GCP Manager– London, South East, UK

GCP Manager needed for a leading healthcare charity based in London, UK.

Reporting to the Head of Quality, Regulatory and Pharmacovigilance, as GCP Manager you will be required to take responsibility of all aspects of GxP within the organisation.

The main focus of this GCP Manager job will be to oversee the GCP programme (for Phase I & II studies), though you will also oversee GCLP for a number of laboratories and GMP for two manufacturing sites.

The successful candidate for this GCP Manager position will be educated to a minimum BSc in a relevant technical subject and will hold the following skills and competencies:

  • Extensive Quality Assurance experience gained within the Clinical Trials arena
  • Experience of the management and implementation of QA and QC systems
  • Experience of the conduct or organisation of audits
  • Good line management capability

For further information, or to apply for this GCP Manager job, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk.

Alternatively, click here to apply for this Quality Assurance job now.

Not quite what you’re looking for? Click here to search for our current pharmaceutical jobs now.

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Statistician – Kent, South East, UK

A Statistician is required for a well known Pharmaceutical company based in Kent, South East, UK. This Statistician job is a 2 year contract position.

The main focus of this Statistician job will be to support project teams in the design and analysis of studies run to assess the efficacy and safety of new chemical entities.

As a Statistician, you will have the opportunity to obtain practical experience in the application of statistical theory, as well as help to assess the value of innovative approaches to study design and analysis.

The ideal candidate for this Statistician job, will have a strong knowledge of statistical theory relevant to the design and analysis of experiments is essential. Candidates for this Statistician job will be required to work independently, as well as working closely and collaboratively with other members of the team. You will ideally hold a PhD in Statistics and have some experience of using SAS.

For more information at this Statistician job, please contact Priya Mukherjee on 01438 87 0028 or email an updated CV to pmukherjee@ckclinical.co.uk.

Alternatively, click here to apply for this Statistician job now.

If this Statistician job is not exactly what you are looking for, click here to search for other recent job openings within the pharmaceutical industry.

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Roche and Novartis Threaten to Relocate Thousands of Pharmaceutical Jobs Abroad

Pharmaceutical Job Cuts, Pharmaceutical Recruitment, UKAs reported on the Guardian website, Roche and Novartis have threatened to pull out of the UK and relocate thousands of pharmaceutical jobs abroad. The announcement comes as a result of an ongoing disagreement over pricing for NHS drugs.  Up to 5,000 pharmaceutical jobs will be at risk if the pharma companies abandon ship.

Head of Roche UK, John Melville, has said that the price cuts on drugs supplied to the NHS has had a significant impact on the erosion of the pharmaceutical companies profit margin. Melville’s worries are well justified as UK drug prices often act as a reference prices for many developed countries, including the majority of the EU. Melville has even said that it could make sense for the pharma company to pull out of the UK, losing 3% of business in order to safeguard pricing levels at the remaining 97% of sales sources.

Novartis have echoed this by stating that they are considering moving some of their drug safety trials out of the Britain “because the slowness of the NHS system is making them uncompetitive”. However, A Roche spokesman said: “We have no plans to quit the UK although we need to work with the UK government to address the uptake of medicines in the UK, many of which are routinely available in other European countries.”

Are you looking for a new job in the pharmaceutical industry? Search here for the latest pharmaceutical jobs now.

Alternatively, you can register your CV with CK Clinical here.

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Medical Liaison Required for Established Pharmaceutical Company based in Hampshire, UK

A new opportunity has arisen to join an established pharmaceutical company in Hampshire as a Medical Liaison. You will support key business needs across therapeutic areas based upon the needs of the clinical experts.

The focus of this Medical Liaison role will be to provide a non-promotional scientific information service for external customers, supporting and enhancing the safe and effective use of products, enabling customers to make informed decisions. GMC registration is not required.

The key responsibilities of this Medical Liaison role will include:

  • Catch therapy trends and/or other developments in the specific therapeutic area
  • Share feedback of external experts internally (Voice of the customer), e.g. expert’s impression of clinical data, experts view of general therapeutic area landscape, experts reaction to promotional pieces, experts research interests
  • Share learning from publications, external meetings and other adequate channels internally
  • Play a role in management of product issues
  • Provide recommendations about potential new investigators to Clinical Operations
  • Identifying future national and regional experts
  • Identifying national, sub-national/local influence or advocacy groups for their assigned product(s)
  • Serve as an educational source for Sales Reps, including actively participating in the training of Sales Reps
  • Provide input on development of brand strategies based on knowledge of the specific therapeutic area

The successful candidate for this Medical Liaison job will ideally have a Health or Life Sciences related degree at postgraduate qualification level. You will also have relevant experience of working in a health science or related environment (e.g. clinical research/CRO, pharmacy, nursing or R&D). The following competencies are also desirable:

  • Demonstrated ability to develop working relationships with thought leaders either in a research or pharmaceutical industry setting
  • Demonstrated project implementation and management skills
  • Good presentation, written & verbal skills

How to apply:

For more information, or to apply for this Medical Liaison role, please contact Hendre on Tel: +44 (0)1438 870 023 or email at hmoolman@ckclinical.co.uk quoting 19456 to indicate your interest.

Alternatively, click here to apply for this Medical Liaison job now.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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Senior Clinical Research Associate (SCRA) based in Hertfordshire, UK

Due to continued growth and success a leading global pharmaceutical company with offices in Hertfordshire are looking for an experienced Senior Clinical Research Associate (CRA) to join them.  This is an initial 12 month fixed term contract with the possibility of going permanent.

 

Responsibilities:

  • Reporting to the Senior Manager/AD or Director, you will undertake primary monitoring and/or co-monitoring of sites participating in studies in accordance with current ICH/GCP guidelines, local regulatory requirements and company SOPs/WPs.
  • The studies may be Phase I through to Phase IV on a European basis.  All site co-ordination activities will also be undertaken including drug accountability and data resolution and the CRA will assist the site in Ethics Committee submissions and preparation of informed consent forms.
  • Where studies have been contracted to CROs for project and site management and monitoring the CRA will perform co-monitoring trips to sites with the monitors of the CRO and will liaise with these monitors regarding site issues.
  • You will be responsible for the quality of the data for those sites to which he or she is assigned as monitor or co-monitor.

 

Requirements:

The ideal candidate for this Senior Clinical Research Associate job will be a science graduate with solid experience of clinical monitoring and site co-ordination, you will have demonstrable experience in the UK and at least one other European country, preferably in a Lead CRA role, and full understanding of current ICH/GCP guidelines. Experience of Oncology clinical trials and tools (such as RECIST and NCI-CTC) is expected.

This is an excellent opportunity to work on ground breaking oncology study.

 

How to Apply

For further information on this role please contact Ben Traies on 01438 743047.  Informal discussions also welcome.  Alternatively, please email a copy of your CV to btraies@ckclinical.co.uk   for consideration.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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Medical Information Officer Wanted for Established Pharma Company based in Middlesex, UK

We are recruiting for a Medical Information Officer to join an established Pharmaceutical company in Middlesex. As a Medical Information Officer, you will provide a timely, high quality Medical Information service to both internal and external customers, including handling adverse event reports and technical complaints. You will interact with Sales and Marketing for designated therapeutic areas. Part of your role will include providing assistance with copy approval and participate in project work as required.

Key responsibilities of this Medical Information Officer role will be to:

  • Respond to enquiries on company products and therapy areas within timescales agreed with the enquirer and in accordance with the company Standard Operating Procedure.
  • Where relevant to seek advice from, or refer enquiries to, the Senior Medical Information Officers, Medical Information Manager, Medical Advisor and/or Medical Director;
  • Prepare standard responses for “frequently asked questions”, subject to approval from Medical Advisor/Medical Director;
  • Carry out literature searches of in-house and external databases in response to requests for information;
  • Ensure that all potential adverse drug reactions received are processed without delay and in accordance with the current SOP(s);
  • Maintain the Medical Information enquiry management database;
  • Proactively provide relevant scientific, news and business information to internal customers in the Sales, Marketing and Medical Departments;
  • Rapidly appraise scientific and medical journals for content that may have immediate or long-term impact on the Companies’ activities, and after discussion with the Medical Information Manager, to notify colleagues with a critical overview;
  • Liaise with the Medical Information Manager on a fortnightly and ad hoc basis;
  • Participate in and feedback from conferences and meetings as required;
  • Work with Senior MIO to identify and work on areas for competency development to enable additional functions to be undertaken;
  • Ensure that all work complies with current SOPs, the ABPI Code of Practice and the Medicines Act.

The ideal candidate for this Medical Information Officer will be educated to a minimum degree level in pharmacy, pharmacology, life sciences or chemistry. You will also hold the following skills and competencies:

  • Ability to communicate confidently with people at all levels within and outside the company
  • A team player
  • Commercially aware
  • Resourceful
  • Computer literacy including familiarity with the Internet, CD-ROM/online searching and MS Office applications

How to Apply

For more information, or to apply for this Medical Information Officer job, please contact Hendre Moolman on +44 (0)1438 870 023 or email hmoolman@ckclinical.co.uk quoting 19446 to indicate your interest.

Alternatively, click here to apply for this Medical Information Officer job now.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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An Interview with a Medical Affairs Professional

Name: Sharon Leighton, BSc, PhD

 

 1. What do you do in Medical Affairs?

Medical Affairs Managers (MAMs) work closely with the brand teams (including marketing, medical and business intelligence colleagues).  We take the brand strategic plan and implement it. The MAM has to know the scientific data on the medicine inside out.  We approve investigator-initiated clinical trials on behalf of the company.  MAMs also approve promotional materials like detail aids (used by sales reps), adverts, websites etc.  We check that the information is balanced, up to date and meets industry standards. The MAMs also help the Medical Information team handle. We sometimes see the doctor to run through the data.

 

2. What is a typical day for you?

Juggling priorities, emails and meetings!  No two days are necessarily the same, which keeps the job interesting. Brand team meetings can easily take all day, especially if there is a promotional campaign to plan and approve.  MAMs also attend scientific meetings where we mingle with the thought leaders in our therapeutic area.

 

3. How did you get into Medical Affairs?

I joined the pharmaceutical industry as a post-doc, working in Neuropharmacological research for a year. But animal allergies forced a job move away from the labs to an office job.  For 3 years I travelled the world training affiliate staff to use product literature databases. I changed company to set up and run a Medical Information Department and moved into more senior roles.  I worked in Global Medical Affairs in AstraZeneca for 3 years before leaving to set up my consultancy business.

 

 4. What do you enjoy most about your job?

Medical Affairs and Medical Information are great jobs for anyone who loves the science behind the medicines, likes to help people and solve problems.  The variety can be breathtaking.  Managing teams, looking for novel, creative solutions to improve our business and services, networking with global colleagues and not least working with doctors and pharmacists in fascinating disease areas.  The intellectual challenge makes it addictive for me.

 

5. What is the hardest part of your job?

Juggling priorities and managing your time can be stressful, especially if you have a perfectionist nature!  You always have a backlog and new deadlines coming in so constantly have to prioritise.  Managing people through change is also challenging, especially when your team are worried about their future.  As long as you can balance personal integrity and empathy with business demands, your leadership qualities will shine through.

 

6. Why did you decide to pursue this career?

I fell into it by circumstance and pure chance! Although it was devastating to give up a research career at the time, on reflection I know it suits my personality and interests more than pure research.

 

7. What can this type of job lead on to?

There is a career pathway in Medical Affairs as a manager. Alternatively you can move into other medical roles like regulatory, Pharmacovigilance, field medical liaison scientist roles etc. Some people move into sales or training.  The skills you develop are easily transferrable. You need to use your finely honed communications and problem solving skills to explain in-depth scientific knowledge at all levels; to patients, doctors or company colleagues.

 

8. What advice would you give to somebody considering Medical Affairs as a career?

Try to shadow someone for a day who works in the role.  Some staff are contractors, usually pharmacists so that can be a route in.  The professional association, Pharmaceutical Information & Pharmacovigilance Association (PIPA. www.pipaonline.org) has more information about the role.  If you work for a company already, could you do a secondment?  Be creative in your solutions!

 

Thank you to Sharon from Sharon Leighton Consultancy for this interesting contribution.  You can visit Sharon’s website here.

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SAS Programmer Required for Company in Switzerland

Our client is  looking for an SAS Programmer to join their Swiss team on a contract basis.

Working as an SAS Programmer, your main responsibilities will include:

  • Coordinate programming activities across several trials with a given compound including publication and regulatory submission activities.
  • Develop programming specifications for analysis datasets, pooled datasets and deliverables in consultation with the statistician.
  • Develop and comply with project/study programming standards and specifications following internal guidelines
  • Program according to specifications, analysis datasets, pooled datasets, listings, and figures for clinical trials and submission activities
  • Support quality control and quality audit of deliverables
  • Provide input as required at all meetings, discussions and activities covering aspects of Statistical Reporting on trial level activities
  • Track clinical trial milestones for statistical reporting deliverables.
  • Maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
  • Maintain efficient interfaces with internal and external customers and communicate effectively across line functions.

How to Apply

Please contact Jonathan Hart-Smith at CK Clinical for more details or to apply for this position on +44 (0)1438 743047 or email jhartsmith@ckclinical.co.uk

Alternatively, click here to apply for this SAS Programmer role now.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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Teva Buys Ratiopharm in Generic Drugs Deal

space4work2As reported on BBC News the Israeli drugs giant, Teva has bought Germany’s second largest generics drug firm Ratiopharm for £3.2bn. Teva beat rival bids from U.S. pharmaceutical powerhouse Pfizer and Iceland’s Actavis.

Teva is already the world’s largest generic drug maker, and as a result of this deal is now number one in Europe, beating Novartis’ generics unit. The deal is also set to increase their presence in Spain, Italy and France.

Teva’s Chief Executive Shlomo Yanai stated, “This is an important acquisition for Teva, This transaction is perfectly aligned with our long-term strategy in which Europe is an important pillar and growth-driver.”

Generics are based around drug patents that have expired, allowing companies to both manufacture and sell them and is therefore seen as a high growth market.

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Project Engineer Required for Medical Device Development Company based in Cambridge, UK

Our client, a successful Medical Device development company are currently looking for a Project Engineer to join their team based in Cambridge.

As Project Engineer, you will be responsible for the implementation and management of product design verification and validation activities. You will also be required to provide innovative solutions to technical problems and work towards goals and targets with minimal guidance. You will occasionally be asked to provide engineering and CAD expertise to project areas.

Further key responsibilities of this Project Engineer role will include:

  • Meeting specific project verification and validation delivery targets.
  • Management and assessment of achievability of technical milestones.
  • Provide feedback to project manager regarding progress and any potential issues.
  • Provision of innovative and realistic technical solutions as part of the design and development team.
  • Assess product and compliance with regulatory and quality management system requirements.
  • Preparation and execution of verification test protocols.
  • Generation of CAD models and engineering drawings.
  • Preparing scientific reports suitable for regulatory submissions and supporting the clinical trial processes as required.
  • Implementing and managing assigned design verification and validation activities to ensure completion of tasks to assigned timelines.
  • Delivery of documentation within assigned project activities that meet the needs of the company’s ISO13485 QMS.
  • Successful management of internal and external resources.

The ideal candidate for this Project Engineer role will have a strong working knowledge of the following:

  • Product development within ISO 13485 system
  • Materials used in medical devices

How to Apply

For more information or to apply for this Project Engineer job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Project Engineer job now.

 

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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