http://www.HalloLondon.co.uk/ en-GB Here is the main description Thu, 29 Mar 2007 18:18:00 GMT 240 58 http://www.hallolondon.co.uk http://www.hallolondon.co.uk/gfx/logo_bw.gif Job duration: 6 Months+ Start date: Negotiable Description: CONTRACT: Senior Statistical Programmer 6Months+ £45 - £55 P/H **HOME BASED** Your Accountabilities/Responsibilities: * Provide output for the Clinical Study Report, the Integrated Summary of Safety (ISS), the Integrated Summary of Efficacy (ISE) and electronic submissions. * You will work with biostatisticians and programmers based also in other sites globally. * This position will require a significant training investment for the use of client specific processes / procedures in particular, SAS macros, creation of analysis data sets and dataset structures. Need for ensuring standardization of programs where applicable. * Apply knowledge of clinical data, the design and phases of clinical trials, statistics, relevant regulations and the pharmaceutical industry to the implementation of tasks. * Handle complex statistical programming issues independently and be familiar with study programming issues. Bring ideasfor new projects and take the initiative to solve issues. Your Essential Skills & Capabilities: At least 4 years Statistical SAS programming experience with prior experience in pharmaceutical related field is required. Working knowledge of clinical legislation (FDA, EMEA), Good Clinical Practice (GCP) and Clinical Data Interchange Standards Consortium (CDISC) is a plus. * SAS expert * Ability to evaluate processes and situations in an orderly and rational manner asking questions and identifying missing information. * Must be able to determine relationships between different parts of a problem and identify appropriatesolutions. * Accurately and efficiently work towards quality results Any home based applicants must have at least 7-8 yearsminimum experience with a solid background in continuous long term positions. For further details or a confidential conversation please contact me directly: Russell Gillam +44 (0) 207 255 6665 russell.gillam@secpharma.com Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: £45 - £55 per hour Job type: Contract Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician Job Reference: 10212JCSTATS2 http://www.hallolondon.co.uk/index.html?op=3&id=792126 Job duration: Permanent Start date: ASAP Description: Respiratory Specialist Physiotherapist - London - Permanent - Full Time- £30,000 to £34,000 STR are currently recruiting fora Specialist Physiotherapist to join an established private hospital based in London. To be successful in this role you will be an experienced clinical Physiotherapist with previous expertise in respiratory. You will be a results driven individual with strong interpersonal skills and the confidence to develop the service. Previous experience with CPET (Cardiopulmonary ExerciseTesting) would be an advantage. In the role you will be providing specialist physiotherapy assessment and treatment for respiratory cases, including outpatient, inpatient, pre-admission and follow up care as required. This is a permanent, full time (37.5 hours per week) role, offering a salary of £30,000 to £34,000 depending on experience. To apply for this position please send a copy of your CV to rcorkett@strgroup.co.uk or call Rachel Corkett on 02392 322314. STR Health Limited is actingas an Employment Agency in relation to this vacancy. Industry: Medical and Nursing Salary currency: gbp Salary Benefits: Salary: £30000 - £34000 per annum Job type: Permanent Job skills: Job Reference: RC/HQ00046508 http://www.hallolondon.co.uk/index.html?op=3&id=792052 Job duration: permanent Start date: March 2012 Description: A new permanent full-or part-time opportunity for an experienced Clinical Research Associate has just become available in one of the most prestigious Pharmaceutical Services provider with their European headquarters located in the UK. My client, a leader on the market, is offering an opportunity to join a stable international team of clinical professionals and a chance to workon prestigious international trials. This leading Clinical Research Organization will offer a successful individual an opportunity to work on trials in a chosen therapeutic area allowing them to broaden their clinical research experience. They will also provide a unique opportunity of regional monitoring and remote monitoring when applicable which could contribute to creating a better work/life balance. An award winning internal training is waiting for a driven and motivated individual and for the best professionals my client has prepared numerous opportunities to progress within their organization. Job responsibilities on this permanent, home-based position will include: Monitoring Clinical Phase I-II trials on site in compliance with ICH/GCPguidelines and the Company's SOPs & Procedures Overall responsibility for essential documents and Trial Master File Planning of data review, data management activities and data base closure based on the monitoring schedule An ideal candidate will fulfill the requirements: Strong knowledge of GCP/ICH guidelines, and local guidelines Minimum 18 months of clinical research experience in a CRO or Pharmaceutical Company, conducting on-site monitoring of clinical trials Good organizational skills and ability to work independently as well as part of a team Excellent communication, presentation and interpersonal skills Ability to work in a multicultural environment, flexibility and assertiveness in dealing with difficult situations Good computer and technical expertise (EXCEL, Word, etc) Fluency in English - other languages are of advantage Willingness to travel In return my client offers: A competitive salary of up to 40 000 GBP per annum and a generous benefits package comprising of a car allowance, private medical care, competitive pension scheme, life assurance, discount vouchers Home-based or office-based position depending on preference Permanent role Possibility of a part-time role (4 days per week) Regional monitoring contributing to a better work/life balance Award winning training scheme The possibility for development and advancement within a constantly growing company The innovative and stimulating atmosphere of a multicultural environment If this or any other opening advertised by SEC Recruitment is of your interest please feel free to send your updated CV to agata.lugowska@secpharma.com or contact me directly on (0) 2072 55 66 65 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: negotiable, benefits Salary: £30000 -£40000 per annum + negotiable, benefits Job type: Permanent Job skills: clinical, CRA, monitoring, UK, home-based, part-time Job Reference: 1466609 http://www.hallolondon.co.uk/index.html?op=3&id=792013 Job duration: Start date: ASAP Description: The Person You will be educated to a degree level in biological, physical, health, pharmacy or other related science together with extensive pharmaceutical or clinical research experience. At least three years of proven Clinical Quality Assurance auditing experience and at least four years of proven Clinical Research Associate or Clinical Study Manager experience are essential. Ideal candidate * Understanding of drug development process and detail processes in clinical trials * Understanding of global and local regulations and guidelines * Experience in training people is an asset * Experience in implementations of risk based monitoring or risk based trial management is an asset * Advanced verbal andwritten communication skills and focused mind-set * Client focused and finds working in Interdisciplinary teams enjoyable * Excellent analytical and organization skills * Fluent in oral and written English * Fluency in German is beneficial * Good knowledge of Microsoft Office applications Responsibilities * You will be responsible for Consulting within Compound Development & Branding-Clinical Development Operations (CDB - CDO) for processes, guidelines, GCP etc. * Developing and executingtraining programs for CDB - CDO * Being responsible for improvement and execution of all the processes within clinical development * Delivering training according to the department needs This is an excellent opportunity to join a successful company which will enable you to continuously develop and grow. Your personal contribution will make a difference and have a direct impact on the business results. The company offers a competitive salary and a benefits package. Please call for more details. Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: £80000 - £100000 per annum Job type: Permanent Job skills: Quality Assurance Job Reference: 133-N http://www.hallolondon.co.uk/index.html?op=3&id=791902 Job duration: Start date: ASAP Description: SEC/Ref: 120210ASeveral Biostatistician Roles | UK | Flexible working Homebased (Senior level or above only) or Office based in Southern UK orScotland Strong Salary + Comprehensive Benefits For immediate consideration please forward your CV to: clive.magill@secpharma.com or call +44 (0) 207 255 6665. Due to a large contract award there is a requirement for a several Biostatisticians, with range of experience levels, the more experienced applicant able to work from home (4+ years experience). With excellent longterm prospects and attractive salary and benefits package this is a great opportunity. Please contact me for full details. Key Experience/Skills: - Strong and proven organisation skills, team player with excellent communication skills - Must have 2+ years of working within the pharmaceutical industry on clinical trials as a minimum up to principal level required. - Experience in any Phase (I-IV) - SAS programming skills with ability to produce and QC TFLs and direct programmers - Awareness of regulatory guidelines, drug safety and clinical research within EU is essential - MSc in Statistics or similar - Superb English written and spoken skills - Current eligibility to work within UK is essential. The company offers great career development and a real long term career prospects, constantly developing your knowledge and responsibilities. For complete details and a confidential consultation please get in contact with me. Contact: Clive Magill Consultant - Pharmaceutical, Healthcare &CRO Division Statistics, Biostatistics & Programming Tel: +44 (0) 207 255 6665 Email: clive.magill@secpharma.com Website: www.secrecruitment.com http://uk.linkedin.com/pub/clive-magill/30/63a/878 Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician, Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Depends on your Experince Salary: £35000 - £65000 per annum + Depends on your Experince Job type: Permanent Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician, project, trial, lead, head, homebased Job Reference: SEC/Ref: 120210A http://www.hallolondon.co.uk/index.html?op=3&id=791893 Job duration: Start date: ASAP Description: SEC/Ref: 120210B Several Statistical Programming Roles | UK | Flexible working Homebased (Senior level or above only) or Office based in SouthernUK or Scotland Strong Salary + Comprehensive Benefits For immediate consideration please forward your CV to: clive.magill@secpharma.com or call +44 (0) 207 255 6665. There is a requirement for a various levels of statistical Programmers due to an award of a large long term contract, the more experienced applicant able to work from home (4+ years experience). With excellentlong term prospects and attractive salary and benefits package this is a great opportunity. Please contact me for full details. Key Experience/Skills: - Must have 2+ years of working within the pharmaceutical industry on clinical trials as a minimum up to principal level required. - Experience in programming within clinical trials (must be current) - Strong SAS programming skills - Must have experience in QC and validation of SAS programmes - Degree in Computer Science or similar - Superb English written and spoken skills - Current eligibility to work within UK is essential. The company offers great career development and a real long term career prospects, constantly developing your knowledge and responsibilities. For complete details anda confidential consultation please get in contact with me. Contact: Clive Magill Consultant - Pharmaceutical, Healthcare& CRO Division Statistics, Biostatistics & Programming Tel: +44 (0) 207 255 6665 Email: clive.magill@secpharma.comWebsite: www.secrecruitment.com http://uk.linkedin.com/pub/clive-magill/30/63a/878 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Experince dependant Salary: £30000 - £60000 per annum + Experince dependant Job type: Permanent Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician, lead, project, homebased, Job Reference: SEC/Ref: 120210B http://www.hallolondon.co.uk/index.html?op=3&id=791890 Job duration: Start date: asap Description: Core Responsibilities The Quality Assurance Auditor is responsible for: * Verifying that operations meets the relevant internal standards, good practices and regulatory requirements with regard to policy, proceduresand systems * Performing audits of investigator sites and facilities to ensure regulatory compliance to the appropriate regulatory bodies * Acting as a consultant on all company quality issues, providing support to the operations and guidance to ensurequality in all deliverables The Person You will be educated to a degree level with concentration in biological, physical, health, pharmacy or other related science together with extensive pharmaceutical or clinical research experience. At least threeyears of proven Clinical Quality Assurance auditing experience is essential. Ideal candidate * Well organized, to maintain anddevelop QM- related processes and documentation * Ability to understand the essential elements of all aspects of a Company's activities * Ability to make pragmatic decisions * Attention to deal * Persistence and patience Essential Work Experience and Qualifications * Several years' work in a regulated environment, preferably within pharmaceutical industry-related industry * 3 years involvement with clinical trials * Sound knowledge of relevant GCP-related guidelines and Regulations Responsibilities * Verify that documents reflect global regulatory requirements. * Undertake study based audits as required and report any observed issues to Quality Assurance Management. * Undertake facility, system and vendor audits as required and report any observed issues to management. * Identify process gaps and/or quality deficiencies in global activities, proposing opportunities for improvement & raising awareness of unmet training needs. * Support Sponsor Company Audits and Regulatory AuthorityInspections. * Pro-actively contribute to management team discussions by providing quality/compliance management & consultancy on international projects & overall business operations. * Support the system for collating, monitoring, reporting andclosing corrective and preventive action items is established and maintained. * Maintain and develop the Quality Management System (QMS) and ensure that documentation is maintained within agreed time scales cycles. * Support employees of the company in their adherence to the documented requirements to observe all aspects of the QMS relevant to their job roles. * Act as a Lead Auditor for a number of studies This is an excellent opportunity to join a rapidly growing company with a fantastic working environment in a vibrant dynamic team. The company offers a competitive salary and a benefits package. Please call for more details. Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: £35000 - £45000 per annum Job type: Permanent Job skills: Quality Assurance Job Reference: 102-N http://www.hallolondon.co.uk/index.html?op=3&id=791819 Job duration: Start date: 05/04/2012 Description: Vous aurez la responsabilité de la conduite des études cliniques internationales - Phase III sur tout leterritoire français. Pour profiter de cette opportunité, veuillez contacter Mr Fabrice Akakpo par email à l'adresse suivante :fabrice.akakpo@secpharma.com ou par téléphone au numéro suivant :+442072556665. Vous aurez l'occasion de parfaire votre expertise dans la gestion des études cliniques internationales dans des aires thérapeutiques délicates au sein d'une équipe dynamique et accueillante. Responsabilités liées au poste: *Procéder aux études de faisabilité *Recruter les investigateurs *Effectuer les visites de sélection, d'initiation, de mise en place, de suivi, de monitoring et de clôture des centres d'investigation à travers toute la France *Organiser et participer aux réunions investigateurs Votre profil : *2 ans d'expérience minimum en qualité d'ARC moniteur *Maitrise de l'anglais *Permis B valide *Bonne connaissance de l'environnement réglementaire et des BPC-ICH *Rigoureux, bien organisés avec le goût du contact Si ce poste vous intéresse, je vous remercie de bien vouloir m'envoyer votre CV en anglais au format Word aux coordonnées suivantes : Fabrice Akakpo. Email : fabrice.akakpo@secpharma.com Tel : +442072556665. Industry: Health and Safety Salary currency: gbp Salary Benefits: Salary: €32000 - €45000 per annum Job type: Permanent Job skills: Clinical Research Associate, CRA, ARC, Attache de Recherche Clinique, Pharmaceutical, CRO, Clinical Trials, Job Reference: 10022012 http://www.hallolondon.co.uk/index.html?op=3&id=791807 Job duration: 6 Months Start date: Negotiable Description: Senior SAS Programmer 6 Months Initial Contract Ideally Office Based in Greater London Home based offers for candidates with 7 years+ experience £45 - £55 P/H Your Main Responsibilities: -Collaborate with Analyst to determine programming and analysis requirements for observational research studies. -Retrieve appropriateobservational data from databases. -Provide SAS programming support to produce tables, listings, statistics, and graphs for analyses. -Provide study results in format required for internal use or external publications. -Load, maintain and update patient level databases, as needed for RWE studies. -Maintain and improve knowledge of UK, European and other patient databases -Collaborate with Analyst to determine programming and analysis requirements for audit analysis. -Provide SAS programming support to produce tables, listings, statistics, and graphs for analyses. Your Essential Skills: -4+ years of relevant SAS programming experience. -7 Years for a full time Home Based Position -Working knowledge of population statistics and analytic techniques Your Desirable Skills: -Experience within an epidemiological , health economics or outcomes research group -Experiencein the pharmaceutical industry -Demonstrable record of collaborative working For a confidential consultation call Russell Gillam on 0044 (0) 207 255 6665 or email your CV to russell.gillam@secpharma.com Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: £40 - £50 per hour Job type: Contract Job skills: Job Reference: 10212JCUKSASH1 http://www.hallolondon.co.uk/index.html?op=3&id=791792 Job duration: Start date: ASAP Description: SEC/Ref: 120116A Epidemiologist | UK | Blue Chip Pharma Office based Hertfordshire Salary dependent upon experience For immediate consideration please forward your CV to: clive.magill@secpharma.com or call +44 (0) 207 255 6665. My client is a successful and well reputed pharmaceutical company who are looking to take on an experienced epidemiologist. Well known for their outstandingtraining and development this company are looking for someone to work in this broad ranging role. Key tasks: - Work withina cross functional team environment - Design and review epidemiological studies - Regulatory submission preparation of studyoutputs - Work with external partners on the studies as required - Analyse and interpret epidemiological data - Work on multiple molecules across therapeutic areas Key Experience/Skills: - MSc or PhD in Epidemiology or similar (or significant proven industrial epidemiology experience) - Must have high level of experience within industry (4+ years) - Require excellent general drug development knowledge - Excellent written and spoken communication skills - Proven ability to work independently and as a team member For complete details and a confidential consultation please get in contact with me. Contact: Clive Magill Consultant - Pharmaceutical, Healthcare & CRO Division Statistics, Biostatistics & Programming Tel: +44 (0) 207255 6665 Email: clive.magill@secpharma.com Website: www.secrecruitment.com http://uk.linkedin.com/pub/clive-magill/30/63a/878 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: Job type: Permanent Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician, epidemiology, epidemiologist, pharma, lead, observational Job Reference: SEC/Ref: 120116A http://www.hallolondon.co.uk/index.html?op=3&id=791590 Job duration: Start date: ASAP Description: SEC/Ref: 111124B Several Biostatistician Vacancies | South + Central Germany | Global Pharma Great salary and strong benefits package. Work on cutting edge projects. Contact me for full details of these roles clive.magill@secpharma.com or call +44 (0) 207 255 6665. My award winning client is looking for several Biostatisticians across their sites currently. They are located in the south of Germany and in central Germany. They have an innovative team involved in exciting projects, they have openings in both pre-clinical development teams and their clinical teams for Biostatisticians and Senior Biostatisticians. Working on a range of cutting edge projects you will be challenged by the work but given the flexibility and freedom to put your mark on the projects and produce successful outcomes. You must: Hold a MSc or PhD in statistics, mathematics or similar Have prior experience in drug development/ pre-clinical development within a pharmaceutical company. Be fluent in English, spoken and written. Be a team player with exceptional self motivation, communication and teamwork skills. You must be eligible to work in and willing to relocate to theareas the company is located in. You will get: Great career development. Stable company environment A range of cutting edge projects to work on Great Salary and benefits package To work as part of an international team For full details and a confidential consultation please get in contact with me. Contact: Clive Magill Consultant - Pharmaceutical, Healthcare &CRO Division Statistics, Biostatistics & Programming Tel: +44 (0) 207 255 6665 Email: clive.magill@secpharma.com Website: www.secrecruitment.com http://uk.linkedin.com/pub/clive-magill/30/63a/878 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Exceptional Package Salary: Exceptional Package Job type: Permanent Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics,statistician, biostatistics, biostatistician, lead, project, expert Job Reference: SEC/Ref: 111124B http://www.hallolondon.co.uk/index.html?op=3&id=791588 Job duration: Start date: ASAP Description: Senior Regulatory Operations Manager - Netherlands - Great Prospects! A large Global pharmaceutical company is currently looking for aSenior Regulatory Operations Manager to join their Global headquarters in Netherlands. To find out more about the company and position call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com As a Senior Regulatory Operations Manageryou will be an expert in the field of document management and style compliance, regulatory submissions management & publishing and regulatory information management. Responsibilities: -Supervision of submission projects and significant interactions inside and outside the Regulatory Affairs department. -Provide expertise and leadership in directing projects within assigned areas, including Regulatory Document Management, Submissions Publishing, and/or Regulatory Liaison. -Significant interactionswith European National Competent Authorities, the European Medicines Agency and Local Affiliates. -Interact on global projects with other areas of the organization, including colleagues in the US and Asia. Your personal qualifications: -Academic level of functioning -At least 5 years relevant experience in the pharmaceutical industry and/or with regulatory authorities -Good knowledge of the regulatory processes and principal dossier requirements -Expert knowledge of document management and electronic publishing systems -Good communication skills in a multi-cultural working environment This is a fantastic opportunityto work for a global pharmaceutical player that offers a challenging and diversified job, great career opportunities, inspiringwork climate and attractive remuneration! Keywords: Regulatory Operations, Regulatory Operations Manager, document management, style compliance, regulatory submissions management, publishing, regulatory information management Nikolay Dimitrov Pharmaceutical Division +44 (0)20 7255 6665 +33 (0)170807489 +49 (0)69 222 22 888 +41 (0)44 580 3717 Email: Nikolay.Dimitrov@secpharma.com Web: www.secrecruitment.com Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Extensive benefits + Relocation Salary: €70000 - €90000 per annum + Extensive benefits + Relocation Job type: Permanent Job skills: Regulatory Operations, Regulatory Operations Manager, document management, style compliance, regulatory submissions management, publishing, regulatory information management Job Reference: ND0031.0902.op http://www.hallolondon.co.uk/index.html?op=3&id=791587 Job duration: Start date: When you can. Description: SEC/Ref:111024A Project Epidemiologist | Permanent | Global Pharma | Germany Location: Southern Germany. Attractive Salary + Benefits. For immediate consideration please forward your CV to: clive.magill@secpharma.com or call +44 (0) 207 255 6665. A highly respected company are looking for an experienced epidemiologist to join their team in Germany. They have a excellent reputation and will provide an excellent long term career path, the epidemiology department is a young and growing and has an excitingfuture. If you want to work for a well reputed Pharmaceutical company covering many exciting projects then please call for full details. You will be have responsibility for developing epidemiological methods and comparing the effectiveness of different products. You will develop the study protocols, design the studies and analyse the data in this rewarding and challenging role. Work will frequently involve networking and coordination with cross functional and international teams. Flexible and analytical, the ideal candidate must have exceptional statistical knowledge as well as an MSc or PhD in epidemiology, statistics, medicine or similar. You must have work experience within epidemiology in an industrial company/ working on clinical trails. A working knowledge of statistical software packages would be advantageous. Exceptional communication skills and teamwork are key to successful applications, you must also enjoy working within epidemiology and be committed to this career path. Fluent English (spoken and written) is essential, other languages will be advantageous. Applicants must be eligible to work in Germany.If you are interested please get in touch for full details of this outstanding opportunity. Contact me for full details of these roles clive.magill@secpharma.com or call +44 (0) 207 255 6665. Contact: Clive Magill Consultant - Pharmaceutical,Healthcare & CRO Division Statistics, Biostatistics & Programming Tel: +44 (0) 207 255 6665 Email: clive.magill@secpharma.com Website: www.secrecruitment.com http://uk.linkedin.com/pub/clive-magill/30/63a/878 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: Job type: Permanent Job skills: Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician, epidemiology, lead, head, project Job Reference: SEC/Ref: 111024A http://www.hallolondon.co.uk/index.html?op=3&id=791583 Job duration: Start date: 01/04/2012 Description: Head of Regulatory and Medical Affairs - Austria - Very rare opportunity!!! My client, the Oncology Injectables arm of a global pharmaceutical player is currently looking for a Head of Regulatory and Medical Affairs in Austria. To find out more about the company and position call Nikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com. As a Headof Medical and Regulatory Affairs you will provide medical and toxicological expertise in the development and maintenance of pharmaceuticals. Responsibilities: -Manage clinical and non-clinical studies for development and maintenance of pharmaceuticals -Writing of toxicological statements (literature justifications on impurities, excipients and residual solvents) -Preparation/updates of non-clinical and clinical overviews and expert statements, SmPC, Patient Information Leaflets -Support in EU registration procedures (MRP, DCP) variations and renewals -Answering of clinical part of deficiency letters, including contacts with assessors at health authorities -Labelling: elaboration of PILs according to valid internal policies and EU Guidelines,and coordination of EU PIL readability tests (user tests) or bridging reports -Regulatory intelligence: tracking of relevant clinical and non- clinical international Guidelines -Medical support for portfolio management, development and patent departments Minimum requirements -PhD in chemistry or medical doctor Master of Drug Regulatory Affairs Toxicologist -Fluent English (oral and written) -At least 5 years in pharmaceutical industry, preferably in medical and/or regulatory affairs -In depthknowledge of Clinical and Non-Clinical development, Regulatory Affairs, Clinical Pharmacology, Toxicology Keywords: Regulatory Affairs, Medical Affairs, Clinical development, Non-Clinical development, Clinical Pharmacology, Toxicology Nikolay Dimitrov Pharmaceutical Division +44 (0)20 7255 6665 +33 (0)170807489 +49 (0)69 222 22 888 +41 (0)44 580 3717 Email: Nikolay.Dimitrov@secpharma.com Web: www.secrecruitment.com Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Benefits + Relocation Salary: €90000 - €120000 per annum + Benefits + Relocation Job type: Permanent Job skills: Regulatory Affairs, Medical Affairs, Toxicology, Clinical Development Job Reference: ND0043.0902.um http://www.hallolondon.co.uk/index.html?op=3&id=791570 Job duration: Start date: 01/04/2012 Description: Regulatory Affairs Manager - CMC - Austria My client, the Oncology Injectables arm of a global pharmaceutical player is currently looking for a CMC Regulatory Affairs Manager to join their team in Austria. To find out more about the company and position callNikolay on +44 (0)207 255 6665 or e-mail Nikolay.dimitrov@secpharma.com. As a Regulatory Affairs Manager you will be responsible for the preparation of high quality CMC documentation and definition of the technical regulatory strategies. Responsibilities: -Support the formulation of a regulatory sound technical project strategy as CMC expert for new applications and life-cycle activities. Provide input to the submission plan. -Write high-quality CMC documentation during development and product registration -Prepare CMC responses to health authority questions during registration and product lifecycle. -Identify the required documentation for submission and coordinate the availability of approved technical source documents in accordance with timelines. Minimum requirements: -University or academic degree in a science field (chemistry, biology, pharmacy or equivalent) -Preferred minimum of 2 years of experience in the pharmaceutical industry in regulatory affairs -Working knowledge of CMC documentation preparation -Working knowledge of drug development, production and analytic process. -Understanding of the regulatoryrequirements for CMC filings worldwide and critical evaluation of emerging requirements -Detail oriented with regulatory background with excellent problem solving acumen -Critical thinking, process and performance oriented -Constant drive to improve working practices -Excellent communication skills -Fluent in German and English (oral and written) Nikolay Dimitrov Pharmaceutical Division +44 (0)20 7255 6665 +33 (0)170807489 +49 (0)69 222 22 888 +41 (0)44 580 3717 Email: Nikolay.Dimitrov@secpharma.com Web: www.secrecruitment.com Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Benefits + Relocation Package Salary: €50000 - €70000 per annum + Benefits + Relocation Package Job type: Permanent Job skills: RA, CMC, Regulatory Affairs, Global Regulatory Affairs Manager Job Reference: ND0043.0902.ur http://www.hallolondon.co.uk/index.html?op=3&id=791564 Job duration: Start date: Description: You willbe in charge of the feasibility activities including site selection and evaluation, ensure a thorough follow-up of clinical site management & monitoring activities throughout monitoring visits, drug supply management and review of clinical data with in-house clinical teams and ensuring compliance with regulatory, quality and study's requirements. With an MSc or Pharmacist degree and proven track record of 5 years in study management, we are looking for a proactive, problem-solving and dynamic clinicalprofessional with a sound knowledge of regulations requirements. In return my client can offer a competitive salary and remuneration package including relocation assistance as well as excellent possibilities for professional career development. If you are interested in this new & exclusive pharmaceutical career opportunity, please send your application to Louis Gicquel at Louis.gicquel@secpharma.com or contact Louis Gicquel on +44 207 255 6600. Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Comapny Benefits & Relocation Ass. Salary: €95000 - €115000 per annum + Comapny Benefits & Relocation Ass. Job type: Permanent Job skills: Trial Manager, Clinical Study Manager, Project Manager, Pharmaceutical, Geneva Job Reference: CPM - Suisse http://www.hallolondon.co.uk/index.html?op=3&id=791543 Job duration: PERM Start date: ASAP Description: For a confidential consultation call Beatriz de Luis on 0044 (0) 207 255 6665 or email your CV to beatriz.deluis@secpharma.com Leader multinational Pharma Company based in Madrid, is currently looking for a Health Outcomes Specialist with previous experience in Spanish Pharmaceutical Industryto join their team of Health Economics. Accountabilities/Responsibilities: Reporting directly to the Health Economics Director, your main responsibilities will be: Participate in International Market Access activities from Phase II (Payer insight,research payer). Provide the required evidence by payers / Spanish decision makers in phase III and indentify the additional evidence necessary to meet the needs of payers / Spanish decision makers. Identify the health outcomes strategy for assigned products and the scientific evidence. Contribute to the definition of the Market Access Value Proposition in collaboration with localand European teams. Develop pricing and funding strategy. Prepare Therapeutic Utility Report to show the value of the assignedproducts to the Spanish Health Authorities. Collaborate with Regulatory and Sales teams to define the presentation and formatting of the assigned products best suited to the requirements of price and financing of Spanish Health Authorities. Essential Skills & Capabilities: With a degree preferably in Sciences, the ideal candidate will have previous experience working in the Spanish Pharmaceutical Industry (knowledge of the Health Spanish System) and also proven experience in a similar position. Knowledge of the decision-making in drug policy entities is required: Ministry of Health, Interterritorial Council... and of the process and evidence required for decision-making. High level of English is required. In return, my client offers the opportunity to join a strategic and growing team, further career progression and a competitive salary package. For further details ora confidential conversation please contact me directly: Beatriz de Luis Pharmaceutical, Healthcare & CRO Division Spain and International Biotech Tel: +44 (0) 207 255 6665 Beatriz.deluis@secpharma.com http://uk.linkedin.com/in/beatrizdelulis Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: Job type: Permanent Job skills: health economy, health economist, heor Job Reference: 090212b http://www.hallolondon.co.uk/index.html?op=3&id=791538 Job duration: PERM Start date: ASAP Description: For a confidential consultation call Beatriz de Luis on 0044 (0) 207 255 6665 or email your CV to beatriz.deluis@secpharma.com Leader multinational Pharma Company based in Madrid, is currently looking for a Health Outcomes Specialist with previous experience in Spanish Pharmaceutical Industry to join their team of Health Economics. Accountabilities/Responsibilities: Reporting directly to the Health Economics Director, your main responsibilities will be: Participate in International Market Access activities from Phase II (Payer insight, research payer). Provide the required evidence by payers / Spanish decision makers in phase III and indentify the additional evidence necessary to meet the needs of payers / Spanish decision makers. Identify the health outcomes strategy for assigned products and the scientific evidence. Contribute to the definition of the Market Access Value Proposition in collaboration with localand European teams. Develop pricing and funding strategy. Prepare Therapeutic Utility Report to show the value of the assigned products to the Spanish Health Authorities. Collaborate with Regulatory and Sales teams to define the presentation and formattingof the assigned products best suited to the requirements of price and financing of Spanish Health Authorities. Essential Skills & Capabilities: With a degree preferably in Sciences, the ideal candidate will have previous experience working in the Spanish Pharmaceutical Industry (knowledge of the Health Spanish System) and also proven experience in a similar position. Knowledge of the decision-making in drug policy entities is required: Ministry of Health, Interterritorial Council... and of the process and evidence required for decision-making. High level of English is required. In return, my client offers the opportunity to join a strategic and growing team, further career progression and a competitive salary package. For further details ora confidential conversation please contact me directly: Beatriz de Luis Pharmaceutical, Healthcare & CRO Division Spain and International Biotech Tel: +44 (0) 207 255 6665 Beatriz.deluis@secpharma.com http://uk.linkedin.com/in/beatrizdelulis Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: Salary: Job type: Permanent Job skills: health economy, health economist, heor Job Reference: 090212b http://www.hallolondon.co.uk/index.html?op=3&id=791537 Job duration: Start date: ASAP Description: Several years' experience in management, administration,implementation and validation of computerized systems relevant for managing data in clinical trials (CDMS, eCRF, Data repositories) Degree or diploma in programming, computational sciences, data sciences, informatics or equivalent Experienced user of CDMS systems and eTools for example EDC and ePRO Proven ability to work in cross-functional teams Please contact Mark at mark.wilkins@secpharma.com or confidentially at 0044 (0) 207 255 6665 Industry: Pharmaceuticals Salary currency: gbp Salary Benefits: negotiable Salary: £80000 - £120000 per annum + negotiable Job type: Permanent Job skills: Data Management, technical Job Reference: SECMAW01 http://www.hallolondon.co.uk/index.html?op=3&id=791534 Job duration: perm Start date: asap Description: Practice Manager - Liverpool - Permanent - £22,000 to £30,000 Our client is a leading Healthcare provider they are currently looking for a Deputy Practice Manager to run there GP/Walk in centre in Wandsworth on a full time basis. Youmust have extensive experience working as a Practice Manager ideally within a GP Surgery or Walk in Centre although similar medical backgrounds will still be considered. It is imputative to have experience in budget management and clinical governance. Your role will be to be in charge of the day to day running the site, assist in recruitment, policies and procedures, budget andfinance responsibility and people management. In return the successful candidate will receive an excellent salary of between£22,000 to £30,000 plus benefits including pension and holiday. To apply for this role, please contact Isobelle Fish on 02392322 317 or email ifish@strgroup.co.uk. STR Health Limited is acting as an Employment Agency in relation to this vacancy. Industry: Medical and Nursing Salary currency: gbp Salary Benefits: Salary: £22000 - £30000 per annum Job type: Permanent Job skills: Deputy Practice Manager Job Reference: IF/HQ00046439 http://www.hallolondon.co.uk/index.html?op=3&id=791521