects surrounding Covance business development (time and cost estimates, bid defense, contracts) • An understanding of relevant Covance procedures, including Standard Operating Procedures • Thorough knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; extensive experience of investigator start-up documents; interaction with operational project teams and investigative sites • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe • Excellent communication / writing skills • Ability to motivate self & others when working under pressure to meet deadlines • Demonstrated ability to delegate effectively, co-ordinate a team to achieve results • Detail and process oriented • Good organizational skills • Positive attitude and approach • Strong computer skills with an ability to understand, access and leverage technology alternatives • Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies • Ability to work independently We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us! Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/senior-associate-drug-safety-maidenhead-200618750.htmThu, 22 Oct 2009 14:37:00 +0000147129COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job • You will take the lead on projects • Regularly communicate with the client either by phone or by email • And case manage projects About You • Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry • You should have an ability to identify potential issues very early on and provide solutions • Typically have 2-5 years experience within Drug Safety • Work well under pressure • Within set timelines • Be organised • And have the ability to prioritse and adapt to changing situations with ease • Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety. Preferred: We Offer Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/manager-drug-safety-crawley-200618613.htmThu, 22 Oct 2009 13:29:23 +0000147091Covance is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner. About the Job * You will be managing a team of Associates * Working on Global projects * And contributing to the Quality aspects of the teams output About You * You should be working in a supervisory capacity in a Drug Safety environment * Have worked in safety surveillance and case management * And worked in a European or global environment What We Are Looking For * Someone with a proactive approach to what is happening in their department * Display leadership and coaching skills * And be able to communicate at all levels * Industry experience of which 4 years is relevant to drug safety knowledge. *Relevant experience includes experience in the pharmaceutical, biotechnology or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, Quality Assurance or Drug Safety. To be considered for this position, candidate must possess relevant experience specifically in safety/AE processing (minimum of 4 years of safety experience in both pre and post-marketing safety reporting) along with 1-2 years supervisory experience. We Offer Covance's ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. There is no better time to join us! Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. http://www.newscientistjobs.com/jobs/job/bioanalytical-development-scientist-biochemist-hplc-elisa-pharma-united-kingdom-200610936.htmTue, 20 Oct 2009 08:57:54 +0000145315Bioanalytical Development Scientist (Biochemist HPLC/ ELISA) c£25-30k South Ref: AF/015026 A fantastic opportunity for a bioanalytical development scientist (HPLC/ ELISA) to support the Process Development Department has arisen for a pharmaceutical organisation. The scientist will work in an expanding team, established to support the manufacture of medicines. The analytical methods used include SDS-PAGE, iso-electric focusing, HPLC methods, ELISAs and spectroscopic techniques; as well as other methods employed in pharmaceutical analysis, such as Karl Fischer and particle counting. The analytical capabilities of the team are expected to expand further. Job Responsibilities • To analyse samples, using appropriate methods, to the required standards, producing high quality data. To develop and validate analytical methods, as appropriate. • To ensure that equipment/instrumentation is calibrated and maintained and that laboratory records/documentation comply with GMPs. • Performs job responsibilities in compliance with cGMPs and all other regulatory agency requirements. • To be a member of project teams and to ensure the completion of tasks within agreed timeframes. • Presenting results in oral or written reports to the relevant supervisor and to produce technical documentation packages on projects under the guidance of the supervisor. • To work in compliance with company and regulatory requirements, and to ensure that client-confidential information is protected at all times. Qualifications, Skills and Experience: Life Sciences Background (Biochemistry/ Bioanalytical) Method validation and development using protein structure/function characterization techniques such as: SDS-PAGE, Iso-electric focusing, HPLC methods, ELISA’s, FTIR, Differential Scanning Calorimeter (DSC), Western Blot, Spectroscopic techniques and pharmaceutical techniques such as Karl Fischer and particle counting. To Apply If you would like to be considered for this role, please contact Alison Fisher at Hudson Shribman Scientific Recruitment, quoting reference AF/014824, outlining your particular skills and experience and their relevance to this post. Please call on 020 7421 5200, or reply via email, entering the job title and reference code in the subject field to alison.fisher@hs-scientific.co.uk For up to date career opportunities please visit www.hs-scientific.co.uk Due to a high volume of applicants only shortlisted candidates will be contacted. If you are not contacted within seven days of submitting your CV please assume that your application will not be taken further. If you wish to receive feedback to obtain why your application was unsuccessful please use the contact details provided on the advert. http://www.newscientistjobs.com/jobs/job/postdoctoral-research-opportunities-oh-ohio-200317788.htmTue, 29 Sep 2009 13:35:15 +0000124770Lerner Research Institute Postdoctoral Research Opportunities Postdoctoral fellowships and advanced postdoctoral positions (Research Associate and Project Scientist) are available in fundamental and translational research, including biomedical engineering, cancer biology, drug discovery and development, vascular cell biology, and molecular cardiology, immunology and transplantation research, molecular genetics, virology, neurosciences, pathobiology, structural biology, human genetics and genomic medicine. For a listing of positions available, visit: www.lerner.ccf.org/jobs/postdoc Visit: www.lerner.ccf.org/education for details about postdoctoral programs, career development programs, living in Cleveland and working at the Cleveland Clinic. Visit the Lerner Research Institute Education website at www.lerner.ccf.org/education for information about recruiting, postdoctoral support, career development programs, living in Cleveland and working at The Cleveland Clinic www.lerner.ccf.org. http://www.newscientistjobs.com/jobs/job/study-director-in-bioanalytical-services-yorkshire-200582004.htmTue, 29 Sep 2009 12:08:24 +0000124751As a Study Director you will ensure that the studies are carried out to the required standards and approve the study data. You will be the single point of study control and have overall responsibility for the scientific, technical and regulatory conduct of studies allocated to you, as well as for the interpretation, documentation and reporting of results. You will have the responsibility to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GxP) specified in the study plans, protocols, or work agreements governing the work in which they are involved. Examples of other responsibilities are: • To ensure that the study is performed in accordance with the study protocol and the Covance standard operating procedures. • To ensure that the study is performed to the required scientific and regulatory standards. • on time delivery targets (protocols, results, reports) Understands PBU process and financial/resource issues. Ensures all studies are costed and quoted. • To be aware at all times of study status and anticipate problems that may affect timing, quality etc taking appropriate action to resolve such problems • Ensure that all study communication is documented and maintained and carried out to meet client requirements • Demonstrates knowledge of customer requirements and plans accordingly (timelines, critical deadlines etc) • Provides client feedback to team • Produces study protocols and reports to meet client and regulatory requirements • Proactively manages client and study changes to meet timelines and ensure all additional costs are captured (workscopes) http://www.newscientistjobs.com/jobs/job/study-director-protein-chemistry-yorkshire-200581466.htmTue, 29 Sep 2009 09:24:24 +0000124693Act as Study Director on GLP and GMP studies where you will be the main point of contact for analysts, supervisors and clients, taking responsibility for ensuring studies meet regulatory and Client requirements. Examples of other responsibilities are: • To ensure efficient development and implementation of client-specific study methods within the Protein Chemistry group. • To ensure day-to-day monitoring and supervision of analyst’s work and ensuring procedures are regulatory and scientifically sound and meet Client deadlines. • To provide supervisory and operational support necessary for the performance of a wide variety of studies and experimental procedures. • To be responsible for the day to day performance of routine assays in Protein Chemistry, particularly with respect to regulatory requirements, trouble shooting, scheduling, method development and validations. • Take responsibility for the technical and practical aspects of designated projects. • As required, provide appropriate technical training for Protein Chemistry staff to develop their skills and the group knowledge base. • Work with senior analysts in taking responsibility for technical aspects of projects undertaken within the group, maintain track of team activity and strive to keep projects on schedule. http://www.newscientistjobs.com/jobs/job/postdoctoral-opportunities-ny-new-york-200406942.htmMon, 22 Jun 2009 14:38:55 +000040043POSTDOCTORAL OPPORTUNITIES The Wadsworth Center of the New York State Department of Health, with basic and applied research programs in the biomedical and environmental sciences, provides a unique and dynamic postdoctoral training experience. Enhancing this environment are state-of-the-art core facilities; broad-based graduate programs with the University of Albany, State University of New York; and new initiatives in bioinformatics; genomics, nanobiotechnology, and biodefense. Position are available in the following ares: - Atmospheric Chemistry - Biodefense - Biomarkers/Nutrition - Cancer Biology/Chemotherapy - Carcinogenesis - Cell Biology/Mitosis - DNA Repair/NMR - Drug Metabolism/Resistaneces - Gene Expression/Regulation - Immunology - Infectious Disease - Medial Entemology - Microbial Genetics/Pathogenesis - Mobile Genetic Elements - Neuroscience/Disease - Stem Cell Biology - Structural Biology - Toxicology/Neurotoxicology For additional information, go to View Contact Details below. To apply online please click the Apply Now button below.