Amgen Investment creates 100’s of jobs in Ireland

Recruiter reported that  Amgen are investing £123 million in their site n Ireland, which will create up to 100 new jobs.

The US biotechnology company’s expansion program in Dun Laoghaire will create 100 jobs and also 350 construction jobs in the construction period.

The expansion includes the construction of an 11,700 sq-metre building extension, a new production plant, an expanded warehouse and the major refurbishment of its existing buildings.

Martin VanTrieste, senior vice-president of Quality at Amgen said ““We are very pleased to expand our investment in Ireland…….As we expand internationally, Dun Laoghaire will enhance our global production capability, ensuring continuity of supply of Amgen medicines for seriously ill patients worldwide.

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Medical Writing Manager – Berkshire

Hendre Moolman at CK Clinical is recruiting for a Medical Writing Manager to join an established pharmaceutical company based in Berkshire.

The Job:

This Medical Writing Manager role offers a unique opportunity to have involvement with a broad range of medical writing documents study reports, investigator brochures, module II documents, and documents that take an overview of study documents (not just the compound/CMC).  This position will support global and regional submissions. This is a customer facing role as part of an internal service provision.

Responsibilities:

The key responsibilities for this Medical Writing Manager role are the following:

  • Ensure that all medical writing documents prepared for assigned Clinical Research Programmes within the company’s R&D are prepared according to appropriately rigorous, objective and informative medical writing procedures and processes.
  • Lead the Medical Writing activities for US, European or other regulatory submissions as assigned.
  • Ensure documents for assigned clinical trials are prepared, reviewed, and approved in a quality, timely and accurate manner such that the date presented will withstand examination by regulatory bodies.
  • Support the full use of the Electronic Document Management System (EDMS), for all clinical documents intended for submission, within the company.
  • Plan, schedule and track all assigned medical writing activities in close cooperation with the GPLs to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle, and to provide monthly status reports and forecasts to the HMW.
  • Take responsibility for supervision/production, review, publishing, and finalization of assigned study reports.
  • Work with the HMW and MWM (IBs) for strategic planning, production & review of assigned summary documents.
  • Provide disease area guidance to internal and external writers for assigned projects
  • Take responsibility for ensuring that assigned medical writing deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Supervise assigned medical writing projects contracted to third party suppliers, including interim and final integrated study reports and, where appropriate, integrated clinical summaries, protocols or other documents.
  • Take responsibility for ensuring that outsourcing of assigned medical writing projects is conducted after a thorough evaluation of the capabilities of the CRO/freelancer concerned, that the deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
  • Undertake assigned medical writing projects within including interim and final integrated study reports and where appropriate, integrated clinical summaries, protocols or other documents.
  • Ensure that assigned protocols, clinical study reports and investigator brochures and other documents as appropriate, are developed with medical writing input as early as possible.
  • Take responsibility as a medical writing adviser to project teams across assigned disease areas.
  • Work with the publishers to ensure quality, timely and accurate deliverables at each stage of the document lifecycle, to contribute to and to supervise accurate and timely publishing within EDMS.
  • Develop awareness of the benefits of the EDMS in the preparation of clinical documents.
  • Interact with other groups in order to provide an efficient, effective and timely medical writing service. Groups will include Clinical Development Teams, Study Teams and other groups as appropriate.
  • Keep abreast of current issues and developments in medical writing, particularly those impaction the neurology disease area.
  • Perform any other activity as may reasonably be required from time to time.
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company.

Benefits:

Successful candidate for this Medical Writing Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary.

Qualifications:

The ideal candidate for this Medical Writing Manager role will have the following qualificaitions and

  • Life Science Degree, preferably with a higher degree (MSc or PhD) or other relevant qualifications
  • Good understanding of GCP, coupled with prior experience in clinical/preclinical pharmaceutical research and development.
  • Good understanding of the clinical development process and of ICH guidelines
  • Significant experience of working on summary level documents such as the Common Technical Document or Investigator’s Brochures.

How to apply:

Apply online:

For more information or to apply for this Medical Writing Manager job please contract Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk. Please quote reference CL24065 in all correspondence.

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Scientific Affairs Manager – Oxfordshire

Hendre Moolman at CK Clinical is recruiting for a Scientific Affairs Manager to join a Pharmaceutical company in an office based role in Hertfordshire.

The Job:

As a Scientific Affairs Manager you will be creating and sustaining the connections with the Scientific Community regarding the company’s Diabetes Care product lines. You will also develop and advance advocacy amongst targeted key opinion leaders. Experience in a similar role and in diabetes is essential.

Responsibilities:

The key responsibilities of this Scientific Affairs Manager role are:

  • Assist with clinical support, they will train health care professionals (physicians) and support clinical operations in medical education
  • Communicate situations and opportunities to the technical, clinical and management teams
  • Participate on Core Teams, providing clinical insight for product development and use
  • Assist Clinical Affairs with development of protocols, Case Report Forms and training materials
  • Develop and maintain professional relationships with KOLs and academic centres that are of commercial and research relevance
  • Present scientific, clinical and educational materials to KOLs, academic centres, and professional diabetes organisations to gain awareness, acceptance, and advocacy of company Diabetes Care products
  • Drive publications and presentations of products based on data and materials collected from KOLs
  • Provide clinical and product training to KOLs and academic centres
  • Implement and support training programs, coordinate activities, information, and resources with other personnel
  • Train healthcare professionals and physicians on products
  • Act as resource for information, ideas and recommendations to R&D and other departments to monitor reactions related to Diabetes Care products
  • Assist with medical content review and professional communication materials and key advocacy initiatives
  • Coordinate and execute regional education and scientific symposia
  • Attend key regional and national scientific and medical meetings

Qualifications and experience;

The successful candidate for this Scientific Affairs Manager will have the experience in one or more of the following areas:

  • Diabetes Clinical Patient Care
  • Diabetes Education
  • Clinical Research and statistical data analysis
  • Health Care management
  • Medical Device industry
  • Scientific and Medical Publications
  • Bachelor’s Degree in a scientific/medical field, Master of Science preferred

Benefits:

Successful candidates for this Scientific Affairs Manager role will enjoy the benefits of working with a global Pharmaceutical company, including a competitive salary, holidays and career progression.

How to apply:

Apply online now

For more information or to apply for this Scientific Affairs Manager role please contact Hendre Moolman on 01438 743 047 or email hmoolman@ckclinical.co.uk Please quote reference CL24122 in all correspondence.

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Discovery of new treatment for pancreatic cancer

As reported by the BBC, Cancer Research funded scientists have identified a previously unknown faulty gene that appears to play a key role in some aggressive forms of pancreatic cancer.

A study published in the journal Nature, showed that a gene was being switched off in the cancerous cells. Scientists from Cancer Research UK’s Cambridge Research Institute and the Wellcome Trust Sanger Institute said drugs were already being tested which had the potential to turn the gene back on, to stop the spread of the cancer.

Currently around 8000 people in the UK are diagnosed with pancreatic cancer every year and fewer than one in five patients survive their disease for a year or more

Dr Julie Sharp, Cancer Research UK’s senior science information manager, said: “These results raise the possibility that a class of promising new cancer drugs may be effective at treating some pancreatic cancers.”

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Our Latest Clinical Jobs in this Week – 30/04/2012

Here is a list of the latest  clinical jobs that the Consultants here at CK Clinical have had in this week:

Clinical Project Physician – Oncology – South East

Regulatory Affairs Manager – Home Counties

Team Lead Pharmacovigilance Physician – South East

Director Clinical Developemnt – Oncology – South East

Head Of Medical Affairs – Surrey

Project Coordinator – Medical Affairs – Berkshire

Senior Pharmacovigilance Executive – Buckinghamshire

CRA Manager for Eastern Europe – Home Counties

Director of Regulatory Affairs – London

Clinical Project Physician – Oncology – Buckinghamshire

Register your CV

Click here to register your CV with CK Clinical.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to confidentially discuss your requirements and any relevant pharmaceutical jobs we are recruiting for.

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Disappointment as NICE turns down Roche’s breast cancer drug

Pharmatimes reported that NICE have turned down Roche’s Avastin for patients with advanced breast cancer in a draft because of uncertainties over the drug’s survival and costing’s. Roche however say this drug could make a real difference to cancer patients.

NICE said despite clinical evidence showing that the drug is able to increase progression-free survival by just under three months compared with capecitabine alone, its effect on overall survival is less clear.. NICE’s appraisal committee concluded that they could not recommend the treatment as an effective use of NHS resources

Basel-based Roche said the draft guidance wasn’t the final recommendation from NICE  in this setting and that it will respond to the draft guidance as per NICE’s process.

Roche said “Avastin in combination with [chemotherapy drug] capecitabine is an important treatment option for women with breast cancer….In a subgroup analysis of women treated with a taxane when their disease was at an early stage, progression-free survival more than doubled from 4.2 months to 8.7 months compared to those treated capecitabine alone.”

Pharmatimes reported that this news will certainly disappoint   thousands of patients suffering from the condition, who will no doubt be hoping that additional evidence will be submitted during the current consultation period to overturn the decision.

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Amgen and AstraZeneca agree a $50M deal

As reported by FierceBiotech, Amgen has struck a $50 million deal to work with AstraZeneca to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio.

AstraZeneca will pay Amgen for access to these 5 antibodies and the companies will share both costs and profits. Amgen will note the sales and take a percentage of the royalties on the antibodies but the companies will share the profits equally beyond that.

This collaboration is designed to strengthen each company where it needed help the most and to develop these antibodies effectively.

Kevin Sharer, Chairman and CEO at Amgen said “We are very excited at the prospect of collaborating with a well-respected organization like AstraZeneca to advance our inflammation pipeline. We believe this collaboration has the potential to bring more therapies to patients sooner, across more geographic areas”

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Once your CV has been registered with us, one of our specialist Recruitment Consultants will be in contact to discuss your requirements and any suitable Biotechnology vacancies we may be handling.

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Sanofi launches the 1st iPhone monitor for Diabetes

Fierce Pharma has reported that Sanofi have launched the first blood-sugar monitor that connects to the iPhone and the iPod Touch.

The product is called the iBGStar, it is a break through new approach for people with diabetes who take insulin as it can help them manage their glucose levels. The iBGStar (which is only an inch long) connects to the iPhone or iPod Touch and delivers results via a free diabetes manager app that tracks and graphs blood-sugar levels, and can collect relevant information about carb consumption, exercise and insulin doses. Patients can see interactive reports and email a report to their doctors.

Dr Andrew Hockey, medical director for Sanofi, said: “It harnesses the power of the latest technology to empower people with diabetes to manage their condition on a day-to-day basis.”

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Clinical Administrator (Named Patient Admin Coordinator) – Berkshire

Russell Oakley at CK Clinical is currently recruiting for a Named Patient Administrative Coordinator to join a global manufacturer of pharmaceuticals to join their oncology clinical research team in Berkshire

Role:

This Named Patient Administrative Coordinator role is to provide full administrative support to the department to make more effective and efficient use of their time. This role will be starting ideally in the beginning of May 2012, the length of contract will be 12 to 18 months (to be reviewed)

 

Responsibilities:

The successful candidate for this Named Patient Administrative Coordinator role will have the following responsibilities:

  • Manage information flow internal & external including gathering, processing and distributing data as necessary
  • Plan and organise meetings internal and external, co-ordinating all necessary arrangements
  • Maintain records for the team including sickness, holidays and training
  • Act as a focal point co-ordinating activities through effective diary management and checking e-mail in managers absence. Handling and resolving internal and external queries
  • Provide administrative support to a department which includes initiating, composing, typing and editing correspondence, memos, reports, taking and transcribing minutes, compiling presentations, producing reports, etc
  • Recommend improvements to processes or procedures within the department and own role

Leadership, team work and decision making expectations:

As a Named Patient Administrative Coordinator you will be expected to: 

  • Contribute as a full team member, supporting others and sharing information and ideas
  • Liaise with other teams or departments regarding the resolution of issues or problems
  • Identify own training/development needs within the team
  • Work on own initiative
  • Decide relevant contact who can deal with non routine problems
  • Prioritise own workload on a daily basis
  • Escalate significant or complex problems
  • Recommend improvements to processes or procedures within own role
  • Accept/decline meetings on behalf of  manager and/or team
  • Organise meetings and deal with all associated administration

Skills and Experience required:

The ideal candidate for this Named Patient Administrative Coordinator role will have the following skills and experience:

  • English and Mathematics essential (GCSE level or equivalent)
  • Minimum 2 years’ experience of working within an office environment, to include budgetary monitoring duties
  • Computer literate in MS Office
  • Good communication skills
  • Able to work in a team
  • Attention to details
  • Excellent experience in excel spread sheet
  • Process driven
  • Customer focused
  • Ideally seeking someone who has previously worked within either:
  • Regulatory affairs or drug safety.  Someone who has maybe been a CTA, Scientific Assistant or Drug Safety Business Assistant.
  • Experience in study or drug safety administration would be an advantage.
  • Excellent filing and archiving skills/ experience.
  • Good organisational Skills – used to putting a system together for filing relevant information.
  • Good English skills as well as they may occasionally be required to write letters.

How to apply:

Apply online now:

For more information or to apply for this a Named Patient Administrative Coordinator role please contact Russell Oakley on +44 (0) 114 283 9956 or email roakley@ckclinical.co.uk. Please quote reference CL24026 in all correspondence.

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Our Latest Clinical Jobs in This Week – 30.3.2012

Here is a list of the latest clinical jobs in the UK and Europe that we have had in this week.

Please click on the links below to find out more and apply online.

Contact Us:

If you are looking for a new clinical job, or are looking to expand your team, please contact us directly on +44 (0)1438 743 047 or email info@ckclinical.co.uk.

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