http://www.newscientistjobs.com/jobsNew Scientist Jobshttp://www.newscientistjobs.com/jobs/job/senior-research-associate-philadelphia-pa-pa-pennsylvania-200631302.htmFri, 20 Nov 2009 22:08:16 +0000196398Senior Research Associate, Philadelphia, PA No relocation! For consideration, applicants must be located near the Philadelphia, PA area. Description: Under the direction of the Director of the Immunology Laboratory, to promote and coordinate the multiple aspects of the growing research program of immunology Laboratory. The job involves performing diverse and complex clinical research activities including, but not limited to, writing study protocols and other research related documents, maintaining IRB and GCRC approval of study protocols, creating and instituting quality assurance procedures, performing research quality bone age and bone mineral density determinations, data management and quantitative analysis, collaborating in developing innovative research and educational programs, writing manuscripts and grant proposals, coordinating activities in multi-center studies, and serving as an educational resource for the laboratory and the Institution. This position has the potential for the candidate to develop into an independent investigator. Qualifications: MD or Ph.D. or equivalent in Immunology or related field with 2 years of experience in pediatric stress/psychometric biomarkers. Previous experience in cell culture, Elisa and PCR preferred. Ability to function independently in a clinical research setting. Excellent writing skills. Excellent communication skills to interact with staff, parents and children. Ability to handle confidential materials. Ability to handle multiple, time dependent tasks. Excellent organizational skills. Ability to use computers, learn new software applications. Ability to manage data and perform quantitative analysis. Ability to write progress reports and scientific manuscripts. To apply please send your CV and three letters of recommendation to Wendy Rochlin by clicking Apply Now. http://www.newscientistjobs.com/jobs/job/clinical-trial-administrator-north-west-200645437.htmFri, 20 Nov 2009 15:20:51 +0000195519Clinical Trial Administrator A fantastic opportunity to work for a young, fast growing company based in the North West. They are now looking for someone to be office based in their offices for a fixed term contract of 1 year which is highly likely to role. Ideally you will have 6 months experience as a CTA but this is not essential, you may be a recent graduate who can demonstrate your knowledge of Clinical Trials and the CTA role. Ideally you may have Phase III Renel therapy area experience. Key Responsiblities: • To provide comprehensive support to the clinical team for the set up and administration of clinical trials ensuring adherence to protocols and quality of information received. • Facilitating submissions of NHS R&D/PCT and ethics committee applications ( e.g. copying and filing regulatory documents and providing administrative support) • The efficient and accurate administrative processing of forms concerning data collection, payments and other materials with regard to clinical trials. Activities are based on the guidelines as described in company SOPs • Set up and maintenance of the trial documentation files, study records and tracking systems including electronic documents in accordance with ICH GCP and the company SOPs in such a way that any relevant information can be presented promptly during internal or external audits. • Be an internal focal point for Clinical Team, ensuring appropriate dissemination of information to team members • Communicate with all relevant internal and external contacts on a professional level: provide adequate information, consult the appropriate persons in case of problems and make a positive contribution to the decision making process. • Co-ordination of investigator meetings and related activities • Co-ordination of Clinical Trial supplies, dispatch and tracking Key Words: Clinical Trial Administrator Entry Level Graduate North West Renal CTA Contract http://www.newscientistjobs.com/jobs/job/drug-safety-physician-hertfordshire-200643911.htmThu, 19 Nov 2009 13:59:55 +0000192481Our client based the Herfordshire area is looking for a Drug Safety Physician to join their team on a permanent position. Reporting to: Team Leader PV Operations Case Management Medical review of the serious and non serious case reports, Review of the narratives, coding, causality and expectedness assessment. Overall responsibility for preparing responses to the regulatory authority questions to safety issues on time. There are tight deadlines for reporting up to a maximum of 12 days. Our client use Oracle Adverse event reporting software and Excel. Periodic Safety Update Reports Medical review of PSURs and writing clinical expert statements Clinical Trials Provide safety input in clinical trial and bioequivalence study protocols. Attend protocol review committee meetings Signal Detection Provide medical input in the signal detection process Other key responsibilities Be responsible for co-ordinating and providing clinical assessment of products under labelling review and help with preparation or amendment of SPCs or PILs, responses to Health Authority questions and queries from the market place. Be responsible for supporting management of activities relating to clinical trials sponsored by the company (Safety plans / protocols review, etc) Liaise with the company international regulatory department, UK operations, affiliated companies and corporate drug safety office in the performance of these tasks; Undertake special Pharmacovigilance / Medical Information projects to support and enhance compliance relating to Pharmacovigilance activities. Help review literature articles relating to safety reports associated with company's products Be involved in departmental procedures and initiatives to improve process / efficiencies; and relay Pharmacovigilance / drug safety information in accordance with company procedures. The successful candidate will have a disciplined work approach proving a methodical and systematic personality. He/she will plan activities and organise time efficiently to meet project timelines. He/she will triage priorities from among a number of demands and be flexible in their approach. He/she will have excellent problem solving abilities - and have the ability to assimilate information and ideas from a wide source to make high quality decisions. He/she should be committed to achieving good quality work and striving to set higher standards and continually trying to achieve them. They will be keen to learn new skills. He/she will have excellent computer skills and proven proficiency in the required software. The Global Pharmacovigilance group of about 20 people integrate and work together as a finely tuned organism with each group member appreciated and valued as important as each other. The ability to work in this type of team requires a mature attitude to work and getting on with people. A solutions attitude is vital to interview success. http://www.newscientistjobs.com/jobs/job/clinical-trial-assistant-cta-uk-maidenhead-200643317.htmThu, 19 Nov 2009 13:37:17 +0000192410CLINICAL TRIAL ASSISTANT (CTA) - SUMMARY OF REQUEST Duration of Contract Start Date: Oct 2009 / ASAP End Date: July 2010 with 1 month notice Description of Role (Maternity Leave cover) Study Specifics: Phase I, II, III Therapeutic Area Urology/Neurology and Pain/EyeCare Full Time Equivalent (FTE) (specify percentage or number of days). 1 FTE = 5 days per week Intended Work Location: In house or Field Based (please note that there is a no working from home policy in place for in house staff). Key Requirements: Proactive not reactive: Able to work on own initiative/ Able to prioritise workload Competent skills in Office 2007, Impact, Electronic document management Experienced in study set up and close out Experience Requirements: High: expertise in study Set up and Close out/must be proactive Our Client's CTA ROLE SUMMARY CTA shall coordinate and perform study administrative activities across selected Clinical project(s). In addition CTA shall provide administrative/secretarial support to the EU Clinical Project Manager (CPM) or EU Senior Clinical Project Manager (sCPM) and other members of the clinical team. Primarily responsible for the co-ordination and tracking of clinical activities throughout a Clinical project such as critical document collection, patient recruitment, drug accountability and the clinical study report, also provides support to the CPM/sCPM in financial items such as invoice payment and forecasting of study budget. KEY DUTIES AND RESPONSIBILITIES It is the responsibility of the CTA to ensure the CPM/sCPM is adequately informed of the study progress and issues. CANDIDATE SELECTION COMPETENCIES SCALE Selection of the candidate will be based on 6 competencies and the 6 key competencies have been defined as follows: 1. CLINICAL PROJECT SUPPORT 2. GENERAL SECRETARIAL SUPPORT 3. DEPARTMENTAL SUPPORT 4. ESSENTIAL SKILLS 5. DESIRED MINIMUM KNOWLEDGE AND EXPERIENCE 6. TEAM FIT (applicable at interview stage) The candidate will be evaluated against the requirements of the 6 key competencies and this will determine if the candidate is successful or not at the CV review and or interview stage. 1. CLINICAL PROJECT SUPPORT ? To understand the relevant study specific protocol items, identify and bring to the attention of the CPM/sCPM study non-compliance that becomes apparent in the process of carrying out their duties ? To gain a full understanding of the relevant SOPs ? To set up and maintain clinical study files and facilitate the critical documentation process e.g. track information received in-house, send out relevant documentation to site/CRAs, identify documentation non-compliance and facilitate corrective action where necessary with consultation with the CPM/sCPM ? To coordinate and track patient recruitment accurately ? To facilitate the coordination of drug supplies/non-drug supplies to site ? To assist in the certain aspects of the generation of the Clinical Study Report e.g. some appendices, QC and raising potential issues with CPM/sCPM ? To set up and maintain applicable electronic files on ERA ? To organise the archive of the study documentation when the study is considered completed ? To develop and maintain good communication with study site personnel, external service providers and other team members both internal and external to our client ? To arrange conference/advisory/investigator meetings, including travel and accommodation in conjunction with the CPM/sCPM, as required ? To arrange CRA Monitoring meetings in conjunction with the CPM/sCPM ? To have an understanding of the payment / forecast / budget process which ensures accurate processing of study finances each month, if applicable 2. GENERAL SECRETARIAL SUPPORT ? To arrange travel, accommodation and team member diaries when required ? To assist with the preparation of presentations ? To provide appropriate handling of telephone calls and other communications for all study related personnel and non-study related personnel ? To edit and distribute Study Newsletters 3. DEPARTMENTAL SUPPORT ? To organise or assist in the development of training workshops if required ? Develop positive relationships across departments and functions ? Provide office telephone cover when required ? Attend departmental meetings when required 4. ESSENTIAL SKILLS ? Good verbal and written communication skills, including interpersonal skills ? Good coordination and organisational skills, including multi-tasking ? Excellent computer skills in key softwares e.g. Word, Excel, Powerpoint, email/outlook and the Internet ? Ability to work autonomously as well as a team ? Flexibility and ability to work under pressure and to timelines ? Ability to adapt to new processes 5. DESIRED MINIMUM KNOWLEDGE AND EXPERIENCE ? Experience of working within the Pharmaceutical or related Healthcare Industry, or a degree, nursing qualification or CTA Qualification ? Current awareness of appropriate EU Pharmaceutical legislation e.g. Clinical Trial and GCP Directives, ICH GCP guidelines or willingness to learn ? Knowledge of clinical trial processes and procedures ? Good secretarial experience ? Proven skills in word processing and spreadsheet database management ? Fluent in written and spoken English 6. TEAM FIT "clinical trial administrator" "CTA" "clinical" "ich-gcp" "cro" "pharmaceutic" http://www.newscientistjobs.com/jobs/job/drug-safety-specialist-middlesex-200643910.htmThu, 19 Nov 2009 12:45:29 +0000192319Our exciting and fast growing client based in the Middlesex area is looking for a Christmas Contractor to start from the 26th October with a view to extend in December. The Drug Safety Specialist will provide technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Key Accountabilities ?Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures ?Develop project specific safety database customization and data entry guidelines ?Triage of incoming reports for completeness, legibility and validity ?Initial data entry of case reports into safety database / tracking system ?Assessment of case reports for seriousness, causality and expectedness ?Requesting follow-up i.e. written, telephone ?Adverse event (AE) and drug coding ?Writing case narratives ?Case reconciliation - coordinating activities with Data Management personnel ?Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc ?Quality control of case reports, line listings and tabulations ?Maintaining local drug safety reporting requirements ?Regulatory authority reporting (electronic and hard copy) ?Literature reviews ?Ad hoc requests / queries ?Provide drug safety and project specific training ?Quality Assurance activities such as preparing for audits, development of templates, checklists and guidelines ?Create and maintain project specific working files, case report files and project central files ?Inform Medical & Drug Safety Managers of potential change-in-scope of projects. ?Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as: odrafting, writing and editing of protocols and CRFs ocollection and review of endpoint packages oreview and follow-up laboratory alerts ?Act as the Medical Monitoring Representative in project teams, as appropriate ?Participate in client meetings / investigator meetings/ project specific training sessions ?Delegate work as appropriate to Drug Safety Associates and Drug Safety Assistants Skills ?Sound knowledge of drug safety and the drug development process ?Knowledge of and ability to interpret and apply global safety regulations. ?Experience in data analysis and evaluation of safety data ?Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations ?Good presentation skills ?Excellent interpersonal skills ?Excellent verbal / written communication skills ?Good time management skills ?Team player ?Client focused approach to work ?Experience with computer applications including database management and pharmacovigilance related computing systems Education ?Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification ?Associates/diploma degree in any of the above with appropriate work experience http://www.newscientistjobs.com/jobs/job/manager-of-clinical-operations-budapest-hungary-hungary-200643016.htmThu, 19 Nov 2009 10:55:18 +0000191930An outstanding opportunity to join one of the worlds leading contract research organisations and be part of a dynamic and growing international company. Join PRA as a Manager of Clinical Operations based at our Budapest office, and help realise your career potential. Manager of Clinical Operations Location: Budapest, Hungary PRA International is a global leader in providing clinical research services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, PRA International works with leading pharmaceutical and biotechnology companies, performing clinical research trials on many of the most advanced experimental drugs, biologicals and medical devices in development today. For more information please see our website: http://www.prainternational.com Our expansion into Europe means the pace of work here is often fast and our people are challenged daily to maintain the highest standards of best practice. Nowhere more so than in our Clinical Operations function, where your brief will be to lead a team of specialists to deliver demanding clinical trials on time and on budget. Collaborating with colleagues throughout PRA International, you will focus on managing resources innovatively and effectively, sharing skills and knowledge between various projects when necessary. Developing your team is also key along with pro-actively promoting communication and the sharing of ideas across departments and offices across the globe. If you’re currently in a similar role or have Clinical Research experience, then this is a unique opportunity to give your ideas a global platform, expand your knowledge base with our cross-continent operations and, ultimately, grow your career with a growing organisation. Fluency in host language and English is required. Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale. To apply please visit https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=185&siteid=5199&AReq=7314BR&Codes=WLI to upload your CV. Please quote source reference code WNS on your covering letter. If you have any questions please email recruiteruk@praintl.com or call our recruitment department on +44 118 9181015. PRA is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace KEY WORDS: MANAGER OF CLINICAL OPERATIONS / TEAM LEAD / CLINICAL RESEARCH MANAGER / COUNTRY MANAGER / COM / CRM http://www.newscientistjobs.com/jobs/job/senior-medical-advisor-oncology-hertfordshire-pharmaceutical-company-hertfordshire-200643539.htmThu, 19 Nov 2009 10:14:26 +0000191838A great opportunity to join this global pharmaceutical company as a Senior Medical Advisor in the Oncology Franchise, based in Hertfordshire. Role: Senior Medical Advisor (ref 0502-1073-MA) Location: Hertfordshire Company: A health care company with a large product portfolio with an extensive pipeline across a range of therapeutic areas. After recently completing a global Phase III study, they are looking to expand the Medical Affairs team to meet the demands of bringing this new chemical compound to market. Summary: A great opportunity to work as a Senior Medical Advisor becoming the lead medic for the Oncology franchise. With previous medical affairs experience in the industry, you will work with a level of autonomy and independence, but also as part of a marketing team. Qualifications: • Medical degree. • Fully registered with the GMC. • A post graduate medical qualification. Eg MRCP or MRCP(psych) • Eligible for Higher Medical Training. • Candidate requirements: • Ideally at least 2 years Medical Affairs experience, gained in the pharmaceutical industry. • Oncology experience. • A high degree of commercial awareness. Responsibilities: • To provide expert strategic medical input to all relevant projects. • To assist the development of Scientific/Medical Advisory Boards to support current and potential new indications/products as allocated. • Approval of promotional and other materials in accordance with appropriate regulations. • A key contact with regards medical information enquiries and drug safety issues. • To provide medical training to staff in the Product Development Teams, Marketing/Sales and other relevant staff as required. • To maintain up-to-date knowledge of current treatments and trends relating to the indications approved and under development for areas for which the Senior Medical Advisor has responsibility. • To provide medical support, as required, to the Health Economics and Re imbursement functions. Benefits: • Remuneration on request. http://www.newscientistjobs.com/jobs/job/project-manager-clinical-trials-bolton-200643321.htmThu, 19 Nov 2009 09:34:29 +0000191645Summary This is an excellent opportunity for a Life Science Graduate who has gained some work experience in clinical trials and is looking to gain experience in a Project management team. This role will be offered on a 12 month contract basis. The Company Our client is a major, global pharmaceutical company who leads the field in the area of providing supply services to clinical trials. The Role This role, within the Project Management group is highly people oriented and offers full training within the area of clinical trials. Once trained you will act as a Project Co-ordinator gaining an in-depth understanding of clients’ clinical trial projects, co-coordinating the internal participating departments and external suppliers. Most importantly you will act as the client interface consulting on all aspects of the evolving study. Often working on global phase 3 trials with international pharmaceutical companies the services provided include trial management, packaging and logistics. For long running established trials you undertake many key activities including order processing from the investigational sites. All work is done to strict trial SOPs and regulatory GMP/GCP standards. Our client offers excellent training and future prospects. Skills in this area are greatly in demand. This role will be offered as a 12 month contract working directly for our client with full company benefits. Experience We are seeking a bright and enthusiastic individual with a life science degree and commercial experience in an clinical trial related discipline. Any experience gained in clinical trials, drug safety/pharmacovigilance, pharmacology, coding, data management or order processing would give you a suitable grounding. You will also need excellent communication skills and good computing expertise. PLEASE NOTE the above experience is essential with regard to the industrial placement / commercial experience. Also our client is not able to offer relocation assistance for this role so you will need to live locally or have local accommodation available. Keywords : Graduate Trainee, Graduate Opportunity, Clinical Supplies, Clinical Trial Supplies, CTS, IMP, Drug Safety, Pharmacovigilance, Pharmacology, Safety Data, Clinical Safety, GCC, Life Science Degree, Lancashire, Adverse Events, Serious Adverse Events, AE's, SAE's, Clinical Trials, CTA, Clinical Trial Coordinator, Clinical Trial Administrator SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions. http://www.newscientistjobs.com/jobs/job/statistician-clinical-trials-cro-surrey-reading-200642980.htmWed, 18 Nov 2009 18:03:56 +0000190074Statistician Clinical Trials CRO Surrey SAS A new opening has become available for an ambitious clinical statistician to join a reputable Clinical Research Organisation (CRO) in Surrey. This is a fantastic opportunity to utilise all your statistical expertise on projects ranging from small early phase I trials to larger phases across a variety of therapeutic areas. Working closely with the SAS Programming team, you will be responsible for providing statistical assistance on clinical studies including: study design, sample size calculations, patient randomization, statistical analyses, and interpretation of data and reporting of results. The ideal candidate will be educated to BSC/MSc level in statistics, biostatistics or related discipline. To succeed in this role it is essential that you have a strong SAS programming background with prior knowledge in applied statistics. You should be confident in your ability to translate client's needs into statistical practice and be able to educate clients in the use of statistics. This opportunity is ideal for a biostatistician/clinical statistician looking for that next step in their career. On offer to you is a very generous starting salary and company benefits package, along with the chance to develop a long term career. For more information on this role please call Kieron McDaid at Paramount recruitment on 0121 616 3462 KEYWORDS: Programmer, SAS, Statistician, Biostatistics, Statistics ,Bio-Statistics, Bio-Statistician Biostatistician, , Clinical research Organization, Clinical Research, Clinical Study, Pharmaceuticals, Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. http://www.newscientistjobs.com/jobs/job/clinical-trials-assistant-cta-cheshire-clinical-research-cheshire-200642942.htmWed, 18 Nov 2009 17:37:25 +0000190043Clinical Trials Assistant - CTA - Cheshire - Clinical Research Due to expansion a fantastic opportunity has arisen for a Clinical Trials Assistant (CTA) within an exciting pharmaceutical company based in Cheshire on a 12 month fixed term contract basis. As a CTA / Clinical Trials Assistant you will be expected to: * Support the team during the set up and administration of clinical trials. * Co-ordinate the dispatch and tracking of supplies. * Write, collate and distribute minutes for team meetings. * Track regulatory and ethical submissions. * Organise your workload to ensure priority work is dealt with first. The ideal candidate will have at least 6 months experience in a similar role preferably within phase III trials, as well as an awareness of ICH-GCP. You will need excellent organisational skills and the ability to work well under pressure. Previous experience of knowledge of the renal therapy area would be highly advantageous. This is a fantastic opportunity to gain some pharmaceutical experience that can act as a stepping stone to a career as a CRA / Clinical Research Associate. There is a strong possibility that this position may go permanent upon completion of the 12 month contract, at which point you would be entitled to a range of benefits to include a pension scheme and shares options. This is a great company to work for as they look to develop their staff and promote from within. For more information on the role and company please call Marie Tucker on 0121 616 3470. Keywords: Clinical Trial, Associate, Co-ordinator, Cheshire, Manchester, Warrington, Altrincham, CTA, Clinical Trial Associate, CRA, Pharmaceutical, North West Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities. http://www.newscientistjobs.com/jobs/job/clinical-trial-head-at-industry-leader-switzerland-basel-200642908.htmWed, 18 Nov 2009 17:14:34 +0000190002This client are not just looking for an excellent clinical professional, they are looking an excellent clinical professional with a real passion for leadership. You will be; - Accountable for clinical planning and management of the program from a day-to-day operational perspective - Function as the Intermediary between the GPT and Clinical to communicate clinical operation, updates, and data - Responsible for Clinical Trial Heads and Clinical Managers and in collaboration with operational supervisors, manage their performance - Operational manager of assigned POM to maximise contribution to GPT in collaboration with the Global Head Clinical Trial Resources. You will have: - At least eight years experience within pharmaceutical clinical research of which 5 years will have been in a management position. (this may include management in a matrix environment). - Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs. - Excellent interpersonal, problem-solving, negotiation and conflict resolution skills and full knowledge of resource planning and management Please contact me for further details. At RBW Consulting Ltd, every one of our consultants has the benefit of five years experience in helping Pharmaceutical Professionals find the jobs they are looking for in the industry. With unrivalled industry knowledge and excellent links with hiring managers in Biotechs, Pharmas and CROs throughout the UK, Europe and across the world, we would be delighted to speak with you about the role you are looking for. Call +44 (0)1293 584 300 or email howard.johnson@rbwconsulting.com for a confidential discussion about your options for progression. Keywords: Lead Clinical Trial Head, Clinical Trial Head, Clinical Research Associate, CRA, Clinical Research, Clinical Research Scientist, International Monitoring, Project Manager, Clinical Project Manager, Clinical Project Director, Director of Clinical Operations, Clinical Study Manager, Oncology, CNS, Junior Project Manager, Lead CRA, Pharma, Biotech, International, CRO http://www.newscientistjobs.com/jobs/job/pharmacovigilance-manager-berne-200642834.htmWed, 18 Nov 2009 16:21:35 +0000189915Requirements: Primary responsibilities: • Collection, registering, handling, analyzing for seriousness and expectedness, processing, narrative writing, and filing of AEs of the marketed products and the SAEs fo IMPs • Data entry using the Clientss safety database ArisG • Preparation of the correspondence, managing follow-up procedures of ADRs • ICSR Authority Reporting • Perform monthly ICSR metrics and regular quality checks of the ADR files • Reconciliation of the Authority databases (e.g. Italy, MHRA, CH, VAERS) • Contribution to the maintenance of the regulatory reporting responsibilities • Managing pharmacovigilance related literature and literature database (Reference Manager) • Support in PSUR and RMP preparation Minimum Qualifications: Your Profile: • Degree in medicine, pharmaceutical or biomedical sciences • Experience in the healthcare, clinical or bio-pharmaceutical field, or other related experience; direct experience in a pharmaceutical or biotechnology company, Drug / Product Safety Department preferred • Ability to analyse and interpret scientific data • Ability to interact with health care professionals, investigators and various internal customers • Proficiency in Microsoft Office – Word, Excel, PowerPoint, ideally Lotus Notes, skilled user of internet/intranet, knowledge in safety databases (e.g., ArisG) preferred • Attention to details • Good organizational skills knowledge of additional languages is an advantage • Self-dependent, systematic and structured approach to work • Precise and concentrated work attitude • Team player with good communications skills • Quick starter with a hands-on and can-do attitude • Flexible mind-set and ability to work in an international environment with sensitivity to multi-cultural/multi-location organization • Good understanding of business requirements http://www.newscientistjobs.com/jobs/job/clinical-development-medical-affairs-manager-berne-200642826.htmWed, 18 Nov 2009 16:17:42 +0000189908Objectives of the Position: • Development of new vaccines according to Target Data Sheet • To bring products (with a competitive profile) for the market in the shortest possible time and within the approved budget • Initiation and carrying out of Clinical Trials for registration purposes or enlargement of indication of licensed vaccines • Representation of Clinical Research in Project Team • Project specific medical and scientific representation of the company at authorities and OPL Service for registration and marketing department • Interface with registration and marketing departments • Active participation in the organizational development of the company Minimum Qualifications: • MD degree, possibly a university degree in pharmacy • Knowledge of GCP regulations • Proven experience in pharmaceutical product development within vaccines (ideally flu) and/or monoclonal antibodies or related fields • Proven success in handling projects Competences: • Excellent organisation, communication and problem solving abilities • Strong interpersonal skills http://www.newscientistjobs.com/jobs/job/clinical-trials-manager-republic-of-ireland-200642765.htmWed, 18 Nov 2009 15:56:59 +0000194314Clinical Trials Manager Our Client is a small R focused pharmaceutical company who are seeking to progress a drug candidate through to next stage clinical trials. The profile of the person that is sought is a dynamic, self-starter who will find working in a small company environment stimulating. The role, initially, is involved liaising with a CRO on a small clinical trial as well as personally performing monitoring of sites in the UK and Ireland. Additionally roles for a suitably qualified person will be internal project management. The candidate will have significant previous (5+ years) experience as a Clinical Research Associate, with previous documented experience of taking ownership of projects and progressing through to their conclusion. For Immediate Consideration Please Apply Online Now If you would like further information before applying please contact: Brian Christensen BA(Mod.)MedChem on +353 1 685 4747 http://www.newscientistjobs.com/jobs/job/claims-development-manager-nottingham-200642569.htmWed, 18 Nov 2009 11:45:30 +0000189563Few brands in the world of healthcare are as well know, well loved and well trusted as Boots. So with an incredible opportunity to build on this unrivalled reputation we’re making major investments into our own brand healthcare portfolio. Who we want: With an impressive background in pharmaceutical or consumer healthcare product development you’ll use your knowledge of phase 3 and 4 clinical research trials to help the business understand what we need to do to produce innovative consumer claims, which will put us one step ahead of our competitors. You’ll work alongside the Boots Brand Marketing and Insights team, helping them to understand which consumer needs are unfulfilled. Using your impressive technical knowledge you’ll then translate complex clinical data and insights, to help influence and shape key marketing claims and messages. Contributing to the design and implementation of clinical trials, you’ll demonstrate an acute awareness and innate understanding of product positioning in everything you do. You’ll also have the ability to translate your medical and clinical knowledge into clear and accessible consumer language, to ensure our customer messages are delivered with maximum impact, appeal and information. What we want from you: • Experience of working with Phase 3 and Phase 4 clinical trials • A significant amount of experience in product development gained within either pharmaceuticals or consumer healthcare • Rigorous analytical ability to enable you to interpret your findings • Excellent communication skills with the ability to deliver complex clinical and medical research in a clear and accessible way • Experience in other areas such as medical writing, pharmacy, relevant academic research may also be of benefit • Qualified to at least to degree level in a chemical or biological science What you'll get from us: We’re offering a competitive salary of between £45-55k, plus a generous benefits package that includes relocation and a company car=- scheme in addition to a company bonus scheme. There are many other additional benefits to enjoy including free gym membership, a considerable holiday allowance, staff discounts and offers on BUPA and dental care. How to apply: If you can bring insight, expertise and enthusiasm for driving healthcare at Boots into an exciting new era, then we’d be very happy to hear from you. Simply click the Apply Now button to send us your application. http://www.newscientistjobs.com/jobs/job/medical-science-liaison-dublin-republic-of-ireland-200642319.htmTue, 17 Nov 2009 21:36:08 +0000194346Medical Science Liaison (MSL) My client is a leading multinational pharmaceutical company with a strong base in Ireland. As part of a recent growth strategy implementation, an immediate requirement exists for a Medical Science Liaison Officer to join the dynamic and high-performance medical department, reporting directly to the medical director. Job Purpose: Build scientific partnerships with decision makers to build advocacy from Phase II clinical trials to launch of new product. Strategically prepare and support the development, launch and commercialization of drug products through medical information sharing, education of the scientific community and KOLs, clinical trial support, and by the scientific exchange seeking external insight to shape the company’s commercial and development programs. Key Activities • Contributes to mapping / profiling of KOL/decision makers in line with segmentation • Develop professional relationships, build advocacy and gain contributions of KOL/decision makers. • Attendance at Conferences. • Collect, analyze and report insights that may impact company development plans / trial designs. • Provide and discuss scientific information and data to healthcare professionals to ensure quality and accuracy of medical and scientific information on new treatment options including company products and selected areas of therapeutic interest. • Liaise and provide up-to-date medical support to relevant external groups to facilitate listing of products in medical guidelines, formularies to impact pricing and health-economic discussions. • Provide speaker training to health care professionals to support the best use of new therapies developed and commercialized by the company. • Contributes to the identification of appropriate clinical investigators and facilitates placement into company sponsored clinical trials. Contribution towards Advisory Boards and focus groups. • Support the investigational sites as needed, as part of a cross-functional team with Medical Director and others as appropriate. • Identifies clinical investigators with research proposals that are consistent with company product development strategies and facilitates the Investigator-Initiated Research Protocol (IIRP) process including study completion, presentation, and publication, as appropriate. • Supports the investigators to comply with the IIRP process in accordance with the guidelines and procedures, providing knowledge and guidance for GCP, legal and financial local regulations, as appropriate. • Collaborate with company colleagues to actively support medical and scientific meetings by collecting and interpreting insights / presentations / results, and evaluating impact of competitive information to share internally and externally as post-meeting deliverables. • Provide medical support and training (i.e. disease state and product) to company colleagues (e.g. sales reps, CRAs, etc…). • Screen business opportunities. • Assist Medical Director in PCC • Collaborate with Sales and Marketing teams and involved in Go to Launch meetings Education: PhD in Life Sciences with solid medical/technical background and proven competencies in influencing skills, clinical research insight, business and market knowledge 3-5 years minimum experience in a pharmaceutical environment, preferably in pharmaceutical sales, pharmacovigilance or clinical research. Experience/Professional requirement: • Demonstrated ability to develop and foster peer-to-peer, credible relationships with health care professionals • Sound knowledge of the Irish Healthcare System and of the research procedures as well as the ICH guidelines, GCP and other ethical guidelines relevant to the pharmaceutical industry. • Thorough knowledge of clinical medicine, disease management, and medical research • Scientific/medical research experience • Capacity as well as high interest to be continuously updated in his/her area of responsibility • Ability to provide scientific and medical support internally • Ability to synthesize recent scientific information, analyze them within strategic and regulatory settings. • Proven ability to use IT tools and interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information. • Strong personal integrity, and customer focus • Ongoing willingness to learn • Excellent interpersonal communication and presentation skills (including ability to network) • Capacity for interaction with multifunctional teams and teamwork • Demonstrated tact and ability to adapt time and means to best carry through the messages tailored to situation and customer. • Must be able to organize, prioritize, and work effectively in a constantly changing field-based environment, including moving scope from one TA to another related one FOR IMMMEDIATE CONSIDERATION PLEASE APPLY ONLINE NOW WITH CURRENT CV OR CONTACT EAMONN O’RAGHALLAIGH, TEL +353 1 6854848 http://www.newscientistjobs.com/jobs/job/senior-clinical-supplies-project-manager-bathgate-200642021.htmTue, 17 Nov 2009 15:34:24 +0000187828• Title: Senior Clinical Trial Supplies Project Manager • Location: Bathgate, Edinburgh • Salary: Depending on experience • Experience in Clinical Supplies (either with a Pharma company or a service company) is essential, covering an understanding of packaging materials and import / export processes for worldwide distribution of controlled substances Summary An excellent opportunity for an experienced CTS Project Manager, to join the industry leader in IMP supplies. You will take ownership of high-level, large-scale distribution projects. This is a senior role that includes budgeting and high-level corporate responsibility, including looking out for Business Development opportunities with existing (and new) clients. The Company The company leads the market in the provision of clinical trial supply services. They handle major contracts for various Pharmaceutical organisations and offer a broad CTS service that includes in-house packaging as well as distribution. The Role Based just outside of Edinburgh, you will take on a series of high-level projects related to clinical supply distribution. Ensuring the utmost adherence to all industry requirements, you will manage budgets, timescales and company demands, delegating work as necessary. This is a challenging, fun position with an excellent employer. You will not necessarily be responsible for directly managing a team but you will be expected to motivate and inspire the project teams through your own professionalism. Benefits In addition to a competitive salary, the package includes private health care, pension scheme, pension and career enhancing training. Experience The successful candidate must have a strong background in clinical supplies project management, or project-based experience in a related field (e.g. logistics, packaging / labelling), with a proven track record of handling several projects at once and seeing them through to completion. You will ideally have a Life Science background and good broad knowledge of the Pharmaceutical R&D process. We are seeking an ambitious individual who has first-rate communication skills, excellent time management and the desire to work in Edinburgh. Keywords Clinical Supplies, CTS, Pharmaceutical Distribution, Packaging, Manager, Operations Manager, cGMP, GDP, SOP, Labelling, Licence, IMP, Clinical Trial SLS Services Ltd operates & advertises as an Employment Agency for permanent positions and as an Employment Business for contract/temporary positions. http://www.newscientistjobs.com/jobs/job/pharmacovigilance-leader-switzerland-200641797.htmTue, 17 Nov 2009 13:22:55 +0000187623Our client is looking for a Pharmacovigilance Leader to join their team based in Switzerland/US. Job Purpose: Performs pharmacovigilance activities for all assigned projects or products including identifying and analysing safety signals based on a comprehensive evaluation of postmarketing data and Serious Adverse Events (SAEs) from clinical trials. Job Description: 1. Monitors the clinical safety of projects/products and responds appropriately 2. Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications. 3. Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools. 4. Provides input into responses to enquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues. 5. Provides pharmacovigilance input to initial development of basic prescribing information and is responsible for pharmacovigilance input into updates of this information. 6. Prepares medical input to aggregate clinical safety regulatory reports 7. Provides input to safety profiling and risk management plan 8. Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/expectedness assessment of adverse event reports. 9. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on drugs. 10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments. 11. Participates in review of clinical study protocols/reports/other regulatory documents as needed. 12. Provides relevant input for IPT, ICT, and CTT meetings as needed. 13. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities Minimum requirements : Experience/Professional: 3 years clinical experience postdoctoral requirement: At least 3 years in drug development in a major pharmaceutical company including 2 years in drug safety at an operational or medical position Proven ability to analyse, interpret, discuss, and represent safety information both in writing and orally. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information. Experience with (safety or others) issue management Required years of experience : Three - Five Years http://www.newscientistjobs.com/jobs/job/policies-processes-verification-manager-switzerland-200641790.htmTue, 17 Nov 2009 13:22:41 +0000187622Our renowned client based in Switzerland is looking for a Policies, Processes and Verification Manager to join their team on a permanent basis. Role; Responsible for the monitoring of inspection readiness and implementation of corrective actions in relation to external inspections and internal audits, developing metrics for and monitoring quality compliance, and input into process improvement initiatives 1. Support the management of the Corrective Actions and Preventative Actions (CAPA) compilation for DS&E 2. Responsible for monitoring of the implementation of the CAPA 3. Monitoring of inspection readiness, including quality and consistency measures 4. Establish and maintain quality metrics for global processes within PVO 5. Proactive management and implementation of new regulatory initiatives and guidelines 6. Maintain updated efficient and uniform processes and procedures (SOPs) to assure that worldwide regulatory reporting requirements for marketed and development compounds are met. 7. Ensure implementation of SOPs in CPOs and other sectors to support consistency in policies and processing of adverse event reports worldwide 8. Maintain working relationship with other group line functions, including EU QPPV, medical and marketing to ensure implementation of CAPA and fulfillment of the safety requirements 9. Provide guidance and assistance for DS & E in the requirement for adverse event reporting of marketed and investigational products, including guidance on post marketing study management 10. Manage or, provide expert input into, process improvement initiatives. Minimum requirements : ? Proven experience mainly in a Clinical Safety Department & closely related areas eg Clinical Development, GCP QA . ? Proven management experience in direct & indirect leadership roles ? Must have knowledge of global regulations for report of clinical safety. ? Experience and ability to work in matrix cross-functional environments. http://www.newscientistjobs.com/jobs/job/drug-safety-physician-hertfordshire-200641086.htmTue, 17 Nov 2009 11:26:54 +0000187381Our client based the Herfordshire area is looking for a Drug Safety Physician to join their team on a permanent position. Reporting to: Team Leader PV Operations Case Management Medical review of the serious and non serious case reports, Review of the narratives, coding, causality and expectedness assessment. Overall responsibility for preparing responses to the regulatory authority questions to safety issues on time. There are tight deadlines for reporting up to a maximum of 12 days. Our client use Oracle Adverse event reporting software and Excel. Periodic Safety Update Reports Medical review of PSURs and writing clinical expert statements Clinical Trials Provide safety input in clinical trial and bioequivalence study protocols. Attend protocol review committee meetings Signal Detection Provide medical input in the signal detection process Other key responsibilities Be responsible for co-ordinating and providing clinical assessment of products under labelling review and help with preparation or amendment of SPCs or PILs, responses to Health Authority questions and queries from the market place. Be responsible for supporting management of activities relating to clinical trials sponsored by the company (Safety plans / protocols review, etc) Liaise with the company international regulatory department, UK operations, affiliated companies and corporate drug safety office in the performance of these tasks; Undertake special Pharmacovigilance / Medical Information projects to support and enhance compliance relating to Pharmacovigilance activities. Help review literature articles relating to safety reports associated with company's products Be involved in departmental procedures and initiatives to improve process / efficiencies; and relay Pharmacovigilance / drug safety information in accordance with company procedures. The successful candidate will have a disciplined work approach proving a methodical and systematic personality. He/she will plan activities and organise time efficiently to meet project timelines. He/she will triage priorities from among a number of demands and be flexible in their approach. He/she will have excellent problem solving abilities - and have the ability to assimilate information and ideas from a wide source to make high quality decisions. He/she should be committed to achieving good quality work and striving to set higher standards and continually trying to achieve them. They will be keen to learn new skills. He/she will have excellent computer skills and proven proficiency in the required software. The Global Pharmacovigilance group of about 20 people integrate and work together as a finely tuned organism with each group member appreciated and valued as important as each other. The ability to work in this type of team requires a professional attitude to work and getting on with people. A solutions attitude is vital to interview success.