Our Latest Pharmaceutical Jobs – 21st January 2012

Looking for a new job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

Pharmceutical jobs Jobs in Europe:

Biostatistical Programming Associate

(Senior) SAS Programmer – Germany

Biometrics:

Biostatistical Programming Associate – Middlesex

Biostatitical Programming Manager – Middlesex

 

RPharmceutical jobs egulatory Affairs:

Regulatory Affairs Manager – Surrey

Senior Manager Regulatory CMC – Middlesex

Director Regulatory Affairs – Uxbridge

Global Regulatory Affairs Manager – Hertfordshire

 

Medic:

Pharmceutical jobs Medical Therapy Area Head  -South East

Clinical:

Research Assistant, Metabolic Genomics – London/Hertfordshire

Epidemiology Research Assistant – London

Affiliate Process And Training Advisor – London

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt.

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Epidemiology Research Assistant – London

Jim Gleeson at CK Clinical is recruiting for an Epidemiology Research Assistant for a one year contract with a major, global pharmaceutical company based in London.

Responsibilities:

As a Epidemiology Research Assistant  you will provide support to a range of epidemiological projects to increase disease understanding related to drug development and clinical trials, such as incidence, risk factors, co-morbidities, phenotypes and biomarkers.

Duties will also involve:

  • Conducting literature reviews
  • Drafting sections of epidemiological documents
  • Management of relevant databases
  • Scheduling meetings
  • Monitoring budgets and maintaining research agreements with external experts.

Qualifications:

The successful candidate will have an MSc in Epidemiology and hands-on experience conducting or supporting epidemiological research.

Jim Gleeson - Senior Consultant at CK ClinicalHow to apply:

Apply online:

For more information or to apply for this Epidemiology Research Assistant  role please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL25999 in all correspondence.

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Our Latest Pharmaceutical Jobs – 07 January 2012

p>Looking for a new job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

Pharmaceutical JobsClinical:

Clinical Study Start-up Associate – Home counties

Senior Specialist – Global Clinical Supplies – Home counties

Clinical Study Facilitator X4 – Manchester

Regulatory Affairs:

Associate Regulatory Affairs (TA) – South East

BiPharmaceutical jobsometrics:

Senior Programmer  -North Home Counties / Cambridgeshire

Principal Statistician – Essex

PV and Drug Safety:

Drug Safety Manager  – South East, London

Drug Safety Contract Role – South East, London

Safety Associate – South East, London

Not discount propecia rx quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt

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Our Latest Pharmaceutical Jobs – 31/12/2012

Looking for a new job in the

Pharmaceutical Industry?

Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

Clinical Jobs of the weekPV and Drug Safety:

Pharmacovigilance Systems Specialist – South East, London

Clinical Administration Assistant – Homecounties

Drug Safety Contract Role – South East, London

Safety Associate – South East, London

Manager Regional Safety Officer – South East, London

PV Process Excellence Coordinator – South East, London

BiomClinical Jobs of the weeketrics:

Principal Statistician – Essex

Study Data Manager – Home counties

Clinical:

Clinical Research Scientist, home-based

Clinical Study Facilitator X4 – Greater Manchester

Biostatistical Programming Associate – Middlesex

 

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt.

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PV Process Excellence Coordinator – South East, London

Hendre Moolman at CK Clinical is recruiting for a PV Process Excellence Coordinator to join a company in the pharmaceutical industry in a fixed term contract role in the South East.

Responsibilities:

As a PV Process Excellence Coordinator you will be responsible for working across the PV team to understand and refine the processes to drive efficiencies and consistency. You will be working with the Head of PV Operations, existing members of the team, global PV colleagues, and colleagues in other departments, to help improve daily processes.

Further responsibilities of PV Process Excellence Coordinator position will include:

  • Leading matrix teams within the local PV team, to help bring consistency in working practice and to strengthen overall PV operations
  • Playing a leading role in the creation of streamlined processes both within the team and in a cross functional and global setting
  • Being responsible for the development and driving better ways of working and also project managing some important process improvement initiative while playing a key role in the training and implementation of these
  • Being involved in the creation and maintenance of appropriate SOPs and WPs
  • Facilitating the implementation of some aspects of the new PV legislation
  • Working together with Head of PV Operations to help strengthen and streamline operations, including any process improvements to create a highly effective and compliant operation.
  • Coordinating cross departmental process improvement activities to strengthen PV working with colleagues.
  • Playing a key role in leading PV operational projects including facilitating complex discussions in matrix teams to successful outcome.
  • Undertaking other activities and projects as required by line manager and to help ensure high quality documentation, guidance and training are in place.
  • Collaborating with other members of the department, including global colleagues and working in collaboration with the PV ICSR manager and PV Scientific Manager as required
  • Interacting with colleagues in clinical, clinical operations or regulatory and possibly IT

Qualifications:

As PV Process Excellence Coordinator you will have the following qualifications, skills and experience:

  • Science Degree (e.g. pharmacy, Nursing, Life Science).
  • Proven experience in pharmacovigilance including case handling, aggregate reports, other PV deliverables
  • Experience of coordinating project improvement initiatives and in leading matrix teams to a successful outcomes, including at a global level.
  • Extensive knowledge of global PV regulatory legislation (both pre and post marketing) including the new EU legislation
  • Strong understanding of PV business, in a global setting.
  • Proven ability in project delivery, including writing working practices and SOPs, training and implementation of new processes
  • Demonstrated experience of leading process improvement initiatives
  • Possessing a strong sense of responsibility and having a good track record of working to strict deadlines
  • Excellent organisation, coordination or project management skills
  • Good communication and facilitation skills
  • A quick thinking decision maker and problem solver
  • Leadership and drive – in pursuit of operational excellence
  • Proven ability to identify streamlining opportunities and to take projects forward.
  • Excellent negotiation skills -with an ability to reach consensus despite disparate views
  • A creative thinker with a sense of urgency
  • Ability to work consistently and autonomously, seeking advice where necessary
  • Able to form strong cross-departmental and cross-functional relationships

Benefits:

As a PV Process Excellence Coordinator you will be joining a global pharmaceutical company based in the South East.

  • You will be working with a global company
  • You will have a competitive salary
  • 2 year fixed term contract role
Hendre Moolman - Pharmacovigilance Recruitment

Please contact Hendre for more details.

How to apply:

Apply online:

For more information or to apply for this PV Process Excellence Coordinator position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25881 in all correspondence.

 

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Project Manager Study Start-up, Europe – Home based

Jim Gleeson at CK Clinical is recruiting for permanent Study Start-up Clinical Project Managers for a leading international Clinical Research Organisation. These will be home based positions and available in most European countries.

Responsibilities:

This Project Manager Study Start-up is an exciting opportunity to project manage and lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Project Director, this varied role will include

  • Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services.
  • Leading implementation of Six Sigma initiatives on projects as applicable.
  • Monitoring project schedule and scope to ensure both remain on track.
  • Initiating and implementing appropriate actions.
  • Accountable for budget across assigned project(s) including the control and minimizing of write-offs.
  • Proactively identifying out of scope activities and ensure necessary change orders are executed.
  • Proactively engaging in both quality assurance and risk management activities to ensure project deliverables are met according to both internal and client requirements.
  • Presenting at external and/or internal meetings.
  • Ensuring client satisfaction.
  • Supporting new staff in region and integrate them into the study process efficiently.

Skills and experience:

To be considered for this Project Manager Study Start-up job this ideal candidate will have the following skills and qualifications:

  • A life science or nursing degree 
  • A thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries  
  • Previous relevant clinical research experience in a pharmaceutical company/CRO, including at experience of full project management responsibility, especially in the study start up phase 
  • Working knowledge of financial control procedures (costing systems, time reporting)  
  • Experience of managing overseas clinical trials  
  • Broad knowledge of drug development process and client needs
  • Proven leadership skills with the ability to inspire and motivate staff within a field based environment  
  • Demonstrated Account Management and business development experience with a previous track record working as a Clinical Project Manager or in a Senior Clinical Study Start-up role would be advantageousJim Gleeson - Senior Recruiter at CK Clinical.

How to apply:

Apply online:

If you would like to find out more or apply for this Project Manager Study Start-up job please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk.  Please quote reference CL25848 in all correspondence.

 

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Our Latest Pharmaceutical Jobs – 10/12/2012

Looking for a new job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:
Clinical jobs

Regulatory Affairs

Senior Manager, EU Reg Strategist – Surrey

Regulatory Affairs Specialist – Berkshire

CTRL Coordinator – South East

Senior Manager Regulatory CMC – Middlesex

MEWA Regulatory (Senior) Associate – South East

Regulatory Affairs Manager II – cambridge/Uxbridge

Biometrics:

SAS Programmer -UK

eCRF Developer – London

Principal Programmer – London

Europe:

Clinical Trial Head – Switzerland

Statistics Report Group Manager – Switzerland

HR Business Partner – France

Senior Data Manager – Switzerland

Biostatistician – Switzerland

Global Programme Regulatory Director – Switzerland

Clinical

Clinical Contracts Analyst – West London

AD, Clinical QA &C – London

PV & Drug Safety Recruitment

Clinical Safety Scientist – South East London

Senior Safety Systems Analyst -South East London

 

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt.

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GSK hope for strong drug pipeline in 2013/2014

As reported by Reuters, the pharmaceutical company, GlaxoSmithKline (GSK) has predicted a strong drug pipeline in 2013 and 2014, particularly focusing on cancer and heart disease treatments.

The global pharma is expecting promising clinical trial results on up to 14 medicines as they take the decision to focus on developing a broader range of drugs, thus moving away from concentrating on those “blockbusters”.

The drugs in GSK’s pipeline are darapladib and MAGE-A3 – both of which have potentially high-reward but are also high-risk. GSK acquired full rights to the heart drug darapladib after acquiring Human Genome Sciences for $3 billion earlier this year. MAGE-A3 is a therapeutic vaccine which is currently being tested in lung cancer and melanoma.

Other drugs within GSK’s 2013/2014 pipeline include:

  • Mepolizumab – used to treat severe asthma
  • Drisapersen – used to treat Duchenne muscular dystrophy
  • Migalastat – used to treat Fabry’s disease

Developing drugs to treat rare diseases is proving more and more popular with those pharmaceutical companies who want to spread their risk across both mass and niche therapeutic areas.

This is explained by Head of Drug Development at GSK, Patrick Vallance “Our strategy is to broaden the number of things coming through late-stage development by not focusing on the blockbuster model. Within this strategy, there will be things that turn out to be very big indeed. What the world has not been good at doing is spotting which ones they are early on.”

 

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GSK hope for strong drug pipeline in 2013/2014   GSK hope for strong drug pipeline in 2013/2014   GSK hope for strong drug pipeline in 2013/2014   GSK hope for strong drug pipeline in 2013/2014

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Roche’s Avastin helps patients with brain cancer

As reported by The Pharma Times, Roche’s cancer drug, Avastin, helped patients suffering with newly diagnosed brain cancer to live longer in a late stage study.

Results from the Phase III study indicated that when combined with radiation and temozolomide chemotherapy, Avastin reduced the risk of the cancer worsening or of death by 36 per cent (compared to those patients who received radiation and temozolomide plus a placebo). However, the drug did not reach statistical significance.

The chief medical officer and head of Global Product Development at Roche, Hall Barron M.D, stated, “People with newly diagnosed glioblastoma have few treatment options and need new medicines. An important outcome from the AVAglio study was that patients who received Avastin plus radiation and chemotherapy lived significantly longer without their disease getting worse, and we plan to discuss these data with regulatory authorities.”

Avastin is the Swiss pharmaceutical company’s third-biggest seller and is approved to treat several types of cancer, including breast, kidney, colorectal and ovarian cancers.

 

 

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Roche’s Avastin helps patients with brain cancer   Roche’s Avastin helps patients with brain cancer  Roche’s Avastin helps patients with brain cancer   Roche’s Avastin helps patients with brain cancer

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US FDA recommends GSK’s flu vaccine for approval

As reported by The Pharma Letter, the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted unanimously in support of GlaxoSmithKline’s (GSK) vaccine in the treatment of influenza.

GSK contracted with the U.S government to develop the flu vaccine which contains antigen-sparing adjuvant that helps boosts the immune response.

The H5N1 vaccine has been developed to treat patients aged 18 years and older who are at increased exposure to the influenza. The vaccine, which is administered in two doses over 21 days, contains GSK’s proprietary adjuvant AS03 which is used to induce a stronger immune response. It has been designated for a national stockpile to be reserved for use during an avian influenza pandemic or outbreak, GSK has no plans to market the vaccine.

The GSK vaccine is currently approved in Europe under the brand name Pumarix. If approved in the US, it could become the first adjuvanted flu vaccine to win approval in the country.

Speaking of the good news, Bruce Innis, vice president, GSL Global Vaccines Discovery and Development stated, “GSK has been collaborating with the US Department of Health and Human Services since 2006 to develop this H5N1 vaccine and we are pleased with the positive vote recommending its approval. We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the US government on public health issues.”

 

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US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval US FDA recommends GSK’s flu vaccine for approval

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